OVCF Tech Report
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罒ω罒KeensterNorth American Spine Society
Evidence-Based Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Adults with
Osteoporotic Vertebral Compression Fractures
Technical Report
I. Author and Contributor Disclosures pg 2
II. Literature Search pg 4
III. PRISMA
Natural History Section pg 617
Cost Effectiveness Section pg 621
Clinical Diagnosis Section pg 622
Medical Treatment Section pg 623
Imaging Diagnosis Section pg 626
Interventional Treatment Section pg 628
Surgical Treatment Section pg 636
IV. Evidentiary Tables
Natural History Section pg 641
Cost Effectiveness pg 721
Clinical Diagnosis Section pg 727
Medical Treatment Section pg 733
Imaging Diagnosis Section pg 783
Interventional Treatment Section pg 801
Surgical Treatment Section pg 1019
1
I. Author and Contributor Disclosures
All participating authors have disclosed potential conflicts of interest consistent with NASS’ Disclosure
Policy (www.spine.org/disclosurepolicy). Additionally, all authors completed the ICMJE Form for
Disclosure of Potential Conflicts of Interest in August 2024 prior to journal submission.
Ahmed Shawky Abdelgawaad
Nothing to Disclose (2/18/24)
Thiru M. Annaswamy
Board of Directors: AAPMR (Nonfinancial). (8/8/24)
Allan L. Brook
Consulting: Agnovos (Future Compensation Expected), Canary (C), Medtronic (B), Stryker (C). (6/20/23)
David S. Cheng
Other: American Academy Of Physical Medicine And Rehabilitation (Nonfinancial, Medical Education Committee - Digital
Learning Committee Chair, Pain Management and Opioid Taskforce), Spine Intervention Society (Nonfinancial); Speaking and/or
Teaching Arrangements: SI-BONE (B). (Aug 22, 2024)
Sean D. Christie
Board of Directors: Canadian Coalition For Green Health Care (Nonfinancial, Primarily an advocacy position for sustainable
health care); Consulting: Medtronic Canada (C); Grants: Praxis (formerly Rick Hansen) Institute (E, Paid directly to
institution/employer); Scientific Advisory Board: North American Spine Society (Nonfinancial). (2/5/24)
Charles H. Cho
Nothing to Disclose (8/21/24)
Zachary A. Cupler
Fellowship Support: NCMIC Foundation (B). (12/21/23)
Dennis E. Enix
Grants: U.S. Department of Health and Human Services (H, Outside 24-Month Requirement, Paid directly to
institution/employer). (2/21/24)
Marjorie Eskay-Auerbach
Consulting: American Medical Association (A), DePuy (Salary, Outside 24-Month Requirement), DePuy (A, Outside 24-Month
Requirement); Royalties: American Medical Association (A). (4/27/23)
Justin M. Goehl
Nothing to Disclose (2/16/24)
Steven W. Hwang
Board of Directors: Ronald McDonald House (Nonfinancial); Stock Ownership: Auctus (7.50%); Trips/Travel: NASS (Travel
Expense Reimbursement). (7/29/24)
G. Alexander Jones
Private Investments: Concierge Innovation (Future Compensation Expected, 25%, founding partner), Innovasis (Future
Compensation Expected, partial ownership); Trips/Travel: Innovasis (B). (2/5/24)
Piyush Kalakoti
Fellowship Support: North American Spine Society (B, Outside 24-Month Requirement); Other: North American Spine Society
(Nonfinancial, Value Committee member, Evidence-based Guidelines Committee member); Research Support (Investigator
Salary): Cervical Spine Research Society (C, Nonfinancial, Outside 24-Month Requirement, Paid directly to institution/employer),
Lumbar Spine Research Society (C, Nonfinancial, Outside 24-Month Requirement, Paid directly to institution/employer).
(2/21/24)
2
Manish Kumar Kasliwal
Nothing to Disclose (1/22/24)
Niranjan U. Kavadi
Consulting: Zsfab (A); Stock Ownership: ATEC Spine (1,900 Shares). (2/21/24)
Cumhur Kilincer
Board of Directors: International Society For Minimal Intervention In Spinal Surgery (Nonfinancial, European Branch Secretary).
(Aug 22, 2024)
Justin M. Lantz
Consulting: Physio U, Clinical Pattern Recognition, LLC (B), SI-BONE (A); Other Office: American Academy Of Orthopedic Manual
Physical Therapists (Nonfinancial, Social Media and Public Relation Committee member), North American Spine Society
(Nonfinancial, Clinical Practice Guideline Committee member, Section on Interdisciplinary Spine member, Early Career Advisory
Council member). (4/29/24)
Daniel J. Mazanec
Stock Ownership: Dorsata (Salary, 90,000 Shares, 1.30%). (Aug 22, 2024)
John O’Toole
Consulting: Cerapedics (B), Globus Medical Inc (B); Royalties: Globus Surgical (D); Stock Ownership: Viseon, Inc (75,000 Shares,
<1%). (1/24/24)
Gazanfar Rahmathulla
Nothing to Disclose (Aug 17, 2024)
Tom Reinsel
Other: Journal Of Bone And Joint Surgery (Nonfinancial, reviewer), NASS (Nonfinancial, The Spine Journal reviewer, EBM
Guideline Committee member). (2/21/24)
Kenneth A. Shaw
Nothing to Disclose (2/16/24)
Andrea Strayer
Royalties: Taylor-Francis (A), Thieme Publishers (A), Wolters Kluwer (B). (2/21/24)
Jeffrey A. Stone
Stone, Jeffrey A.: Other: North American Spine Society (Coding Committee member, Radiology Committee member); Research
Support (Staff and/or materials): Benvenue Medical (Nonfinancial, Outside 24-Month Requirement); Speaking and/or Teaching
Arrangements: North American Spine Society (Honorarium). (4/9/24)
Andrew Nguyen Vo
Nothing to Disclose 8/10/24
William C. Watters
Board of Directors: American Board Of Spine Surgery (Nonfinancial); Consulting: Interqual (B), Intrinsic Therapeutics (A);
Scientific Advisory Board: Change Healthcare (A), TurningPoint Healthcare (B). (4/1/24)
Range Key:
Level A. $100 to $1,000
Level B. $1,001 to $10,000
Level C. $10,001 to $25,000
Level D. $25,001 to $50,000
Level E. $50,001 to $100,000
Level F. $100,001 to $500,000
Level G. $500,001 to $1M 22
Level H. $1,000,001 to $2.5M
Level I. Greater than $2.5M
3
II. Literature Search
Databases Searched
• Ovid MEDLINE
• The Cochrane Library
• Embase
• Duplicate records eliminated
Eligibility Criteria:
• Humans
• English language
• Adult patients ≥ 18 years
• Date range: All literature published on or before September 30, 2020
• Included study designs:
o Systematic Reviews/Meta-analyses*
o Randomized Controlled Trials
o Clinical Trials
o Prospective and Retrospective Cohort and Comparative Studies
o Observational Studies
o Case-Controlled
o Case-Series
• Excluded study designs:
o Narrative reviews
o Opinion manuscripts
o Single case-reports
o Editorials
o Conference abstracts
* Systematic Reviews/Meta-analyses were included in the literature search and bibliographies were reviewed;
however, pre-published systematic reviews were not used to inform guideline recommendations.
Population Inclusion Criteria
• Age ≥ 18 years
• Spine or sacral fractures
• Single or multiple level fractures
• Simple or complex fractures
• With or without pain. Pain may be axial, radicular, generalized or combination.
Exclusion Criteria
• Cervical spine
• Acute or chronic spine infection including epidural abscess, discitis, and/or osteomyelitis
• Major trauma
• Prior surgery at the affected level
• Primary or metastatic tumor involvement to the spine
Search Strategies: The literature search was completed by the American Academy of Orthopaedic
Surgeons (AAOS) Medical Research Librarian
4
Summary
This literature search was conducted in the Ovid MEDLINE, Embase, and The Cochrane Library
bibliographic databases. Limits were used to return only the relevant literature that was published in the
English language between January 1, 1900 and September 30, 2020.
Ovid MEDLINE
Interface: Ovid MEDLINE® and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions ® 1946 to
October 4, 2020
Date searched: October 1, 2020
Search Query Results Concept
1 ((spine OR spinal OR vertebra* OR sacral OR sacrum) AND fracture?).mp. 45,771 Spinal Fractures Concept
(osteoporo* OR osteopenia OR ((insufficiency OR fragility) ADJ4 Osteoporosis/Low BMD
2 101,244
fracture?)).mp. Concept
(exp Infant/ OR exp Child/ OR exp Adolescent/ OR (p?ediatric* OR child OR
3 2,042,253 Limit to Adult Population
children OR childhood OR adolescen*).ti.) NOT (exp Adult/ OR adult*.ti.)
(exp Animals/ NOT Humans/) OR exp Cadaver/ OR (animal? OR dog OR dogs
OR canine OR cat OR cats OR feline OR horse? OR equine OR mouse OR
mice OR rat OR rats OR rabbit? OR sheep OR porcine OR pig OR pigs OR
Limit to Humans Only &
rodent? OR monkey?).ti. OR (cadaver* OR in vitro).ti,ab. OR ((comment OR 10,397,585
4 Remove Irrelevant
editorial OR letter OR historical article) NOT clinical trial).pt. OR address.pt. Publication Types
OR news.pt. OR newspaper article.pt. OR pmcbook.af. OR case reports.pt.
OR (case report? OR abstracts OR editorial OR reply OR comment? OR
commentary OR letter OR biomechanic*).ti.
5 ((1 AND 2) NOT (3 OR 4)) and English.lg. 4,501 Limits Applied
6 limit 5 to dt=19000101-20200930 4,441 Limit by Date
(conservative* OR nonoperativ* OR non operativ* OR nonsurgical* OR non
Conservative Treatment
7 surgical* OR no surgery OR without surgery OR without surgical* OR 352,586
Concept
untreated).mp.
Osteoporotic Vertebral
8 6 AND 7 884 Fractures Treated
Conservatively
exp Disease Progression/ OR exp Treatment Outcome/ OR (progressi* OR
Long-Term Sequelae
9 natural history OR ((clinical OR natural) ADJ course)).ti,ab. OR 4,993,389
Concept
(complications OR adverse effects).fx.
496 Natural History, Question 1:
10 8 AND 9
(494 de-duplicated) Long-Term Sequelae
11 (pain OR visual analog* OR VAS OR quality of life).mp. 1,078,673 Pain Concept
Natural History, Questions
506
12 8 AND 11 2 and 3: Time to Resolution
(480 de-duplicated)
of Pain + Long-Term Pain
Morbidity and Mortality
13 (mortalit* OR death OR survival OR morbidit*).mp. 2,709,734
Concept
148 Natural History, Question 4:
14 8 AND 13
(139 de-duplicated) Morbidity and Mortality
(exp Recurrence/ OR (refracture? OR re fracture? OR (adjacent ADJ4
(fracture? OR VCF? OR OVCF? OR VF OR VFs OR VFF? OR VFX))).mp. OR
Risk of Vertebral Re-fracture
15 ((new OR recurr* OR additional OR subsequent OR future OR secondary) 25,041
Concept
ADJ4 ((fracture? ADJ3 (spine OR spinal OR vertebra* OR sacral OR sacrum))
OR VCF? OR OVCF? OR VF OR VFs OR VFF? OR VFX)).mp.) AND (risk factor?
5
OR (risk adj5 (fracture? or refracture? or re fracture? OR VCF? OR OVCF? OR
VF OR VFs OR VFF? OR VFX))).mp.
71 Natural History, Question 5:
16 8 AND 15
(70 de-duplicated) Risk of Vertebral Re-fracture
17 exp Costs-and-Cost-Analysis/ OR cost?.ti,ab,kf. 686,660 Cost-Effectiveness Concept
18 6 AND 17 295 Cost-Effectiveness Question
(exp Sensitivity and Specificity/ OR (sensitiv* OR (predictive AND value?) OR
accuracy).ti,ab.) NOT ((exp *Diagnostic Imaging/ OR (tomograph* OR
radiograph* OR magnetic resonance OR MRI OR MR OR CT OR (X AND ray*) Sensitivity & Specificity
19 1,737,831
OR imaging OR ultrasonography OR ultrasound? OR scan*).ti.) NOT (exp (Clinical Diagnosis) Concept
*Physical Examination/ OR ((physical OR clinical) ADJ (examination? OR
test?)).ti,ab.))
240
20 6 AND 19 Clinical Diagnosis Question
(238 de-duplicated)
(exp Sensitivity and Specificity/ OR (sensitiv* OR (predictive AND value?) OR
accuracy).ti,ab.) NOT ((exp *Physical Examination/ OR ((physical OR clinical)
ADJ (examination? OR test?)).ti,ab.) NOT (exp *Diagnostic Imaging/ OR Sensitivity & Specificity
21 1,917,999
(tomograph* OR radiograph* OR magnetic resonance OR MRI OR MR OR CT (Imaging Diagnosis) Concept
OR (X AND ray*) OR imaging OR ultrasonography OR ultrasound? OR
scan*).ti.))
Imaging Diagnosis Question
400
22 6 AND 21 1
(397 de-duplicated)
(Sensitivity & Specificity)
23 ((acuity NOT visual-acuity) OR edema* OR oedema*).mp. 190,344 Imaging Findings by Acuity
Imaging Diagnosis Question
24 6 AND 23 50 2
(Acuity)
exp Rehabilitation/ OR exp Complementary-Therapies/ OR exp Laser-
Therapy/ OR exp Orthotic Devices/ OR exp Patient-Education-as-Topic/ OR
(physical therap* OR physiotherap* OR manipulation? OR manipulative OR
manual therap* OR mobilization OR mobilisation OR rehabilitation OR
cryotherap* OR cold-therapy OR ice OR cooling OR warming OR heating OR Medical Treatment
Questions 1, 2, & 4
TENS OR NMES OR ((electric OR electrical) AND stimulat*) OR
26 1,918,095 Non-pharm Treatments,
electrostimulation OR electrotherapy OR ((nerve OR muscle) ADJ Activity Restrictions,
stimulation) OR massag* OR exercise? OR ultrasound OR laser OR Manipulative Treatment
acupuncture OR taping OR bed-rest OR bedrest OR brace? OR bracing? OR
((early OR accelerated OR immediate or late or delay*) AND (ambulat* OR
walking OR mobilization OR mobilisation OR motion OR weightbearing OR
weight-bearing OR rehabilitation))).ti,ab.
Medical Treatment
494 Questions 1, 2, & 4
27 6 AND 26
(492 de-duplicated) (Non-Pharmacologic
Therapy)
6
exp Analgesics/ OR exp Adrenal-Cortex-Hormones/ OR exp
Diphosphonates/ OR Denosumab/ OR Calcitonin/ OR exp Bone-Density-
Conservation-Agents/ OR exp Antidepressive-Agents/ OR Serotonin-and-
Noradrenaline-Reuptake-Inhibitors/ OR Monoamine-Oxidase-Inhibitors/ OR
Serotonin-Uptake-Inhibitors/ OR Dopamine-Uptake-Inhibitors/ OR
Tramadol/ OR exp Neuromuscular-Agents/ OR Succinylcholine/ OR
Rocuronium/ OR Mivacurium/ OR Pancuronium/ OR exp Benzodiazepines/
OR Hydroxyzine/ OR (analgesi* OR adrenal-cortex-hormone? OR
corticosteroid* OR cortico-steroid OR corticoid* OR cortisone OR
prednisone OR prednisolone OR methylprednisolone OR triamcinolone OR
dexamethasone OR glucocorticoid* OR cortisone OR hydrocortisone OR
betamethasone OR budesonide OR mineralocorticoid* OR corticosteroid*
OR cortisone OR prednisolone OR methylprednisolone OR triamcinolone OR
glucocorticoid* OR steroid* OR anti-inflammat* OR meloxicam OR Mobic
OR naproxen OR Aleve OR ibuprofen OR Advil OR flurbiprofen OR ketorolac
OR Toradol OR COX-2-inhibitor? OR COX2-inhibitor? OR celecoxib OR
Celebrex OR diclofenac OR misoprostol OR sulindac OR ketoprofen OR
tolmetin OR etodolac OR fenoprofen OR piroxicam OR indomethacin OR
nabumetone OR aspirin OR diphosphonate? OR bisphosphonate? OR
antiresorptive OR anti-resorptive OR denosumab OR cathepsin OR
odanacatib OR pth-inhibitor? OR pamidronate or zoledronic acid OR
ibandronate OR (bone-modifying ADJ (agent? OR inhibitor?)) OR bone-
conserving-agent? OR bone-density-conservation-agent? or osteoclast-
inhibitor? OR bone-targeted-therapy OR clodronate OR calcitonin OR
antidepressant? OR anti-depressant? OR SNRI* OR (serotonin AND Medical Treatment
(norepinephrine OR noradrenaline OR antagonist) AND inhibitor*) OR Questions 3 & 5
duloxetine OR desvenlafaxine OR levomilnacipran OR venlafaxine OR Analgesics, Antidepressants,
28 1,905,823
nefazodone OR trazodone OR SSRI* OR (selective AND serotonin AND Anti-inflammatory Agents,
inhibitor*) OR citalopram OR escitalopram OR fluoxetine OR fluvoxamine Bone-Modifying Agents,
OR paroxetine OR sertraline OR vilazodone OR (monoamine AND oxidase Muscle Relaxants
AND inhibitor*) OR MAOI OR MAOIs OR isocarboxazid OR phenelzine OR
tranylcypromine OR NDRI* OR (norepinephrine AND dopamine AND
inhibitor*) OR bupropion OR amitriptyline OR clomipramine OR
desipramine OR doxepin OR imipramine OR nortriptyline OR protriptyline
OR trimipramine OR amoxapine OR maprotiline OR mirtazapine OR
vortioxetine OR narcotic* OR opioid* OR opiate? OR papaver* OR
oxycodone OR Oxycontin OR Oxy-ER OR Oxy-CRF OR OxyIR OR Oxy-IR OR
Percodan OR Percocet OR Roxicet OR hydrocodone OR dihydrocodeinone
OR Vicodin OR Vicoprofen OR Norco OR Lortab OR Lorcet OR oxymorphone
OR Opana OR morphine OR Kadian OR Avinza OR MS-Contin OR Duramorph
OR Roxanol OR codeine OR fentanyl OR Duragesic OR Actiq OR Sublimaze
OR hydromorphone OR Dilaudid OR meperidine OR Demerol OR tramadol
OR Ultram OR buprenorphine OR propoxyphene OR Darvocet OR Omnopon
OR methadone OR Dolophine OR Methadose OR suboxone OR nalbuphine
OR propoxyphene OR pentazocine OR muscle-relax* OR
abobotulinumtoxinA OR baclofen OR Botox OR carisoprodol OR
chlorzoxazone OR cyclobenzaprine OR Dantrium OR dantrolene OR Dysport
OR Flexeril OR incobotulinumtoxinA OR Lioresal OR metaxalone OR
methocarbamol OR Myobloc OR Norflex OR onabotulinumtoxinA OR
orphenadrine OR Parafon OR rimabotulinumtoxinB OR Robaxin OR Skelaxin
OR tizanidine OR Xeomin OR atracurium OR cisatracurium OR mivacurium
OR pancuronium OR rocuronium OR succinylcholine OR vecuronium OR
Norgesic OR quazepam OR chlordiazepoxide OR flurazepam OR alprazolam
OR diazepam OR oxazepam OR clonazepam OR estazolam OR clorazepate
7
OR triazolam OR lorazepam OR temazepam OR clobazam OR midazolam OR
Doral OR Valium OR Versed OR hydroxyzine).ti,ab.
1,290 Medical Treatment
29 6 AND 28 (1,285 de- Questions 3 & 5
duplicated) (Pharmacologic Therapy)
Delivery-of-Health-Care-Integrated/ OR exp Patient-Care-Team/ OR
(comanag* OR co-manag* OR interdisciplinary OR multidisciplinary OR Medical Treatment
30 multi-disciplinary OR ((care OR clinical OR treatment OR rehabilitation) ADJ 493,559 Questions 6
pathway?) OR coordinat* OR orthogeriatric* OR ortho-geriatric* OR Multidisciplinary Care
(comprehensive ADJ3 (assessment? OR care OR treatment))).ti,ab.
Medical Treatment
31 6 AND 30 54 Question 6
(Multidisciplinary Care)
(exp Anesthesia-Conduction/ OR exp Adrenal-Cortex-Hormones/ OR
(an?esthesia OR an?esthetic? OR adrenal-cortex-hormone? OR
corticosteroid* OR cortico-steroid OR corticoid* OR cortisone OR
Interventional Treatment
prednisone OR prednisolone OR methylprednisolone OR triamcinolone OR
Question 1
32 dexamethasone OR glucocorticoid* OR cortisone OR hydrocortisone OR 145,653
Steroid/Anesthetic
betamethasone OR budesonide OR mineralocorticoid* OR corticosteroid* Injections
OR cortisone OR prednisolone OR methylprednisolone OR triamcinolone OR
glucocorticoid* OR steroid*).ti,ab,kf.) AND (exp Injections/ OR (inject* OR
block*).ti,ab,kf.)
Interventional Treatment
61 Question 1
33 6 AND 32
(59 de-duplicated) (Steroidal & Anesthetic
Injections)
8
Interventional Treatment
(multi-level OR multilevel OR (multiple ADJ4 (fracture? or level? or
34 62,741 Question 2
vertebra*))).ti,ab,kf. Multi-Level Fractures
Interventional Treatment
197
35 6 AND 34 Question 2
(195 de-duplicated)
(Multi-Level Fx)
Interventional Treatment
(exp Cementoplasty/ OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
36 40,829 Question 3
augment*).ti,ab,kf.) AND (26 OR 28) Augmentation
Interventional Treatment
277 Question 3
37 6 AND 36
(275 de-duplicated) (Augmentation vs. Medical
Therapy)
Interventional Treatment
(instrumented OR instrumentation OR device? OR cage? OR expander OR
38 563,234 Question 4
spacer).ti,ab,kf. Mechanical Device
Interventional Treatment
205
39 6 AND 38 Question 4
(204 de-duplicated)
(Devices)
Interventional Treatment
(exp Cementoplasty/ OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
Question 5
40 augment*).ti,ab,kf.) AND ((height ADJ3 (vertebra* OR body)) OR kyphosis 1,268
Correction to Vertebral
OR kyphotic).ti,ab,kf. Height and Kyphotic Angle
Interventional Treatment
453
41 6 AND 40 Question 5
(450 de-duplicated)
(Height Loss)
(exp Cementoplasty/ OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
Interventional Treatment
augment*).ti,ab,kf.) AND ((time OR timing OR earl*) ADJ5 (surgery OR
42 4543 Question 6
surgical OR intervention OR operative OR vertebroplast* OR kyphoplast* Timing of Augmentation
OR augment*)).ti,ab,kf.
Interventional Treatment
116
43 6 AND 42 Question 6
(115 de-duplicated)
(Augmentation Timing)
Interventional Treatment
(exp Cementoplasty/ OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
44 569 Question 7
augment*).ti,ab,kf.) AND cleft?.ti,ab,kf. Intervertebral Cleft
Interventional Treatment
75
45 6 AND 44 Question 7
(74 de-duplicated)
(Intervertebral Cleft)
(exp Cementoplasty/ OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
Interventional Treatment
augment*).ti,ab,kf.) and (exp comorbidity/ OR risk-factors/ OR risk-
46 16,616 Question 8
assessment/ OR prognosis/ OR (comorbidit* OR co-morbidit* OR ((predict* Patient Characteristics
OR risk? OR prognos*) and (outcome? OR factors?)) or variables).ti,ab,kf.)
Interventional Treatment
349
47 6 AND 46 Question 8
(345 de-duplicated)
(Patient Characteristics)
Surgical Treatment Question
48 (instrument* and (fusion or arthrodesis)).mp. 19,165 1
Instrumented Fusion
Surgical Treatment
49 6 AND 48 69 Question 1
(Instrumented Fusion)
(open ADJ5 (surgery OR surgical OR approach* OR procedure? OR Surgical Treatment
stabilization OR reduction OR correction OR vertebroplast* OR kyphoplast* Questions 2 & 3
50 77,539
OR sacroplast* OR fusion OR arthrodesis OR augment* OR Open & Minimally Invasive
instrument*)).ti,ab,kf. Procedures
36 Surgical Treatment
51 6 AND 50
(35 de-duplicated) Questions 2 & 3
9
(Open Surgical Procedures)
(exp comorbidity/ OR risk-factors/ OR risk-assessment/ OR prognosis/ OR Surgical Treatment Question
(comorbidit* OR co-morbidit* OR ((predict* OR risk? OR prognos*) and 4
52 208
(outcome? OR factors?)) or variables).ti,ab,kf.) AND (adjacent ADJ4 Risk Factors for Adjacent
(fracture? OR VCF? OR OVCF? OR VF OR VFs OR VFF? OR VFX)).mp. Fracture
Surgical Treatment
94
53 6 AND 52 Question 4
(93 de-duplicated)
(Adjacent Fractures)
(exp Cementoplasty/ OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
augment* OR fixat* OR stabiliz* OR instrument* OR fusion OR Surgical Treatment Question
54 arthrodesis).ti,ab,kf.) AND (exp comorbidity/ OR risk-factors/ OR risk- 96,078 5
assessment/ OR prognosis/ OR (comorbidit* OR co-morbidit* OR ((predict* Patient Characteristics
OR risk? OR prognos*) and (outcome? OR factors?)) or variables).ti,ab,kf.)
Surgical Treatment
396
55 6 AND 54 Question 5
(391 de-duplicated)
(Patient Characteristics)
(exp Cementoplasty/ OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
Surgical Treatment Question
augment* OR fixat* OR stabiliz* OR instrument* OR fusion OR
56 120,555 6
arthrodesis).ti,ab,kf.) AND (implant* or device? or cage? or plate? or Implants
fixator?).mp.
Surgical Treatment
149
57 5 AND 56 Question 6
(148 de-duplicated)
(Implants)
Query notes
.mp. = “multi-purpose,” which includes, title, abstract, other terms, name of substance word, subject heading word,
floating sub-heading word, keyword heading word, organism supplementary concept word, protocol
supplementary concept word, rare disease supplementary concept word, unique identifier, and synonyms
exp [Term]/ = MeSH term, exploded
[Term]/ = MeSH term, not exploded
dt = create date, date when the citation was added to PubMed
fx = floating sub-heading word
* = unlimited truncation
? = wildcard, 0 or 1 character
Embase
Interface: Elsevier (http://www.embase.com)
Date searched: October 1, 2020
Search Query Results Concept
'spine fracture'/exp OR ((spine OR spinal OR vertebra* OR sacral OR
1 71,303 Spinal Fractures Concept
sacrum):ti,ab,kw AND (fracture/exp OR fracture$:ti,ab,kw))
'osteoporosis'/exp OR 'osteopenia'/exp OR 'fragility fracture'/de OR
Osteoporosis/Low BMD
2 (osteoporo* OR osteopenia OR ((insufficiency OR fragility) NEAR/4 176,570
Concept
fracture?)):ti,ab,kw
(Juvenile/exp OR p$ediatric*:ti OR child:ti OR children:ti) NOT (adult/exp OR
3 2,605,580 Limit to Adult Population
adult*:ti)
abstract-report/de OR book/de OR editorial/de OR editorial:it OR note/de
OR note:it OR letter/de OR letter:it OR case-study/de OR case-report/de OR
chapter:it OR conference-paper/exp OR conference-paper:it OR Limit to Humans Only &
4 conference-abstract:it OR conference-review:it OR (abstracts OR editorial 16,748,554 Remove Irrelevant
OR reply OR comment$ OR commentary OR letter OR biomechanic*):ti OR Publication Types
cadaver/de OR in-vitro-study/exp OR (cadaver* OR in-vitro):ti,ab OR animal-
experiment/exp OR (animal$ OR dog OR dogs OR canine OR cat OR cats OR
10
feline OR horse$ OR equine OR mouse OR mice OR rat OR rats OR rabbit$
OR sheep OR porcine OR pig OR pigs OR rodent$ OR monkey$):ti
#1 AND #2 NOT (#3 OR #4) AND [english]/lim AND [1-1-1900]/sd NOT [1-10-
5 4,047 Limits Applied
2020]/sd
'Conservative Treatment'/de OR (conservative* OR nonoperativ* OR 'non
Conservative Treatment
6 operativ*' OR nonsurgical* OR 'non surgical*' OR ((no OR without) NEXT/2 514,686
Concept
(surgery OR surgical*)) OR untreated):ti,ab,kw
Osteoporotic Vertebral
7 #5 AND #6 1,583 Fractures Treated
Conservatively
'disease course'/exp OR 'treatment outcome'/exp OR 'complication'/exp OR
Long-Term Sequelae
8 'adverse event'/exp OR (progressi* OR 'natural history' OR ((clinical OR 6,559,556
Concept
natural) NEXT/1 course)):ti,ab,kw
781 Natural History, Question 1:
9 #7 AND #8
(474 de-duplicated) Long-Term Sequelae
'pain assessment'/exp OR 'quality of life assessment'/exp OR (pain OR
10 1,403,998 Pain Concept
'visual analog*' OR VAS OR 'quality of life'):ti,ab,kw
Natural History, Questions
839
11 #7 AND #10 2 and 3: Time to Resolution
(406 de-duplicated)
of Pain + Long-Term Pain
mortality/exp OR morbidity/exp OR survival/exp OR (mortalit* OR death OR Morbidity and Mortality
12 3,750,264
survival OR morbidit*):ti,ab,kw Concept
298 Natural History, Question 4:
13 #7 and #12
(165 de-duplicated) Morbidity and Mortality
14 'recurrence risk'/de 75,762 Risk of Re-fracture Concept
'risk factor'/de OR ('risk factor$' OR (risk NEAR/5 (fracture$ OR refracture$
15 OR 're fracture$' OR VCF$ OR OVCF$ OR VF OR VFs OR VFF$ OR 1,408,945 Risk Concept
VFX))):ti,ab,kw
(refracture$ OR 're fracture$' OR (adjacent NEAR/4 (fracture$ OR VCF$ OR
OVCF$ OR VF OR VFs OR VFF$ OR VFX))):ti,ab,kw OR ((new OR recurr* OR
additional OR subsequent OR future OR secondary) NEAR/4 (VCF$ OR Vertebral Re-fracture
16 6,213
OVCF$ OR VF OR VFs OR VFF$ OR VFX)):ti,ab,kw OR ((new OR recurr* OR Concept
additional OR subsequent OR future OR secondary) NEAR/4 fracture$
NEAR/3 (spine OR spinal OR vertebra$ OR sacral OR sacrum)):ti,ab,kw
113 Natural History, Question 5:
17 #7 AND (#14 OR (#15 AND #16))
(44 de-duplicated) Risk of Vertebral Re-fracture
18 economic-evaluation/exp OR health-care-cost/exp OR costs$:ti,ab,kw 689,448 Cost-Effectiveness Concept
268
19 #5 AND #18 Cost-Effectiveness Question
(103 de-duplicated)
(sensitivity-and-specificity/de OR diagnostic-accuracy/de OR (sensitiv* OR
(predictive AND value$) OR accuracy):ti,ab) NOT ((radiodiagnosis/exp/mj
OR (tomograph* OR radiograph* OR magnetic-resonance OR MRI OR MR Sensitivity & Specificity
20 2,240,517
OR CT OR (X AND ray*) OR imaging OR ultrasonography OR ultrasound$ OR (Clinical Diagnosis) Concept
scan*):ti) NOT (physical-examination/exp/mj OR ((physical OR clinical)
NEXT/1 (examination$ OR test$)):ti,ab))
253
21 #5 AND #20 Clinical Diagnosis Question
(77 de-duplicated)
(sensitivity-and-specificity/de OR diagnostic-accuracy/de OR (sensitiv* OR
(predictive AND value$) OR accuracy):ti,ab) NOT ((physical-
examination/exp/mj OR ((physical OR clinical) NEXT/1 (examination$ OR Sensitivity & Specificity
22 2,489,356
test$)):ti,ab) NOT (radiodiagnosis/exp/mj OR (tomograph* OR radiograph* (Imaging Diagnosis) Concept
OR magnetic-resonance OR MRI OR MR OR CT OR (X AND ray*) OR imaging
OR ultrasonography OR ultrasound$ OR scan*):ti))
384 Imaging Diagnosis Question
23 #5 AND #22
(97 de-duplicated) 1
11
(Sensitivity & Specificity)
bone-marrow-edema/de OR ((acuity NOT visual-acuity) OR edema* OR
24 232,572 Imaging Findings by Acuity
oedema*):ti,ab
Imaging Diagnosis Question
50
25 #5 AND #24 2
(12 de-duplicated)
(Acuity)
physical-medicine/exp or rehabilitation/exp or orthosis/exp or alternative-
medicine/exp or patient-education/de or ('physical therap*' or
physiotherap* OR manipulation$ or 'manual therap*' or mobilization or
mobilisation or rehabilitation or cryotherap* or 'cold therapy' or ice or Medical Treatment
cooling or warming or heating or TENS or NMES or ((electric or electrical) Questions 1, 2, & 4
26 and stimulat*) or electrostimulation or electrotherapy or ((nerve or muscle) 2,737,719 Non-pharm Treatments,
NEXT/1 stimulation) or massag* or exercise$ or ultrasound or laser or Activity Restrictions,
acupuncture or taping or 'bed rest' or bedrest or brace$ or bracing$ or Manipulative Treatment
((early OR accelerated OR immediate or late or delay*) AND (ambulat* OR
walking OR mobilization OR mobilisation OR motion OR weightbearing OR
'weight bearing' OR rehabilitation))):ti,ab
Medical Treatment
570 Questions 1, 2, & 4
27 #5 AND #26
(226 de-duplicated) (Non-Pharmacologic
Therapy)
analgesic-agent/exp OR antiinflammatory-agent/exp OR corticosteroid/exp
OR cyclooxygenase-2-inhibitor/exp OR bisphosphonic-acid-derivative/exp
OR calcitonin/de OR bone-density-conservation-agent/de OR
antidepressive-agent/exp OR serotonin-noradrenalin-reuptake-
inhibitor/exp OR monoamine-oxidase-inhibitor/exp OR serotonin-uptake-
inhibitor/exp OR dopamine-uptake-inhibitor/exp OR narcotic-agent/exp OR
narcotic-analgesic-agent/exp OR muscle-relaxant-agent/exp OR
suxamethonium/exp OR rocuronium/exp OR mivacurium/exp OR
pancuronium/exp OR benzodiazepine-derivative/exp OR hydroxyzine/exp
OR (analgesi* OR 'adrenal cortex hormone$' OR corticosteroid* OR 'cortico
steroid' OR corticoid* OR cortisone OR prednisone OR prednisolone OR
methylprednisolone OR triamcinolone OR dexamethasone OR
glucocorticoid* OR cortisone OR hydrocortisone OR betamethasone OR
budesonide OR mineralocorticoid* OR corticosteroid* OR cortisone OR
prednisolone OR methylprednisolone OR triamcinolone OR glucocorticoid* Medical Treatment
Questions 3 & 5
OR steroid* OR 'anti inflammat*' OR meloxicam OR Mobic OR naproxen OR
Analgesics, Antidepressants,
28 Aleve OR ibuprofen OR Advil OR flurbiprofen OR ketorolac OR Toradol OR 3,858,322
Anti-inflammatory Agents,
'COX 2 inhibitor$' OR 'COX2 inhibitor$' OR celecoxib OR Celebrex OR Bone-Modifying Agents,
diclofenac OR misoprostol OR sulindac OR ketoprofen OR tolmetin OR Muscle Relaxants
etodolac OR fenoprofen OR piroxicam OR indomethacin OR nabumetone
OR aspirin OR diphosphonate$ OR bisphosphonate$ OR antiresorptive OR
'anti resorptive' OR denosumab OR cathepsin OR odanacatib OR 'pth
inhibitor$' OR pamidronate or 'zoledronic acid' OR ibandronate OR ('bone
modifying' NEXT/1 (agent$ OR inhibitor$)) OR 'bone conserving agent$' OR
'bone density conservation agent$' OR 'osteoclast inhibitor$' OR 'bone
targeted therapy' OR clodronate OR calcitonin OR antidepressant$ OR 'anti
depressant$' OR SNRI* OR (serotonin AND (norepinephrine OR
noradrenaline OR antagonist) AND inhibitor*) OR duloxetine OR
desvenlafaxine OR levomilnacipran OR venlafaxine OR nefazodone OR
trazodone OR SSRI* OR (selective AND serotonin AND inhibitor*) OR
citalopram OR escitalopram OR fluoxetine OR fluvoxamine OR paroxetine
OR sertraline OR vilazodone OR (monoamine AND oxidase AND inhibitor*)
OR MAOI OR MAOIs OR isocarboxazid OR phenelzine OR tranylcypromine
12
OR NDRI* OR (norepinephrine AND dopamine AND inhibitor*) OR
bupropion OR amitriptyline OR clomipramine OR desipramine OR doxepin
OR imipramine OR nortriptyline OR protriptyline OR trimipramine OR
amoxapine OR maprotiline OR mirtazapine OR vortioxetine OR narcotic* OR
opioid* OR opiate$ OR papaver* OR oxycodone OR Oxycontin OR 'Oxy ER'
OR 'Oxy CRF' OR OxyIR OR 'Oxy IR' OR Percodan OR Percocet OR Roxicet OR
hydrocodone OR dihydrocodeinone OR Vicodin OR Vicoprofen OR Norco OR
Lortab OR Lorcet OR oxymorphone OR Opana OR morphine OR Kadian OR
Avinza OR 'MS Contin' OR Duramorph OR Roxanol OR codeine OR fentanyl
OR Duragesic OR Actiq OR Sublimaze OR hydromorphone OR Dilaudid OR
meperidine OR Demerol OR tramadol OR Ultram OR buprenorphine OR
propoxyphene OR Darvocet OR Omnopon OR methadone OR Dolophine OR
Methadose OR suboxone OR nalbuphine OR propoxyphene OR pentazocine
OR 'muscle relax*' OR abobotulinumtoxinA OR baclofen OR Botox OR
carisoprodol OR chlorzoxazone OR cyclobenzaprine OR Dantrium OR
dantrolene OR Dysport OR Flexeril OR incobotulinumtoxinA OR Lioresal OR
metaxalone OR methocarbamol OR Myobloc OR Norflex OR
onabotulinumtoxinA OR orphenadrine OR Parafon OR rimabotulinumtoxinB
OR Robaxin OR Skelaxin OR tizanidine OR Xeomin OR atracurium OR
cisatracurium OR mivacurium OR pancuronium OR rocuronium OR
succinylcholine OR vecuronium OR Norgesic OR quazepam OR
chlordiazepoxide OR flurazepam OR alprazolam OR diazepam OR oxazepam
OR clonazepam OR estazolam OR clorazepate OR triazolam OR lorazepam
OR temazepam OR clobazam OR midazolam OR Doral OR Valium OR Versed
OR hydroxyzine):ti,ab
Medical Treatment
1,345
29 #5 AND #28 Questions 3 & 5
(491 de-duplicated)
(Pharmacologic Therapy)
(comanag* OR 'co manag*' OR interdisciplinary OR multidisciplinary OR
Medical Treatment
'multi disciplinary' OR ((care OR clinical OR treatment OR rehabilitation)
30 557,698 Questions 6
NEXT/1 pathway$) OR coordinat* OR orthogeriatric* OR 'ortho geriatric*' Multidisciplinary Care
OR (comprehensive NEXT/3 (assessment$ or care or treatment))):ti,ab
Medical Treatment
51
31 #5 AND #30 Question 6
(10 de-duplicated)
(Multidisciplinary Care)
(epidural-anesthesia/exp OR local-anesthesia/exp OR regional-
anesthesia/exp OR spinal-anesthesia/de OR corticosteroid/exp OR
(an$esthesia OR an$esthetic$ OR 'adrenal cortex hormone$' OR
corticosteroid* OR 'cortico steroid' OR corticoid* OR cortisone OR Interventional Treatment
prednisone OR prednisolone OR methylprednisolone OR triamcinolone OR Question 1
32 205,690
dexamethasone OR glucocorticoid* OR cortisone OR hydrocortisone OR Steroid/Anesthetic
betamethasone OR budesonide OR mineralocorticoid* OR corticosteroid* Injections
OR cortisone OR prednisolone OR methylprednisolone OR triamcinolone OR
glucocorticoid* OR steroid*):ti,ab,kw) AND (injection/exp OR (inject* OR
block*):ti,ab,kw)
60 Interventional Treatment
33 #5 AND #32
(15 de-duplicated) Question 1
13
(Steroidal & Anesthetic
Injections)
Interventional Treatment
('multi level' OR multilevel OR (multiple NEAR/4 (fracture$ or level$ or
34 76,209 Question 2
vertebra*))):ti,ab,kw Multi-Level Fractures
Interventional Treatment
177
35 #5 AND #34 Question 2
(27 de-duplicated)
(Multi-Level Fx)
Interventional Treatment
(cementoplasty/exp OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
36 65,879 Question 3
augment*):ti,ab,kw) AND (#26 OR #28) Augmentation
Interventional Treatment
422 Question 3
37 #5 AND #36
(205 de-duplicated) (Augmentation vs. Medical
Therapy)
Interventional Treatment
spine-implant/exp OR (instrumented OR instrumentation OR device$ OR
38 704,158 Question 4
cage$ OR expander OR spacer):ti,ab,kw Mechanical Device
Interventional Treatment
198
39 #5 AND #38 Question 4
(53 de-duplicated)
(Devices)
Interventional Treatment
(cementoplasty/exp OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
Question 5
40 augment*):ti,ab,kw) AND ((height NEAR/3 (vertebra* OR body)) OR 1,890
Correction to Vertebral
kyphosis OR kyphotic):ti,ab,kw Height and Kyphotic Angle
Interventional Treatment
457
41 #5 AND #40 Question 5
(77 de-duplicated)
(Height Loss)
(cementoplasty/exp OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
Interventional Treatment
augment*):ti,ab,kw) AND ((time OR timing OR earl*) NEAR/5 (surgery OR
42 6,367 Question 6
surgical OR intervention OR operative OR vertebroplast* OR kyphoplast* Timing of Augmentation
OR augment*)):ti,ab,kw
Interventional Treatment
109
43 #5 AND #42 Question 6
(17 de-duplicated)
(Augmentation Timing)
Interventional Treatment
(cementoplasty/exp OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
44 691 Question 7
augment*):ti,ab,kw) AND cleft$:ti,ab,kw Intervertebral Cleft
Interventional Treatment
71
45 #5 AND #44 Question 7
(6 de-duplicated)
(Intervertebral Cleft)
(cementoplasty/exp OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
augment*):ti,ab,kw) AND (comorbidity/de OR risk-factor/de OR risk- Interventional Treatment
46 assessment/de OR prognosis/de OR (comorbidit* OR 'co morbidit*' OR 24,938 Question 8
((predict* OR risk$ OR prognos*) AND (outcome$ OR factors$)) or Patient Characteristics
variables):ti,ab,kw)
Interventional Treatment
347
47 #5 AND #46 Question 8
(87 de-duplicated)
(Patient Characteristics)
Surgical Treatment Question
48 instrument* AND (spine-fusion/exp OR (fusion OR arthrodesis):ti,ab,kw) 13,952 1
Instrumented Fusion
Surgical Treatment
43
49 #5 AND #48 Question 1
(8 de-duplicated)
(Instrumented Fusion)
(open NEAR/5 (surgery OR surgical OR approach* OR procedure$ OR Surgical Treatment
50 108,717
stabilization OR reduction OR correction OR vertebroplast* OR kyphoplast* Questions 2 & 3
14
OR sacroplast* OR fusion OR arthrodesis OR augment* OR Open & Minimally Invasive
instrument*)):ti,ab,kw Procedures
Surgical Treatment
43
51 #5 AND #50 Questions 2 & 3
(8 de-duplicated)
(Open Surgical Procedures)
(comorbidity/de OR risk-factor/de OR risk-assessment/de OR prognosis/de Surgical Treatment Question
OR (comorbidit* OR 'co morbidit*' OR ((predict* OR risk$ OR prognos*) 4
52 270
AND (outcome$ OR factors$)) or variables):ti,ab,kw) AND (adjacent NEAR/4 Risk Factors for Adjacent
(fracture$ OR VCF$ OR OVCF$ OR VF OR VFs OR VFF$ OR VFX)):ti,ab,kw Fracture
Surgical Treatment
83
53 #5 AND #52 Question 4
(11 de-duplicated)
(Adjacent Fractures)
(spine-surgery/exp OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
augment* OR fixat* OR stabiliz* OR instrument* OR fusion OR
Surgical Treatment Question
arthrodesis):ti,ab,kw) AND (comorbidity/de OR risk-factor/de OR risk-
54 145,650 5
assessment/de OR prognosis/de OR (comorbidit* OR 'co morbidit*' OR Patient Characteristics
((predict* OR risk$ OR prognos*) AND (outcome$ OR factors$)) or
variables):ti,ab,kw)
Surgical Treatment
400
55 #5 AND #54 Question 5
(110 de-duplicated)
(Patient Characteristics)
(spine-surgery/exp OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
Surgical Treatment Question
augment* OR fixat* OR stabiliz* OR instrument* OR fusion OR
56 141,373 6
arthrodesis):ti,ab,kw) AND (spine-implant/exp OR (implant* or device$ or Implants
cage$ or plate$ or fixator$):ti,ab,kw)
Surgical Treatment
138
57 #5 AND #56 Question 6
(48 de-duplicated)
(Implants)
Query notes
/de = Emtree term
/exp = Emtree term., exploded
:ti,ab,kw = title, abstract, and author keywords
/lim = Limits
* = unlimited truncation
$ = wildcard, 0 or 1 character
The Cochrane Library
(CENTRAL – The Cochrane Register of Controlled Trials)
Interface: Wiley (http://onlinelibrary.wiley.com/cochranelibrary/search)
Date searched: October 1, 2020
Search Query Results Concept
(spine OR spinal OR vertebra* OR sacral OR sacrum):ti,ab,kw AND
1 5,261 Spinal Fractures Concept
fracture?:ti,ab,kw
(osteoporo* OR osteopenia OR ((insufficiency OR fragility) NEAR/4 Osteoporosis/Low BMD
2 11,664
fracture?)):ti,ab,kw Concept
([mh Infant] OR [mh Child] OR [mh Adolescent] OR (pediatric* OR
3 paediatric* OR child OR children OR childhood OR adolescen*):ti) NOT ([mh 113,076 Limit to Adult Population
Adult] OR adult*:ti)
"conference abstract":pt OR (abstracts OR editorial OR reply OR comment?
OR commentary OR letter OR biomechanic*):ti OR (cadaver* OR "in Limit to Humans Only &
4 vitro"):ti,ab OR (animal? OR dog OR dogs OR canine OR cat OR cats OR 193,620 Remove Irrelevant
feline OR horse? OR equine OR mouse OR mice OR rat OR rats OR rabbit? Publication Types
OR sheep OR porcine OR pig OR pigs OR rodent? OR monkey?):ti
15
(#1 AND #2) NOT (#3 OR #4) with Cochrane Library publication date from
5 1,072 Limits Applied
Jan 1900 to Sep 2020
(conservative* OR nonoperativ* OR "non operativ*" OR nonsurgical* OR
Conservative Treatment
6 "non surgical*" OR ((no OR without) NEXT/2 (surgery OR surgical*)) OR 34,004
Concept
untreated):ti,ab,kw
Osteoporotic Vertebral
7 #5 AND #6 189 Fractures Treated
Conservatively
(progressi* OR "natural history" OR ((clinical OR natural) NEXT/1 Long-Term Sequelae
8 85,412
course)):ti,ab,kw Concept
11 Natural History, Question 1:
9 #7 AND #8
(3 de-duplicated) Long-Term Sequelae
10 (pain OR "visual analog*" OR VAS OR "quality of life"):ti,ab,kw 275,989 Pain Concept
Natural History, Questions
120
11 #7 AND #10 2 and 3: Time to Resolution
(39 de-duplicated
of Pain + Long-Term Pain
mortality/exp OR morbidity/exp OR survival/exp OR (mortalit* OR death OR Morbidity and Mortality
12 208,734
survival OR morbidit*):ti,ab,kw Concept
23 Natural History, Question 4:
13 #7 and #12
(8 de-duplicated) Morbidity and Mortality
("risk factor?" OR (risk NEAR/5 (fracture? OR refracture? OR "re fracture?"
14 31,289 Risk Concept
OR VCF? OR OVCF? OR VF OR VFF? OR VFX))):ti,ab,kw
(refracture? OR "re fracture?" OR (adjacent NEAR/4 (fracture? OR VCF? OR
OVCF? OR VF OR VFF? OR VFX))):ti,ab,kw OR ((new OR recurr* OR
additional OR subsequent OR future OR secondary) NEAR/4 (VCF? OR Vertebral Re-fracture
15 793
OVCF? OR VF OR VFF? OR VFX)):ti,ab,kw OR ((new OR recurr* OR additional Concept
OR subsequent OR future OR secondary) NEAR/4 fracture? NEAR/3 (spine
OR spinal OR vertebra? OR sacral OR sacrum)):ti,ab,kw
24 Natural History, Question 5:
16 #7 AND #14 AND #15
(3 de-duplicated) Risk of Vertebral Re-fracture
17 cost?:ti,ab,kw 68,889 Cost-Effectiveness Concept
74
18 #5 AND #17 Cost-Effectiveness Question
(33 de-duplicated)
([mh "Sensitivity and Specificity"] OR (sensitiv* OR (predictive AND value?)
OR accuracy):ti,ab) NOT (([mh "Diagnostic Imaging"] OR (tomograph* OR
radiograph* OR "magnetic resonance" OR MRI OR MR OR CT OR (X AND Sensitivity & Specificity
19 80,899
ray*) OR imaging OR ultrasonography OR ultrasound? OR scan*):ti) NOT (Clinical Diagnosis) Concept
([mh "Physical Examination"] OR ((physical OR clinical) NEXT/1
(examination? OR test?)):ti,ab))
30
20 #5 AND #19 Clinical Diagnosis Question
(12 de-duplicated)
([mh "Sensitivity and Specificity"] OR (sensitiv* OR (predictive AND value?)
OR accuracy):ti,ab) NOT (([mh "Physical Examination"] OR ((physical OR
clinical) NEXT/1 (examination? OR test?)):ti,ab) NOT ([mh "Diagnostic Sensitivity & Specificity
21 83,983
Imaging"] OR (tomograph* OR radiograph* OR "magnetic resonance" OR (Imaging Diagnosis) Concept
MRI OR MR OR CT OR (X AND ray*) OR imaging OR ultrasonography OR
ultrasound? OR scan*):ti))
Imaging Diagnosis Question
42
22 #5 AND #21 1
(17 de-duplicated)
(Sensitivity & Specificity)
23 ((acuity NOT "visual acuity") OR edema* OR oedema*):ti,ab 14,708 Imaging Findings by Acuity
Imaging Diagnosis Question
8
24 #5 AND #23 2
(2 de-duplicated)
(Acuity)
16
[mh Rehabilitation] or [mh "Complementary Therapies"] or [mh "Laser
Therapy"] or [mh "Orthotic Devices"] or [mh "Patient Education as Topic"]
or ("physical therap*" or physiotherap* OR manipulation? or "manual
therap*" or mobilization or mobilisation or rehabilitation or cryotherap* or Medical Treatment
"cold therapy" or ice or cooling or warming or heating or TENS or NMES or Questions 1, 2, & 4
25 ((electric or electrical) and stimulat*) or electrostimulation or 240,319 Non-pharm Treatments,
electrotherapy or ((nerve or muscle) NEXT/1 stimulation) or massag* or Activity Restrictions,
exercise? or ultrasound or laser or acupuncture OR taping or "bed rest" or Manipulative Treatment
bedrest or brace? or bracing? or ((early OR accelerated OR immediate or
late or delay*) AND (ambulat* OR walking OR mobilization OR mobilisation
OR motion OR weightbearing OR "weight bearing" OR rehabilitation))):ti,ab
Medical Treatment
157 Questions 1, 2, & 4
26 #5 AND #25
(65 de-duplicated) (Non-Pharmacologic
Therapy)
[mh Analgesics] OR [mh "Adrenal Cortex Hormones"] OR [mh
Diphosphonates] OR [mh Denosumab] OR [mh Calcitonin] OR [mh "Bone
Density Conservation Agents"] OR [mh "Antidepressive Agents"] OR [mh
"Serotonin and Noradrenaline Reuptake Inhibitors"] OR [mh "Monoamine
Oxidase Inhibitors"] OR [mh "Serotonin Uptake Inhibitors"] OR [mh
"Dopamine Uptake Inhibitors"] OR [mh Tramadol] OR [mh "Neuromuscular
Agents"] OR [mh Succinylcholine] OR [mh Rocuronium] OR [mh
Mivacurium] OR [mh Pancuronium] OR [mh Benzodiazepines] OR [mh
Hydroxyzine] OR (analgesi* OR "adrenal cortex hormone?" OR
corticosteroid* OR "cortico steroid" OR corticoid* OR cortisone OR
prednisone OR prednisolone OR methylprednisolone OR triamcinolone OR
dexamethasone OR glucocorticoid* OR cortisone OR hydrocortisone OR
betamethasone OR budesonide OR mineralocorticoid* OR corticosteroid*
OR cortisone OR prednisolone OR methylprednisolone OR triamcinolone OR
glucocorticoid* OR steroid* OR "anti inflammat*" OR meloxicam OR Mobic
OR naproxen OR Aleve OR ibuprofen OR Advil OR flurbiprofen OR ketorolac
OR Toradol OR "COX 2 inhibitor?" OR "COX2 inhibitor?" OR celecoxib OR
Celebrex OR diclofenac OR misoprostol OR sulindac OR ketoprofen OR Medical Treatment
Questions 3 & 5
tolmetin OR etodolac OR fenoprofen OR piroxicam OR indomethacin OR
Analgesics, Antidepressants,
27 nabumetone OR aspirin OR diphosphonate? OR bisphosphonate? OR 230,384
Anti-inflammatory Agents,
antiresorptive OR "anti resorptive" OR denosumab OR cathepsin OR Bone-Modifying Agents,
odanacatib OR "pth inhibitor?" OR pamidronate or "zoledronic acid" OR Muscle Relaxants
ibandronate OR ("bone modifying" NEXT/1 (agent? OR inhibitor?)) OR
"bone conserving agent?" OR "bone density conservation agent?" or
"osteoclast inhibitor?" OR "bone targeted therapy" OR clodronate OR
calcitonin OR antidepressant? OR "anti depressant?" OR SNRI* OR
(serotonin AND (norepinephrine OR noradrenaline OR antagonist) AND
inhibitor*) OR duloxetine OR desvenlafaxine OR levomilnacipran OR
venlafaxine OR nefazodone OR trazodone OR SSRI* OR (selective AND
serotonin AND inhibitor*) OR citalopram OR escitalopram OR fluoxetine OR
fluvoxamine OR paroxetine OR sertraline OR vilazodone OR (monoamine
AND oxidase AND inhibitor*) OR MAOI OR MAOIs OR isocarboxazid OR
phenelzine OR tranylcypromine OR NDRI* OR (norepinephrine AND
dopamine AND inhibitor*) OR bupropion OR amitriptyline OR clomipramine
OR desipramine OR doxepin OR imipramine OR nortriptyline OR
protriptyline OR trimipramine OR amoxapine OR maprotiline OR
mirtazapine OR vortioxetine OR narcotic* OR opioid* OR opiate? OR
papaver* OR oxycodone OR Oxycontin OR "Oxy ER" OR "Oxy CRF" OR OxyIR
OR "Oxy IR" OR Percodan OR Percocet OR Roxicet OR hydrocodone OR
17
dihydrocodeinone OR Vicodin OR Vicoprofen OR Norco OR Lortab OR Lorcet
OR oxymorphone OR Opana OR morphine OR Kadian OR Avinza OR MS
Contin OR Duramorph OR Roxanol OR codeine OR fentanyl OR Duragesic OR
Actiq OR Sublimaze OR hydromorphone OR Dilaudid OR meperidine OR
Demerol OR tramadol OR Ultram OR buprenorphine OR propoxyphene OR
Darvocet OR Omnopon OR methadone OR Dolophine OR Methadose OR
suboxone OR nalbuphine OR propoxyphene OR pentazocine OR "muscle
relax*" OR abobotulinumtoxinA OR baclofen OR Botox OR carisoprodol OR
chlorzoxazone OR cyclobenzaprine OR Dantrium OR dantrolene OR Dysport
OR Flexeril OR incobotulinumtoxinA OR Lioresal OR metaxalone OR
methocarbamol OR Myobloc OR Norflex OR onabotulinumtoxinA OR
orphenadrine OR Parafon OR rimabotulinumtoxinB OR Robaxin OR Skelaxin
OR tizanidine OR Xeomin OR atracurium OR cisatracurium OR mivacurium
OR pancuronium OR rocuronium OR succinylcholine OR vecuronium OR
Norgesic OR quazepam OR chlordiazepoxide OR flurazepam OR alprazolam
OR diazepam OR oxazepam OR clonazepam OR estazolam OR clorazepate
OR triazolam OR lorazepam OR temazepam OR clobazam OR midazolam OR
Doral OR Valium OR Versed OR hydroxyzine):ti,ab
Medical Treatment
434
28 #5 AND #27 Questions 3 & 5
(179 de-duplicated)
(Pharmacologic Therapy)
[mh ^"Delivery of Health Care Integrated"] OR [mh "Patient Care Team"] OR
(comanag* OR "co manag*" OR interdisciplinary OR multidisciplinary OR Medical Treatment
29 "multi disciplinary" OR ((care OR clinical OR treatment OR rehabilitation) 22,574 Questions 6
NEXT/1 pathway?) OR coordinat* OR orthogeriatric* OR "ortho geriatric*" Multidisciplinary Care
OR (comprehensive NEAR/3 (assessment? OR care OR treatment))):ti,ab
Medical Treatment
14
30 #5 and #29 Question 6
(11 de-duplicated)
(Multidisciplinary Care)
([mh "Anesthesia, Conduction"] or [mh "Adrenal Cortex Hormones"] OR
(an?esthesia OR an?esthetic? OR "adrenal cortex hormone?" OR
corticosteroid* OR "cortico steroid" OR corticoid* OR cortisone OR
Interventional Treatment
prednisone OR prednisolone OR methylprednisolone OR triamcinolone OR
Question 1
31 dexamethasone OR glucocorticoid* OR cortisone OR hydrocortisone OR 40,434
Steroid/Anesthetic
betamethasone OR budesonide OR mineralocorticoid* OR corticosteroid* Injections
OR cortisone OR prednisolone OR methylprednisolone OR triamcinolone OR
glucocorticoid* OR steroid*):ti,ab,kw) AND ([mh Injections] OR (inject* OR
block*):ti,ab,kw)
Interventional Treatment
19 Question 1
32 #5 AND #31
(8 de-duplicated) (Steroidal & Anesthetic
Injections)
18
Interventional Treatment
("multi level" OR multilevel OR (multiple NEAR/4 (fracture? or level? or
33 5,179 Question 2
vertebra*))):ti,ab,kw Multi-Level Fractures
Interventional Treatment
28
34 #5 AND #33 Question 2
(8 de-duplicated)
(Multi-Level Fx)
Interventional Treatment
([mh Cementoplasty] OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
35 6,535 Question 3
augment*):ti,ab,kw) AND (#25 OR #27) Augmentation
Interventional Treatment
76 Question 3
36 #5 AND #35
(28 de-duplicated) (Augmentation vs. Medical
Therapy)
Interventional Treatment
(instrumented OR instrumentation OR device? OR cage? OR expander OR
37 76,109 Question 4
spacer):ti,ab,kw Mechanical Device
Interventional Treatment
61
38 #5 AND #37 Question 4
(38 de-duplicated)
(Devices)
Interventional Treatment
([mh Cementoplasty] OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
Question 5
39 augment*):ti,ab,kw) AND ((height NEAR/3 (vertebra* OR body)) OR 252
Correction to Vertebral
kyphosis OR kyphotic):ti,ab,kw Height and Kyphotic Angle
Interventional Treatment
114
40 #5 AND #39 Question 5
(46 de-duplicated)
(Height Loss)
([mh Cementoplasty] OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
Interventional Treatment
augment*):ti,ab,kw) AND ((time OR timing OR earl*) NEAR/5 (surgery OR
41 867 Question 6
surgical OR intervention OR operative OR vertebroplast* OR kyphoplast* Timing of Augmentation
OR augment*)):ti,ab,kw
Interventional Treatment
28
42 #5 AND #41 Question 6
(14 de-duplicated)
(Augmentation Timing)
Interventional Treatment
([mh Cementoplasty] OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
43 26 Question 7
augment*):ti,ab,kw) AND cleft?:ti,ab,kw Intervertebral Cleft
Interventional Treatment
44 #5 AND #43 1 Question 7
(Intervertebral Cleft)
([mh Cementoplasty] OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
augment*):ti,ab,kw) and ([mh Comorbidity] OR [mh "Risk Factors"] OR [mh Interventional Treatment
45 "Risk Assessment"] OR [mh ^Prognosis] OR (comorbidit* OR "co morbidit*" 4,631 Question 8
OR ((predict* OR risk? OR prognos*) AND (outcome? OR factors?)) or Patient Characteristics
variables):ti,ab,kw)
Interventional Treatment
53
46 #5 AND #45 Question 8
(20 de-duplicated)
(Patient Characteristics)
Surgical Treatment Question
47 (instrument* and (fusion or arthrodesis)):ti,ab,kw 965 1
Instrumented Fusion
Surgical Treatment
3
48 #5 AND #47 Question 1
(1 de-duplicated)
(Instrumented Fusion)
(open NEAR/5 (surgery OR surgical OR approach* OR procedure? OR Surgical Treatment
stabilization OR reduction OR correction OR vertebroplast* OR kyphoplast* Questions 2 & 3
49 10,034
OR sacroplast* OR fusion OR arthrodesis OR augment* OR Open & Minimally Invasive
instrument*)):ti,ab,kw Procedures
19
Surgical Treatment
3
50 #5 AND #49 Questions 2 & 3
(1 de-duplicated)
(Open Surgical Procedures)
([mh Comorbidity] OR [mh "Risk Factors"] OR [mh "Risk Assessment"] OR
Surgical Treatment Question
[mh ^Prognosis] OR (comorbidit* OR "co morbidit*" OR ((predict* OR risk?
4
51 OR prognos*) AND (outcome? OR factors?)) or variables):ti,ab,kw) AND 31
Risk Factors for Adjacent
(adjacent NEAR/4 (fracture? OR VCF? OR OVCF? OR VF OR VFs OR VFF? OR Fracture
VFX)):ti,ab,kw
Surgical Treatment
22
52 #5 AND #52 Question 4
(5 de-duplicated)
(Adjacent Fractures)
([mh Cementoplasty] OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
augment* OR fixat* OR stabiliz* OR instrument* OR fusion OR
Surgical Treatment Question
arthrodesis):ti,ab,kw) AND ([mh Comorbidity] OR [mh "Risk Factors"] OR
53 17,725 5
[mh "Risk Assessment"] OR [mh ^Prognosis] OR (comorbidit* OR "co Patient Characteristics
morbidit*" OR ((predict* OR risk? OR prognos*) and (outcome? OR
factors?)) or variables):ti,ab,kw)
Surgical Treatment
57
54 #5 AND #53 Question 5
(22 de-duplicated)
(Patient Characteristics)
([mh Cementoplasty] OR (vertebroplast* OR kyphoplast* OR sacroplast* OR
Surgical Treatment Question
augment* OR fixat* OR stabiliz* OR instrument* OR fusion OR
55 17,318 6
arthrodesis):ti,ab,kw) AND (implant* or device? or cage? or plate? or Implants
fixator?):ti,ab,kw
Surgical Treatment
42
56 #5 AND #55 Question 6
(21 de-duplicated)
(Implants)
Query notes
:ti,ab,kw = title, abstract, and keywords
[mh] = MeSH term
* = unlimited truncation
? = wildcard, 0 or 1 character
Summary
This literature search was conducted in the Ovid MEDLINE, Embase, and The Cochrane Library bibliographic databases. Limits
were used to return only the relevant literature that was published in the English language between January 1, 1900 and
September 30, 2020. The table below provides an overview of the unique results returned for each question.
Question Unique Results
Natural History – Long-Term Sequelae 971
Natural History – Pain 925
Natural History – Mortality & Morbidity 312
Natural History – Risk of Re-fracture 117
Cost-Effectiveness 431
Clinical Diagnosis 327
Medical Treatment – Non-Pharmacologic 783
Medical Treatment – Pharmacologic 1,955
Medical Treatment – Multidisciplinary Care 75
Imaging Diagnosis – Sensitivity & Specificity 511
Imaging Diagnosis – Acuity 64
Interventional Treatment – Steroidal & 82
Anesthetic Injections
20
Interventional Treatment – Multi-Level Fractures 230
Interventional Treatment – Augmentation vs. 508
Medical Therapy
Interventional Treatment – Devices 295
Interventional Treatment – Height Loss 573
Interventional Treatment – Augmentation Timing 146
Interventional Treatment – Intervertebral Cleft 81
Interventional Treatment – Patient 452
Characteristics
Surgical Treatment – Instrumented Fusion 78
Surgical Treatment – Open Surgical Procedures 44
Surgical Treatment – Adjacent Fractures 109
Surgical Treatment – Patient Characteristics 523
Surgical Treatment – Implants 217
Search Results
This bibliography contains the full literature search results for each question. Work group members reviewed all
abstracts yielded from the literature search and identified the literature to review in order to address the clinical
questions. The references that were ultimately used to answer each clinical question can be found in the main text
of the guideline. Source: Literature Search conducted by AAOS Librarian
Question 1.1 – Long-Term Sequelae
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content in postmenopausal women. American Journal of Obstetrics & Gynecology. 1985;152(6 Pt 1):630-634.
7. Coralli CH, Raisz LG, Wood CL. Osteoporosis: significance, risk factors and treatment. Nurse Practitioner.
1986;11(9):16-20, 25-17, 30 passim.
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women treated with sodium fluoride. Journal of Bone & Mineral Research. 1987;2(2):123-126.
21
11. Wilson RJ, Sudhaker Rao D, Ellis B, Kleerekoper M, Parfitt AM. Mild asymptomatic primary hyperparathyroidism is not
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https://doi.org/10.7326/0003-4819-109-12-959.
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1989;14(10):1065-1070.
13. Levy E. Cost analysis of osteoporosis related to untreated menopause. Clinical Rheumatology. 1989;8 Suppl 2:76-82.
14. Mackie IG, Ralis ZA, Leyshon RL, Lane J, Watkins G, Berry PF. Treatment of bone weakness in patients with femoral
neck fracture by fluoride, calcium and vitamin D. Journal of Bone & Joint Surgery - British Volume. 1989;71(1):111-117.
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1989;82:25-32.
16. Schnitzler CM, Wing JR, Gear KA, Robson HJ. Bone fragility of the peripheral skeleton during fluoride therapy for
osteoporosis. Clinical Orthopaedics & Related Research. 1990(261):268-275.
17. Treadwell EL, Cunningham PR, Kowalski HM, Weaver MD. Thoracolumbar compression fractures presenting with an
acute ileus. Journal of the National Medical Association. 1990;82(9):669-672.
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1991;49 Suppl:S5-7.
19. Montemurro L, Fraioli P, Rizzato G. Bone loss in untreated longstanding sarcoidosis. Sarcoidosis. 1991;8(1):29-34.
20. Kaneda K, Asano S, Hashimoto T, Satoh S, Fujiya M. The treatment of osteoporotic-posttraumatic vertebral collapse
using the Kaneda device and a bioactive ceramic vertebral prosthesis. Spine. 1992;17(8 Suppl):S295-303.
21. Isdale AH. Stress fractures of the pubic rami in rheumatoid arthritis. Annals of the Rheumatic Diseases.
1993;52(9):681-684.
22. Chrischilles E, Shireman T, Wallace R. Costs and health effects of osteoporotic fractures. Bone. 1994;15(4):377-386.
23. Hu RW, Bohlman HH. Fracture at the iliac bone graft harvest site after fusion of the spine. Clinical Orthopaedics and
Related Research. 1994(309):208-213.
24. Kalla AA, Meyers OL, Kotze TJ, Laubscher R. Corticosteroid therapy and bone mass--comparison of rheumatoid
arthritis and systemic lupus erythematosus. South African Medical Journal Suid-Afrikaanse Tydskrif Vir Geneeskunde.
1994;84(7):404-409.
25. Korkala O, Jokinen M, Matikainen A. Three years' audit of a bone bank. Annales Chirurgiae et Gynaecologiae.
1994;83(3):244-250.
26. Nelson ME, Fiatarone MA, Morganti CM, Trice I, Greenberg RA, Evans WJ. Effects of high-intensity strength training
on multiple risk factors for osteoporotic fractures. A randomized controlled trial. JAMA. 1994;272(24):1909-1914.
27. Worth H, Stammen D, Keck E. Therapy of steroid-induced bone loss in adult asthmatics with calcium, vitamin D, and a
diphosphonate. American Journal of Respiratory & Critical Care Medicine. 1994;150(2):394-397.
28. Cosman F, Nieves J, Walliser J, Lindsay R. Postmenopausal osteoporosis: patient choices and outcomes. Maturitas.
1995;22(2):137-143.
29. Erlichman M, Holohan TV. Bone densitometry: patients with asymptomatic primary hyperparathyroidism part I.
Technical report. Health Technology Assessment (Rockville, Md). 1995(6):1-30.
30. Peh WC, Khong PL, Ho WY. Insufficiency fractures of the sacrum and os pubis. British Journal of Hospital Medicine.
1995;54(1):15-19.
22
31. Prasad VS, Vidyasagar JV, Purohit AK, Dinakar I. Early surgery for thoracolumbar spinal cord injury: initial experience
from a developing spinal cord injury centre in India. Paraplegia. 1995;33(6):350-353.
32. Walters JR, Banks LM, Butcher GP, Fowler CR. Detection of low bone mineral density by dual energy x ray
absorptiometry in unsuspected suboptimally treated coeliac disease. Gut. 1995;37(2):220-224.
33. Caniggia A, Nuti R, Martini G, et al. Efficacy and safety of long-term, open-label treatment of calcitriol in
postmenopausal osteoporosis: A retrospective analysis. Current Therapeutic Research - Clinical and Experimental.
1996;57(11):857-868. https://doi.org/10.1016/S0011-393X(96)80019-1.
34. Douketis JD, Ginsberg JS, Burrows RF, Duku EK, Webber CE, Brill-Edwards P. The effects of long-term heparin therapy
during pregnancy on bone density. A prospective matched cohort study. Thrombosis & Haemostasis. 1996;75(2):254-
257.
35. Otte MT, Helms CA, Fritz RC. MR imaging of supra-acetabular insufficiency fractures. Skeletal Radiology.
1997;26(5):279-283. https://doi.org/10.1007/s002560050235.
36. Cokolic M. Diabetes mellitus and osteoporosis. Diabetologia Croatica. 1998;27(4):135-142.
37. Di Somma C, Colao A, Pivonello R, et al. Effectiveness of chronic treatment with alendronate in the osteoporosis of
Cushing's disease. Clinical Endocrinology. 1998;48(5):655-662.
38. Elffors L. Are osteoporotic fractures due to osteoporosis? Impacts of a frailty pandemic in an aging world. Aging-
Clinical & Experimental Research. 1998;10(3):191-204.
39. Mathis JM, Petri M, Naff N. Percutaneous vertebroplasty treatment of steroid-induced osteoporotic compression
fractures. Arthritis & Rheumatism. 1998;41(1):171-175.
40. Alonso-Bartolome P, Martinez-Taboada VM, Blanco R, Rodriguez-Valverde V. Insufficiency fractures of the tibia and
fibula. Seminars in Arthritis & Rheumatism. 1999;28(6):413-420.
41. Backos M, Rai R, Thomas E, Murphy M, Dore C, Regan L. Bone density changes in pregnant women treated with
heparin: a prospective, longitudinal study. Human Reproduction. 1999;14(11):2876-2880.
42. Huang TJ, Hsu RW, Sum CW, Liu HP. Complications in thoracoscopic spinal surgery: a study of 90 consecutive patients.
Surgical Endoscopy. 1999;13(4):346-350.
43. Isdale AH. Sacral insufficiency fractures: An unsuspected cause of low back pain [5]. Rheumatology. 1999;38(1):90.
44. Lee TT, Singh RVP, Manzano GR, Green BA. Contemporary treatment of spinal cord injury. Neurosurgery Quarterly.
1999;9(2):138-153.
45. Mitchell D. New approaches to the therapy of sarcoidosis. Clinical Pulmonary Medicine. 1999;6(6):339-346.
https://doi.org/10.1097/00045413-199911000-00003.
46. van Allen MI, Fung J, Jurenka SB. Health care concerns and guidelines for adults with Down syndrome. American
Journal of Medical Genetics. 1999;89(2):100-110.
47. Andersson S, Rodrigues M, Olerud C. Odontoid fractures: high complication rate associated with anterior screw
fixation in the elderly. European Spine Journal. 2000;9(1):56-59.
48. Babayev M, Lachmann E, Nagler W. The controversy surrounding sacral insufficiency fractures: to ambulate or not to
ambulate? American journal of physical medicine & rehabilitation / Association of Academic Physiatrists.
2000;79(4):404-409.
49. Chandler G, Dalley G, Hemmer J, Seely T. Comparison of thoracic versus lumbar Gray Ramus communicans nerve
block in the treatment of painful osteoporotic vertebral compression fracture. Pain Physician. 2000;3(2):240.
50. Cormier C, Souberbielle JC, Kindermans C. Hyperparathyroidism: the limits of surgery in cases of bone or
cardiovascular involvement. Current Opinion in Rheumatology. 2000;12(4):349-353.
23
51. Grados F, Depriester C, Cayrolle G, Hardy N, Deramond H, Fardellone P. Long-term observations of vertebral
osteoporotic fractures treated by percutaneous vertebroplasty. Rheumatology. 2000;39(12):1410-1414.
52. Obermayer-Pietsch BM, Walter D, Kotschan S, Freigassner-Pritz M, Windhager R, Leb G. Congenital hip dysplasia and
bone mineral density of the hip--a new risk factor for osteoporotic fracture? Journal of Bone & Mineral Research.
2000;15(9):1678-1682.
53. Seeman E. Selection of individuals for prevention of fractures due to bone fragility. Bailliere's Best Practice and
Research in Clinical Endocrinology and Metabolism. 2000;14(2):233-249. https://doi.org/10.1053/beem.2000.0071.
54. Black DM, Steinbuch M, Palermo L, et al. An assessment tool for predicting fracture risk in postmenopausal women.
Osteoporosis International. 2001;12(7):519-528.
55. Cahill BC, O'Rourke MK, Parker S, Stringham JC, Karwande SV, Knecht TP. Prevention of bone loss and fracture after
lung transplantation: a pilot study. Transplantation. 2001;72(7):1251-1255.
56. Chandler G, Dalley G, Hemmer J, Jr., Seely T. Gray ramus communicans nerve block: novel treatment approach for
painful osteoporotic vertebral compression fracture. Southern Medical Journal. 2001;94(4):387-393.
57. Lin J, Lachmann E, Nagler W. Sacral insufficiency fractures: A report of two cases and a review of the literature.
Journal of Women's Health and Gender-Based Medicine. 2001;10(7):699-705.
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58. Mathews V, McCance SE, O'Leary PF. Early fracture of the sacrum or pelvis: an unusual complication after multilevel
instrumented lumbosacral fusion. Spine. 2001;26(24):E571-575.
59. Matsunaga S, Sakou T, Arishima Y, Koga H, Hayashi K, Komiya S. Quality of life in elderly patients with ossification of
the posterior longitudinal ligament. Spine. 2001;26(5):494-498.
60. McNally EG, Wilson DJ, Ostlere SJ. Limited magnetic resonance imaging in low back pain instead of plain radiographs:
experience with first 1000 cases. Clinical Radiology. 2001;56(11):922-925.
61. Spuentrup E, Buecker A, Adam G, van Vaals JJ, Guenther RW. Diffusion-weighted MR imaging for differentiation of
benign fracture edema and tumor infiltration of the vertebral body. AJR American Journal of Roentgenology.
2001;176(2):351-358.
62. Tremollieres FA, Pouilles JM, Ribot C. Withdrawal of hormone replacement therapy is associated with significant
vertebral bone loss in postmenopausal women. Osteoporosis International. 2001;12(5):385-390.
63. Weber TJ, Drezner MK. Effect of alendronate on bone mineral density in male idiopathic osteoporosis. Metabolism:
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64. Yamamoto H. Osteoporotic vertebral fracture. Current Orthopaedics. 2001;15(2):101-109.
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65. Allcroft LC, Varanasi SS, Dimopoulos D, Francis RM, Datta HK. Mutational and polymorphic analysis of the estradiol
receptor-alpha gene in men with symptomatic vertebral fractures. Calcified Tissue International. 2002;71(5):400-405.
66. Berlemann U, Ferguson SJ, Nolte LP, Heini PF. Adjacent vertebral failure after vertebroplasty. A biomechanical
investigation. Journal of Bone & Joint Surgery - British Volume. 2002;84(5):748-752.
67. Casebeer L, James N. Practice pattern variation in the prevention and treatment of osteoporosis. Current Opinion in
Rheumatology. 2002;14(4):453-457.
68. Chen JF, Lee ST, Lui TN, Wu CT, Liao CC. Percutaneous vertebroplasty for the treatment of osteoporotic vertebral
compression fractures: a preliminary report. Chang Gung Medical Journal. 2002;25(5):306-314.
69. Goh LH, Tan SB, Liaw JS. Advances in surgical treatment of osteoporotic fractures of the spine. Annals of the Academy
of Medicine, Singapore. 2002;31(5):623-630.
24
70. Lippert JA, McGraw JK. Spine interventions. Seminars in Roentgenology. 2002;37(4):266-281.
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71. Ninkovic M, Love S, Tom BD, Bearcroft PW, Alexander GJ, Compston JE. Lack of effect of intravenous pamidronate on
fracture incidence and bone mineral density after orthotopic liver transplantation. Journal of Hepatology.
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72. O'Connor PA, Eustace S, O'Byrne J. Spinal cord injury following osteoporotic vertebral fracture: case report. Spine.
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73. Oner FC, van Gils AP, Faber JA, Dhert WJ, Verbout AJ. Some complications of common treatment schemes of
thoracolumbar spine fractures can be predicted with magnetic resonance imaging: prospective study of 53 patients
with 71 fractures. Spine. 2002;27(6):629-636.
74. Parker CR, Blackwell PJ, Fairbairn KJ, Hosking DJ. Alendronate in the treatment of primary hyperparathyroid-related
osteoporosis: a 2-year study. Journal of Clinical Endocrinology & Metabolism. 2002;87(10):4482-4489.
75. Pérez-Higueras A, Alvarez L, Rossi RE, Quiñones D, Al-Assir I. Percutaneous vertebroplasty: Long-term clinical and
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76. Peris P. Stress fractures in rheumatological practice: clinical significance and localizations. Rheumatology
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77. Predey TA, Sewall LE, Smith SJ. Percutaneous vertebroplasty: new treatment for vertebral compression fractures.
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78. Zoarski GH, Snow P, Olan WJ, et al. Percutaneous vertebroplasty for osteoporotic compression fractures: quantitative
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79. Adler RA, Funkhouser HL, Petkov VI, Berger MM. Glucocorticoid-induced osteoporosis in patients with sarcoidosis.
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80. Bese NS, Ozguroglu M, Kamberoglu K, Karahasanoglu T, Ober A. Pentoxifylline in the treatment of radiation-related
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81. Bose B. Fracture of S1-2 after L4-S1 decompression and fusion. Case report and review of the literature. Journal of
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83. Derman R. Identifying the osteopenic patient and preventing worsening of the disease. Current Women's Health
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84. Diamond TH, Champion B, Clark WA. Management of acute osteoporotic vertebral fractures: a nonrandomized trial
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85. Franck H, Boszczyk BM, Bierschneider M, Jaksche H. Interdisciplinary approach to balloon kyphoplasty in the
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86. Glassman SD, Alegre GM. Adult spinal deformity in the osteoporotic spine: options and pitfalls. Instructional Course
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87. Guillevin L, Cohen P, Mahr A, et al. Treatment of polyarteritis nodosa and microscopic polyangiitis with poor prognosis
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25
88. Kim DJ, Yun YH, Wang JM. Nerve-root injections for the relief of pain in patients with osteoporotic vertebral fractures.
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89. Lieberman I, Reinhardt MK. Vertebroplasty and Kyphoplasty for Osteolytic Vertebral Collapse. Clinical Orthopaedics
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91. Meiners T, Keil M, Flieger R, Abel R. Use of the ring fixator in the treatment of fractures of the lower extremity in long-
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92. Nguyen HV, Ludwig S, Gelb D. Osteoporotic vertebral burst fractures with neurologic compromise. Journal of Spinal
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93. Phillips FM, Pfeifer BA, Lieberman IH, Kerr EJ, 3rd, Choi IS, Pazianos AG. Minimally invasive treatments of osteoporotic
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94. van Everdingen AA, Siewertsz van Reesema DR, Jacobs JW, Bijlsma JW. Low-dose glucocorticoids in early rheumatoid
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95. Watts NB. Is percutaneous vertebral augmentation (vertebroplasty) effective treatment for painful vertebral
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97. Arias M, Villalba C, Requena I, Vazquez-Veiga H, Sesar A, Pereiro I. Acute spinal epidural hematoma and systemic
mastocytosis. Spine. 2004;29(8):E161-163.
98. Bodelier AGL, Groeneveld W, van der Linden AN, Haak HR. Symptomatic epidural lipomatosis in ectopic Cushing's
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99. Boonen S, Haentjens P, Vandenput L, Vanderschueren D. Preventing osteoporotic fractures with antiresorptive
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100. Chen JF, Lee ST. Percutaneous vertebroplasty for treatment of thoracolumbar spine bursting fracture. Surgical
Neurology. 2004;62(6):494-500; discussion 500.
101. Chen LH, Niu CC, Yu SW, Fu TS, Lai PL, Chen WJ. Minimally invasive treatment of osteoporotic vertebral compression
fracture. Chang Gung Medical Journal. 2004;27(4):261-267.
102. Cosman F, Lindsay R. Therapeutic potential of parathyroid hormone. Current Osteoporosis Reports. 2004;2(1):5-11.
103. Deer TR. An overview of interventional spinal techniques. Seminars in Pain Medicine. 2004;2(3):154-166.
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104. Fraser WD. The burden of osteoporosis and the case for disease management. Disease Management and Health
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105. Fribourg D, Tang C, Sra P, Delamarter R, Bae H. Incidence of subsequent vertebral fracture after kyphoplasty. Spine.
2004;29(20):2270-2276; discussion 2277.
106. Hide IG, Gangi A. Percutaneous vertebroplasty: history, technique and current perspectives. Clinical Radiology.
2004;59(6):461-467.
107. Hoshino Y, Doita M, Yoshikawa M, Hirayama K, Sha N, Kurosaka M. Unstable pelvic insufficiency fracture in a patient
with rheumatoid arthritis. Rheumatology International. 2004;24(1):46-49.
26
108. Khanna AJ, Kebaish KM, Ozdemir HM, Cohen DB, Gonzales RA, Kostuik JP. Sacral insufficiency fracture surgically
treated by fibular allograft. Journal of Spinal Disorders and Techniques. 2004;17(3):167-173.
https://doi.org/10.1097/00024720-200406000-00001.
109. Legroux-Gerot I, Lormeau C, Boutry N, Cotten A, Duquesnoy B, Cortet B. Long-term follow-up of vertebral
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Question 1.4 – Mortality & Morbidity
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225. Hoch A, Ozkurtul O, Pieroh P, Josten C, Bohme J. Outcome and 2-Year Survival Rate in Elderly Patients With Lateral
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226. Josan ES, McCommons M. Is that a wire in my lung-pulmonary embolism from bone cement. American Journal of
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228. Killinger Z, Čierny D, Jackuliak P, Kužma M, Payer J. Prediction of asymptomatic vertebral fractures by selected clinical
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229. Kim JH, Koh KH, Kim SS. Risk factors including age, gender, osteoporosis in spine or hip, and local osteoporosis for
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230. Nct. Percutaneous Vertebroplasty Versus Conservative Treatment in GIOPVCF.
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251. Lin HH, Chang MC, Wang ST, Liu CL, Chou PH. The fates of pedicle screws and functional outcomes in a geriatric
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255. Ong KL, Beall DP, Frohbergh M, Lau E, Hirsch JA. Were VCF patients at higher risk of mortality following the 2009
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256. Ong T, Kantachuvesiri P, Sahota O, Gladman JRF. Characteristics and outcomes of hospitalised patients with vertebral
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257. Ortiz UNG, Rivera MAF, Moga AG, Benitez HAS. Kyphoplasty and vertebroplasty in the treatment of osteoporotic
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258. Peker O. Management of acute osteoporotic vertebral fractures in turkey. Osteoporosis International.
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263. Sebastian AS, Rihn JA. Vertebral fracture management. Seminars in Spine Surgery. 2018;30(1):17-23.
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265. Zuo XH, Zhu XP, Bao HG, et al. Network meta-analysis of percutaneous vertebroplasty, percutaneous kyphoplasty,
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275. Dydyk AM, J MD. Vertebral Augmentation. StatPearls Publishing. 2019;01:01.
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285. Ong KL. Understanding morality risk for patients with VCF. Osteoporosis International. 2019;30:S47.
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286. Ong T, Sahota O, Gladman JRF. Is there a role for an orthogeriatric model of care in the management of vertebral
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287. Orhurhu V, Urits I, Musa A, Simopoulos T, Jatinder G. Thoracolumbar injury classification and severity score (TLICS) in
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290. Suvar T. Spinal cord stimulation in the treatment of chronic pain related to kyphoplasty cement leakage.
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300. Jennings JW. Vertebral augmentation is more than just pain palliation, it is about improved mortality. Radiology.
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Question 1.5 – Risk of Re-fracture
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7. Wilcox RK. The biomechanical effect of vertebroplasty on the adjacent vertebral body: a finite element study.
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151
15. Lin DW, Marks LS, Morton RA, Rodriguez D. Positive fracture reduction trial of toremifene 80 mg in men on ADT
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249
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Question 4.6 – Medical Treatment (Multidisciplinary Care)
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53. Denoix E, Viry F, Ostertag A, et al. What are the predictors of clinical success after percutaneous vertebroplasty for
osteoporotic vertebral fractures? European Radiology. 2018;28(7):2735-2742.
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54. Marcia S, Muto M, Hirsch JA, et al. What is the role of vertebral augmentation for osteoporotic fractures? A review of
the recent literature. Neuroradiology. 2018;60(8):777-783. https://doi.org/10.1007/s00234-018-2042-0.
55. Schnake KJ, Blattert TR, Hahn P, et al. Classification of Osteoporotic Thoracolumbar Spine Fractures:
Recommendations of the Spine Section of the German Society for Orthopaedics and Trauma (DGOU). Global Spine
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56. Schwaiger BJ, Gersing AS, Hammel J, et al. Three-material decomposition with dual-layer spectral CT compared to MRI
for the detection of bone marrow edema in patients with acute vertebral fractures. Skeletal Radiology.
2018;47(11):1533-1540. https://doi.org/https://dx.doi.org/10.1007/s00256-018-2981-x.
57. Shah LM, Jennings JW, Kirsch CFE, et al. ACR Appropriateness Criteria® Management of Vertebral Compression
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58. Xu W, Wang S, Chen C, et al. Correlation analysis between the magnetic resonance imaging characteristics of
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study. BMC Musculoskeletal Disorders. 2018;19(1):114. https://doi.org/https://dx.doi.org/10.1186/s12891-018-2040-
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59. Dydyk AM, J MD. Vertebral Augmentation. StatPearls Publishing. 2019;01:01.
60. McGowan SM, Ramski DE, Homcha B, Sokunbi G. Are CT Scans Overutilized in the Workup of Vertebral Compression
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61. Moser M, Schmassmann P, Noger M, Baur M, Nevzati E. Usefulness of Fat Suppression Magnetic Resonance Imaging
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62. Shankar JJS, Merdad R, Finitsis S, Parker R. Imaging Improves Efficacy of Vertebroplasty - A Systematic Review and
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63. Li Y, Yue J, Huang M, et al. Risk factors for postoperative residual back pain after percutaneous kyphoplasty for
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404
64. Mendel T, Ullrich BW, Hofmann GO, et al. Progressive instability of bilateral sacral fragility fractures in osteoporotic
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Question 6.1 – Interventional Treatment (Steroidal & Anesthetic Injections)
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4. Gangji V, Appelboom T. Analgesic effect of intravenous pamidronate on chronic back pain due to osteoporotic
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6. Chen JF, Lee ST, Lui TN, Wu CT, Liao CC. Percutaneous vertebroplasty for the treatment of osteoporotic vertebral
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7. Crandall C. Parathyroid hormone for treatment of osteoporosis. Archives of Internal Medicine. 2002;162(20):2297-
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8. Lin CN, Wu YC, Wang NP. Transpedicula PMMA vertebroplasty for the treatment of osteoporotic vertebral
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9. Chen JF, Lee ST, Lui TN, Wu CT. Percutaneous vertebroplasty for the treatment of osteoporotic vertebral compression
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10. Kim DJ, Yun YH, Wang JM. Nerve-root injections for the relief of pain in patients with osteoporotic vertebral fractures.
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11. Ringe JD, Dorst A, Faber H, Ibach K, Sorenson F. Intermittent intravenous ibandronate injections reduce vertebral
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12. Zapalowicz K, Radek A, Blaszczyk B, Kozinski T, Zelechowski J. Percutaneous vertebroplasty with methyl methacrylate
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13. Zapalowicz K, Radek A, Blaszczyk B, Kozinski T, Zelechowski J. Percutaneous vertebroplasty with bone cement in the
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14. Hammond A, Riley LH, 3rd, Gailloud P, et al. Treatment considerations for vertebroplasty in men. Ajnr: American
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16. Medical Advisory S. Balloon kyphoplasty: an evidence-based analysis. Ontario Health Technology Assessment Series.
2004;4(12):1-45.
405
17. Munoz-Torres M, Alonso G, Raya MP. Calcitonin therapy in osteoporosis. Treatments in Endocrinology. 2004;3(2):117-
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18. Compston J. Recombinant parathyroid hormone in the management of osteoporosis. Calcified Tissue International.
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19. Hee HT. Percutaneous vertebroplasty: current concepts and local experience. Neurology India. 2005;53(4):475-482.
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21. Nct. VERTOS-II. Percutaneous Vertebroplasty Versus Conservative Therapy.
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23. Reginster JY. Oral and intravenous ibandronate in the management of postmenopausal osteoporosis: a
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24. Zapalowicz K, Radek M, Radek A, et al. Percutaneous vertebroplasty in the treatment of diseases causing vertebral
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25. Foo LS, Yeo W, Fook S, et al. Results, experience and technical points learnt with use of the SKy Bone Expander
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29. Manuele S, Sorbello L, Puglisi N, et al. The teriparatide in the treatment of severe senile osteoporosis. Archives of
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33. Karnezis IA. Minimally invasive therapeutic interventional procedures in the spine: an evidence-based review. Surgical
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45. Esses SI, McGuire R, Jenkins J, et al. The treatment of symptomatic osteoporotic spinal compression fractures. Journal
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Pitfalls. JBJS Essential Surgical Techniques. 2020;10(2):e0032.
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218. Gonzalez-Rodriguez E, Aubry-Rozier B, Stoll D, Zaman K, Lamy O. Sixty spontaneous vertebral fractures after
denosumab discontinuation in 15 women with early-stage breast cancer under aromatase inhibitors. Breast Cancer
Research & Treatment. 2020;179(1):153-159. https://doi.org/https://dx.doi.org/10.1007/s10549-019-05458-8.
219. Kelly MA, McCabe E, Bergin D, et al. Osteoporotic Vertebral Fractures are Common in Hip Fracture Patients and are
Under-recognized. Journal of Clinical Densitometry. 2020;21:21.
https://doi.org/https://dx.doi.org/10.1016/j.jocd.2020.05.007.
220. Kochai A, Enercan M, Kahraman S, Ozturk C, Hamzaoglu A. Effect of cementing on pulmonary arterial pressure in
vertebroplasty: A comparison of two techniques. Journal of Orthopaedic Surgery. 2020;28(1):2309499019897659.
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221. Laakso S, Borchers J, Toiviainen-Salo S, Pekkinen M, Makitie O. Severe Phenotype of APECED (APS1) Increases Risk for
Structural Bone Alterations. Frontiers in Endocrinology. 2020;11:109.
https://doi.org/https://dx.doi.org/10.3389/fendo.2020.00109.
222. Leslie WD, Lix LM, Binkley N. Targeted vertebral fracture assessment for optimizing fracture prevention in Canada.
Archives of Osteoporosis. 2020;15(1):65. https://doi.org/https://dx.doi.org/10.1007/s11657-020-00735-2.
223. Malik AT, Retchin S, Phillips FM, et al. Declining trend in osteoporosis management and screening following vertebral
compression fractures - a national analysis of commercial insurance and medicare advantage beneficiaries. Spine
Journal: Official Journal of the North American Spine Society. 2020;20(4):538-546.
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224. Moulin B, Delpla A, Tselikas L, et al. Multi-Level Vertebroplasty for 6 or More Painful Osteoporotic Vertebral Body
Compression Fractures Performed in the Same Procedural Setting: A Safety and Efficacy Report in Cancer Patients.
Cardiovascular & Interventional Radiology. 2020;43(7):1041-1048.
https://doi.org/https://dx.doi.org/10.1007/s00270-020-02480-y.
225. Pongchaiyakul C, Charoensri S, Leerapun T, Wongsiri S, Songpatanasilp T, Taechakraichana N. Prevalence of
asymptomatic radiographic vertebral fracture in postmenopausal Thai women. Archives of Osteoporosis.
2020;15(1):78. https://doi.org/https://dx.doi.org/10.1007/s11657-020-00762-z.
226. Shi G, Feng F, Hao C, Pu J, Li B, Tang H. A case of multilevel percutaneous vertebroplasty for vertebral metastases
resulting in temporary paraparesis. Journal of International Medical Research. 2020;48(2):300060519835084.
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227. Shimizu T, Lenke LG, Cerpa M, Lehman RA, Jr., Pongmanee S, Sielatycki JA. Preoperative halo-gravity traction for
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228. Tuan TA, Luong TV, Cuong PM, Long V, Huy HQ, Duc NM. Cement Leakage in Percutaneous Vertebroplasty for
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2020;12:105-111. https://doi.org/https://dx.doi.org/10.2147/ORR.S255517.
423
229. Wang S, Duan C, Yang H, Kang J, Wang Q. Percutaneous intervertebral bridging cementoplasty for adjacent multilevel
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230. Warhurst M, Hartman J, Granville M, Jacobson RE. The Role of Minimally Invasive Spinal Surgical Procedures in the
Elderly Patient: An Analysis of 49 Patients Between 75 and 95 Years of Age. Cureus. 2020;12(3):e7180.
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Question 6.3 – Interventional Treatment (Augmentation vs. Medical Therapy)
1. Lawoyin S, Zerwekh JE, Glass K, Pak CY. Ability of 25-hydroxyvitamin D3 therapy to augment serum 1,25- and 24,25-
dihydroxyvitamin D in postmenopausal osteoporosis. Journal of Clinical Endocrinology & Metabolism. 1980;50(3):593-
596.
2. Jensen ME, Evans AJ, Mathis JM, Kallmes DF, Cloft HJ, Dion JE. Percutaneous polymethylmethacrylate vertebroplasty
in the treatment of osteoporotic vertebral body compression fractures: technical aspects. Ajnr: American Journal of
Neuroradiology. 1997;18(10):1897-1904.
3. Pak CYC, Sakhaee K, Rubin CD, et al. Sustained-release sodium fluoride in the management of established
postmenopausal osteoporosis. American Journal of the Medical Sciences. 1997;313(1):23-32.
https://doi.org/10.1097/00000441-199701000-00005.
4. Tamayo-Orozco J, Arzac-Palumbo P, Peon-Vidales H, Mota-Bolfeta R, Fuentes F. Vertebral fractures associated with
osteoporosis: patient management. American Journal of Medicine. 1997;103(2A):44S-48S; discussion 48S-50S.
5. Cortet B, Cotten A, Boutry N, et al. Percutaneous vertebroplasty in the treatment of osteoporotic vertebral
compression fractures: an open prospective study. Journal of Rheumatology. 1999;26(10):2222-2228.
6. Maynard AS, Jensen ME, Schweickert PA, Marx WF, Short JG, Kallmes DF. Value of bone scan imaging in predicting
pain relief from percutaneous vertebroplasty in osteoporotic vertebral fractures. Ajnr: American Journal of
Neuroradiology. 2000;21(10):1807-1812.
7. Garfin SR, Yuan HA, Reiley MA. New technologies in spine: kyphoplasty and vertebroplasty for the treatment of
painful osteoporotic compression fractures. Spine. 2001;26(14):1511-1515.
8. Lieberman IH, Dudeney S, Reinhardt MK, Bell G. Initial outcome and efficacy of "kyphoplasty" in the treatment of
painful osteoporotic vertebral compression fractures. Spine. 2001;26(14):1631-1638.
9. Lin DDM, Gailloud P, Murphy KJ. Percutaneous vertebroplasty in benign and malignant disease. Neurosurgery
Quarterly. 2001;11(4):290-301. https://doi.org/10.1097/00013414-200112000-00005.
10. Rubin CD, Pak CY, Adams-Huet B, Genant HK, Li J, Rao DS. Sustained-release sodium fluoride in the treatment of the
elderly with established osteoporosis. Archives of Internal Medicine. 2001;161(19):2325-2333.
11. Chen JF, Lee ST, Lui TN, Wu CT, Liao CC. Percutaneous vertebroplasty for the treatment of osteoporotic vertebral
compression fractures: a preliminary report. Chang Gung Medical Journal. 2002;25(5):306-314.
12. Cortet B, Roches E, Logier R, et al. Evaluation of spinal curvatures after a recent osteoporotic vertebral fracture. Joint,
Bone, Spine: Revue du Rhumatisme. 2002;69(2):201-208.
13. Kallmes DF, Schweickert PA, Marx WF, Jensen ME. Vertebroplasty in the mid- and upper thoracic spine. American
Journal of Neuroradiology. 2002;23(7):1117-1120.
14. Lin CN, Wu YC, Wang NP. Transpedicula PMMA vertebroplasty for the treatment of osteoporotic vertebral
compression fracture. Formosan Journal of Surgery. 2002;35(2):74-79.
424
15. Ortiz AO, Zoarski GH, Beckerman M. Kyphoplasty. Techniques in Vascular and Interventional Radiology. 2002;5(4):239-
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16. Papaioannou A, Watts NB, Kendler DL, Yuen CK, Adachi JD, Ferko N. Diagnosis and management of vertebral fractures
in elderly adults. American Journal of Medicine. 2002;113(3):220-228.
17. Predey TA, Sewall LE, Smith SJ. Percutaneous vertebroplasty: new treatment for vertebral compression fractures.
American Family Physician. 2002;66(4):611-615.
18. Truumees E. The roles of vertebroplasty and kyphoplasty as parts of a treatment strategy for osteoporotic vertebral
compression fractures. Current Opinion in Orthopaedics. 2002;13(3):193-199. https://doi.org/10.1097/00001433-
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19. Tsou IY, Goh PY, Peh WC, Goh LA, Chee TS. Percutaneous vertebroplasty in the management of osteoporotic vertebral
compression fractures: initial experience. Annals of the Academy of Medicine, Singapore. 2002;31(1):15-20.
20. Ventura KA, Szigeti E. New advances in treating osteoporotic compression fractures. MEDSURG Nursing.
2002;11(5):251-253, 255.
21. Beattie K, Papaioannou A, Boulos P, Adachi JD. Kyphoplasty and vertebroplasty for the treatment of osteoporotic
vertebral compression fractures. Geriatrics and Aging. 2003;6(2):47-52.
22. Burton AW, Mendel E. Vertebroplasty and kyphoplasty. Pain Physician. 2003;6(3):335-341.
23. Chen JF, Lee ST, Lui TN, Wu CT. Percutaneous vertebroplasty for the treatment of osteoporotic vertebral compression
fractures. Acta Neurologica Taiwanica. 2003;12(2):69-74.
24. Cornell CN, Lane JM, Poynton AR. Orthopedic management of vertebral and long bone fractures in patients with
osteoporosis. Clinics in Geriatric Medicine. 2003;19(2):433-455.
25. Diamond TH, Champion B, Clark WA. Management of acute osteoporotic vertebral fractures: a nonrandomized trial
comparing percutaneous vertebroplasty with conservative therapy. American Journal of Medicine. 2003;114(4):257-
265.
26. Glassman SD, Alegre GM. Adult spinal deformity in the osteoporotic spine: options and pitfalls. Instructional Course
Lectures. 2003;52:579-588.
27. Kim DH, Silber JS, Albert TJ. Osteoporotic vertebral compression fractures. Instructional Course Lectures. 2003;52:541-
550.
28. Kim DJ, Yun YH, Wang JM. Nerve-root injections for the relief of pain in patients with osteoporotic vertebral fractures.
Journal of Bone & Joint Surgery - British Volume. 2003;85(2):250-253.
29. Mehbod A, Aunoble S, Le Huec JC. Vertebroplasty for osteoporotic spine fracture: prevention and treatment.
European Spine Journal. 2003;12 Suppl 2:S155-162.
30. Nct. Vertebroplasty for the Treatment of Fractures Due to Osteoporosis. https://clinicaltrialsgov/show/NCT00068822.
2003.
31. Phillips FM, Pfeifer BA, Lieberman IH, Kerr EJ, 3rd, Choi IS, Pazianos AG. Minimally invasive treatments of osteoporotic
vertebral compression fractures: vertebroplasty and kyphoplasty. Instructional Course Lectures. 2003;52:559-567.
32. Stallmeyer MJB, Zoarski GH, Obuchowski AM. Optimizing patient selection in percutaneous vertebroplasty. Journal of
Vascular and Interventional Radiology. 2003;14(6):683-696. https://doi.org/10.1097/01.RVI.0000064859.87207.FA.
33. Tanner SB. Back pain, vertebroplasty, and kyphoplasty: Treatment of osteoporotic vertebral compression fractures.
Bulletin on the Rheumatic Diseases. 2003;52(2).
34. Wu SS, Lachmann E, Nagler W. Current medical, rehabilitation, and surgical management of vertebral compression
fractures. Journal of Women's Health. 2003;12(1):17-26.
425
35. Biermasz NR, Hamdy NA, Pereira AM, Romijn JA, Roelfsema F. Long-term skeletal effects of recombinant human
growth hormone (rhGH) alone and rhGH combined with alendronate in GH-deficient adults: a seven-year follow-up
study. Clinical Endocrinology. 2004;60(5):568-575.
36. Boszczyk BM, Bierschneider M, Schmid K, Grillhosl A, Robert B, Jaksche H. Microsurgical interlaminary vertebro- and
kyphoplasty for severe osteoporotic fractures. Journal of Neurosurgery. 2004;100(1 Suppl Spine):32-37.
37. Chen JF, Lee ST. Percutaneous vertebroplasty for treatment of thoracolumbar spine bursting fracture. Surgical
Neurology. 2004;62(6):494-500; discussion 500.
38. Cohen JE, Lylyk P, Ceratto R, Kaplan L, Umanskyt F, Gomori JM. Percutaneous vertebroplasty: technique and results in
192 procedures. Neurological Research. 2004;26(1):41-49.
39. Francis RM, Baillie SP, Chuck AJ, et al. Acute and long-term management of patients with vertebral fractures. QJM -
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40. Fribourg D, Tang C, Sra P, Delamarter R, Bae H. Incidence of subsequent vertebral fracture after kyphoplasty. Spine.
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41. Hammond A, Riley LH, 3rd, Gailloud P, et al. Treatment considerations for vertebroplasty in men. Ajnr: American
Journal of Neuroradiology. 2004;25(4):639-641.
42. Harrop JS, Prpa B, Reinhardt MK, Lieberman I. Primary and secondary osteoporosis' incidence of subsequent vertebral
compression fractures after kyphoplasty. Spine. 2004;29(19):2120-2125.
43. Hoh BL, Rabinov JD, Pryor JC, Hirsch JA. Balloon kyphoplasty for vertebral compression fracture using a unilateral
balloon tamp via a uni-pedicular approach: technical note. Pain Physician. 2004;7(1):111-114.
44. Lee ST, Chen JF. A syringe compressor for vertebroplasty: technical note. Surgical Neurology. 2004;61(6):580-584.
45. Legroux-Gérot I, Lormeau C, Boutry N, Cotten A, Duquesnoy B, Cortet B. Long-term follow-up of vertebral
osteoporotic fractures treated by percutaneous vertebroplasty. Clinical Rheumatology. 2004;23(4):310-317.
46. Lin JT, Lane JM. The osteoporotic spine. Europa Medicophysica. 2004;40(3):233-237.
47. McKiernan F, Faciszewski T, Jensen R. Quality of life following vertebroplasty. Journal of Bone & Joint Surgery -
American Volume. 2004;86(12):2600-2606.
48. Medical Advisory S. Balloon kyphoplasty: an evidence-based analysis. Ontario Health Technology Assessment Series.
2004;4(12):1-45.
49. Old JL, Calvert M. Vertebral compression fractures in the elderly. American Family Physician. 2004;69(1):111-116.
50. Sabharwal T, Gangi A. Percutaneous vertebroplasty. CME Journal Radiology. 2004;4(2):71-75.
51. Truumees E, Hilibrand A, Vaccaro AR. Percutaneous vertebral augmentation. Spine Journal. 2004;4(2):218-229.
https://doi.org/10.1016/j.spinee.2003.08.029.
52. Winking M, Stahl JP, Oertel M, Schnettler R, Boker DK. Treatment of pain from osteoporotic vertebral collapse by
percutaneous PMMA vertebroplasty. Acta Neurochirurgica. 2004;146(5):469-476.
53. Yu SW, Lee PC, Ma CH, Chuang TY, Chen YJ. Vertebroplasty for the Treatment of Osteoporotic Compression Spinal
Fracture: Comparison of Remedial Action at Different Stages of Injury. Journal of Trauma - Injury, Infection and Critical
Care. 2004;56(3):629-632. https://doi.org/10.1097/01.TA.0000053471.73514.2E.
54. Actrn. Efficacy and safety of vertebroplasty for treatment of painful osteoporotic spinal fractures: a randomised
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426
55. Anselmetti GC, Corgnier A, Debernardi F, Regge D. Treatment of painful compression vertebral fractures with
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56. Brunton S, Carmichael B, Gold D, et al. Vertebral compression fractures in primary care: Recommendations from a
consensus panel. Journal of Family Practice. 2005;54(9):781-788.
57. Cahana A, Seium Y, Diby M, Martin JB, Ruefenacht D, Dietrich PY. Percutaneous vertebroplasty in octogenarians:
results and follow-up. Pain Practice. 2005;5(4):316-323.
58. Do HM, Kim BS, Marcellus ML, Curtis L, Marks MP. Prospective analysis of clinical outcomes after percutaneous
vertebroplasty for painful osteoporotic vertebral body fractures. Ajnr: American Journal of Neuroradiology.
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59. Gardner MJ, Demetrakopoulos D, Shindle MK, Griffith MH, Lane JM. Prevention and treatment of osteoporotic
fractures. Minerva Medica. 2005;96(5):343-352.
60. Grafe IA, Da Fonseca K, Hillmeier J, et al. Reduction of pain and fracture incidence after kyphoplasty: 1-Year outcomes
of a prospective controlled trial of patients with primary osteoporosis. Osteoporosis International. 2005;16(12):2005-
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61. Hacein-Bey L, Baisden JL, Lemke DM, Wong SJ, Ulmer JL, Cusick JF. Treating osteoporotic and neoplastic vertebral
compression fractures with vertebroplasty and kyphoplasty. Journal of Palliative Medicine. 2005;8(5):931-938.
62. Hee HT. Percutaneous vertebroplasty: current concepts and local experience. Neurology India. 2005;53(4):475-482.
63. Hu MM, Eskey CJ, Tong SC, et al. Kyphoplasty for vertebral compression fracture via a uni-pedicular approach. Pain
Physician. 2005;8(4):363-367.
64. Kaplan RJ, Vo AN, Stitik TP, Kamen LB, Bitar AA, Shih VC. Rehabilitation of orthopedic and rheumatologic disorders. 1.
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65. Kasperk C, Hillmeier J, Noldge G, et al. Treatment of painful vertebral fractures by kyphoplasty in patients with
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66. Kim TK, Kim KH, Kim CH, et al. Percutaneous vertebroplasty and facet joint block. Journal of Korean Medical Science.
2005;20(6):1023-1028.
67. Kobayashi K, Shimoyama K, Nakamura K, Murata K. Percutaneous vertebroplasty immediately relieves pain of
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68. Kumar K, Verma AK, Wilson J, LaFontaine A. Vertebroplasty in osteoporotic spine fractures: A quality of life
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69. Lee JY, Lim MR, Ludwig SC, Elias I, Kuklo TR, Vaccaro AR. Vertebroplasty and kyphoplasty for vertebral compression
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70. Liliang PC, Su TM, Liang CL, Chen HJ, Tsai YD, Lu K. Percutaneous vertebroplasty improves pain and physical
functioning in elderly osteoporotic vertebral compression fracture patients. Gerontology. 2005;51(1):34-39.
71. Link TM, Guglielmi G, Kuijk C, Adams JE. Radiologic assessment of osteoporotic vertebral fractures: Diagnostic and
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72. Nakano M, Hirano N, Ishihara H, Kawaguchi Y, Matsuura K. Calcium phosphate cement leakage after percutaneous
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73. Nct. VERTOS-II. Percutaneous Vertebroplasty Versus Conservative Therapy.
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74. Palussiere J, Berge J, Gangi A, et al. Clinical results of an open prospective study of a bis-GMA composite in
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75. Peh WCG, Gilula LA. Percutaneous vertebroplasty: An update. Seminars in Ultrasound, CT and MRI. 2005;26(2):52-64.
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77. Babb A, Carlson WO. Vertebral compression fractures: treatment and evaluation. South Dakota Medicine: The Journal
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78. Cheung G, Chow E, Holden L, et al. Percutaneous vertebroplasty in patients with intractable pain from osteoporotic or
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79. Deen HG. Current status of percutaneous vertebral augmentation techniques for vertebral compression fractures.
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80. Deen HG, Aranda-Michel J, Reimer R, Miller DA, Putzke JD. Balloon kyphoplasty for vertebral compression fractures in
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81. Diamond TH, Bryant C, Browne L, Clark WA. Clinical outcomes after acute osteoporotic vertebral fractures: a 2-year
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82. Eichholz KM, O'Toole JE, Christie SD, Fessler RG. Vertebroplasty and Kyphoplasty. Neurosurgery Clinics of North
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84. Kim DH, Vaccaro AR. Osteoporotic compression fractures of the spine; current options and considerations for
treatment. Spine Journal: Official Journal of the North American Spine Society. 2006;6(5):479-487.
85. Lavelle WF, Cheney R. Recurrent fracture after vertebral kyphoplasty. Spine Journal. 2006;6(5):488-493.
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86. Moroni A, Hoang-Kim A, Lio V, Giannini S. Current augmentation fixation techniques for the osteoporotic patient.
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87. Nakano M, Hirano N, Ishihara H, Kawaguchi Y, Watanabe H, Matsuura K. Calcium phosphate cement-based
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88. Nct. KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body
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92. Prather H, Van Dillen L, Metzler JP, Riew KD, Gilula LA. Prospective measurement of function and pain in patients with
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93. Satre TJ, Mackler L. Who should receive vertebroplasty? Journal of Family Practice. 2006;55(7):637-638.
94. Shen MS, Kim YH. Vertebroplasty and kyphoplasty: Treatment techniques for managing osteoporotic vertebral
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95. Shindle MK, Gardner MJ, Koob J, Bukata S, Cabin JA, Lane JM. Vertebral height restoration in osteoporotic
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96. Shindle MK, Shindle L, Gardner MJ, Lane JM. Supportive care aspects of vertebroplasty and kyphoplasty in patients
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97. Singh AK, Pilgram TK, Gilula LA. Osteoporotic compression fractures: outcomes after single- versus multiple-level
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98. Syed M, Jan S, Patel NA, et al. Vertebroplasty: The alternative treatment for osteoporotic vertebral compression
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99. Tanigawa N, Komemushi A, Kariya S, Kojima H, Shomura Y, Sawada S. Radiological follow-up of new compression
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101. Vallejo R, Benyamin R, Floyd B, Casto JM, Joseph NJ, Mekhail N. Percutaneous cement injection into a created cavity
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103. Voormolen MH, van Rooij WJ, Sluzewski M, et al. Pain response in the first trimester after percutaneous
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Ajnr: American Journal of Neuroradiology. 2006;27(7):1579-1585.
104. Voormolen MH, van Rooij WJ, van der Graaf Y, et al. Bone marrow edema in osteoporotic vertebral compression
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105. Voormolen MHJ, Van Rooij WJ, Van Der Graaf Y, et al. Bone marrow edema in osteoporotic vertebral compression
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thoracolumbar spine: Comprehensive evaluations of 5 typical surgical fusion techniques. Journal of Orthopaedic
Science. 2019;24(6):1020-1026. https://doi.org/https://dx.doi.org/10.1016/j.jos.2019.07.018.
273. Watanabe K, Katsumi K, Ohashi M, et al. Surgical outcomes of spinal fusion for osteoporotic thoracolumbar vertebral
fractures in patients with Parkinson's disease: what is the impact of Parkinson's disease on surgical outcome? BMC
Musculoskeletal Disorders. 2019;20(1):103. https://doi.org/https://dx.doi.org/10.1186/s12891-019-2473-8.
274. Wu Y, Chen CH, Tsuang FY, Lin YC, Chiang CJ, Kuo YJ. The stability of long-segment and short-segment fixation for
treating severe burst fractures at the thoracolumbar junction in osteoporotic bone: A finite element analysis. PLoS
ONE [Electronic Resource]. 2019;14(2):e0211676. https://doi.org/https://dx.doi.org/10.1371/journal.pone.0211676.
275. Zhong R, Liu J, Wang R, et al. Unilateral curved versus bipedicular vertebroplasty in the treatment of osteoporotic
vertebral compression fractures. BMC surgery. 2019;19(1):193. https://doi.org/https://dx.doi.org/10.1186/s12893-
019-0653-y.
276. Zhong W, Liang X, Luo X, Quan Z. Vertebroplasty and vertebroplasty in combination with intermediate bilateral
pedicle screw fixation for OF4 in osteoporotic vertebral compression fractures: a retrospective single-Centre cohort
study. BMC surgery. 2019;19(1):178. https://doi.org/https://dx.doi.org/10.1186/s12893-019-0646-x.
277. Zidan I, Khedr W, Fayed AA, Farhoud A. Retroperitoneal Extrapleural Approach for Corpectomy of the First Lumbar
Vertebra : Technique and Outcome. Journal of Korean Neurosurgical Society. 2019;62(1):61-70.
https://doi.org/https://dx.doi.org/10.3340/jkns.2017.0271.
278. Chi JE, Hsu JY, Chan R, Lo WC, Chiang YH, Lin JH. Kyphoplasty with an intravertebral reduction device for osteoporotic
vertebral compression fractures with spinal canal encroachment. Formosan Journal of Surgery. 2020;53(1):20-28.
https://doi.org/10.4103/fjs.fjs_38_19.
472
279. Ehresman J, Pennington Z, Schilling A, et al. Novel MRI-based score for assessment of bone density in operative spine
patients. Spine Journal: Official Journal of the North American Spine Society. 2020;20(4):556-562.
https://doi.org/https://dx.doi.org/10.1016/j.spinee.2019.10.018.
280. Erichsen CJ, Heyde CE, Josten C, et al. Percutaneous versus open posterior stabilization in AOSpine type A3
thoracolumbar fractures. BMC Musculoskeletal Disorders. 2020;21(1):74.
https://doi.org/https://dx.doi.org/10.1186/s12891-020-3099-6.
281. Fatima N, Massaad E, Hadzipasic M, Shankar GM, Shin JH. Assessment of the efficacy of teriparatide treatment for
osteoporosis on lumbar fusion surgery outcomes: a systematic review and meta-analysis. Neurosurgical Review.
2020;30:30. https://doi.org/https://dx.doi.org/10.1007/s10143-020-01359-3.
282. Hsu WL, Lin YH, Chuang HY, et al. Cortical Bone Trajectory Instrumentation with Vertebroplasty for Osteoporotic
Thoracolumbar Compression Fracture. Medicina. 2020;56(2):17.
https://doi.org/https://dx.doi.org/10.3390/medicina56020082.
283. Huang IKH, Pua U, Quek LHH, Kwan J, Lim GHT. Cone-beam computed tomography guided unipedicular central
stentoplasty of the thoracolumbar spine: Early technical experience and results. Journal of Medical Imaging and
Radiation Oncology. 2020;64(5):620-625. https://doi.org/10.1111/1754-9485.13067.
284. Jacobs E, McCrum C, Senden R, van Rhijn LW, Meijer K, Willems PC. Gait in patients with symptomatic osteoporotic
vertebral compression fractures over 6 months of recovery. Aging-Clinical & Experimental Research. 2020;32(2):239-
246. https://doi.org/https://dx.doi.org/10.1007/s40520-019-01203-9.
285. Kawabata A, Yoshii T, Hirai T, et al. Effect of bisphosphonates or teriparatide on mechanical complications after
posterior instrumented fusion for osteoporotic vertebral fracture: a multi-center retrospective study. BMC
Musculoskeletal Disorders. 2020;21(1):420. https://doi.org/https://dx.doi.org/10.1186/s12891-020-03452-6.
286. Kweh BTS, Lee HQ, Tan T, et al. The Role of Spinal Orthoses in Osteoporotic Vertebral Fractures of the Elderly
Population (Age 60 Years or Older): Systematic Review. Global Spine Journal. 2020:2192568220948036.
https://doi.org/https://dx.doi.org/10.1177/2192568220948036.
287. Liu G, Liu B, Yang Y, Tian L, Liu Y, Wang J. Minimally invasive percutaneous pedicle screw fixation versus open pedicle
screw fixation for senile osteoporotic vertebral fracture. International Journal of Clinical and Experimental Medicine.
2020;13(3):1816-1822.
288. Luo PJ, Tang YC, Zhou TP, et al. Risk Factor Analysis of the Incidence of Subsequent Adjacent Vertebral Fracture After
Lumbar Spinal Fusion Surgery with Instrumentation. World Neurosurgery. 2020;135:e87-e93.
https://doi.org/https://dx.doi.org/10.1016/j.wneu.2019.11.010.
289. Machino M, Ando K, Kobayashi K, et al. A comparative study of two reconstruction procedures for osteoporotic
vertebral fracture with lumbar spinal stenosis: Posterior lumbar interbody fusion versus posterior and anterior and
combined surgery. Journal of Orthopaedic Science. 2020;25(1):52-57.
https://doi.org/https://dx.doi.org/10.1016/j.jos.2019.02.013.
290. Maruo K, Arizumi F, Kusuyama K, Kishima K, Tachibana T. Incidence and Risk Factors of Anterior Longitudinal Ligament
Rupture After Posterior Corrective Surgery Using Lateral Lumbar Interbody Fusion for Adult Spinal Deformity. Clinical
Spine Surgery : A Spine Publication. 2020;28:28. https://doi.org/https://dx.doi.org/10.1097/BSD.0000000000001000.
291. Meyblum L, Premat K, Elhorany M, et al. Safety of vertebral augmentation with cranio-caudal expansion implants in
vertebral compression fractures with posterior wall protrusion. European Radiology. 2020;30(10):5641-5649.
https://doi.org/https://dx.doi.org/10.1007/s00330-020-06889-4.
292. Murata K, Matsuoka Y, Nishimura H, et al. The factors related to the poor ADL in the patients with osteoporotic
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https://doi.org/https://dx.doi.org/10.1007/s00586-019-06092-0.
293. Rometsch E, Spruit M, Zigler JE, et al. Screw-Related Complications After Instrumentation of the Osteoporotic Spine: A
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https://doi.org/https://dx.doi.org/10.1177/2192568218818164.
473
294. Taiji R, Takami M, Yukawa Y, et al. A short-segment fusion strategy using a wide-foot-plate expandable cage for
vertebral pseudarthrosis after an osteoporotic vertebral fracture. Journal of Neurosurgery Spine. 2020:1-8.
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295. van den Berg P, Schweitzer DH, van Haard PMM, Geusens PP, van den Bergh JP. The use of pulse-echo ultrasound in
women with a recent non-vertebral fracture to identify those without osteoporosis and/or a subclinical vertebral
fracture: a pilot study. Archives of Osteoporosis. 2020;15(1):56. https://doi.org/https://dx.doi.org/10.1007/s11657-
020-00730-7.
Question 6.5 – Interventional Treatment (Height Loss)
1. Garfin SR, Yuan HA, Reiley MA. New technologies in spine: kyphoplasty and vertebroplasty for the treatment of
painful osteoporotic compression fractures. Spine. 2001;26(14):1511-1515.
2. Lieberman IH, Dudeney S, Reinhardt MK, Bell G. Initial outcome and efficacy of "kyphoplasty" in the treatment of
painful osteoporotic vertebral compression fractures. Spine. 2001;26(14):1631-1638.
3. Cortet B, Roches E, Logier R, et al. Evaluation of spinal curvatures after a recent osteoporotic vertebral fracture. Joint,
Bone, Spine: Revue du Rhumatisme. 2002;69(2):201-208.
4. Garfin SR, Reilley MA. Minimally invasive treatment of osteoporotic vertebral body compression fractures. Spine
Journal: Official Journal of the North American Spine Society. 2002;2(1):76-80.
5. Hardouin P, Fayada P, Leclet H, Chopin D. Kyphoplasty. Joint, Bone, Spine: Revue du Rhumatisme. 2002;69(3):256-261.
6. Nakano M, Hirano N, Matsuura K, et al. Percutaneous transpedicular vertebroplasty with calcium phosphate cement
in the treatment of osteoporotic vertebral compression and burst fractures. Journal of Neurosurgery. 2002;97(3
SUPPL.):287-293.
7. Ortiz AO, Zoarski GH, Beckerman M. Kyphoplasty. Techniques in Vascular and Interventional Radiology. 2002;5(4):239-
249. https://doi.org/10.1053/tvir.2002.36432.
8. Peh WC, Gilula LA, Peck DD. Percutaneous vertebroplasty for severe osteoporotic vertebral body compression
fractures. Radiology. 2002;223(1):121-126.
9. Phillips FM, Todd Wetzel F, Lieberman I, Campbell-Hupp M. An in vivo comparison of the potential for extravertebral
cement leak after vertebroplasty and kyphoplasty. Spine. 2002;27(19):2173-2178; discussion 2178-2179.
10. Theodorou DJ, Theodorou SJ, Duncan TD, Garfin SR, Wong WH. Percutaneous balloon kyphoplasty for the correction
of spinal deformity in painful vertebral body compression fractures. Clinical Imaging. 2002;26(1):1-5.
11. Beattie K, Papaioannou A, Boulos P, Adachi JD. Kyphoplasty and vertebroplasty for the treatment of osteoporotic
vertebral compression fractures. Geriatrics and Aging. 2003;6(2):47-52.
12. Franck H, Boszczyk BM, Bierschneider M, Jaksche H. Interdisciplinary approach to balloon kyphoplasty in the
treatment of osteoporotic vertebral compression fractures. European Spine Journal. 2003;12 Suppl 2:S163-167.
13. Glassman SD, Alegre GM. Adult spinal deformity in the osteoporotic spine: options and pitfalls. Instructional Course
Lectures. 2003;52:579-588.
14. Hillmeier J, Meeder PJ, Nöldge G, Kasperk C. Minimally invasive reduction and internal stabilization of osteoporotic
vertebral body fractures (Balloon Kyphoplasty). Operative Orthopadie und Traumatologie. 2003;15(4):343-362.
https://doi.org/10.1007/s00064-003-1083-6.
15. Kim DH, Silber JS, Albert TJ. Osteoporotic vertebral compression fractures. Instructional Course Lectures. 2003;52:541-
550.
474
16. McKiernan F, Jensen R, Faciszewski T. The dynamic mobility of vertebral compression fractures. Journal of Bone &
Mineral Research. 2003;18(1):24-29.
17. Mehbod A, Aunoble S, Le Huec JC. Vertebroplasty for osteoporotic spine fracture: prevention and treatment.
European Spine Journal. 2003;12 Suppl 2:S155-162.
18. Phillips FM. Minimally invasive treatments of osteoporotic vertebral compression fractures. Spine. 2003;28(15
Suppl):S45-53.
19. Phillips FM, Ho E, Campbell-Hupp M, McNally T, Todd Wetzel F, Gupta P. Early radiographic and clinical results of
balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. Spine. 2003;28(19):2260-
2265; discussion 2265-2267.
20. Tanner SB. Back pain, vertebroplasty, and kyphoplasty: Treatment of osteoporotic vertebral compression fractures.
Bulletin on the Rheumatic Diseases. 2003;52(2).
21. Weisskopf M, Herlein S, Birnbaum K, Siebert C, Stanzel S, Wirtz DC. Kyphoplasty - a new minimally invasive treatment
for repositioning and stabilising vertebral bodies. Zeitschrift fur orthopadie und ihre grenzgebiete. 2003;141(4):406‐
411. https://doi.org/10.1055/s-2003-41564.
22. Youssef JA, Salas VM, Loschiavo RG. Management of painful osteoporotic vertebral compression fractures:
Vertebroplasty and kyphoplasty. Operative Techniques in Orthopaedics. 2003;13(3):222-226.
https://doi.org/10.1016/S1048-6666(03)00018-1.
23. Berlemann U, Franz T, Orler R, Heini PF. Kyphoplasty for treatment of osteoporotic vertebral fractures: a prospective
non-randomized study. European Spine Journal. 2004;13(6):496-501.
24. Francis RM, Baillie SP, Chuck AJ, et al. Acute and long-term management of patients with vertebral fractures. QJM -
Monthly Journal of the Association of Physicians. 2004;97(2):63-74. https://doi.org/10.1093/qjmed/hch012.
25. Heini PF, Orler R. Kyphoplasty for treatment of osteoporotic vertebral fractures. European Spine Journal.
2004;13(3):184-192.
26. Lee ST, Chen JF. Closed reduction vertebroplasty for the treatment of osteoporotic vertebral compression fractures.
Technical note. Journal of Neurosurgery. 2004;100(4 Suppl Spine):392-396.
27. Lieberman IH, Phillips FM, Togawa D, et al. Vertebral augmentation and the limits of interpreting complications
reported in the food and drug administration manufacturer and user facility device experience database. Journal of
Vascular and Interventional Radiology. 2004;15(11):1193-1196.
https://doi.org/10.1097/01.RVI.0000136028.86147.A4.
28. Medical Advisory S. Balloon kyphoplasty: an evidence-based analysis. Ontario Health Technology Assessment Series.
2004;4(12):1-45.
29. Rhyne A, 3rd, Banit D, Laxer E, Odum S, Nussman D. Kyphoplasty: report of eighty-two thoracolumbar osteoporotic
vertebral fractures. Journal of Orthopaedic Trauma. 2004;18(5):294-299.
30. Sabharwal T, Gangi A. Percutaneous vertebroplasty. CME Journal Radiology. 2004;4(2):71-75.
31. Alvarez L, Perez-Higueras A, Granizo JJ, de Miguel I, Quinones D, Rossi RE. Predictors of outcomes of percutaneous
vertebroplasty for osteoporotic vertebral fractures. Spine. 2005;30(1):87-92.
32. Ambrosanio G, Lavanga A, Vassallo P, Izzo R, Diano AA, Muto M. Vertebroplasty in the treatment of spine disease.
Interventional Neuroradiology. 2005;11(4):309-323.
33. Armsen N, Boszczyk B. Vertebro-/kyphoplasty history, development, results. European Journal of Trauma.
2005;31(5):433-441. https://doi.org/10.1007/s00068-005-2103-z.
34. Atalay B, Caner H, Gokce C, Altinors N. Kyphoplasty: 2 years of experience in a neurosurgery department. Surgical
Neurology. 2005;64 Suppl 2:S72-76.
475
35. Brunton S, Carmichael B, Gold D, et al. Vertebral compression fractures in primary care: Recommendations from a
consensus panel. Journal of Family Practice. 2005;54(9):781-788.
36. Dublin AB, Hartman J, Latchaw RE, Hald JK, Reid MH. The vertebral body fracture in osteoporosis: restoration of
height using percutaneous vertebroplasty. Ajnr: American Journal of Neuroradiology. 2005;26(3):489-492.
37. Feltes C, Fountas KN, Machinis T, et al. Immediate and early postoperative pain relief after kyphoplasty without
significant restoration of vertebral body height in acute osteoporotic vertebral fractures. Neurosurgical Focus.
2005;18(3):e5.
38. Gaitanis IN, Hadjipavlou AG, Katonis PG, Tzermiadianos MN, Pasku DS, Patwardhan AG. Balloon kyphoplasty for the
treatment of pathological vertebral compressive fractures. European Spine Journal. 2005;14(3):250-260.
39. Grohs JG, Matzner M, Trieb K, Krepler P. Minimal invasive stabilization of osteoporotic vertebral fractures: a
prospective nonrandomized comparison of vertebroplasty and balloon kyphoplasty. Journal of Spinal Disorders &
Techniques. 2005;18(3):238-242.
40. Heini PF. The current treatment--a survey of osteoporotic fracture treatment. Osteoporotic spine fractures: the spine
surgeon's perspective. Osteoporosis International. 2005;16 Suppl 2:S85-92.
41. Kasperk C, Hillmeier J, Noldge G, et al. Treatment of painful vertebral fractures by kyphoplasty in patients with
primary osteoporosis: a prospective nonrandomized controlled study. Journal of Bone & Mineral Research.
2005;20(4):604-612.
42. Majd ME, Farley S, Holt RT. Preliminary outcomes and efficacy of the first 360 consecutive kyphoplasties for the
treatment of painful osteoporotic vertebral compression fractures. Spine Journal: Official Journal of the North
American Spine Society. 2005;5(3):244-255.
43. McKiernan F, Faciszewski T, Jensen R. Does vertebral height restoration achieved at vertebroplasty matter? Journal of
Vascular & Interventional Radiology. 2005;16(7):973-979.
44. Ortiz AO, Buonocore BJ, Zoarski GH. Height restoration following kyphoplasty for treatment of painful osteoporotic
vertebral compression fractures. Journal of Women's Imaging. 2005;7(3):102-110.
https://doi.org/10.1097/01.jwi.0000179611.18896.88.
45. Singh K, Heller JG, Samartzis D, et al. Open vertebral cement augmentation combined with lumbar decompression for
the operative management of thoracolumbar stenosis secondary to osteoporotic burst fractures. Journal of Spinal
Disorders & Techniques. 2005;18(5):413-419.
46. Voggenreiter G. Balloon kyphoplasty is effective in deformity correction of osteoporotic vertebral compression
fractures. Spine. 2005;30(24):2806-2812.
47. Chang CY, Teng MM, Wei CJ, Luo CB, Chang FC. Percutaneous vertebroplasty for patients with osteoporosis: a one-
year follow-up. Acta Radiologica. 2006;47(6):568-573.
48. Chin DK, Kim YS, Cho YE, Shin JJ. Efficacy of postural reduction in osteoporotic vertebral compression fractures
followed by percutaneous vertebroplasty. Neurosurgery. 2006;58(4):695-700; discussion 695-700.
49. Deramond H, Saliou G, Aveillan M, Lehmann P, Vallee JN. Respective contributions of vertebroplasty and kyphoplasty
to the management of osteoporotic vertebral fractures. Joint, Bone, Spine: Revue du Rhumatisme. 2006;73(6):610-
613.
50. Hsu YH, Hueng DY, Ma HI, Liu MY, Chiang YH. Treatment of osteoporotic vertebral fracture by percutaneous
vertebroplasty or kyphoplasty. Journal of Medical Sciences. 2006;26(1):5-12.
51. Hulme PA, Krebs J, Ferguson SJ, Berlemann U. Vertebroplasty and kyphoplasty: a systematic review of 69 clinical
studies. Spine. 2006;31(17):1983-2001.
476
52. Machinis TG, Fountas KN, Feltes CH, Johnston KW, Robinson JS. Pain outcome and vertebral body height restoration
in patients undergoing kyphoplasty. Southern Medical Journal. 2006;99(5):457-460.
53. McKiernan F, Faciszewski T, Jensen R. Latent mobility of osteoporotic vertebral compression fractures. Journal of
Vascular and Interventional Radiology. 2006;17(9):1479-1487. https://doi.org/10.1097/01.RVI.0000235742.26624.37.
54. Mirovsky Y, Anekstein Y, Shalmon E, Blankstein A, Peer A. Intradiscal cement leak following percutaneous
vertebroplasty. Spine. 2006;31(10):1120-1124.
55. Nakano M, Hirano N, Ishihara H, Kawaguchi Y, Watanabe H, Matsuura K. Calcium phosphate cement-based
vertebroplasty compared with conservative treatment for osteoporotic compression fractures: a matched case-
control study. Journal of Neurosurgery Spine. 2006;4(2):110-117.
56. Nct. A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis.
https://clinicaltrialsgov/show/NCT00290862. 2006.
57. Orler R, Frauchiger LH, Lange U, Heini PF. Lordoplasty: report on early results with a new technique for the treatment
of vertebral compression fractures to restore the lordosis. European Spine Journal. 2006;15(12):1769-1775.
58. Park YS, Cho WJ, Cho JL. Comparison of the Result of Vertebroplasty and Conservative Treatment in Osteoporotic
Vertebral Compression Fracture. Journal of the korean fracture society. 2006;19(3):363‐368.
59. Pflugmacher R, Schroeder RJ, Klostermann CK. Incidence of adjacent vertebral fractures in patients treated with
balloon kyphoplasty: two years' prospective follow-up. Acta Radiologica. 2006;47(8):830-840.
60. Pippan MC, Richter M. Spinal body reconstruction in osteoporosis. European Journal of Trauma. 2006;32(3):238-243.
https://doi.org/10.1007/s00068-006-6025-1.
61. Pradhan BB, Bae HW, Kropf MA, Patel VV, Delamarter RB. Kyphoplasty reduction of osteoporotic vertebral
compression fractures: correction of local kyphosis versus overall sagittal alignment. Spine. 2006;31(4):435-441.
62. Rohlmann A, Zander T, Bergmann G. Spinal loads after osteoporotic vertebral fractures treated by vertebroplasty or
kyphoplasty. European Spine Journal. 2006;15(8):1255-1264.
63. Shindle MK, Gardner MJ, Koob J, Bukata S, Cabin JA, Lane JM. Vertebral height restoration in osteoporotic
compression fractures: kyphoplasty balloon tamp is superior to postural correction alone. Osteoporosis International.
2006;17(12):1815-1819.
64. Shindle MK, Shindle L, Gardner MJ, Lane JM. Supportive care aspects of vertebroplasty and kyphoplasty in patients
with cancer. Supportive Cancer Therapy. 2006;3(4):214-219.
https://doi.org/https://dx.doi.org/10.3816/SCT.2006.n.019.
65. Wu CT, Lee SC, Lee ST, Chen JF. Classification of symptomatic osteoporotic compression fractures of the thoracic and
lumbar spine. Journal of Clinical Neuroscience. 2006;13(1):31-38.
66. Zhang Q, Zou DW, Hai Y, Ma HS, Bai KW. Balloon kyphoplasty: an experience of 38 patients with painful osteoporotic
vertebral compressive fractures. Chinese Journal of Traumatology. 2006;9(4):206-210.
67. Alanay A, Pekmezci M, Karaeminogullari O, et al. Radiographic measurement of the sagittal plane deformity in
patients with osteoporotic spinal fractures evaluation of intrinsic error. European Spine Journal. 2007;16(12):2126-
2132.
68. Cho YJ, Choi JH, Cho SM. Vertebroplasty utilizing percutaneous vertebral body access (PVBA) technique for
osteoporotic vertebral compression fractures in the middle thoracic vertebrae. Journal of Korean Neurosurgical
Society. 2007;41(3):161-165. https://doi.org/10.3340/jkns.2007.41.3.161.
69. Foo LS, Yeo W, Fook S, et al. Results, experience and technical points learnt with use of the SKy Bone Expander
kyphoplasty system for osteoporotic vertebral compression fractures: a prospective study of 40 patients with a
minimum of 12 months of follow-up. European Spine Journal. 2007;16(11):1944-1950.
477
70. Fuentes S, Metellus P, Pech-Gourg G, Adetchessi T, Dufour H, Grisoli F. Open kyphoplasty for management of
metastatic and severe osteoporotic spinal fracture. Technical note. Journal of Neurosurgery Spine. 2007;6(3):284-288.
71. Guglielmino A, Sorbello M, Barbagallo G, et al. Osteoporotic vertebral compression fracture pain (back pain): our
experience with balloon kyphoplasty. Minerva Anestesiologica. 2007;73(1-2):77-100.
72. Hiwatashi A, Westesson PL. Vertebroplasty for osteoporotic fractures with spinal canal compromise. Ajnr: American
Journal of Neuroradiology. 2007;28(4):690-692.
73. Kim HS, Kim SW, Ju CI. Balloon Kyphoplasty through Extrapedicular Approach in the Treatment of Middle Thoracic
Osteoporotic Compression Fracture : T5-T8 Level. Journal of Korean Neurosurgical Society. 2007;42(5):363-366.
https://doi.org/https://dx.doi.org/10.3340/jkns.2007.42.5.363.
74. Lee JH, Kwon JT, Kim YB, Suk JS. Segmental deformity correction after balloon kyphoplasty in the osteoporotic
vertebral compression fracture. Journal of Korean Neurosurgical Society. 2007;42(5):371-376.
https://doi.org/https://dx.doi.org/10.3340/jkns.2007.42.5.371.
75. Lee TO, Jo DJ, Kim SM. Outcome and efficacy of height gain and sagittal alignment after kyphoplasty of osteoporotic
vertebral compression fractures. Journal of Korean Neurosurgical Society. 2007;42(4):271-275.
https://doi.org/https://dx.doi.org/10.3340/jkns.2007.42.4.271.
76. Manson NA, Phillips FM. Minimally invasive techniques for the treatment of osteoporotic vertebral fractures.
Instructional Course Lectures. 2007;56:273-285.
77. Mao KY, Liu BW, Wang Y, et al. Effect of carbonated hydroxyapatite cement for filing vertebral body on the vertebral
heights and pain in patients with osteoporotic vertebral compression fractures. Journal of Clinical Rehabilitative
Tissue Engineering Research. 2007;11(1):188-190.
78. Mohit AA, Orr RD. Percutaneous vertebral augmentation in osteoporotic fractures. Current Opinion in Orthopaedics.
2007;18(3):221-225. https://doi.org/10.1097/BCO.0b013e32813aeafd.
79. Ryu KS, Park CK, Kim MK, Kim DH. Single balloon kyphoplasty using far-lateral extrapedicular approach: technical note
and preliminary results. Journal of Spinal Disorders & Techniques. 2007;20(5):392-398.
80. Siemionow K, Lieberman IH. Vertebral augmentation in osteoporosis and bone metastasis. Current Opinion in
Supportive & Palliative Care. 2007;1(4):323-327. https://doi.org/https://dx.doi.org/10.1097/SPC.0b013e3282f33714.
81. Stoffel M, Wolf I, Ringel F, Stuer C, Urbach H, Meyer B. Treatment of painful osteoporotic compression and burst
fractures using kyphoplasty: a prospective observational design. Journal of Neurosurgery Spine. 2007;6(4):313-319.
82. Taylor RS, Fritzell P, Taylor RJ. Balloon kyphoplasty in the management of vertebral compression fractures: an
updated systematic review and meta-analysis. European Spine Journal. 2007;16(8):1085-1100.
83. Yang HL, Zhao L, Liu J, et al. Changes of pulmonary function for patients with osteoporotic vertebral compression
fractures after kyphoplasty. Journal of Spinal Disorders & Techniques. 2007;20(3):221-225.
84. Yi WJ, Lee JH, Lee HG, Ryu KY, Kang DG, Kim SC. Efficacy and safety of balloon kyphoplasty in the treatment of
osteoporotic vertebral body compression fractres: Compared with vertebroplasty. Journal of Korean Neurosurgical
Society. 2007;42(2):112-117.
85. An KC, Kang S, Choi JS, Seo JH. The clinical and radiological availability of percutaneous balloon kyphoplasty as a
treatment for osteoporotic burst fractures. Asian Spine Journal. 2008;2(1):9-14.
https://doi.org/https://dx.doi.org/10.4184/asj.2008.2.1.9.
86. Becker S, Tuschel A, Chavanne A, Meissner J, Ogon M. Balloon kyphoplasty for vertebra plana with or without
osteonecrosis. Journal of Orthopaedic Surgery. 2008;16(1):14-19.
87. Chung HJ, Chung KJ, Yoon HS, Kwon IH. Comparative study of balloon kyphoplasty with unilateral versus bilateral
approach in osteoporotic vertebral compression fractures. International Orthopaedics. 2008;32(6):817-820.
478
88. Doo TH, Shin DA, Kim HI, et al. Clinical relevance of pain patterns in osteoporotic vertebral compression fractures.
Journal of Korean Medical Science. 2008;23(6):1005-1010.
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89. Francis RM, Aspray TJ, Hide G, Sutcliffe AM, Wilkinson P. Back pain in osteoporotic vertebral fractures. Osteoporosis
International. 2008;19(7):895-903.
90. Korovessis P, Zacharatos S, Repantis T, Michael A, Karachalios D. Evolution of bone mineral density after
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546. Lin TY, Liu YC, Wang YC, Chang CW, Wong CB, Fu TS. Cement Augmentation for Single-Level Osteoporotic Vertebral
Compression Fracture: Comparison of Vertebroplasty With High-Viscosity Cement and Kyphoplasty. World
Neurosurgery. 2020;141:e266-e270. https://doi.org/https://dx.doi.org/10.1016/j.wneu.2020.05.107.
547. Liu MX, Xia L, Zhong J, Dou NN, Li B. Is it necessary to approach the compressed vertebra bilaterally during the process
of PKP? Journal of Spinal Cord Medicine. 2020;43(2):201-205.
https://doi.org/https://dx.doi.org/10.1080/10790268.2018.1451238.
548. Lu X, Yang J, Zhu Z, et al. Changes of the adjacent discs and vertebrae in patients with osteoporotic vertebral
compression fractures treated with or without bone cement augmentation. Spine Journal: Official Journal of the North
American Spine Society. 2020;20(7):1048-1055. https://doi.org/https://dx.doi.org/10.1016/j.spinee.2020.02.012.
549. Luo K, Jiang G, Zhu J, et al. Poly(methyl methacrylate) bone cement composited with mineralized collagen for
osteoporotic vertebral compression fractures in extremely old patients. Regenerative Biomaterials. 2020;7(1):29-34.
https://doi.org/https://dx.doi.org/10.1093/rb/rbz045.
550. Lv B, Ji P, Fan X, et al. Clinical Efficacy of Different Bone Cement Distribution Patterns in Percutaneous Kyphoplasty: A
Retrospective Study. Pain Physician. 2020;23(4):E409-E416.
508
551. Ma Y, Wu X, Xiao X, et al. Effects of teriparatide versus percutaneous vertebroplasty on pain relief, quality of life and
cost-effectiveness in postmenopausal females with acute osteoporotic vertebral compression fracture: A prospective
cohort study. Bone. 2020;131:115154. https://doi.org/https://dx.doi.org/10.1016/j.bone.2019.115154.
552. Ma Z, Jiao J, Yang D, Ding W. Posterior Vertebral Column Resection Combined With Bone Cement Augmentation of
Pedicle Screw Fixation for Treatment of Severe Vertebral Compression Fractures With Kyphotic Deformity: A
Retrospective Case Series. Clinical Spine Surgery : A Spine Publication. 2020;33(6):E269-E275.
https://doi.org/https://dx.doi.org/10.1097/BSD.0000000000000941.
553. Meyblum L, Premat K, Elhorany M, et al. Safety of vertebral augmentation with cranio-caudal expansion implants in
vertebral compression fractures with posterior wall protrusion. European Radiology. 2020;30(10):5641-5649.
https://doi.org/https://dx.doi.org/10.1007/s00330-020-06889-4.
554. Miao F, Zeng X, Wang W, Zhao Z. Percutaneous vertebroplasty with high- versus low-viscosity bone cement for
osteoporotic vertebral compression fractures. Journal of Orthopaedic Surgery. 2020;15(1):302.
https://doi.org/https://dx.doi.org/10.1186/s13018-020-01835-y.
555. Mishra PK, Dwivedi R, Dhillon CS. Osteoporotic Vertebral Compression Fracture and Single Balloon Extrapedicular
Kyphoplasty: Findings and Technical Considerations. Bulletin of Emergency & Trauma. 2020;8(1):34-40.
https://doi.org/https://dx.doi.org/10.29252/beat-080106.
556. Moulin B, Delpla A, Tselikas L, et al. Multi-Level Vertebroplasty for 6 or More Painful Osteoporotic Vertebral Body
Compression Fractures Performed in the Same Procedural Setting: A Safety and Efficacy Report in Cancer Patients.
Cardiovascular & Interventional Radiology. 2020;43(7):1041-1048.
https://doi.org/https://dx.doi.org/10.1007/s00270-020-02480-y.
557. Nguyen DH, Vu DD, Doan TN, Vo HL. Safety of Balloon Kyphoplasty in the Treatment of Thoracic Osteoporotic
Vertebral Compression Fractures in Vietnamese Patients. Clinics in Orthopedic Surgery. 2020;12(2):209-216.
https://doi.org/https://dx.doi.org/10.4055/cios19160.
558. Oishi Y, Nakamura E, Murase M, et al. Presence or absence of adjacent vertebral fractures has no effect on long-term
global alignment and quality of life in patients with osteoporotic vertebral fractures treated with balloon kyphoplasty.
Journal of Orthopaedic Science. 2020;25(6):931-937. https://doi.org/https://dx.doi.org/10.1016/j.jos.2019.12.001.
559. Palmowski Y, Balmer S, Burger J, Schomig F, Hu Z, Pumberger M. Influence of operative timing on the early post-
operative radiological and clinical outcome after kyphoplasty. European Spine Journal. 2020;29(10):2560-2567.
https://doi.org/https://dx.doi.org/10.1007/s00586-020-06491-8.
560. Pan M, Ge J, Li Q, et al. Percutaneous vertebral augmentation in special Genant IV osteoporotic vertebral compression
fractures. Journal of Orthopaedic Translation. 2020;20:94-99.
https://doi.org/https://dx.doi.org/10.1016/j.jot.2019.07.002.
561. Qin R, Zhang X, Liu H, Zhou B, Zhou P, Hu C. Application of Anchoring Technique in Unilateral Percutaneous
Vertebroplasty for Neurologically Intact Kummell's Disease. Pain Research & Management. 2020;2020:4145096.
https://doi.org/https://dx.doi.org/10.1155/2020/4145096.
562. Song S, Liu S, Wang YK, Zhang CQ. A comparative study on the treatment of osteoporotic vertebral compression
fracture with different injection volumes of high viscosity bone cement in percutaneous vertebroplasty. Indian Journal
of Pharmaceutical Sciences. 2020;82:103-106. https://doi.org/10.36468/pharmaceutical-sciences.spl.19.
563. Sonmez E, Comert S, Akdur A, et al. Balloon Kyphoplasty Is a Safe and Effective Option for the Treatment of Vertebral
Compression Fractures in Solid-Organ Transplant Recipients. Experimental & Clinical Transplantation: Official Journal
of the Middle East Society for Organ Transplantation. 2020;18(1):53-59.
https://doi.org/https://dx.doi.org/10.6002/ect.2016.0035.
564. Spiegl UJ, Ahrberg AB, Anemuller C, et al. Which anatomic structures are responsible for the reduction loss after
hybrid stabilization of osteoporotic fractures of the thoracolumbar spine? BMC Musculoskeletal Disorders.
2020;21(1):54. https://doi.org/https://dx.doi.org/10.1186/s12891-020-3065-3.
509
565. Sun X, Liu X, Wang J, et al. The Effect of Early Limited Activity after Bipedicular Percutaneous Vertebroplasty to Treat
Acute Painful Osteoporotic Vertebral Compression Fractures. Pain Physician. 2020;23(1):E31-E40.
566. Tan L, Wen B, Guo Z, Chen Z. The effect of bone cement distribution on the outcome of percutaneous Vertebroplasty:
a case cohort study. BMC Musculoskeletal Disorders. 2020;21(1):541.
https://doi.org/https://dx.doi.org/10.1186/s12891-020-03568-9.
567. Wang S, Xu H, Ni W, Huang Q, Wang X. Unilateral versus bilateral balloon kyphoplasty in treatment of osteoporotic
vertebral compression fractures: A randomized controlled trial protocol. Medicine. 2020;99(25):e20524.
https://doi.org/https://dx.doi.org/10.1097/MD.0000000000020524.
568. Wei H, Dong C, Zhu Y, Ma H. Analysis of two minimally invasive procedures for osteoporotic vertebral compression
fractures with intravertebral cleft: a systematic review and meta-analysis. Journal of Orthopaedic Surgery.
2020;15(1):401. https://doi.org/https://dx.doi.org/10.1186/s13018-020-01938-6.
569. Yang YS, Tsou YS, Lo WC, Chiang YH, Lin JH. Teriparatide Associated with Fewer Refractures and Higher Body Heights
of Cemented Vertebrae after Vertebroplasty: A Matched Cohort Study. Scientific Reports. 2020;10(1):6005.
https://doi.org/https://dx.doi.org/10.1038/s41598-020-62869-0.
570. Yu Z, Sendong H. Comparative efficacy and safety of high-viscosity versus low-viscosity bone cement in the treatment
of osteoporotic vertebral fractures. Indian Journal of Pharmaceutical Sciences. 2020;82:12-15.
https://doi.org/10.36468/pharmaceutical-sciences.spl.3.
571. Zhao P, Guo A, Tan Z, et al. The evaluation of the treatment for old osteoporotic vertebral compression fracture pain
by percutaneous vertebroplasty. Medicine. 2020;99(27):e20479.
https://doi.org/https://dx.doi.org/10.1097/MD.0000000000020479.
572. Zhou Z, Sun Z, Wang Y, Zhu X, Qian Z. Kyphoplasty for occult and non-occult osteoporotic vertebral fractures: a
retrospective study. Journal of International Medical Research. 2020;48(4):300060519894764.
https://doi.org/https://dx.doi.org/10.1177/0300060519894764.
573. Zhu S, Su Q, Zhang Y, Sun Z, Yin P, Hai Y. Risk factors of cemented vertebral refracture after percutaneous vertebral
augmentation: a systematic review and meta-analysis. Neuroradiology. 2020;62(11):1353-1360.
https://doi.org/https://dx.doi.org/10.1007/s00234-020-02495-9.
Question 6.6 – Interventional Treatment (Augmentation Timing)
1. Heini PF, Walchli B, Berlemann U. Percutaneous transpedicular vertebroplasty with PMMA: operative technique and
early results. A prospective study for the treatment of osteoporotic compression fractures. European Spine Journal.
2000;9(5):445-450.
2. Lieberman IH, Dudeney S, Reinhardt MK, Bell G. Initial outcome and efficacy of "kyphoplasty" in the treatment of
painful osteoporotic vertebral compression fractures. Spine. 2001;26(14):1631-1638.
3. Franck H, Boszczyk BM, Bierschneider M, Jaksche H. Interdisciplinary approach to balloon kyphoplasty in the
treatment of osteoporotic vertebral compression fractures. European Spine Journal. 2003;12 Suppl 2:S163-167.
4. Glassman SD, Alegre GM. Adult spinal deformity in the osteoporotic spine: options and pitfalls. Instructional Course
Lectures. 2003;52:579-588.
5. Hart RA. Percutaneous treatment of osteoporotic spinal compression fractures. Current Women's Health Reports.
2003;3(1):72-74.
6. McKiernan F, Faciszewski T. Intravertebral clefts in osteoporotic vertebral compression fractures. Arthritis &
Rheumatism. 2003;48(5):1414-1419.
7. Mehbod A, Aunoble S, Le Huec JC. Vertebroplasty for osteoporotic spine fracture: prevention and treatment.
European Spine Journal. 2003;12 Suppl 2:S155-162.
510
8. Phillips FM. Minimally invasive treatments of osteoporotic vertebral compression fractures. Spine. 2003;28(15
Suppl):S45-53.
9. Hammond A, Riley LH, 3rd, Gailloud P, et al. Treatment considerations for vertebroplasty in men. Ajnr: American
Journal of Neuroradiology. 2004;25(4):639-641.
10. Hoh BL, Rabinov JD, Pryor JC, Hirsch JA. Balloon kyphoplasty for vertebral compression fracture using a unilateral
balloon tamp via a uni-pedicular approach: technical note. Pain Physician. 2004;7(1):111-114.
11. Lieberman IH, Phillips FM, Togawa D, et al. Vertebral augmentation and the limits of interpreting complications
reported in the food and drug administration manufacturer and user facility device experience database. Journal of
Vascular and Interventional Radiology. 2004;15(11):1193-1196.
https://doi.org/10.1097/01.RVI.0000136028.86147.A4.
12. Matsuyama Y, Goto M, Yoshihara H, et al. Vertebral reconstruction with biodegradable calcium phosphate cement in
the treatment of osteoporotic vertebral compression fracture using instrumentation. Journal of Spinal Disorders and
Techniques. 2004;17(4):291-296. https://doi.org/10.1097/01.bsd.0000097253.54459.a6.
13. McKiernan F, Faciszewski T, Jensen R. Quality of life following vertebroplasty. Journal of Bone & Joint Surgery -
American Volume. 2004;86(12):2600-2606.
14. Benyamin R, Vallejo R. Vertebroplasty. Techniques in Regional Anesthesia and Pain Management. 2005;9(2 SPEC.
ISS.):62-67. https://doi.org/10.1053/j.trap.2005.05.003.
15. Feltes C, Fountas KN, Machinis T, et al. Immediate and early postoperative pain relief after kyphoplasty without
significant restoration of vertebral body height in acute osteoporotic vertebral fractures. Neurosurgical Focus.
2005;18(3):e5.
16. Hu MM, Eskey CJ, Tong SC, et al. Kyphoplasty for vertebral compression fracture via a uni-pedicular approach. Pain
Physician. 2005;8(4):363-367.
17. Kim JH, Park KS, Yi S, Shin HC, Yoon DH, Kim KN. Real-time CT fluoroscopy (CTF)-guided vertebroplasty in osteoporotic
spine fractures. Yonsei Medical Journal. 2005;46(5):635-642.
18. Lowe RW, Phillips FM. Percutaneous vertebral augmentation for malignant disease of the spine. Current Opinion in
Orthopaedics. 2005;16(6):489-493. https://doi.org/10.1097/01.bco.0000183680.07036.87.
19. Lavelle WF, Cheney R. Recurrent fracture after vertebral kyphoplasty. Spine Journal. 2006;6(5):488-493.
https://doi.org/10.1016/j.spinee.2005.10.013.
20. Pippan MC, Richter M. Spinal body reconstruction in osteoporosis. European Journal of Trauma. 2006;32(3):238-243.
https://doi.org/10.1007/s00068-006-6025-1.
21. Ryu KS, Park CK, Kim MK, Kim DH. Single balloon kyphoplasty using far-lateral extrapedicular approach: technical note
and preliminary results. Journal of Spinal Disorders & Techniques. 2007;20(5):392-398.
22. Siemionow K, Lieberman IH. Vertebral augmentation in osteoporosis and bone metastasis. Current Opinion in
Supportive & Palliative Care. 2007;1(4):323-327. https://doi.org/https://dx.doi.org/10.1097/SPC.0b013e3282f33714.
23. Huntoon EA, Schmidt CK, Sinaki M. Significantly fewer refractures after vertebroplasty in patients who engage in back-
extensor-strengthening exercises. Mayo Clinic Proceedings. 2008;83(1):54-57. https://doi.org/10.4065/83.1.54.
24. Lavelle WF, Khaleel MA, Cheney R, Demers E, Carl AL. Effect of kyphoplasty on survival after vertebral compression
fractures. Spine Journal: Official Journal of the North American Spine Society. 2008;8(5):763-769.
25. Liu JB, Tang XM, Xu NW, Bao HT. Preliminary results for the treatment of a pain-causing osteoporotic vertebral
compression fracture with a sky bone expander. Korean Journal of Radiology. 2008;9(5):420-425.
https://doi.org/10.3348/kjr.2008.9.5.420.
511
26. Allen RT, Kum JB, Weidner N, Hulst JB, Garfin SR. Biopsy of osteoporotic vertebral compression fractures during
kyphoplasty: unsuspected histologic findings of chronic osteitis without clinical evidence of osteomyelitis. Spine.
2009;34(14):1486-1491. https://doi.org/https://dx.doi.org/10.1097/BRS.0b013e3181a55539.
27. Bayley E, Srinivas S, Boszczyk BM. Clinical outcomes of sacroplasty in sacral insufficiency fractures: a review of the
literature. European Spine Journal. 2009;18(9):1266-1271. https://doi.org/https://dx.doi.org/10.1007/s00586-009-
1048-z.
28. Diel P, Merky D, Roder C, Popp A, Perler M, Heini PF. Safety and efficacy of vertebroplasty: Early results of a
prospective one-year case series of osteoporosis patients in an academic high-volume center. Indian Journal of
Orthopaedics. 2009;43(3):228-233. https://doi.org/https://dx.doi.org/10.4103/0019-5413.53452.
29. Erkan S, Ozalp TR, Yercan HS, Okcu G. Does timing matter in performing kyphoplasty? Acute versus chronic
compression fractures. Acta Orthopaedica Belgica. 2009;75(3):396-404.
30. Izadpanah K, Konrad G, Sudkamp NP, Oberst M. Computer navigation in balloon kyphoplasty reduces the
intraoperative radiation exposure. Spine. 2009;34(12):1325-1329.
https://doi.org/https://dx.doi.org/10.1097/BRS.0b013e3181a18529.
31. Ryu KS, Huh HY, Jun SC, Park CK. Single-balloon kyphoplasty in osteoporotic vertebral compression fractures : far-
lateral extrapedicular approach. Journal of Korean Neurosurgical Society. 2009;45(2):122-126.
https://doi.org/https://dx.doi.org/10.3340/jkns.2009.45.2.122.
32. Schmelzer-Schmied N, Cartens C, Meeder PJ, Dafonseca K. Comparison of kyphoplasty with use of a calcium
phosphate cement and non-operative therapy in patients with traumatic non-osteoporotic vertebral fractures.
European Spine Journal. 2009;18(5):624-629. https://doi.org/https://dx.doi.org/10.1007/s00586-008-0880-x.
33. Siemionow K, Lieberman IH. Vertebral augmentation in osteoporotic and osteolytic fractures. Current Opinion in
Supportive & Palliative Care. 2009;3(3):219-225. https://doi.org/https://dx.doi.org/10.1097/SPC.0b013e32832ea6e6.
34. Beck M, Mittlmeier T, Gierer P, Harms C, Rotter R, Gradl G. Intraoperative position determination of bone cement
trocars by 3-dimensional imaging in patients with osteoporotic vertebral fractures. Journal of Spinal Disorders &
Techniques. 2010;23(7):e16-23. https://doi.org/https://dx.doi.org/10.1097/BSD.0b013e3181c29cfa.
35. Brinjikji W, Comstock BA, Gray L, Kallmes DF. Local Anesthesia with Bupivacaine and Lidocaine for Vertebral Fracture
trial (LABEL): a report of outcomes and comparison with the Investigational Vertebroplasty Efficacy and Safety Trial
(INVEST). Ajnr: American Journal of Neuroradiology. 2010;31(9):1631-1634.
https://doi.org/https://dx.doi.org/10.3174/ajnr.A2145.
36. Chen C, Chen L, Gu Y, et al. Kyphoplasty for chronic painful osteoporotic vertebral compression fractures via
unipedicular versus bipedicular approachment: a comparative study in early stage. Injury. 2010;41(4):356-359.
https://doi.org/https://dx.doi.org/10.1016/j.injury.2009.09.021.
37. Ha KY, Kim KW, Kim YH, Oh IS, Park SW. Revision surgery after vertebroplasty or kyphoplasty. Clinics in Orthopedic
Surgery. 2010;2(4):203-208. https://doi.org/https://dx.doi.org/10.4055/cios.2010.2.4.203.
38. Hu M, Ma H, Shi H, Liang Y, Zeng Y, Wang J. Early clinical outcome of manual reduction combined with uni-lateral
percutaneous kyphoplasty to treat osteoporotic vertebral compression fracture. Zhongguo xiu fu chong jian wai ke za
zhi [Chinese journal of reparative and reconstructive surgery]. 2010;24(9):1092‐1096.
39. Lin H, Bao LH, Zhu XF, Qian C, Chen X, Han ZB. Analysis of recurrent fracture of a new vertebral body after
percutaneous vertebroplasty in patients with osteoporosis. Orthopaedic Audio-Synopsis Continuing Medical Education
[Sound Recording]. 2010;2(2):119-123. https://doi.org/https://dx.doi.org/10.1111/j.1757-7861.2010.00074.x.
40. Park HT, Lee CB, Ha JH, Choi SJ, Kim MS, Ha JM. Results of kyphoplasty according to the operative timing. Current
Orthopaedic Practice. 2010;21(5):489-493. https://doi.org/10.1097/BCO.0b013e3181e56d96.
41. Wang HK, Lu K, Liang CL, et al. Comparing clinical outcomes following percutaneous vertebroplasty with conservative
therapy for acute osteoporotic vertebral compression fractures. Pain Medicine. 2010;11(11):1659-1665.
https://doi.org/https://dx.doi.org/10.1111/j.1526-4637.2010.00959.x.
512
42. Drees P, Kafchitsas K, Mattyasovszky S, Juri S, Breijawi N. Radiofrequency kyphoplasty - An innovative method of
treating osteoporotic vertebral body compression fractures. Journal fur Mineralstoffwechsel. 2011;18(SUPPL.1):13-17.
43. Sun YC, Teng MM, Yuan WS, et al. Risk of post-vertebroplasty fracture in adjacent vertebral bodies appears correlated
with the morphologic extent of bone cement. Journal of the Chinese Medical Association: JCMA. 2011;74(8):357-362.
https://doi.org/https://dx.doi.org/10.1016/j.jcma.2011.06.008.
44. Garnier L, Tonetti J, Bodin A, et al. Kyphoplasty versus vertebroplasty in osteoporotic thoracolumbar spine fractures.
Short-term retrospective review of a multicentre cohort of 127 consecutive patients. Orthopaedics & traumatology,
surgery & research. 2012;98(6 Suppl):S112-119. https://doi.org/https://dx.doi.org/10.1016/j.otsr.2012.03.018.
45. Guan H, Yang H, Mei X, Liu T, Guo J. Early or delayed operation, which is more optimal for kyphoplasty? A
retrospective study on cement leakage during kyphoplasty. Injury. 2012;43(10):1698-1703.
https://doi.org/https://dx.doi.org/10.1016/j.injury.2012.06.008.
46. Heini PF, Teuscher R. Vertebral body stenting / stentoplasty. Swiss Medical Weekly. 2012;142:w13658.
https://doi.org/https://dx.doi.org/10.4414/smw.2012.13658.
47. Nakano M, Hirano N, Zukawa M, et al. Vertebroplasty Using Calcium Phosphate Cement for Osteoporotic Vertebral
Fractures: Study of Outcomes at a Minimum Follow-up of Two Years. Asian Spine Journal. 2012;6(1):34-42.
https://doi.org/https://dx.doi.org/10.4184/asj.2012.6.1.34.
48. Nieuwenhuijse MJ, van Erkel AR, Dijkstra PD. Percutaneous vertebroplasty for subacute and chronic painful
osteoporotic vertebral compression fractures can safely be undertaken in the first year after the onset of symptoms.
Journal of Bone & Joint Surgery - British Volume. 2012;94(6):815-820.
https://doi.org/https://dx.doi.org/10.1302/0301-620X.94B6.28368.
49. Prokop A, Koukal C, Dolezych R, Chmielnicki M. Schmerzenkyphoplasty in the treatment of osteoporotic spine
fractures. Experience in over 500 patients. Zeitschrift fur Gerontologie und Geriatrie. 2012;45(8):756-760.
https://doi.org/10.1007/s00391-012-0325-3.
50. Wang Z, Wang G, Yang H. Comparison of unilateral versus bilateral balloon kyphoplasty for the treatment of
osteoporotic vertebral compression fractures. Journal of Clinical Neuroscience. 2012;19(5):723-726.
https://doi.org/https://dx.doi.org/10.1016/j.jocn.2011.08.023.
51. Abe Y, Sato S, Kato K, et al. A novel 3D guidance system using augmented reality for percutaneous vertebroplasty:
technical note. Journal of Neurosurgery Spine. 2013;19(4):492-501.
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52. Ha KY, Kim YH, Chang DG, Son IN, Kim KW, Kim SE. Causes of late revision surgery after bone cement augmentation in
osteoporotic vertebral compression fractures. Asian Spine Journal. 2013;7(4):294-300.
https://doi.org/https://dx.doi.org/10.4184/asj.2013.7.4.294.
53. Lin J, Zhang L, Yang HL. Unilateral versus bilateral balloon kyphoplasty for osteoporotic vertebral compression
fractures. Pain Physician. 2013;16(5):447-453.
54. Magnan B, Bondi M, Maluta T, Samaila E, Schirru L, Dall'Oca C. Acrylic bone cement: current concept review.
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55. Otten LA, Bornemnn R, Jansen TR, et al. Comparison of balloon kyphoplasty with the new Kiva R VCF system for the
treatment of vertebral compression fractures. Pain Physician. 2013;16(5):E505-512.
56. Potet J, Weber-Donat G, Curis E, et al. Incidence of pulmonary cement embolism after real-time CT fluoroscopy-
guided vertebroplasty. Journal of Vascular & Interventional Radiology. 2013;24(12):1853-1860.
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57. Rebolledo BJ, Gladnick BP, Unnanuntana A, Nguyen JT, Kepler CK, Lane JM. Comparison of unipedicular and
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513
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58. Rollinghoff M, Zarghooni K, Zeh A, Wohlrab D, Delank KS. Is there a stable vertebral height restoration with the new
radiofrequency kyphoplasty? A clinical and radiological study. European journal of orthopaedic surgery &
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59. Sudo H, Ito M, Kaneda K, et al. Anterior decompression and strut graft versus posterior decompression and pedicle
screw fixation with vertebroplasty for osteoporotic thoracolumbar vertebral collapse with neurologic deficits. Spine
Journal: Official Journal of the North American Spine Society. 2013;13(12):1726-1732.
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60. Bornemann R, Koch EM, Wollny M, Pflugmacher R. Treatment options for vertebral fractures an overview of different
philosophies and techniques for vertebral augmentation. European journal of orthopaedic surgery & traumatologie.
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61. Chen H, Tang P, Zhao Y, Gao Y, Wang Y. Unilateral versus bilateral balloon kyphoplasty in the treatment of
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63. Huang Z, Wan S, Ning L, Han S. Is unilateral kyphoplasty as effective and safe as bilateral kyphoplasties for
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64. Li D, Huang Y, Yang H, et al. Jack vertebral dilator kyphoplasty for treatment of osteoporotic vertebral compression
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65. Papanastassiou ID, Filis A, Aghayev K, Kokkalis ZT, Gerochristou MA, Vrionis FD. Adverse prognostic factors and
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66. Son S, Lee SG, Kim WK, Park CW, Yoo CJ. Early Vertebroplasty versus Delayed Vertebroplasty for Acute Osteoporotic
Compression Fracture : Are the Results of the Two Surgical Strategies the Same? Journal of Korean Neurosurgical
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109. Yang CC, Chien JT, Tsai TY, Yeh KT, Lee RP, Wu WT. Earlier Vertebroplasty for Osteoporotic Thoracolumbar
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110. Yang L. Osteoporotic vertebral compression fractures treated by vertebroplasty with bone cements of different
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116. Ge J, Cheng X, Li P, Yang H, Zou J. The Clinical Effect of Kyphoplasty Using the Extrapedicular Approach in the
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119. Mao Y, Zheng Y, Li Y, Wang G, Sun J, Cui X. Factors Associated with Perioperative Serum Calcium Levels in
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Question 6.7 – Interventional Treatment (Intervertebral Cleft)
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3. McKiernan F, Faciszewski T, Jensen R. Quality of life following vertebroplasty. Journal of Bone & Joint Surgery -
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4. Mirovsky Y, Anekstein Y, Shalmon E, Peer A. Vacuum clefts of the vertebral bodies. Ajnr: American Journal of
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6. Jung JY, Lee MH, Ahn JM. Leakage of polymethylmethacrylate in percutaneous vertebroplasty: comparison of
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https://doi.org/https://dx.doi.org/10.1148/radiol.2511080854.
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14. Kim YJ, Lee JW, Kim KJ, et al. Percutaneous vertebroplasty for intravertebral cleft: analysis of therapeutic effects and
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17. Wu MH, Huang TJ, Cheng CC, Li YY, Hsu RW. Role of the supine lateral radiograph of the spine in vertebroplasty for
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18. Koike Y, Takizawa K, Ogawa Y, Fujikawa A, Yoshimatsu M, Nakajima Y. Percutaneous vertebroplasty for vertebral
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19. Lee KA, Hong SJ, Lee S, Cha IH, Kim BH, Kang EY. Analysis of adjacent fracture after percutaneous vertebroplasty: does
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25. Nieuwenhuijse MJ, van Erkel AR, Dijkstra PD. Percutaneous vertebroplasty for subacute and chronic painful
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32. Wu AM, Lin ZK, Ni WF, et al. The existence of intravertebral cleft impact on outcomes of non-acute osteoporotic
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35. Kong LD, Wang P, Wang LF, Shen Y, Shang ZK, Meng LC. Comparison of vertebroplasty and kyphoplasty in the
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36. Sun G, Tang H, Li M, Liu X, Jin P, Li L. Analysis of risk factors of subsequent fractures after vertebroplasty. European
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37. Wang C, Fan S, Liu J, Suyou L, Shan Z, Zhao F. Basivertebral foramen could be connected with intravertebral cleft: a
potential risk factor of cement leakage in percutaneous kyphoplasty. Spine Journal: Official Journal of the North
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38. Wang YT, Wu XT, Chen H, Wang C, Mao ZB. Adjacent-level symptomatic fracture after percutaneous vertebral
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41. Ha KY, Kim YH, Yoo SR, Molon JN. Bone cement dislodgement : One of complications following bone cement
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45. Ding J, Zhang Q, Zhu J, et al. Risk factors for predicting cement leakage following percutaneous vertebroplasty for
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47. Nakajima H, Uchida K, Honjoh K, Sakamoto T, Kitade M, Baba H. Surgical treatment of low lumbar osteoporotic
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48. Xie W, Jin D, Ma H, et al. Cement Leakage in Percutaneous Vertebral Augmentation for Osteoporotic Vertebral
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49. He X, Meng Y, Huang Y, Hao D, Wu Q, Liu J. Factors Affecting Delayed Union of Vertebral Fractures Following
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50. Hutchins TA, Wiggins RH, Stein JM, Shah LM. Acute traumatic intraosseous fluid sign predisposes to dynamic fracture
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51. Jacobson RE, Palea O, Granville M. Progression of Vertebral Compression Fractures After Previous Vertebral
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52. Lee JM, Lee YS, Kim YB, Park SW, Kang DH, Lee SH. What Effects Does Necrotic Area of Contrast-Enhanced MRI in
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53. Nakamae T, Fujimoto Y, Yamada K, et al. Relationship between clinical symptoms of osteoporotic vertebral fracture
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54. Niu J, Song D, Zhou H, Meng Q, Meng B, Yang H. Percutaneous Kyphoplasty for the Treatment of Osteoporotic
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55. Yu W, Jiang X, Liang, et al. Intravertebral Vacuum Cleft and Its Varied Locations within Osteoporotic Vertebral
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56. Yu W, Liang, Jiang X, Yao Z, Qiu T, Ye L. Efficacy and safety of the target puncture technique for treatment of
osteoporotic vertebral compression fractures with intravertebral clefts. Journal of Neurointerventional Surgery.
2017;9(11):1113-1117. https://doi.org/https://dx.doi.org/10.1136/neurintsurg-2016-012690.
57. Yu W, Liang, Yao Z, et al. Risk factors for recollapse of the augmented vertebrae after percutaneous vertebroplasty for
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58. Yu W, Liang, Yao Z, Qiu T, Ye L, Jiang X. The therapeutic effect of intravertebral vacuum cleft with osteoporotic
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59. Zhan Y, Jiang J, Liao H, Tan H, Yang K. Risk Factors for Cement Leakage After Vertebroplasty or Kyphoplasty: A Meta-
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60. Chiu CK, Lisitha KA, Elias DM, Yong VW, Chan CYW, Kwan MK. Do the dynamic stress mobility radiographs predict the
postoperative vertebral height restoration, kyphosis correction, and cement volume injected after vertebroplasty for
osteoporotic thoracolumbar vertebral fractures with intravertebral cleft? Journal of Orthopaedic Surgery.
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osteoporotic vertebral fractures? European Radiology. 2018;28(7):2735-2742.
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62. Gao C, Zong M, Wang WT, Xu L, Cao D, Zou YF. Analysis of risk factors causing short-term cement leakages and long-
term complications after percutaneous kyphoplasty for osteoporotic vertebral compression fractures. Acta
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63. Nakamae T, Yamada K, Tsuchida Y, Osti OL, Adachi N, Fujimoto Y. Risk Factors for Cement Loosening after
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64. Park SM, Park JW, Kim H, et al. Morphological changes of vertebral compression fracture with intra-vertebral cleft
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65. Sun HB, Jing XS, Liu YZ, Qi M, Wang XK, Hai Y. The Optimal Volume Fraction in Percutaneous Vertebroplasty Evaluated
by Pain Relief, Cement Dispersion, and Cement Leakage: A Prospective Cohort Study of 130 Patients with Painful
Osteoporotic Vertebral Compression Fracture in the Thoracolumbar Vertebra. World Neurosurgery. 2018;114:e677-
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66. Yu W, Xu W, Jiang X, Liang, Jian W. Risk Factors for Recollapse of the Augmented Vertebrae After Percutaneous
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67. Cianfoni A, Distefano D, Isalberti M, et al. Stent-screw-assisted internal fixation: the SAIF technique to augment
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68. Li Z, Liu T, Yin P, et al. The therapeutic effects of percutaneous kyphoplasty on osteoporotic vertebral compression
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69. Nakamae T, Yamada K, Tsuchida Y, Osti OL, Adachi N, Fujimoto Y. Response to: Risk Factors for Cement Loosening
after Vertebroplasty for Osteoporotic Vertebral Fracture with Intravertebral Cleft: A Retrospective Analysis. Asian
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70. Tang S, Fu W, Zhang H, Zhang H, Liang B. Efficacy and Safety of High-Viscosity Bone Cement Vertebroplasty in
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71. Wang WF, Lin CW, Xie CN, et al. The association between sarcopenia and osteoporotic vertebral compression
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72. Wei H, Dong C, Zhu Y. Posterior Fixation Combined with Vertebroplasty or Vertebral Column Resection for the
Treatment of Osteoporotic Vertebral Compression Fractures with Intravertebral Cleft Complicated by Neurological
Deficits. BioMed Research International. 2019;2019:4126818.
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73. Wei P, Yao Q, Xu Y, Zhang H, Gu Y, Wang L. Percutaneous kyphoplasty assisted with/without mixed reality technology
in treatment of OVCF with IVC: a prospective study. Journal of Orthopaedic Surgery. 2019;14(1):255.
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74. Yu W, Xiao X, Zhang J, et al. Cement Distribution Patterns in Osteoporotic Vertebral Compression Fractures with
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76. Zhang J, He X, Fan Y, Du J, Hao D. Risk factors for conservative treatment failure in acute osteoporotic vertebral
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77. Distefano D, Scarone P, Isalberti M, et al. The 'armed concrete' approach: stent-screw-assisted internal fixation (SAIF)
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78. Li M, Zhang Y, Jin P, et al. Percutaneous vertebral augmentation using drill rotation for osteoporotic vertebral
compression fractures with intravertebral vacuum cleft. Skeletal Radiology. 2020;49(9):1459-1465.
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79. Li Y, Yue J, Huang M, et al. Risk factors for postoperative residual back pain after percutaneous kyphoplasty for
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80. Wei H, Dong C, Zhu Y, Ma H. Analysis of two minimally invasive procedures for osteoporotic vertebral compression
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2020;15(1):401. https://doi.org/https://dx.doi.org/10.1186/s13018-020-01938-6.
81. Zhu S, Su Q, Zhang Y, Sun Z, Yin P, Hai Y. Risk factors of cemented vertebral refracture after percutaneous vertebral
augmentation: a systematic review and meta-analysis. Neuroradiology. 2020;62(11):1353-1360.
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Question 6.8 – Interventional Treatment (Patient Characteristics)
1. Maynard AS, Jensen ME, Schweickert PA, Marx WF, Short JG, Kallmes DF. Value of bone scan imaging in predicting
pain relief from percutaneous vertebroplasty in osteoporotic vertebral fractures. Ajnr: American Journal of
Neuroradiology. 2000;21(10):1807-1812.
2. Lieberman IH, Dudeney S, Reinhardt MK, Bell G. Initial outcome and efficacy of "kyphoplasty" in the treatment of
painful osteoporotic vertebral compression fractures. Spine. 2001;26(14):1631-1638.
3. Rubin CD, Pak CY, Adams-Huet B, Genant HK, Li J, Rao DS. Sustained-release sodium fluoride in the treatment of the
elderly with established osteoporosis. Archives of Internal Medicine. 2001;161(19):2325-2333.
4. Watts NB. Osteoporotic vertebral fractures. Neurosurgical Focus. 2001;10(4):E12.
5. Cortet B, Roches E, Logier R, et al. Evaluation of spinal curvatures after a recent osteoporotic vertebral fracture. Joint,
Bone, Spine: Revue du Rhumatisme. 2002;69(2):201-208. https://doi.org/10.1016/S1297-319X(02)00381-0.
6. Papaioannou A, Watts NB, Kendler DL, Yuen CK, Adachi JD, Ferko N. Diagnosis and management of vertebral fractures
in elderly adults. American Journal of Medicine. 2002;113(3):220-228.
7. Predey TA, Sewall LE, Smith SJ. Percutaneous vertebroplasty: New treatment for vertebral compression fractures.
American Family Physician. 2002;66(4):611-615+617-618.
8. Diamond TH, Champion B, Clark WA. Management of acute osteoporotic vertebral fractures: a nonrandomized trial
comparing percutaneous vertebroplasty with conservative therapy. American Journal of Medicine. 2003;114(4):257-
265.
9. Glassman SD, Alegre GM. Adult spinal deformity in the osteoporotic spine: options and pitfalls. Instructional Course
Lectures. 2003;52:579-588.
525
10. Hart RA. Percutaneous treatment of osteoporotic spinal compression fractures. Current Women's Health Reports.
2003;3(1):72-74.
11. Kim DH, Silber JS, Albert TJ. Osteoporotic vertebral compression fractures. Instructional Course Lectures. 2003;52:541-
550.
12. Phillips FM. Minimally invasive treatments of osteoporotic vertebral compression fractures. Spine. 2003;28(15
Suppl):S45-53.
13. Rao RD, Singrakhia MD. Painful osteoporotic vertebral fracture. Pathogenesis, evaluation, and roles of vertebroplasty
and kyphoplasty in its management. Journal of Bone and Joint Surgery - Series A. 2003;85(10):2010-2022.
https://doi.org/10.2106/00004623-200310000-00024.
14. Uppin AA, Hirsch JA, Centenera LV, Pfiefer BA, Pazianos AG, Choi S. Occurrence of new vertebral body fracture after
percutaneous vertebroplasty in patients with osteoporosis. Radiology. 2003;226(1):119-124.
https://doi.org/10.1148/radiol.2261011911.
15. Wu SS, Lachmann E, Nagler W. Current medical, rehabilitation, and surgical management of vertebral compression
fractures. Journal of Women's Health. 2003;12(1):17-26.
16. Biermasz NR, Hamdy NA, Pereira AM, Romijn JA, Roelfsema F. Long-term skeletal effects of recombinant human
growth hormone (rhGH) alone and rhGH combined with alendronate in GH-deficient adults: a seven-year follow-up
study. Clinical Endocrinology. 2004;60(5):568-575.
17. Boszczyk BM, Bierschneider M, Schmid K, Grillhosl A, Robert B, Jaksche H. Microsurgical interlaminary vertebro- and
kyphoplasty for severe osteoporotic fractures. Journal of Neurosurgery. 2004;100(1 Suppl Spine):32-37.
18. Fribourg D, Tang C, Sra P, Delamarter R, Bae H. Incidence of subsequent vertebral fracture after kyphoplasty. Spine.
2004;29(20):2270-2276; discussion 2277.
19. Legroux-Gérot I, Lormeau C, Boutry N, Cotten A, Duquesnoy B, Cortet B. Long-term follow-up of vertebral
osteoporotic fractures treated by percutaneous vertebroplasty. Clinical Rheumatology. 2004;23(4):310-317.
20. Lieberman IH, Phillips FM, Togawa D, et al. Vertebral augmentation and the limits of interpreting complications
reported in the food and drug administration manufacturer and user facility device experience database. Journal of
Vascular and Interventional Radiology. 2004;15(11):1193-1196.
https://doi.org/10.1097/01.RVI.0000136028.86147.A4.
21. Lin JT, Lane JM. The osteoporotic spine. Europa Medicophysica. 2004;40(3):233-237.
22. Medical Advisory S. Balloon kyphoplasty: an evidence-based analysis. Ontario Health Technology Assessment Series.
2004;4(12):1-45.
23. Old JL, Calvert M. Vertebral compression fractures in the elderly. American Family Physician. 2004;69(1):111-116.
24. Sabharwal T, Gangi A. Percutaneous vertebroplasty. CME Journal Radiology. 2004;4(2):71-75.
25. Truumees E, Hilibrand A, Vaccaro AR. Percutaneous vertebral augmentation. Spine Journal: Official Journal of the
North American Spine Society. 2004;4(2):218-229.
26. Alvarez L, Perez-Higueras A, Granizo JJ, de Miguel I, Quinones D, Rossi RE. Predictors of outcomes of percutaneous
vertebroplasty for osteoporotic vertebral fractures. Spine. 2005;30(1):87-92.
27. Brown DB, Glaiberman CB, Gilula LA, Shimony JS. Correlation between preprocedural MRI findings and clinical
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https://doi.org/https://dx.doi.org/10.2214/AJR.13.11590.
40. Goldstein CL, Brodke DS, Choma TJ. Surgical Management of Spinal Conditions in the Elderly Osteoporotic Spine.
Neurosurgery. 2015;77 Suppl 4:S98-107. https://doi.org/https://dx.doi.org/10.1227/NEU.0000000000000948.
41. Lehman RA, Jr., Kang DG, Wagner SC. Management of osteoporosis in spine surgery. Journal of the American Academy
of Orthopaedic Surgeons. 2015;23(4):253-263. https://doi.org/https://dx.doi.org/10.5435/JAAOS-D-14-00042.
556
42. Miyakoshi N, Hongo M, Kobayashi T, Abe T, Abe E, Shimada Y. Improvement of spinal alignment and quality of life
after corrective surgery for spinal kyphosis in patients with osteoporosis: a comparative study with non-operated
patients. Osteoporosis International. 2015;26(11):2657-2664. https://doi.org/https://dx.doi.org/10.1007/s00198-015-
3163-5.
43. Nakashima H, Imagama S, Yukawa Y, et al. Comparative study of 2 surgical procedures for osteoporotic delayed
vertebral collapse: anterior and posterior combined surgery versus posterior spinal fusion with vertebroplasty. Spine.
2015;40(2):E120-126. https://doi.org/https://dx.doi.org/10.1097/BRS.0000000000000661.
44. Ravindra VM, Godzik J, Guan J, et al. Prevalence of Vitamin D Deficiency in Patients Undergoing Elective Spine
Surgery: A Cross-Sectional Analysis. World Neurosurgery. 2015;83(6):1114-1119.
https://doi.org/10.1016/j.wneu.2014.12.031.
45. Kim HS, Heo DH. Percutaneous Pedicle Screw Fixation with Polymethylmethacrylate Augmentation for the Treatment
of Thoracolumbar Intravertebral Pseudoarthrosis Associated with Kummell's Osteonecrosis. BioMed Research
International. 2016;2016:3878063. https://doi.org/https://dx.doi.org/10.1155/2016/3878063.
46. Nakajima H, Uchida K, Honjoh K, Sakamoto T, Kitade M, Baba H. Surgical treatment of low lumbar osteoporotic
vertebral collapse: a single-institution experience. Journal of Neurosurgery Spine. 2016;24(1):39-47.
https://doi.org/https://dx.doi.org/10.3171/2015.4.SPINE14847.
47. Granville M, Berti A, Jacobson RE. Vertebral Compression Fractures after Lumbar Instrumentation. Cureus.
2017;9(9):e1729. https://doi.org/https://dx.doi.org/10.7759/cureus.1729.
48. Janssen I, Ryang YM, Gempt J, et al. Risk of cement leakage and pulmonary embolism by bone cement-augmented
pedicle screw fixation of the thoracolumbar spine. Spine Journal: Official Journal of the North American Spine Society.
2017;17(6):837-844. https://doi.org/https://dx.doi.org/10.1016/j.spinee.2017.01.009.
49. Kim DK, Kim JY, Kim DY, Rhim SC, Yoon SH. Risk factors of proximal junctional kyphosis after multilevel fusion surgery:
more than 2 years follow-up data. Journal of Korean Neurosurgical Society. 2017;60(2):174‐180.
https://doi.org/10.3340/jkns.2016.0707.014.
50. Pham MH, Buser Z, Wang JC, Acosta FL. Low-magnitude mechanical signals and the spine: A review of current and
future applications. Journal of Clinical Neuroscience. 2017;40:18-23.
https://doi.org/https://dx.doi.org/10.1016/j.jocn.2016.12.017.
51. Tomé-Bermejo F, Piñera AR, Alvarez L. Osteoporosis and the management of spinal degenerative disease (II). Archives
of Bone and Joint Surgery. 2017;5(6):363-374. https://doi.org/10.22038/abjs.2017.19349.1498.
52. Yasuda T, Kawaguchi Y, Suzuki K, et al. Five-year follow up results of posterior decompression and fixation surgery for
delayed neural disorder associated with osteoporotic vertebral fracture. Medicine (United States). 2017;96(51).
https://doi.org/10.1097/MD.0000000000009395.
53. Yeung YK, Ho ST. Delayed Neurological Deficits after Osteoporotic Vertebral Fractures: Clinical Outcomes after
Surgery. Asian Spine Journal. 2017;11(6):981-988. https://doi.org/https://dx.doi.org/10.4184/asj.2017.11.6.981.
54. Alpantaki K, Dohm M, Korovessis P, Hadjipavlou AG. Surgical options for osteoporotic vertebral compression fractures
complicated with spinal deformity and neurologic deficit. Injury. 2018;49(2):261-271.
https://doi.org/https://dx.doi.org/10.1016/j.injury.2017.11.008.
55. Díaz-Romero Paz R, Reimunde Figueira P. Osteoporosis and spinal surgery: Strategies for medical and surgical
treatment. Revista de Osteoporosis y Metabolismo Mineral. 2018;10(1):41-53. https://doi.org/10.4321/S1889-
836X2018000100007.
56. Karikari IO, Metz LN. Preventing Pseudoarthrosis and Proximal Junctional Kyphosis: How to Deal with the
Osteoporotic Spine. Neurosurgery Clinics of North America. 2018;29(3):365-374.
https://doi.org/https://dx.doi.org/10.1016/j.nec.2018.03.005.
557
57. Rong Z, Zhang F, Xiao J, et al. Application of Cement-Injectable Cannulated Pedicle Screw in Treatment of
Osteoporotic Thoracolumbar Vertebral Compression Fracture (AO Type A): A Retrospective Study of 28 Cases. World
Neurosurgery. 2018;120:e247-e258. https://doi.org/https://dx.doi.org/10.1016/j.wneu.2018.08.045.
58. Schwarz F, Lawson McLean A, Waschke A, Kalff R. Cement-augmented anterior odontoid screw fixation in elderly
patients with odontoid fracture. Clinical Neurology & Neurosurgery. 2018;175:144-148.
https://doi.org/https://dx.doi.org/10.1016/j.clineuro.2018.11.005.
59. Tempel ZJ, McDowell MM, Panczykowski DM, et al. Graft subsidence as a predictor of revision surgery following
stand-alone lateral lumbar interbody fusion. Journal of Neurosurgery Spine. 2018;28(1):50-56.
https://doi.org/https://dx.doi.org/10.3171/2017.5.SPINE16427.
60. Uei H, Tokuhashi Y, Maseda M, et al. Exploratory analysis of predictors of revision surgery for proximal junctional
kyphosis or additional postoperative vertebral fracture following adult spinal deformity surgery in elderly patients: a
retrospective cohort study. Journal of Orthopaedic Surgery. 2018;13(1):252.
https://doi.org/https://dx.doi.org/10.1186/s13018-018-0960-5.
61. Wanderman N, Freedman B, Currier B, Huddleston P, Yaszemski M, Nassr A. Interpreting the DXA analysis: When
should you hold off on spinal fusion? Seminars in Spine Surgery. 2018;30(1):36-40.
https://doi.org/10.1053/j.semss.2017.09.007.
62. Cianfoni A, Distefano D, Isalberti M, et al. Stent-screw-assisted internal fixation: the SAIF technique to augment
severe osteoporotic and neoplastic vertebral body fractures. Journal of Neurointerventional Surgery. 2019;11(6):603-
609. https://doi.org/https://dx.doi.org/10.1136/neurintsurg-2018-014481.
63. Kohno M, Iwamura Y, Inasaka R, et al. Surgical Intervention for Osteoporotic Vertebral Burst Fractures in Middle-low
Lumbar Spine with Special Reference to Postoperative Complications Affecting Surgical Outcomes. Neurologia
Medico-Chirurgica. 2019;59(3):98-105. https://doi.org/https://dx.doi.org/10.2176/nmc.oa.2018-0232.
64. Maruo K, Tachibana T, Arizumi F, Kusuyama K, Kishima K, Yoshiya S. Effect of Teriparatide on Subsequent Vertebral
Fractures after Instrumented Fusion Surgery for Osteoporotic Vertebral Fractures with Neurological Deficits. Asian
Spine Journal. 2019;13(2):283-289. https://doi.org/https://dx.doi.org/10.31616/asj.2018.0098.
65. Masuda S, Onishi E, Ota S, et al. Vertebroplasty Using Allograft Bone Chips with Posterior Instrumented Fusion in the
Treatment of Osteoporotic Vertebral Fractures with Neurological Deficits. Spine Surgery & Related Research.
2019;3(3):249-254. https://doi.org/https://dx.doi.org/10.22603/ssrr.2018-0102.
66. McCoy S, Tundo F, Chidambaram S, Baaj AA. Clinical considerations for spinal surgery in the osteoporotic patient: A
comprehensive review. Clinical Neurology & Neurosurgery. 2019;180:40-47.
https://doi.org/https://dx.doi.org/10.1016/j.clineuro.2019.03.010.
67. Salzmann SN, Ortiz Miller C, Carrino JA, et al. BMI and gender increase risk of sacral fractures after multilevel
instrumented spinal fusion compared with bone mineral density and pelvic parameters. Spine Journal: Official Journal
of the North American Spine Society. 2019;19(2):238-245.
https://doi.org/https://dx.doi.org/10.1016/j.spinee.2018.05.021.
68. Tamai K, Terai H, Suzuki A, et al. Risk Factors for Proximal Junctional Fracture Following Fusion Surgery for
Osteoporotic Vertebral Collapse with Delayed Neurological Deficits: A Retrospective Cohort Study of 403 Patients.
Spine Surgery & Related Research. 2019;3(2):171-177. https://doi.org/https://dx.doi.org/10.22603/ssrr.2018-0068.
69. Watanabe K, Katsumi K, Ohashi M, et al. Surgical outcomes of spinal fusion for osteoporotic vertebral fracture in the
thoracolumbar spine: Comprehensive evaluations of 5 typical surgical fusion techniques. Journal of Orthopaedic
Science. 2019;24(6):1020-1026. https://doi.org/https://dx.doi.org/10.1016/j.jos.2019.07.018.
70. Watanabe K, Katsumi K, Ohashi M, et al. Surgical outcomes of spinal fusion for osteoporotic thoracolumbar vertebral
fractures in patients with Parkinson's disease: what is the impact of Parkinson's disease on surgical outcome? BMC
Musculoskeletal Disorders. 2019;20(1):103. https://doi.org/https://dx.doi.org/10.1186/s12891-019-2473-8.
558
71. Zidan I, Khedr W, Fayed AA, Farhoud A. Retroperitoneal Extrapleural Approach for Corpectomy of the First Lumbar
Vertebra : Technique and Outcome. Journal of Korean Neurosurgical Society. 2019;62(1):61-70.
https://doi.org/https://dx.doi.org/10.3340/jkns.2017.0271.
72. Ehresman J, Pennington Z, Schilling A, et al. Novel MRI-based score for assessment of bone density in operative spine
patients. Spine Journal: Official Journal of the North American Spine Society. 2020;20(4):556-562.
https://doi.org/https://dx.doi.org/10.1016/j.spinee.2019.10.018.
73. Erichsen CJ, Heyde CE, Josten C, et al. Percutaneous versus open posterior stabilization in AOSpine type A3
thoracolumbar fractures. BMC Musculoskeletal Disorders. 2020;21(1):74.
https://doi.org/https://dx.doi.org/10.1186/s12891-020-3099-6.
74. Kawabata A, Yoshii T, Hirai T, et al. Effect of bisphosphonates or teriparatide on mechanical complications after
posterior instrumented fusion for osteoporotic vertebral fracture: a multi-center retrospective study. BMC
Musculoskeletal Disorders. 2020;21(1):420. https://doi.org/https://dx.doi.org/10.1186/s12891-020-03452-6.
75. Luo PJ, Tang YC, Zhou TP, et al. Risk Factor Analysis of the Incidence of Subsequent Adjacent Vertebral Fracture After
Lumbar Spinal Fusion Surgery with Instrumentation. World Neurosurgery. 2020;135:e87-e93.
https://doi.org/https://dx.doi.org/10.1016/j.wneu.2019.11.010.
76. Machino M, Ando K, Kobayashi K, et al. A comparative study of two reconstruction procedures for osteoporotic
vertebral fracture with lumbar spinal stenosis: Posterior lumbar interbody fusion versus posterior and anterior and
combined surgery. Journal of Orthopaedic Science. 2020;25(1):52-57.
https://doi.org/https://dx.doi.org/10.1016/j.jos.2019.02.013.
77. Rometsch E, Spruit M, Zigler JE, et al. Screw-Related Complications After Instrumentation of the Osteoporotic Spine: A
Systematic Literature Review With Meta-Analysis. Global Spine Journal. 2020;10(1):69-88.
https://doi.org/https://dx.doi.org/10.1177/2192568218818164.
78. Taiji R, Takami M, Yukawa Y, et al. A short-segment fusion strategy using a wide-foot-plate expandable cage for
vertebral pseudarthrosis after an osteoporotic vertebral fracture. Journal of Neurosurgery Spine. 2020:1-8.
https://doi.org/https://dx.doi.org/10.3171/2020.5.SPINE2062.
Question 7.2 & 7.3 – Surgical Treatment (Open Surgical Procedures)
1. Cohen LD. Fractures of the osteoporotic spine. Orthopedic Clinics of North America. 1990;21(1):143-150.
2. Wenger M, Markwalder TM. Surgically controlled, transpedicular methyl methacrylate vertebroplasty with
fluoroscopic guidance. Acta Neurochirurgica. 1999;141(6):625-631.
3. Grados F, Depriester C, Cayrolle G, Hardy N, Deramond H, Fardellone P. Long-term observations of vertebral
osteoporotic fractures treated by percutaneous vertebroplasty. Rheumatology. 2000;39(12):1410-1414.
4. Kostuik JP, Shapiro MB. Open surgical treatment of osteoporotic fractures and deformity of the spine. Instructional
Course Lectures. 2003;52:569-578.
5. Youssef JA, Salas VM, Loschiavo RG. Management of painful osteoporotic vertebral compression fractures:
Vertebroplasty and kyphoplasty. Operative Techniques in Orthopaedics. 2003;13(3):222-226.
https://doi.org/10.1016/S1048-6666(03)00018-1.
6. Boszczyk BM, Bierschneider M, Schmid K, Grillhosl A, Robert B, Jaksche H. Microsurgical interlaminary vertebro- and
kyphoplasty for severe osteoporotic fractures. Journal of Neurosurgery. 2004;100(1 Suppl Spine):32-37.
7. Atalay B, Caner H, Gokce C, Altinors N. Kyphoplasty: 2 years of experience in a neurosurgery department. Surgical
Neurology. 2005;64 Suppl 2:S72-76.
559
8. Bierschneider M, Boszczyk BM, Schmid K, Robert B, Jaksche H. Minimally invasive vertebral augmentation techniques
in osteoporotic fractures. European Journal of Trauma. 2005;31(5):442-452. https://doi.org/10.1007/s00068-005-
2090-0.
9. Boszczyk BM, Bierschneider M, Hauck S, Beisse R, Potulski M, Jaksche H. Transcostovertebral kyphoplasty of the mid
and high thoracic spine. European Spine Journal. 2005;14(10):992-999.
10. Singh K, Heller JG, Samartzis D, et al. Open vertebral cement augmentation combined with lumbar decompression for
the operative management of thoracolumbar stenosis secondary to osteoporotic burst fractures. Journal of Spinal
Disorders & Techniques. 2005;18(5):413-419.
11. Kim DH, Vaccaro AR. Osteoporotic compression fractures of the spine; current options and considerations for
treatment. Spine Journal: Official Journal of the North American Spine Society. 2006;6(5):479-487.
12. Fuentes S, Metellus P, Pech-Gourg G, Adetchessi T, Dufour H, Grisoli F. Open kyphoplasty for management of
metastatic and severe osteoporotic spinal fracture. Technical note. Journal of Neurosurgery Spine. 2007;6(3):284-288.
13. Patel AA, Vaccaro AR, Martyak GG, et al. Neurologic deficit following percutaneous vertebral stabilization. Spine.
2007;32(16):1728-1734.
14. Hiraizumi Y. Spinal cord anterior decompression for delayed spinal cord paralysis after osteoporotic vertebral
compression fracture: application of thoracoscopic approach. Chirurgia Narzadow Ruchu i Ortopedia Polska.
2008;73(1):67-73.
15. Kapural L. Indications for minimally invasive disk and vertebral procedures. Pain Medicine. 2008;9(SUPPL. 1):S65-S72.
https://doi.org/10.1111/j.1526-4637.2008.00441.x.
16. Blondel B, Fuentes S, Metellus P, Adetchessi T, Pech-Gourg G, Dufour H. Severe thoracolumbar osteoporotic burst
fractures: treatment combining open kyphoplasty and short-segment fixation. Orthopaedics & traumatology, surgery
& research. 2009;95(5):359-364. https://doi.org/https://dx.doi.org/10.1016/j.otsr.2009.06.001.
17. Fuentes S, Blondel B, Metellus P, Adetchessi T, Gaudart J, Dufour H. Open kyphoplasty for management of severe
osteoporotic spinal fractures. Neurosurgery. 2009;64(5 Suppl 2):350-354; discussion 354-355.
https://doi.org/https://dx.doi.org/10.1227/01.NEU.0000337066.59130.61.
18. Doria C, Tranquilli Leali P. Percutaneous techniques in the treatment of osteoporotic, traumatic and neoplastic
fractures of thoraco-lumbar spine: our institutional experience. Injury. 2010;41(11):1136-1139.
https://doi.org/https://dx.doi.org/10.1016/j.injury.2010.09.032.
19. Hofbauer LC, Hamann C, Ebeling PR. Approach to the patient with secondary osteoporosis. European Journal of
Endocrinology. 2010;162(6):1009-1020. https://doi.org/https://dx.doi.org/10.1530/EJE-10-0015.
20. Kakarla UK, Little AS, Chang SW, Sonntag VKH, Theodore N. Placement of percutaneous thoracic pedicle screws using
neuronavigation. World Neurosurgery. 2010;74(6):606-610. https://doi.org/10.1016/j.wneu.2010.03.028.
21. Medical Advisory S. Percutaneous vertebroplasty for treatment of painful osteoporotic vertebral compression
fractures: an evidence-based analysis. Ontario Health Technology Assessment Series. 2010;10(19):1-45.
22. Vougioukas V, Hubbe U, Kogias E, Psarras N, Halatsch ME. Vertebroplasty combined with image-guided percutaneous
cement augmented transpedicular fixation for the treatment of complex vertebral fractures in osteoporotic patients.
Journal of Neurosurgical Sciences. 2010;54(4):135-141.
23. Burton AW, Mendoza T, Gebhardt R, et al. Vertebral compression fracture treatment with vertebroplasty and
kyphoplasty: experience in 407 patients with 1,156 fractures in a tertiary cancer center. Pain Medicine.
2011;12(12):1750-1757. https://doi.org/https://dx.doi.org/10.1111/j.1526-4637.2011.01278.x.
24. Robinson Y, Heyde CE, Forsth P, Olerud C. Kyphoplasty in osteoporotic vertebral compression fractures--guidelines
and technical considerations. Journal of Orthopaedic Surgery. 2011;6:43.
https://doi.org/https://dx.doi.org/10.1186/1749-799X-6-43.
560
25. Jain N. Vertebroplasty/kyphoplasty: A novel approach for treatment of spine fractures. Journal International Medical
Sciences Academy. 2013;26(4):251-254.
26. Patil S, Rawall S, Singh D, et al. Surgical patterns in osteoporotic vertebral compression fractures. European Spine
Journal. 2013;22(4):883-891. https://doi.org/https://dx.doi.org/10.1007/s00586-012-2508-4.
27. Trouillier HH, Birkenmaier C, Seidl T, Jansson V. Complications following kyphoplasty in unstable osteoporotic
vertebral body fractures. A guide to correct fracture analysis. Acta Orthopaedica Belgica. 2013;79(5):488-494.
28. Bakhsheshian J, Dahdaleh NS, Fakurnejad S, Scheer JK, Smith ZA. Evidence-based management of traumatic
thoracolumbar burst fractures: a systematic review of nonoperative management. Neurosurgical Focus.
2014;37(1):E1. https://doi.org/https://dx.doi.org/10.3171/2014.4.FOCUS14159.
29. Nieto-Iglesias C, Andrés-Nieto I, Peces-García E, et al. Vertebroplasty and kyphoplasty: Techniques, complications, and
troubleshooting. Techniques in Regional Anesthesia and Pain Management. 2014;18(1-2):40-48.
https://doi.org/10.1053/j.trap.2015.01.007.
30. Zografos GN, Perysinakis I, Vassilatou E. Subclinical Cushing's syndrome: current concepts and trends. Hormones.
2014;13(3):323-337. https://doi.org/https://dx.doi.org/10.14310/horm.2002.1506.
31. Balkarli H, Demirtas H, Kilic M, Ozturk I. Treatment of osteoporotic vertebral compression fractures with
percutaneous vertebroplasty under local anesthesia: clinical and radiological results. International Journal of Clinical
and Experimental Medicine. 2015;8(9):16287-16293.
32. Boland P, Moussazadeh N, Laufer I, et al. Sacroplasty for cancer-associated insufficiency fractures. Neurosurgery.
2015;76(4):446-450. https://doi.org/10.1227/NEU.0000000000000658.
33. Buchbinder R, Golmohammadi K, Johnston RV, et al. Percutaneous vertebroplasty for osteoporotic vertebral
compression fracture. Cochrane Database of Systematic Reviews. 2015(4):CD006349.
https://doi.org/https://dx.doi.org/10.1002/14651858.CD006349.pub2.
34. Wagner D, Ossendorf C, Gruszka D, Hofmann A, Rommens PM. Fragility fractures of the sacrum: how to identify and
when to treat surgically? European Journal of Trauma & Emergency Surgery. 2015;41(4):349-362.
https://doi.org/https://dx.doi.org/10.1007/s00068-015-0530-z.
35. Barbagallo GMV, Raudino G, Visocchi M, et al. Restoration of Thoracolumbar Spine Stability and Alignment in Elderly
Patients Using Minimally Invasive Spine Surgery (MISS). A Safe and Feasible Option in Degenerative and Traumatic
Spine Diseases. Acta Neurochirurgica - Supplement. 2017;124:69-74. https://doi.org/https://dx.doi.org/10.1007/978-
3-319-39546-3_11.
36. Kim JH, Park YS, Oh KJ, Choi HS. Surgical treatment of severe osteoporosis including new concept of advanced severe
osteoporosis. Osteoporosis and Sarcopenia. 2017;3(4):164-169.
https://doi.org/https://dx.doi.org/10.1016/j.afos.2017.11.006.
37. Sebaaly A, Rizkallah M, Bachour F, Atallah F, Moreau PE, Maalouf G. Percutaneous cement augmentation for
osteoporotic vertebral fractures. EFORT Open Reviews. 2017;2(6):293-299.
https://doi.org/https://dx.doi.org/10.1302/2058-5241.2.160057.
38. Takura T, Yoshimatsu M, Sugimori H, et al. Cost-Effectiveness Analysis of Percutaneous Vertebroplasty for
Osteoporotic Compression Fractures. Clinical Spine Surgery. 2017;30(3):E205‐E210.
https://doi.org/10.1097/BSD.0b013e3182aa4c29.
39. Alpantaki K, Dohm M, Korovessis P, Hadjipavlou AG. Surgical options for osteoporotic vertebral compression fractures
complicated with spinal deformity and neurologic deficit. Injury. 2018;49(2):261-271.
https://doi.org/https://dx.doi.org/10.1016/j.injury.2017.11.008.
40. Buchbinder R, Johnston RV, Rischin KJ, et al. Percutaneous vertebroplasty for osteoporotic vertebral compression
fracture. Cochrane Database of Systematic Reviews. 2018;11:CD006349.
https://doi.org/https://dx.doi.org/10.1002/14651858.CD006349.pub4.
561
41. Balling H. 3D image-guided surgery for fragility fractures of the sacrum. Operative Orthopadie und Traumatologie.
2019;31(6):491-502. https://doi.org/https://dx.doi.org/10.1007/s00064-019-00629-8.
42. Cheng WZ, Lin YL, Su YC, et al. Post-surgery cholecystectomy, hepatectomy, and pancreatectomy patients increase
the risk of osteoporotic vertebral fracture. Journal of Bone & Mineral Metabolism. 2020;05:05.
https://doi.org/https://dx.doi.org/10.1007/s00774-020-01129-7.
43. Erichsen CJ, Heyde CE, Josten C, et al. Percutaneous versus open posterior stabilization in AOSpine type A3
thoracolumbar fractures. BMC Musculoskeletal Disorders. 2020;21(1):74.
https://doi.org/https://dx.doi.org/10.1186/s12891-020-3099-6.
44. Vestergaard V, Pedersen AB, Tengberg PT, Troelsen A, Schroder HM. 20-year trends of distal femoral, patellar, and
proximal tibial fractures: a Danish nationwide cohort study of 60,823 patients. Acta Orthopaedica. 2020;91(1):109-
114. https://doi.org/https://dx.doi.org/10.1080/17453674.2019.1698148.
Question 7.4 – Surgical Treatment (Adjacent Fractures)
1. Uppin AA, Hirsch JA, Centenera LV, Pfiefer BA, Pazianos AG, Choi S. Occurrence of new vertebral body fracture after
percutaneous vertebroplasty in patients with osteoporosis. Radiology. 2003;226(1):119-124.
https://doi.org/10.1148/radiol.2261011911.
2. Fribourg D, Tang C, Sra P, Delamarter R, Bae H. Incidence of subsequent vertebral fracture after kyphoplasty. Spine.
2004;29(20):2270-2276; discussion 2277.
3. Medical Advisory S. Balloon kyphoplasty: an evidence-based analysis. Ontario Health Technology Assessment Series.
2004;4(12):1-45.
4. Gaitanis IN, Hadjipavlou AG, Katonis PG, Tzermiadianos MN, Pasku DS, Patwardhan AG. Balloon kyphoplasty for the
treatment of pathological vertebral compressive fractures. European Spine Journal. 2005;14(3):250-260.
5. Nct. VERTOS-II. Percutaneous Vertebroplasty Versus Conservative Therapy.
https://clinicaltrialsgov/show/NCT00232466. 2005.
6. Komemushi A, Tanigawa N, Kariya S, et al. Percutaneous vertebroplasty for osteoporotic compression fracture:
multivariate study of predictors of new vertebral body fracture. Cardiovascular & Interventional Radiology.
2006;29(4):580-585.
7. Trout AT, Kallmes DF, Lane JI, Layton KF, Marx WF. Subsequent vertebral fractures after vertebroplasty: association
with intraosseous clefts. Ajnr: American Journal of Neuroradiology. 2006;27(7):1586-1591.
8. Voormolen MH, Lohle PN, Juttmann JR, van der Graaf Y, Fransen H, Lampmann LE. The risk of new osteoporotic
vertebral compression fractures in the year after percutaneous vertebroplasty. Journal of Vascular & Interventional
Radiology. 2006;17(1):71-76.
9. Becker S, Garoscio M, Meissner J, Tuschel A, Ogon M. Is there an indication for prophylactic balloon kyphoplasty? A
pilot study. Clinical Orthopaedics and Related Research. 2007;458:83‐89.
https://doi.org/10.1097/BLO.0b013e318034032c.
10. Frankel BM, Monroe T, Wang C. Percutaneous vertebral augmentation: an elevation in adjacent-level fracture risk in
kyphoplasty as compared with vertebroplasty. Spine Journal: Official Journal of the North American Spine Society.
2007;7(5):575-582.
11. Moon ES, Kim HS, Park JO, et al. The incidence of new vertebral compression fractures in women after kyphoplasty
and factors involved. Yonsei Medical Journal. 2007;48(4):645-652.
12. Buchbinder R, Osborne RH, Ebeling PR, et al. Efficacy and safety of vertebroplasty for treatment of painful
osteoporotic vertebral fractures: a randomised controlled trial [ACTRN012605000079640]. BMC Musculoskeletal
Disorders. 2008;9:156. https://doi.org/https://dx.doi.org/10.1186/1471-2474-9-156.
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III. PRISMA Flow Diagrams
Natural History Section
Natural History Question 1: For patients with osteoporotic vertebral compression fractures managed without augmentation or surgery, what is the risk of development of long-term sequelae of
vertebral compression fractures (e.g., spinal deformity, respiratory compromise, gastrointestinal tract dysfunction, physical and psychological functional impairment)?
617
Natural History Question 2: For patients with acute osteoporotic vertebral compression fractures managed without augmentation or surgery, what is the expected time to resolution of pain?
Natural History Question 3: For patients with acute osteoporotic vertebral compression fractures managed without augmentation or surgery, what is the risk of persistent long-term (>6 months)
pain?
618
Natural History Question 4: For patients with osteoporotic vertebral compression fractures, are rates of morbidity and mortality different for those managed with augmentation or surgery versus
those managed without?
619
Natural History Question 5: For patients with osteoporotic vertebral compression fractures managed without augmentation or surgery, are there specific variables that increase the risk for re-
fracture of the same or other vertebral levels?
620
Cost Effectiveness Section
Cost Effectiveness Question 1: In the treatment of osteoporotic vertebral compression fractures, what is the comparative cost-effectiveness of (a) Medical therapy alone vs. (b) Vertebral
augmentation vs. (c) Thermal ablation, radiofrequency ablation or cryoablation with or without augmentation vs. (d) Operative fusion/fixation?
621
Clinical Diagnosis Section
Clinical Diagnosis Question 1: Which elements (individual or in combination) of a history, symptoms, and/or physical examination are most sensitive and specific for identifying a patient with an acute
osteoporotic vertebral compression fracture?
622
Medical Treatment Section
Medical Treatment Question 1: How do non-pharmacologic treatments (e.g. bracing, physical therapy, acupuncture, massage, cannabis, exercise, etc.) compare in terms of reducing severity and
duration of pain and disability in osteoporotic vertebral compression fractures?
Medical Treatment Question 2: Do restrictions on patient activity alter outcomes in patients with acute osteoporotic vertebral compression fractures?
Medical Treatment Question 4: Does spinal manipulative treatment improve outcomes for patients with acute osteoporotic vertebral compression fractures?
623
Medical Treatment Question 3: Which pharmacologic treatments are effective in improving outcomes in acute osteoporotic vertebral compression fractures?
Medical Treatment Question 5: In patients presenting with symptomatic acute osteoporotic vertebral compression fractures, does medical treatment of the underlying bone loss improve long-term
outcomes such as reduction in risk of future fragility fractures?
624
Medical Treatment Question 6: Does the involvement of multiple specialties in clinical management change the outcomes of acute osteoporotic vertebral compression fractures?
625
Imaging Diagnosis Section
Imaging Diagnosis Question 1: Which imaging modalities and findings are most sensitive and specific for the accurate diagnosis of symptomatic osteoporotic vertebral compression fractures?
626
Imaging Diagnosis Question 2: Which imaging findings stratify the acuity of osteoporotic vertebral compression fractures?
627
Interventional Treatment Section
Interventional Treatment Question 1: Do steroid and/or anaesthetics injections improve outcomes in patients with acute osteoporotic vertebral compression fractures?
628
Interventional Treatment Question 2: What is the risk of treating multiple vertebral levels at one time, for patients with multi-level osteoporotic vertebral compression fractures?
629
Interventional Treatment Question 3: Does vertebral augmentation improve outcomes in patients with acute osteoporotic vertebral compression fractures compared to medical therapy?
630
Interventional Treatment Question 4: Does mechanical device (an implant that includes more than a bone filler) improve outcomes in patients with symptomatic osteoporotic vertebral compression
fractures compared to medical care?
631
Interventional Treatment Question 5: Does the correction of vertebral height loss or segmental kyphosis during vertebral augmentation for symptomatic osteoporotic vertebral compression
fractures result in improved clinical outcomes?
632
Interventional Treatment Question 6: For patients with symptomatic acute osteoporotic vertebral compression fractures, what is the optimal timing for vertebral augmentation?
633
Interventional Treatment Question 7: Does vertebral augmentation improve clinical outcomes in patients with back pain and an intravertebral cleft on imaging of chronic osteoporotic vertebral
compression fractures?
634
Interventional Treatment Question 8: Are there specific characteristics of the fracture or the patient that influence outcomes in patients with osteoporotic compression fractures undergoing
vertebral augmentation?
635
Surgical Treatment Section
Surgical Treatment Question 1: Does instrumented fusion improve outcomes in patients with acute osteoporotic vertebral compression fractures compared to nonoperative care or interventional
procedures?
636
Surgical Treatment Question 2: What are the clinical or radiological indications for recommending open surgical procedures in patients with acute osteoporotic vertebral compression fractures?
Surgical Treatment Question 3: Does the use of minimally invasive surgical approaches (e.g., percutaneous pedicle screws, muscle-sparing decompression/arthrodesis techniques) improve outcomes
compared to open surgical approaches in patients undergoing surgery for acute osteoporotic vertebral compression fractures?
637
Surgical Treatment Question 4: What are the risk factors for adjacent vertebral body factures after surgical intervention in patients with osteoporotic vertebral compression fractures?
638
Surgical Treatment Question 5: Are there specific characteristics of the fracture or the patient that influence outcomes in patients with osteoporotic vertebral compression fractures undergoing
surgical treatment?
639
Surgical Treatment Question 6: In patients undergoing surgery for symptomatic osteoporotic vertebral compression fractures, are clinical and radiological outcomes affected by the types of implants
used?
640
IV. Evidentiary Tables
Natural History Section
Natural History Question 1: For patients with osteoporotic vertebral compression fractures managed without augmentation or surgery, what is the risk of
development of long-term sequelae of vertebral compression fractures (e.g., spinal deformity, respiratory compromise, gastrointestinal tract dysfunction,
physical and psychological functional impairment)?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Colangelo D, Nasto LA, Type of evidence: Prognostic ☐ Prospective ☒ Retrospective Critique of methodology:
Genitiempo M, et al. Kyphoplasty ☐ Patients not enrolled at
vs conservative treatment: a case- Level IV Study Design*: Case Series same point in their
control study in 110 post- disease
menopausal women population. Is Explanation of failure to meet Stated objective of study: to ☐ <80% follow-up
kyphoplasty better than guideline inclusion criteria compare effects in terms of ☐ Follow-up not
conservative treatment?. Eur Rev (when applicable) recovery and quality of life and to standardized
Med Pharmacol Sci. compare deformity prevention
☐ No validated outcome
2015;19(21):3998-4003. ☐ Level V (expert consensus) efficacy of kyphoplasty and
measures used
conservative treatment in post-
☐ Small sample size
☐ Level IV in presence of higher menopausal women with an
quality studies osteoporotic VCF and to provide an ☐ Lacked subgroup analysis
efficacy assessment of kyphoplasty ☐ Diagnostic methods not
☐ Subgroup analysis data not as compared with standard described.
available conservative treatment in post- ☒ Other: Data only
menopausal women (bracing presented in graphical and
immobilization). narrative form; no tables
☐ Not relevant to question
Total number of patients in the Level of Evidence
study: 110 Determination
Number of patients in Potential Level: IV
relevant subgroup(s): 52 Downgraded Level: Not
kyphoplasty and 58 braced (if Downgraded
bracing less than 85% compliance
then excluded) Conclusions
This paper provides evidence
Duration of follow-up: 12 months that: kyphosis angles
increased by 6.7% at 12
Validated outcome measures used months for adults with
(list): VAS, EQ5D, SF-12, OVCF treated without
augmentation or surgery.
641
Nonvalidated outcome measures
used (list): kyphosis analysis
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: x-rays
Results/subgroup analysis (relevant
to question): Only graphical data
shown; no numerical data.
Group VAS change @1m:
2.13; @12m no statistical diff with
kypho group. Kypho group did
better on EQ5D @1m, but at 12-
months, similar. SF-12 changes
were similar in both groups. Kypho
angles, 6.67% dec over 12months
in conservative group. No major
adverse events in conservative grp.
Author conclusions (relevant to
question): Kyphoplasty is a modern
minimal invasive surgery, allowing
faster recovery than bracing
treatment. It can avoid the
deformity in kyphosis due to VCF.
In fact, the risk to develop a new
vertebral fracture after the first one
is very high.
Du JP, Fan Y, Liu JJ, et al. The Type of evidence: Prognostic ☒ Prospective ☐ Retrospective Critique of methodology:
analysis of MSTMOVCF (Multi- ☐ Patients not enrolled at
segment thoracolumbar mild Level II Study Design: Comparative same point in their
osteoporotic fractures surgery or disease
conservative treatment) based on Explanation of failure to meet Stated objective of study: to ☐ <80% follow-up
ASTLOF (the assessment system guideline inclusion criteria address the decision of ☐ Follow-up not
of thoracolumbar osteoporotic (when applicable) conservative or surgical treatment standardized
642
fracture). Sci Rep. 2018;8(1):8185. for mulit segmental TL osteoporotic ☐ No validated outcome
Published 2018 May 29. ☐ Level V (expert consensus) compression fractures and to revise measures used
doi:10.1038/s41598-018-26562-7 a classification system ☐ Small sample size
☐ Level IV in presence of higher ☐ Lacked subgroup analysis
Total number of patients in the
quality studies
study:470 ☐ Diagnostic methods not
Number of patients in described.
☐ Subgroup analysis data not ☒ Other: non-randomly
relevant subgroup(s): 277
available assigned patient; control
conservative and 193 subject
group from non-RCT; Non-
☐ Not relevant to question Duration of follow-up: 1 year randomly assigned,
potential for selection bias
Validated outcome measures used
(list): VAS, ODI, SF-36, Height of Level of Evidence
anterior and middle column; Beck Determination
value Potential Level: II
Downgraded Level: Not
Nonvalidated outcome measures Downgraded
used (list): complications
(secondary), ASTLOF score-used Conclusions
to classify , . >75% ODI This paper provides evidence
improvement was considered that: 9.2% of adults with
excellent; 50-75-good, 25-49-fair; OVCF treated without
<25% poor. augmentation or surgery
developed a bed-related
Diagnosis made by: complication and loss of
height of 11.4%.
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: PROMs and Xray
Results/subgroup analysis (relevant
to question): in conservative group;
1 died; 4 lost to follow-up; 5 had
adjacent segment fracture; 39 had
reoperation (failure of conservative
care, including 13 who couldn’t
tolerate bed rest). 228 stayed in
conservative group.
643
Conservative VAS: baseline 7.1+/-
1.8, 3m-6.4 +/- 1.9, 12m-4.6 +/- 1.3.
ODI: baseline 69.6 +/- 7.5, 3m-
60.1+/-6.8, 12m-43.6 +/- 4.4. ODI
improvement in conservative group
was considered fair (12m).
Surgical group had significant
difference with conservative grp in
short-term.
SF-36 (PCS/MCS), pre: 27.4/26.7;
1yr: 37.6/39. Greater improvements
noted in surgical group
VAH, VMH and Beck value: lower
than pre-treatment, suggesting
vertebral collapse and increased
cobb angle.
Bed-rest related complications in 21
(9%) patients including 5 hypostatic
pneumonia, 2 UTI, 13 bedsore, 1
PE. 5 had adjacent segment
fracture, 26 with loss in vertebral
height, low bak pain.
Author conclusions (relevant to
question): 9% of conservatively
treated patients developed bed
related complications and 11% lost
TL kyphosis. Authors narratively
state that patients in conservative
group had more VAS of LBP (not
fracture pain) at 1-year f/u than
surgery group.
Edidin AA, Ong KL, Lau E, Kurtz Type of evidence: Prognostic ☐ Prospective ☒ Retrospective Critique of methodology:
SM. Morbidity and Mortality After ☐ Patients not enrolled at
Vertebral Fractures: Comparison Level IV Study Design: Case Series same point in their
of Vertebral Augmentation and disease
Nonoperative Management in the Explanation of failure to meet Stated objective of study: compare ☐ <80% follow-up
Medicare Population. Spine (Phila guideline inclusion criteria M&M for VCF with CT, BKP, VP ☐ Follow-up not
Pa 1976). 2015;40(15):1228-1241. (when applicable)
standardized
doi:10.1097/BRS.0000000000000 Total number of patients in the
☐ No validated outcome
992 ☐ Level V (expert consensus) study: 1,038,956
measures used
644
Number of patients in ☐ Small sample size
☐ Level IV in presence of higher relevant subgroup(s): 141343 BKP, ☐ Lacked subgroup analysis
75364 VP, 822249 nonop
quality studies ☐ Diagnostic methods not
described.
☐ Subgroup analysis data not Duration of follow-up: 4 years
☒ Other: ICD 9 claims based
available data
Validated outcome measures used
☐ Not relevant to question (list): Survival & Morbidity DVT,
UTI based on ICD coding Level of Evidence
Determination
Nonvalidated outcome measures Potential Level: IV
used (list): mortality Downgraded Level: Not
Downgraded
Diagnosis made by:
Conclusions
☐ Clinical exam/history This paper provides evidence
☐ Electromyography that: non-operative
☐ Myelogram treatment has 55% and 25%
☐ MRI higher adjusted risk of
☐ CT mortality than BKP and VP.
☐ CT/Myelogram
☒ Other: ICD 9 codes, claims data
Results/subgroup analysis (relevant
to question): nonoperated cohort
had significantly higher adjusted
risks of pneumonia, myocardial
infarction/cardiac complications,
deep venous thrombosis (DVT),
and urinary tract infection (UTI)
than the BKP cohort at 4 years. For
the propensity-matched group,
the corresponding AHRs were 1.15
( P < 0.001), 1.09
( P < 0.001), 1.04 ( P = 0.001), and
1.10 ( P < 0.001). On the
contrary, the nonoperated patient
cohort had lower adjusted
risks of subsequent
augmentation/fusion, subsequent
augmentation, and
pulmonary/respiratory
complications at
645
4 years. When comparing
nonmatched and matched patients
in the nonoperated and VP cohorts
after 4 years of follow-up, patients
in the nonoperated cohort were
found to have a
higher adjusted risk of UTI than
patients in the VP cohort. On the
contrary, the nonoperated patient
cohort had lower adjusted risks of
subsequent augmentation/fusion,
subsequent augmentation,
pulmonary/respiratory
complications, and pulmonary
embolism at 4 years
Author conclusions (relevant to
question): VCF patients in the
Medicare population who received
vertebral augmentation therapies,
specifically BKP and VP,
experienced lower mortality and
overall morbidity than VCF patients
who received conservative
management
Hoshino M, Takahashi S, Yasuda Type of evidence: Prognostic ☐ Prospective ☒ Retrospective Critique of methodology:
H, et al. Balloon Kyphoplasty ☐ Patients not enrolled at
Versus Conservative Treatment Level III Study Design: Case Control same point in their
for Acute Osteoporotic Vertebral disease
Fractures With Poor Prognostic Explanation of failure to meet Stated objective of study: The aim ☐ <80% follow-up
Factors: Propensity Score guideline inclusion criteria of this study was to investigate ☐ Follow-up not
Matched Analysis Using Data (when applicable) efficacy of balloon kyphoplasty standardized
From Two Prospective Multicenter (BKP) for acute osteoporotic
☐ No validated outcome
Studies. Spine (Phila Pa 1976). ☐ Level V (expert consensus) vertebral fractures (OVFs) in
2019;44(2):110-117. measures used
patients with poor prognostic
☒ Small sample size
doi:10.1097/BRS.0000000000002 ☐ Level IV in presence of higher factors
769. quality studies ☐ Lacked subgroup analysis
Total number of patients in the ☐ Diagnostic methods not
☐ Subgroup analysis data not study: 222 described.
available Number of patients in relevant ☒ Other: historical control;
subgroup(s): 90 in BPK group and non-randomized; selection
90 in conservative group bias
☐ Not relevant to question
646
Duration of follow-up: 6 months Level of Evidence
Determination
Validated outcome measures used Potential Level: III
(list): VAS, SF-36 Downgraded Level: Not
Downgraded
Nonvalidated outcome measures
used (list): degree of independence Conclusions
(long-term care insurance system in This paper provides evidence
Japanese Health and Welfare that: the medical
Ministry); vertebral body deformity management approach may
result in decrease in ADL’s
Diagnosis made by: and be less effective in
☒ Clinical exam/history preventing vertebral
deformity.
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☐ Other:
ADL score dec in 25.6%, SF-36
vitality subscale improved by
14.5+/-29.4, pain change 52.2 +/-
29.8, wedge angle -6.3, % height -
20.6 +/- 14.2%, adjacent fracture
6.7%, hospitalization days 37.1 +/-
35 days
Author conclusions (relevant to
question): .BKP improved ADLs
and QOL, while reducing vertebral
body deformity compared to CT
Hoshino M, Tsujio T, Terai H, et Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
al. Impact of initial conservative Prognostic ☐ Patients not enrolled at
treatment interventions on the Study Design: Observational same point in their
outcomes of patients with Level III disease
osteoporotic vertebral fractures. Stated objective of study: To ☒ <80% follow-up
Spine (Phila Pa 1976). Explanation of failure to meet examine whether initial ☐ Follow-up not
2013;38(11):E641-E648. guideline inclusion criteria conservative tx for OVF influence standardized
doi:10.1097/BRS.0b013e31828ce (when applicable) patient outcomes
d9d ☐ No validated outcome
measures used
☐ Level V (expert consensus)
647
Total number of patients in the ☐ Small sample size
☐ Level IV in presence of higher study: 362 ☐ Lacked subgroup analysis
Number of patients in relevant
quality studies ☐ Diagnostic methods not
subgroup(s): N/A
described.
☐ Subgroup analysis data not ☒ Other: bracing was
available Duration of follow-up: 6 months
allowed, but I think we
Validated outcome measures used okay’d this
☐ Not relevant to question
(list): SF-36, VAS, MMSE, %
vertebral collapse, Level of Evidence
Nonvalidated outcome measures Determination
used (list): Japanese long-term Potential Level: II
care insurance 4 step classification Downgraded Level: III
for ADL,Vertebral height and % loss Downgraded due to less than
80% follow-up; 362/485
Diagnosis made by: (74.6%) had complete
followup data
☒ Clinical exam/history
☐ Electromyography Conclusions
☐ Myelogram This paper provides evidence
☒ MRI that: after 6 months of
☐ CT conservative therapy ~1/5
☐ CT/Myelogram pts had reduced ADLs, ¼
☒ Other: xray, radiograph pts had prolonged back
pain, ~1/3 had further
vertebral body collapse and
Results/subgroup analysis (relevant
1/20 pts had cognitive
to question): at 6 months: 72.3%
decline.
had SF36(PCS) <=40; 22.9% had
SF36(MCS) <=40, 22% had
reduced ADLs; 25.7% had
prolonged back pain; 5.4 % had
cognitive impairment and 31.2%
had vertebral body collapse.
Author conclusions (relevant to
question): treatment intervention
factors did not affect patient
outcomes 6 months after OVF. The
presence of middle-column injuries
was a significant risk factor that
was common to both clinical and
radiological outcomes. In the
future, systematic treatments for
648
cases with middle-column
injuries need to be established.
Kato T, Inose H, Ichimura S, et al. Type of evidence: Prognostic ☒ Prospective ☐ Retrospective Critique of methodology:
Comparison of Rigid and Soft- Study Design: RCT ☐ Patients not enrolled at
Brace Treatments for Acute Level II same point in their
Osteoporotic Vertebral Stated objective of study: to clarify disease
Compression Fracture: A Explanation of failure to meet and to compare the preventive ☐ <80% follow-up
Prospective, Randomized, guideline inclusion criteria effect of the different brace ☐ Follow-up not
Multicenter Study. J Clin Med. (when applicable) treatments on the deformity of the standardized
2019;8(2):198. Published 2019 vertebral body and other clinical
Feb 6. doi:10.3390/jcm8020198 ☐ Level V (expert consensus) ☐ No validated outcome
results in patients with vertebral
measures used
compression fractures.
☐ Small sample size
☐ Level IV in presence of higher
Total number of patients in the ☐ Lacked subgroup analysis
quality studies
study: 284 ☐ Diagnostic methods not
Number of patients in described.
☐ Subgroup analysis data not
available
relevant subgroup(s): 141 rigid ☒ Other: non-blinded
brace, 143 soft brace (combined patients and providers
conservative group)
☐ Not relevant to question
Level of Evidence
Duration of follow-up: 48 weeks Determination
Potential Level: II
Validated outcome measures used Downgraded Level: Not
(list): EQ-5D-3L, VAS, JOABPEQ Downgraded
Nonvalidated outcome measures Conclusions
used (list): AVBCP This paper provides evidence
that: adults with acute OVCF
Diagnosis made by: treated without
☐☒ Clinical exam/history augmentation or surgery
☐ Electromyography have a 5.6% risk of
developing new fractures
☐ Myelogram
by 48 weeks.
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: “Fresh” fracture based on
MRI or radiograph
Results/subgroup analysis (relevant
to question): VAS improved in soft
and rigid brace groups. Tables 1
and 2. Text description in heading
Rigid brace: baseline VAS 72,1 ->
649
28.9 @ 12 weeks -> 28.2 @ 48
weeks ; soft brace VAS baseline
77,3 -> 29.1 @ 12 weeks -> 26.3.
@ 48 weeks
Author conclusions (relevant to
question): We found that the 12-
week rigid-brace treatment for
acute vertebral compression
fractures didnot result in statistically
greater prevention of spinal
deformity, better QOL, or lesser
back pain thansoft-brace treatment
at 48 weeks. Therefore, the routine
use of a custom-made rigid brace
for acutevertebral compression
fractures is not justified
Klezl Z, Bhangoo N, Phillips J, Type of evidence: Prognostic ☒ Prospective ☐ Retrospective Critique of methodology:
Swamy G, Calthorpe D, ☐ Patients not enrolled at
Bommireddy R. Social implications Level III Study Design: Case Control same point in their
of balloon kyphoplasty: disease
prospective study from a single Stated objective of study: to ☐ <80% follow-up
UK centre. Eur Spine J. Explanation of failure to meet determine the social and functional ☐ Follow-up not
2012;21(9):1880-1886. guideline inclusion criteria consequences of balloon standardized
doi:10.1007/s00586-012-2262-7 (when applicable) kyphoplasty in patients who have
☒ No validated outcome
sustained OVCFs
measures used
☐ Level V (expert consensus)
Total number of patients in the ☐ Small sample size
☐ Level IV in presence of higher study: 118 ☐ Lacked subgroup analysis
quality studies Number of patients in ☐ Diagnostic methods not
relevant subgroup(s): 55 in case described.
☐ Subgroup analysis data not control group, 63 undergoing ☐ Other: Click or tap here to
available balloon kyphoplasty enter text.
Duration of follow-up: 1 year Level of Evidence
☐ Not relevant to question
Determination
Validated outcome measures used Potential Level: III
(list): ODI, mortality, VAS Downgraded Level: Not
Downgraded
Nonvalidated outcome measures
used (list): Hospital Anxiety and Conclusions
Depression Scale, social function This paper provides evidence
measures that: of patients with OVCF
managed without
650
Diagnosis made by: augmentation or surgery
☒ Clinical exam/history requiring admission to
☐ Electromyography hospital, 21.6% died and
52.9% experienced
☐ Myelogram
decrease in function at one
☒ MRI year.
☐ CT
☐ CT/Myelogram
☒ Other: NB – this was stated for
the treatment group (not relevant to
this question), presumes the same
for the control (natural history)
group
Results/subgroup analysis (relevant
to question): Of 51, 27 experienced
a “drift to a lower status at 1-year”,
11 died. 36 went from I before to 7
died, and 10 needing social input
(decreased social functioning); 19 –
maintained. Compared to 94% of
kypho group who were ambulating,
only 56.5% of control group were
ambulating by 1 wk. mortality at 1yr
was 22% in conservative group and
11% in surgical group.
Author conclusions (relevant to
question): the reduction in mortality
and drift in social functionality at 1
year following treatment with
balloon kyphoplasty suggests that it
is a viable option for the
management of OVCFs
Levy H, Seydafkan S, Rice JD, Type of evidence: Prognostic ☐ Prospective ☒Retrospective Critique of methodology:
Easley KA, Tangpricha V. ☒ Patients not enrolled at
Comparative efficacy of Level IV Study Design: Case Control same point in their
vertebroplasty, kyphoplasty, and disease
medical therapy for vertebral Explanation of failure to meet Stated objective of study: to ☐ <80% follow-up
fractures on survival and guideline inclusion criteria examine the survival rate and ☐ Follow-up not
prevention of recurrent fractures. (when applicable) recurrent fracture rate after surgical standardized
Endocr Pract 2012;18(4):499– therapy, medical therapy or both ☐ No validated outcome
507. ☐ Level V (expert consensus)
measures used
651
Total number of patients in the ☐ Small sample size
☐ Level IV in presence of higher study: 250 ☐ Lacked subgroup analysis
quality studies ☐ Diagnostic methods not
Number of patients in relevant described.
☐ Subgroup analysis data not subgroup(s): 149 117 ☒ Other: baseline different
available groups, younger patients in
Duration of follow-up: 10 years non-op, not clear duration
☐ Not relevant to question of f/u
Validated outcome measures used
Level of Evidence
(list): survival rate, refracture rate
Determination
Potential Level: III
Nonvalidated outcome measures Downgraded Level: IV
used (list): Click or tap here to enter Downgraded due to different
text. times of enrollment for
disease for comparative
Diagnosis made by: component.
☐ Clinical exam/history
☐ Electromyography Conclusions
This paper provides evidence
☐ Myelogram that: adults with OVCF
☐ MRI treated without
☐ CT augmentation or surgery
☐ CT/Myelogram have a 6% refracture rate
☒ Other: ICD 9 and CPT, chart and a 24.8% mortality rate.
review
Results/subgroup analysis (relevant
to question):
There was no significant difference
in the cumulative survival rates
among the 4 study groups nor
between the treatment groups.
There was, how-ever, a significant
difference in the cumulative
refracture-free rates among the 4
study groups (P<.0001). Recurrent
fracture-free rates were highest in
the group that received no
treatment. The 2-year cumulative
refracture-free rates were 95.9%,
84.8%, 81.7%, and 68.5%,
respectively, for the no treatment,
medical therapy only, surgical
652
treatment only, and medical plus
surgical therapy groups. Recurrent
fracture-free rates were significantly
different for patients who received
surgical or medical or surgical plus
medical therapy (P = .0007), with
patients in the medical plus surgical
group having the shortest time to
refracture, although these patients
may have been sicker and more
frail than the other groups.
Author conclusions (relevant to
question): surgical treatment with
vertebroplasty or kyphoplasty did
not decrease recurrent vertebral
fractures in patients presenting with
an initial vertebral fracture. Medical
and surgical therapies together may
shorten the time to refracture, but
the observed elevated risk may be
due to other confounding factors.
We found no difference in survival
in patients undergoing kyphoplasty
or vertebroplasty in comparison
with medical or no treatment
groups.
Lin JH, Chien LN, Tsai WL, Chen Type of evidence: Prognostic ☐ Prospective ☒ Retrospective Critique of methodology:
LY, Chiang YH, Hsieh YC. Early ☒ Patients not enrolled at
vertebroplasty associated with a Level IV Study Design: Comparative same point in their
lower risk of mortality and disease
respiratory failure in aged patients Stated objective of study: to ☐ <80% follow-up
with painful vertebral compression Explanation of failure to meet elucidate the benefits of an early ☐ Follow-up not
fractures: a population-based guideline inclusion criteria VP intervention in aged patients standardized
cohort study in Taiwan. Spine J (when applicable) with a PVCF by comparing the risks ☐ No validated outcome
2017;17(9):1310–1318 of mortality and respiratory-related measures used
☐ Level V (expert consensus) morbidity based on the population-
☐ Small sample size
based propensity score matched
☐ Level IV in presence of higher cohort . ☐ Lacked subgroup analysis
quality studies ☐ Diagnostic methods not
Total number of patients in the described.
☐ Subgroup analysis data not study: 10,785 ☒ Other: patients > 70,
available treatment within 3 months,
653
☐ Not relevant to question Number of patients in
relevant subgroup(s): 1773 VP, Level of Evidence
5324 non-VP Determination
Potential Level: III
Duration of follow-up: 1 year Downgraded Level: IV
Downgraded due to possible
Validated outcome measures used crossover of patients and
(list): death, pneumonia and unclear intervention.
respiratory complications
Nonvalidated outcome measures
used (list): Click or tap here to enter Conclusions
text. This paper provides evidence
that: in adults with OVCF
Diagnosis made by: treated without
☐ Clinical exam/history augmentation or surgery
☐ Electromyography the risk of mortality was 389
☐ Myelogram over 61427 person-months
☐ MRI observed.
☐ CT
☐ CT/Myelogram
☒ Other: Taiwan registry, claims
data
Results/subgroup analysis (relevant
to question): The incidences of
death at 1 year of VP and non-VP
patients were 0.46 (95% confidence
interval [CI]: 0.38–0.56) and 0.63
(95% CI: 0.57–0.70) per 100
person-months, respectively. We
observed a hazard ratio (HR) of
1.39 (95% CI: 1.09–1.78, p=.008)
when comparing non-VP to VP
patients. This phenomenon was
seen when estimating the benefits
of respiratory failure (HR: 1.46;95%
CI: 1.04–2.05, p=.028)
Author conclusions (relevant to
question): VP was associated with
lower risks of mortality and
respiratory failure in aged patients
with a PVCF. VP should be
654
considered a priority for the aged
patients with a PVCF requiring
admission and analgesics
~~~~~~~~~~
Matsumoto T, Hoshino M, Tsujio Type of evidence: Prognostic ☒ Prospective ☐ Retrospective Critique of methodology:
T, et al. Prognostic factors for ☐ Patients not enrolled at
reduction of activities of daily living Level II Study Design: Observational same point in their
following osteoporotic vertebral disease
fractures. Spine (Phila Pa 1976). Explanation of failure to meet Stated objective of study: To ☒ <80% follow-up
2012;37(13):1115-1121. guideline inclusion criteria elucidate the prognostic factors ☐ Follow-up not
doi:10.1097/BRS.0b013e3182432 (when applicable) indicating reduced activities of daily standardized
823 living (ADL) at the time of the 6-
☐ No validated outcome
☐ Level V (expert consensus) month follow-up after osteoporotic
measures used
vertebral fracture (OVF)
☐ Small sample size
☐ Level IV in presence of higher
quality studies Total number of patients in the ☐ Lacked subgroup analysis
study: 420 ☐ Diagnostic methods not
☐ Subgroup analysis data not Number of patients in described.
available relevant subgroup(s): N/A ☐ Other: Click or tap here to
enter text.
Duration of follow-up: 6 months
☐ Not relevant to question
Level of Evidence
Validated outcome measures used Determination
(list): Japanese health and welfare, Potential Level: I
VAS; SF36; Pain, ADL (Japanese Downgraded Level: II
system), QOL Downgraded due to <80%
follow-up and shprt follow-up
Nonvalidated outcome measures
used (list): ADL from Japanese Conclusions
Health and Welfare Ministry, This paper provides evidence
Japanese long-term care insurance that: 21% of adults with
system ranking system OVCF treated without
augmentation or surgery
Diagnosis made by: experienced a reduction in
☒ Clinical exam/history ADLs at 6 months.
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: “radiography”
655
Results/subgroup analysis (relevant
to question): ADL were reduced at
6 months after OVF in 66 of 310
patients (21.3%). In univariate
analysis, age more than 75 years (
P = 0.044), female sex ( P = 0.041),
2 or more previous spine fractures (
P = 0.009), presence of middle
column injury ( P = 0.021), and lack
of regular exercise before fracture (
P = 0.001) were significantly
associated with reduced ADL. In
multivariate analysis, presence of
middle column injury (odds ratio
[OR], 2.26; P = 0.022) and lack of
regular exercise before fracture
(OR, 2.49; P = 0.030) were
significantly associated with
reduced ADL
Author conclusions (relevant to
question): presence of middle
column injury of the vertebral body
and lack of regular exercise before
fracture as prognostic factors for
reduced ADL. With clarification and
validation, these risk factors may
provide crucial tools for determining
subsequent OVF treatments.
McCullough BJ, Comstock BA, Type of evidence: Prognostic ☐ Prospective ☒ Retrospective Critique of methodology:
Deyo RA, Kreuter W, Jarvik JG. ☐ Patients not enrolled at
Major medical outcomes with Level IV Study Design: Case Series same point in their
spinal augmentation vs disease
conservative therapy. JAMA Intern Explanation of failure to meet Stated objective of study: to ☐ <80% follow-up
Med. 2013;173(16):1514-1521. guideline inclusion criteria compare major medical outcomes ☐ Follow-up not
doi:10.1001/jamainternmed.2013. (when applicable) following treatment of osteoporotic standardized
8725 vertebral fractures with spinal
☐ No validated outcome
☐ Level V (expert consensus) augmentation or conservative
measures used
therapy
☐ Small sample size
☐ Level IV in presence of higher
quality studies Total number of patients in the ☐ Lacked subgroup analysis
study: 126392 ☒ Diagnostic methods not
described.
656
☐ Subgroup analysis data not Number of patients in relevant ☒ Other: ICD 9
available subgroup(s): 115851 in
conservative group, 10,541 in Level of Evidence
☐ Not relevant to question spinal augmentation group Determination
Work group conclusions
Duration of follow-up: 1 year Potential Level: III
Downgraded Level: IV
Validated outcome measures used Downgraded due to unclear
(list): Mortality, major medical diagnostic definition
complications, HCU
Conclusions
Nonvalidated outcome measures This paper provides evidence
used (list): Presence of a major that: through the use of
medical complication (as listed) Medicare data, patients with
OVCF treated without
Diagnosis made by: augmentation or surgery
☐ Clinical exam/history experience a mortality rate
☐ Electromyography of 6.7% and an incidence of
☐ Myelogram major medical complication
of 28.9% at 1 year following
☐ MRI
OCVF.
☐ CT
☐ CT/Myelogram
☒ Other: ICD 9 code and CPT,
claims data
Results/subgroup analysis (relevant
to question): 1.5% mortality in
control group at 30 days, @1year
6.7%. Complications 10.4% @ 30
days and 28.9% @ 1 year
Author conclusions (relevant to
question): after accounting for
selection bias, conservative care
mortality and complication rate was
similar to augmentation care
Park JH, Kang KC, Shin DE, Koh Type of evidence: Prognostic ☐ Prospective ☒ Retrospective Critique of methodology:
YG, Son JS, Kim BH. Preventive ☐ Patients not enrolled at
effects of conservative treatment Level III Study Design: Case Control same point in their
with short-term teriparatide on the disease
progression of vertebral body Stated objective of study: Evaluate ☐ <80% follow-up
collapse after osteoporotic preventative effects of short-term
657
vertebral compression Explanation of failure to meet teriparatide on progression of ☐ Follow-up not
fracture. Osteoporos Int. guideline inclusion criteria vertebral body collapse after OVCF standardized
2014;25(2):613-618. (when applicable) ☐ No validated outcome
doi:10.1007/s00198-013-2458-7 Total number of patients in the measures used
☐ Level V (expert consensus) study: 68
☒ Small sample size
Number of patients in relevant
☐ Lacked subgroup analysis
☐ Level IV in presence of higher subgroup(s): 32 treated
quality studies conservatively (teriparatide) and 26 ☐ Diagnostic methods not
treated with antiresorptive described.
☐ Other: Click or tap here to
☐ Subgroup analysis data not
Duration of follow-up: 6 months enter text.
available
Validated outcome measures used Level of Evidence
☐ Not relevant to question (list): Determination
Potential Level: III
Nonvalidated outcome measures Downgraded Level: Not
used (list): Kyphosis angle, wedge Downgraded
angle, ant/mid/post height, posterior
border height of an upper normal Conclusions
vertebral body This paper provides evidence
that: kyphosis and wedge
Diagnosis made by: angle increase, while
☒ Clinical exam/history anterior and middle column
heights decrease in OVCF
☐ Electromyography
long-term.
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: radiography
Results/subgroup analysis (relevant
to question):
Kyphosis and wedge angle
increased 82.6% and 43.4% at last
follow up; Anterior and Middle
border heights decreased 21.7%
and 18.2%
Group I (teriparatide) increments of
mean kyphosis and wedge angle
were significant lower (4.0+/-4.2*
and 3.6+/-3.6*) than Group II
(6.8+/-4.1* and 5.8+/-3.5*)
658
percentage of anterior and middle
border height decrement ratios sign
lower in Group I (9.6+/-10.3 and
7.4+/-7.5%) than group II (18.1+/-
9.7 and 13.8+/-12.2%) =
Author conclusions (relevant to
question): In female patients with
single-level osteoporotic VCF at the
thoracolumbar junction, short-term
teriparatide treatment did not
prevent but did decrease the
progression of fractured vertebral
body collapse.
Natural History Question 2: For patients with acute osteoporotic vertebral compression fractures managed without augmentation or surgery,
what is the expected time to resolution of pain?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Andrei D, Popa I, Brad S, et al. The Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
variability of vertebral body volume Prognostic Study Design: Observational ☐ Patients not enrolled at
and pain associated with osteoporotic same point in their
vertebral fractures: conservative Level II Stated objective of study: to disease
treatment versus percutaneous compare the efficacy and ☐ <80% follow-up
transpedicular vertebroplasty. Int Explanation of failure to meet safety of vertebroplasty against ☐ Follow-up not
Orthop. 2017;41(5):963-968. guideline inclusion criteria conservative management of standardized
doi:10.1007/s00264-017-3409-2 (when applicable) osteoporotic vertebral fractures ☐ No validated outcome
without neurologic symptoms.
measures used
☐ Level V (expert consensus)
Total number of patients in the ☐ Small sample size
☐ Level IV in presence of study: 66 ☐ Lacked subgroup analysis
higher quality studies Number of patients in ☐ Diagnostic methods not
relevant subgroup(s): treated: 33, described.
control: 30 ☒ Other: graph fig 3 doesn’t
fit the reported 6- and 12-
659
☐ Subgroup analysis data not Duration of follow-up: 6 and 12 m month outcomes…??
available Table also lists 3 groups
Validated outcome measures used erroneously
☐ Not relevant to question (list): VAS, QUALEFFO
Level of Evidence
Nonvalidated outcome measures Determination
used (list): duration of analgesics Potential Level: II
Downgraded Level: Not
Diagnosis made by: Downgraded
☒ Clinical exam/history
☐ Electromyography Conclusions
☐ Myelogram This paper provides evidence
☒ MRI that: with OVCF treated
without augmentation or
☒ CT surgery improve by 6
☐ CT/Myelogram months and are off
☒ Other: radiograph analgesics by 2 weeks. The
mean VAS was improved
Results/subgroup analysis from 6.28 (at onset) to 3.0 at
(relevant to question): Baseline 6 months and 2.36 at 12
VAS 6.28 improved to 3 at 6 months with medical
months and 2.36 at 12 months; management (starting at
mean analgesic use was 13.97 6.28).
days, independent ambulation 25
days,
Author conclusions (relevant to
question): PMMA had better
radiographic and clinical results at
1 year than conservative
treatment. Patients had lower VAS
at 6 months in augmentation
groupi
Blasco J, Garcia A, Manzanera LSR, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
et al. Randomized trial comparing Prognostic Study Design: Observational ☐ Patients not enrolled at
vertebroplasty and conservative same point in their disease
treatment analyzing pain relief and Level III Stated objective of study: to ☒ <80% follow-up
quality of life on the long term basis. compare the effects of VP vs ☐ Follow-up not standardized
CardioVascular and Interventional Explanation of failure to meet conservative approach on quality
Radiology. 2010;33:182-183. guideline inclusion criteria ☐ No validated outcome
of life and pain relief in patients
(when applicable) measures used
with painful OVF and analyze
secondary adverse effects and the ☐ Small sample size
☐ Level V (expert consensus) ☐ Lacked subgroup analysis
660
development of new fractures in ☐ Diagnostic methods not
☐ Level IV in presence of both treatments’ groups described.
higher quality studies ☒ Other: no values for 6
Total number of patients in the month and 12-month VAS,
☐ Subgroup analysis data not study: 125 control group
available Number of patients in relevant
subgroup(s): 64 VP, 61 CT Level of Evidence
☐ Not relevant to question Determination
Duration of follow-up:12 months Potential Level: II
Downgraded Level: III
Validated outcome measures used Downgraded due to
(list): Qualeffo-41, VAS
Nonvalidated outcome measures Conclusions
used (list): analgesic consumption, This paper provides evidence
clinical complications, radiological that: adults with OVCF
vertebral fractures, Qualeffo-41? treated without
augmentation or surgery
Diagnosis made by: have significant
☒ Clinical exam/history improvement in back pain
☐ Electromyography by 1 year, but 42% still
☐ Myelogram experience moderate or
☒ MRI severe pain at 12 months.
☒ CT
☐ CT/Myelogram
☒ Other: bone scan or MRI,
DEXA, radiograph
Results/subgroup analysis
(relevant to question): pain
reduction on VAS significantly
greater in VP group at 2Baseline
VAS 6.31 -> 3.07 @ 2months ,
QOL measures only statistically
improved @ 6 months. Difference
was NS at all other time points.
Figure A. \
Author conclusions (relevant to
question): VP and conservative
treatment both associated with
significant improvement in pain
and QOL.
661
Boonen S, Van Meirhaeghe J, Bastian Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
L, et al. Balloon kyphoplasty for the Prognostic Study Design: Observational ☐ Patients not enrolled at
treatment of acute vertebral same point in their disease
compression fractures: 2-year results Level III Stated objective of study: To ☒ <80% follow-up
from a randomized trial. J Bone Miner compare the effectiveness of ☐ Follow-up not standardized
Res. 2011;26(7):1627-1637. Explanation of failure to meet kyphoplasty with that of standard
doi:10.1002/jbmr.364 guideline inclusion criteria ☐ No validated outcome
nonsurgical management of the
(when applicable) measures used
treatment compare efficacy and
safety of BKP to CT over 24 ☐ Small sample size
☐ Level V (expert consensus) months. ☐ Lacked subgroup analysis
☐ Diagnostic methods not
☐ Level IV in presence of Total number of patients in the described.
higher quality studies study: 300 ☒ Other: industry funded
Number of patients in relevant
☐ Subgroup analysis data not subgroup(s): 151 BKP, 149 Level of Evidence
available nonsurgical Determination
Potential Level: II
Duration of follow-up: 24 months Downgraded Level: III
☐ Not relevant to question
Downgraded due to:
Validated outcome measures used
(list): SF-36 PCS, VAS, Euro Conclusions
QOL, SF-36 subscales, RMDQ This paper provides evidence
Likert scale that: LBP improves steadily
until 12 month after
Nonvalidated outcome measures fracture, but a subgroup of
used (list): days of inactivity, likert conservativ LBP improves
scale of satisfaction, days bedrest steadily until 12 months
after fracture, but a
Diagnosis made by: subgroup of treated
☒ Clinical exam/history patients have persistent
☐ Electromyography back pain (VAS > 3.0) at 24
☐ Myelogram months ely treated patients
have persistent pack pain
☒ MRI
(VAS>3.0) at 24 months.
☒ CT
☐ CT/Myelogram
☐ Other:
Results/subgroup analysis
(relevant to question): 69/101 pt
used pain meds @ 12 months and
23/105 @ 24 months; 42.9% using
opioids @ 6 months -> 33.7% @
12 months -> 9.5% @ 24 months.
662
Author conclusions (relevant to
question): compared with
nonsurgical treatment, BKP rapidly
reduces pain and improves
function, disability anmd QOL over
the course of 2 years without
increasing the risk of additional
vertebral fractures.
Diamond TH, Bryant C, Browne L, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Clark WA. Clinical outcomes after Prognostic Study Design: Observational ☒ Patients not enrolled at
acute osteoporotic vertebral fractures: same point in their disease
a 2-year non-randomised trial Level III Stated objective of study: To (dx criteria unclear)
comparing percutaneous assess the safety and efficacy of ☐ <80% follow-up
vertebroplasty with conservative percutaneous vertebroplasty for ☐ Follow-up not standardized
therapy. Med J Aust. Explanation of failure to meet the treatment of acute
2006;184(3):113-117. guideline inclusion criteria ☐ No validated outcome
osteoporotic vertebral fractures.
doi:10.5694/j.1326- (when applicable) measures used
5377.2006.tb00148.x Total number of patients in the ☒Small sample size
☐ Level V (expert consensus) study: 126 ☐ Lacked subgroup analysis
Number of patients in relevant ☒ Diagnostic methods not
☐ Level IV in presence of subgroup(s): 38 by conservative described.
higher quality studies therapy and 88 PV ☒ Other: selection bias?
Patients who declined VP
☐ Subgroup analysis data not Duration of follow-up: 24 months were control group; no
available statistical comparison
Validated outcome measures used between time intervals
☐ Not relevant to question (list) VAS, level of function
(Barthel index) , pain score Level of Evidence
Determination
Nonvalidated outcome measures Potential Level: II
used (list): number of hospital Downgraded Level: III
days, vertebral morphometry via Downgraded due to:
XR, new fx, recurrent pain
Conclusions
Diagnosis made by: This paper provides evidence
☒ Clinical exam/history that: adults with OVCF
☐ Electromyography treated without
☐ Myelogram augmentation or surgery
experienced an 80%
☒ MRI
reduction in pain scores at
☐ CT 6-12 months and an 85%
☐ CT/Myelogram reduction at 48 months
after fracture.
663
☒ Other: unclear, imaging criteria
of acute fracture activity
Results/subgroup analysis
(relevant to question): VAS 19 @
24 hrs -> 7@6weeks ->4@6-12
months and 3 @ 24 months, 85%
improvement in pain score at 24
months with conservative therapy
Author conclusions (relevant to
question): The analgesic benefit
of percutaneous vertebroplasty
and the low complication rates
suggest that it is a useful therapy
for acute painful osteoporotic
vertebral fractures
Diamond TH, Champion B, Clark WA. Type of evidence: ☒ Prospective ☒ Retrospective Critique of methodology:
Management of acute osteoporotic Prognostic Study Design: Comparative ☐ Patients not enrolled at
vertebral fractures: a nonrandomized same point in their disease
trial comparing percutaneous Level II Stated objective of study: To ☐ <80% follow-up
vertebroplasty with conservative determine whether PV may be an ☐ Follow-up not standardized
therapy. Am J Med. 2003;114(4):257- Explanation of failure to meet effective treatment for vertebral
265. doi:10.1016/s0002- guideline inclusion criteria ☐ No validated outcome
fracture
9343(02)01524-3 (when applicable) measures used
Total number of patients in the ☒☐ Small sample size
☐ Level V (expert consensus) study: 79 ☐ Lacked subgroup analysis
Number of patients in relevant ☐ Diagnostic methods not
☐ Level IV in presence of subgroup(s): 24 described.
higher quality studies ☐ Other: non-randomized
Duration of follow-up: 12 months patients
☐ Subgroup analysis data not
available Validated outcome measures used Level of Evidence
(list): VAS, Barthel index Determination
☒ Not relevant to question Potential Level: II
Nonvalidated outcome measures Downgraded Level: Not
used (list): level of function, Downgraded
complications
Conclusions
Diagnosis made by: This paper provides evidence
☒ Clinical exam/history that: the pain levels
☐ Electromyography continue to improve out to
☐ Myelogram 12 months in adults with
☒ MRI
664
☐ CT OVCF treated without
☐ CT/Myelogram augmentation or surgery).
☒ Other: DEXA, MRI or 99Tc,
radiograph
Results/subgroup analysis
(relevant to question): 61%
improvement in pain score at 6
weeks; 71% improvement in pain
score at 6-12 months
Author conclusions (relevant to
question): our results suggest that
the pain and disability of acute
osteoporotic vertebral
compression fractures appear to
be treated more effectively by
percutaneous vertebroplasty than
by conservative therapy alone.
Du JP, Fan Y, Liu JJ, et al. The Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
analysis of MSTMOVCF (Multi- Prognostic Study Design: Observational ☐ Patients not enrolled at
segment thoracolumbar mild same point in their disease
osteoporotic fractures surgery or Level II Stated objective of study: To ☐ <80% follow-up
conservative treatment) based on assess the utility of the ☐ Follow-up not standardized
ASTLOF (the assessment system of MSTMOVCF system to direct care
thoracolumbar osteoporotic Explanation of failure to meet ☐ No validated outcome
and to revise their system.
fracture). Sci Rep. 2018;8(1):8185. guideline inclusion criteria measures used
Published 2018 May 29. (when applicable) Total number of patients in the ☐ Small sample size
doi:10.1038/s41598-018-26562-7 study: 470 ☐ Lacked subgroup analysis
☐ Level V (expert consensus) Number of patients in relevant ☐ Diagnostic methods not
subgroup(s): 277 conservative, described.
☐ Level IV in presence of 193 surgery ☒ Other: selection bias in
higher quality studies enrollment, included burst
Duration of follow-up: 1 year fractures; multisegment
☐ Subgroup analysis data not OCVF; non-randomly
available Validated outcome measures used assigned patient
(list): VAS, ODI, SF36
☐ Not relevant to question Level of Evidence
Nonvalidated outcome measures Determination
used (list): imaging Potential Level: II
Downgraded Level: Not
Diagnosis made by: Downgraded
☒ Clinical exam/history
☐ Electromyography Conclusions
665
☐ Myelogram This paper provides evidence
☒ MRI that: patients treated
without augmentation or
☒ CT
surgery experience
☐ CT/Myelogram improvement in pain out to
☒ Other: xray, DEXA 1 year, however, the nature
of the study makes it
Results/subgroup analysis difficult to determine when
(relevant to question): the improvement plateaus.
Conservative group VAS Post 3M
6.4+/- 1.8; Post 1y 4.6+/-1.3)
Author conclusions (relevant to
question): great short-term clinical
results in patients undergoing
surgery.
Hoshino M, Takahashi S, Yasuda H, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
et al. Balloon Kyphoplasty Versus Prognostic Study Design: Observational ☐ Patients not enrolled at
Conservative Treatment for Acute same point in their disease
Osteoporotic Vertebral Fractures With Level III Stated objective of study: The aim ☒ <80% follow-up
Poor Prognostic Factors: Propensity of this study was to investigate ☐ Follow-up not standardized
Score Matched Analysis Using Data Explanation of failure to meet efficacy of balloon kyphoplasty
From Two Prospective Multicenter guideline inclusion criteria ☐ No validated outcome
(BKP) for acute osteoporotic
Studies. Spine (Phila Pa 1976). (when applicable) measures used
vertebral fractures (OVFs) in
2019;44(2):110-117. patients with poor prognostic ☐ Small sample size
doi:10.1097/BRS.0000000000002769. ☐ Level V (expert consensus) factors. ☐ Lacked subgroup analysis
☐ Diagnostic methods not
☐ Level IV in presence of Total number of patients in the described.
higher quality studies study: 180 ☐ Other: Click or tap here to
enter text.
☐ Subgroup analysis data not Number of patients in relevant
available subgroup(s): 90 Level of Evidence
Determination
Duration of follow-up: 6 months Potential Level: II
☐ Not relevant to question
Downgraded Level: III
Validated outcome measures used Downgraded due to:<80%
(list): VAS, SF-36 followup
Nonvalidated outcome measures Conclusions
used (list): reduction in ADLs, VB This paper provides evidence
deformity, degree of that: pain from OVCF that
independence (long-term care was treated without
insurance system in Japanese augmentation or surgery
Health and Welfare Ministry) significantly improves
666
Diagnosis made by: (Mean VAS 36.1mm at 6
☒ Clinical exam/history months).
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☐ Other:
Results/subgroup analysis
(relevant to question): decrease
in ADL in 25.6% of conservative
group by VAS improved for
conservative group 52.2 +/- 29.8
at 6 months from pre-injury;
baseline VAS (mm) 84,4 -> 36.1
@ 6 months
Author conclusions (relevant to
question): Pain gradually
improved with conservative
treatment
Hoshino M, Tsujio T, Terai H, et al. Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Impact of initial conservative Prognostic Study Design: Observational ☒ Patients not enrolled at
treatment interventions on the same point in their disease
outcomes of patients with osteoporotic Level II Stated objective of study: To ☒ <80% follow-up
vertebral fractures. Spine (Phila Pa examine whether initial ☐ Follow-up not standardized
1976). 2013;38(11):E641-E648. Explanation of failure to meet conservative treatment
doi:10.1097/BRS.0b013e31828ced9d guideline inclusion criteria ☐ No validated outcome
interventions for osteoporotic
Also in OVCF 1 (when applicable) measures used
vertebral fractures (OVF) influence
patient outcomes. ☐ Small sample size
☐ Level V (expert consensus) ☐ Lacked subgroup analysis
Total number of patients in the ☐ Diagnostic methods not
☐ Level IV in presence of study: 362 described.
higher quality studies Number of patients in relevant ☐ Other: Click or tap here to
subgroup(s): n/a enter text.
☐ Subgroup analysis data not
available Duration of follow-up: 6 months Level of Evidence
Determination
Validated outcome measures used Potential Level: II
☐ Not relevant to question
(list): VAS, SF36, MMSE, PCS Downgraded Level: Not
MCS others , % vertebral collapse Downgraded
667
Nonvalidated outcome measures Conclusions
used (list): Japanese 4 ADL This paper provides evidence
categories that: by 6 months, 74.3% of
adults with OVCF treated
Diagnosis made by: without augmentation or
☒ Clinical exam/history surgery have significant
☐ Electromyography improvement in back pain.
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: x-ray, radiograph
Results/subgroup analysis
(relevant to question): Prolonged
back pain in Click or tap here to
enter text. 93/362 (25.7% of%)
had VAS > 5 @ 6 months (mean
VAS 6.67 @ 6 months for these
patients. There); for others is MV
analysis of risk factors for
prolonged back pain, of which only
middle column injury and steroid
use were significant.
Author conclusions (relevant to
question): treatment intervention
factors did not affect patient
outcomes 6 months after OCVF
Iwata A, Kanayama M, Oha F, et al. Is Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Bone Nonunion, Vertebral Deformity, Prognostic Study Design: Case Series ☐ Patients not enrolled at
or Spinopelvic Malalignment the Best same point in their disease
Therapeutic Target for Amelioration of Level III Stated objective of study: The aim ☐ <80% follow-up
Low Back Pain After Osteoporotic of this study was to identify ☐ Follow-up not standardized
Vertebral Fracture?. Spine (Phila Pa independent risk factors for
1976). 2020;45(13):E760-E767. Explanation of failure to meet ☐ No validated outcome
residual low back pain (LBP)
doi:10.1097/BRS.0000000000003422 guideline inclusion criteria measures used
following osteoporotic vertebral
Also in OVCF NH 1 (when applicable) fracture (OVF) ☐ Small sample size
☐ Lacked subgroup analysis
☐ Level V (expert consensus) Total number of patients in the ☐ Diagnostic methods not
study: 67 described.
☒ Level IV in presence of ☐ Other: Click or tap here to
higher quality studies enter text.
668
Number of patients in relevant
☐ Subgroup analysis data not subgroup(s): LBP=36, non- Level of Evidence
available LBP=31 Determination
Potential Level: III
☐ Not relevant to question Duration of follow-up: 24 weeks Downgraded Level: Not
Downgraded
Validated outcome measures used
(list): VAS, ODI, RMDQ, VKA Conclusions
This paper provides evidence
Nonvalidated outcome measures that: improvement plateaus
used (list): spinopelvic alignment around 3 weeks post
fracture in adults with
Diagnosis made by: OVCF treated without
☒ Clinical exam/history augmentation or surgery.
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: DEXA, X-ray
Results/subgroup analysis
(relevant to question): 24% had
ODI LBP > 40% @ 6 months, 39%
by VAS and 39% by RDQ,
combined 53% @ 6
Author conclusions (relevant to
question): Although spinopelvic
malalignment is considered as a
preexisting factor for LBP, VKA
exacerbated by nonunion
predominantly led to LBP after a
new OVF. Each incidence of
OVF should be treated to limit
further morphological changes to
the fractured vertebra.
Kato T, Inose H, Ichimura S, et al. Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Comparison of Rigid and Soft-Brace Prognostic Study Design: RCT ☐ Patients not enrolled at
Treatments for Acute Osteoporotic same point in their disease
Vertebral Compression Fracture: A Level II Stated objective of study: to clarify ☐ <80% follow-up
Prospective, Randomized, Multicenter and to compare the preventive ☐ Follow-up not standardized
Study. J Clin Med. 2019;8(2):198. effect of the different brace
669
Published 2019 Feb 6. Explanation of failure to meet treatments on the deformity of the ☐ No validated outcome
doi:10.3390/jcm8020198 guideline inclusion criteria vertebral body and other clinical measures used
4/28/22: include for Q2 (when applicable) results in patients with vertebral ☐ Small sample size
compression fractures.
☐ Lacked subgroup analysis
☐ Level V (expert consensus)
Total number of patients in the ☐ Diagnostic methods not
described.
☐ Level IV in presence of study: 284
Number of patients in relevant ☒ Other: non-blinded
higher quality studies
subgroup(s): 141 rigid brace, 143 patients and providers
soft brace (combined conservative
☐ Subgroup analysis data not Level of Evidence
group)
available Determination:
Duration of follow-up: 48 weeks Potential Level: II
☐ Not relevant to question Downgraded Level: Not
Validated outcome measures used Downgraded
(list): EQ-5D-3L, VAS, JOABPEQ
Conclusions
Nonvalidated outcome measures This paper provides evidence
used (list): AVBCP that: adults with OVCF
treated without
Diagnosis made by: augmentation or surgery
☐☒ Clinical exam/history have significant
improvement in pain by 12
☐ Electromyography
weeks.
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: “Fresh” fracture based
on MRI or radiograph
Results/subgroup analysis
(relevant to question): VAS
improved in soft and rigid brace
groups. Tables 1 and 2. Text
description in heading Rigid brace:
baseline VAS 72,1 -> 28.9 @ 12
weeks -> 28.2 @ 48 weeks ; soft
brace VAS baseline 77,3 -> 29.1
@ 12 weeks -> 26.3. @ 48 weeks
Author conclusions (relevant to
question): We found that the 12-
week rigid-brace treatment for
670
acute vertebral compression
fractures did not result in
statistically greater prevention of
spinal deformity, better QOL, or
lesser back pain than soft-brace
treatment at 48 weeks. Therefore,
the routine use of a custom-made
rigid brace for acute vertebral
compression fractures is not
justified
Kim YC, Bok DH, Chang HG, et al. Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Increased sagittal vertical axis is Prognostic Study Design: ☒ Patients not enrolled at
associated with less effective control ObservationalComparative same point in their disease
of acute pain following Level III ☐ <80% follow-up
vertebroplasty. Bone Joint Res. Stated objective of study: to ☐ Follow-up not standardized
2016;5(11):544-551. identify the pre-op prognostic
doi:10.1302/2046-3758.511.BJR- Explanation of failure to meet ☐ No validated outcome
factors related to the effect of
2016-0135.R1 guideline inclusion criteria measures used
vertebroplasty on acute pain
(when applicable) control using a cohort of surgically ☐ Small sample size
and non-surgically managed ☐ Lacked subgroup analysis
☐ Level V (expert consensus) patients ☐ Diagnostic methods not
described.
☐ Level IV in presence of Total number of patients in the ☒ Other: odd methodology;
higher quality studies study: 342 pts who did not improve at 3
Number of patients in relevant weeks were then given choice
☐ Subgroup analysis data not subgroup(s): 222 of vertebroplasty; 35%
available crossover
Duration of follow-up: 12 weeks
☐ Not relevant to question Level of Evidence
Validated outcome measures used Determination
(list): McGill Pain Map, VAS Potential Level: II
Downgraded Level: III
Nonvalidated outcome measures Downgraded due to
used (list): Click or tap here to enrollment differences in both
enter text. cohorts
Diagnosis made by: Conclusions relative to
☒ Clinical exam/history question
☐ Electromyography This paper provides evidence
☐ Myelogram that: pain improvement
plateaus between 4-6 weeks
☒ MRI
after fracture for both
☐ CT groups, and there is a
☐ CT/Myelogram significant difference in
671
☒ Other: DEXA VAS at 12 weeks for the two
groups.
Results/subgroup analysis
(relevant to question): patients
underwent 3 weeks of
conservative treatment. Patients
not satisfied could elect for VP. VP
significant better at 4VAS @
diagnosis 6.6 -> 4.5 @ 3 weeks ->
3.5 @ 4 weeks -> 2.9@ 6 weeks
and 6 weeks, but same as
conservative at2.0@ 12 weeks.
Author conclusions (relevant to
question): In conclusion, for the
patients with single-level acute
osteoporotic vertebral
compression fracture,
vertebroplasty was more effective
for acute pain control than
conservative treatment
regardless of age, bmI,
medical comorbidity, presence
of previous fracture, pain
duration, bone mineral density,
degree of vertebral body
compression, canal
encroachment, and kyphotic
Cobb angle.
Klazen CA, Lohle PN, de Vries J, et Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
al. Vertebroplasty versus conservative Prognostic Study Design: Observational ☐ Patients not enrolled at
treatment in acute osteoporotic same point in their disease
vertebral compression fractures Level II Stated objective of study: to clarify ☒ <80% follow-up
(Vertos II): an open-label randomised whether vertebroplasty has the ☐ Follow-up not standardized
trial. Lancet. 2010;376(9746):1085- Explanation of failure to meet additional value compared with
1092. doi:10.1016/S0140- guideline inclusion criteria ☐ No validated outcome
optimum pain treatment in patients
6736(10)60954-3 (when applicable) measures used
with acute vertebral fractures
☐ Small sample size
☐ Level V (expert consensus) Total number of patients in the ☒ Lacked subgroup analysis
study: 202 ☐ Diagnostic methods not
☐ Level IV in presence of Number of patients in relevant described.
higher quality studies subgroup(s): 101 assigned to PV ☒ Other: selection bias, VAS
and 101 assigned to conservative had to be 5 +
672
☐ Subgroup analysis data not Duration of follow-up: 1 year Maybe not a limitation but
available less generalizable
Validated outcome measures used
☐ Not relevant to question (list): VAS, EQ5D , RMD Level of Evidence
Determination
Nonvalidated outcome measures Potential Level: II
used (list): QUALEFFO<cost- Downgraded Level: Not
effectiveness Downgraded
Diagnosis made by: Conclusions
☒ Clinical exam/history This paper provides evidence
☐ Electromyography that: adults with OVCF
treated without
☐ Myelogram
augmentation or surgery
☒ MRI will gradually improve until
☐ CT 3 months and achieve
☐ CT/Myelogram significant improvement on
☒ Other: DEXA, radiograph average by 115 days.
Results/subgroup analysis
(relevant to question): baseline
VAS 7.5 -> 4.8 @ 1 month -> 3.8
@ 1 year ; 3 months to plateau;
115.6 days until plateau in
significant improvement
Author conclusions (relevant to
question): none
Klazen CA, Verhaar HJ, Lohle PN, et Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
al. Clinical course of pain in acute Prognostic Study Design: Observational ☐ Patients not enrolled at
osteoporotic vertebral compression same point in their disease
fractures. J Vasc Interv Radiol. Level II Stated objective of study: The ☒ <80% follow-up
2010;21(9):1405-1409. authors prospectively determined ☒ Follow-up not standardized
doi:10.1016/j.jvir.2010.05.018 the natural course of pain in
Explanation of failure to meet ☐ No validated outcome
patients with conservatively
guideline inclusion criteria measures used
treated acute osteoporotic
(when applicable) vertebral compression fractures ☐ Small sample size
(VCF). In addition, the type of ☐ Lacked subgroup analysis
☐ Level V (expert consensus) conservative therapy that these ☐ Diagnostic methods not
patients received was assessed described.
☐ Level IV in presence of ☒ Other: not MRI confirmed,
higher quality studies Total number of patients in the selection process was
study: 49 restricted to conservative tx,
not really bracing
673
☐ Subgroup analysis data not Number of patients in relevant
available subgroup(s): n/a Level of Evidence
Determination
☐ Not relevant to question Duration of follow-up: 23 months Potential Level: I
Downgraded Level: II
Validated outcome measures used Downgraded due to
(list): VAS <80% followup and
inconsistent followup
Nonvalidated outcome measures
used (list): Click or tap here to Conclusions
enter text. This paper provides evidence
that: adults with OVCF
Diagnosis made by: treated without
☒☐ Clinical exam/history augmentation or surgery
☐ Electromyography (mostly without bracing)
have improvement of
☐ Myelogram
significant back pain at 6
☐ MRI months.
☐ CT
☐ CT/Myelogram
☒ Other: radiograph and back
pain less than 2 weeks , xray
Results/subgroup analysis
(relevant to question): 63% of
patients had significant pain relief
at 6 months and 69% at 23
months
Author conclusions (relevant to
question): The natural fracture
healing, in terms of pain relief, of
an acute, osteo-porotic VCF
mainly took place within the first 6
months. In view of the high
percentage (31%) of patients with
chronic pain caused by an acute
VCF with conservative therapy
only, minimally invasive
techniques should be considered
Li Y, Zhu J, Xie C. A comparative Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
study of percutaneous kyphoplasty Prognostic Study Design: Observational ☐ Patients not enrolled at
and conservative therapy on vertebral same point in their disease
osteoporotic compression fractures in Level II ☐ <80% follow-up
674
elderly patients. International Journal Stated objective of study: to ☐ Follow-up not standardized
of Clinical and Experimental Medicine. Explanation of failure to meet compare the therapeutic efficacy ☐ No validated outcome
2017;10(5):8139-8145. guideline inclusion criteria of PKP with that of conservative measures used
(when applicable) treatment in elderly patients with
☐ Small sample size
OVCF
☐ Lacked subgroup analysis
☐ Level V (expert consensus)
Total number of patients in the ☐ Diagnostic methods not
described.
☐ Level IV in presence of study: 80
higher quality studies Number of patients in relevant ☒ Other: untreated controls
subgroup(s): PKP:40 and from RCT
☐ Subgroup analysis data not conservative=40
Level of Evidence
available
Duration of follow-up: 6 months Determination
Potential Level: II
☐ Not relevant to question Validated outcome measures used Downgraded Level: Not
(list): VAS, ODI Downgraded
Nonvalidated outcome measures Conclusions
used (list): Click or tap here to This paper provides evidence
enter text. that: patients treated with
bedrest will have significant
Diagnosis made by: improvement in pain by 1
☒ Clinical exam/history month with continued
☐ Electromyography improvement up to 6
months.
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☐☒ Other: XR CT or MRI. Course
of disease lasting 2 days to 2
weeks, radiograph
Results/subgroup analysis
(relevant to question): CT VAS at
1 month 3.10+/-.45, 3 month
2.38+/-.52, and 6 month 1.53+/-
.21 from starting of 8.42+/-.60
Author conclusions (relevant to
question):
The PKP treatment could provide
immediate pain relief for the
patients and takes the advantages
675
of bringing more significant
improvements in vertebral fracture
restoration, better correction in
kyphosis and weight-bearing
capacity at an earlier stage.
However, although conservative
treatment might lead to smaller
trauma, it cannot bring complete
restoration in compressed
vertebral height and in Cobb
angle. Also, it was found to have a
high incidence of complications. In
such cases, the patients’ quality of
life warrants further improvement.
Ma Y, Wu X, Xiao X, et al. Effects of Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
teriparatide versus percutaneous Prognostic Study Design: ☐ Patients not enrolled at
vertebroplasty on pain relief, quality of ObservationalComparative same point in their disease
life and cost-effectiveness in Level III ☐ <80% follow-up
postmenopausal females with acute Stated objective of study: To ☐ Follow-up not standardized
osteoporotic vertebral compression Explanation of failure to meet compare the 3-month
fracture: A prospective cohort guideline inclusion criteria ☐ No validated outcome
therapeutic effects of TPTD and
study. Bone. 2020;131:115154. (when applicable) measures used
PVP on acute OVCFs, aiming to
doi:10.1016/j.bone.2019.115154 evaluate the utility of this new ☐ Small sample size
☐ Level V (expert consensus) conservative treatment strategy. ☐ Lacked subgroup analysis
☐ Diagnostic methods not
☐ Level IV in presence of Total number of patients in the described.
higher quality studies study: 60 ☒ Other: values not available
Number of patients in relevant non-randomized
☐ Subgroup analysis data not subgroup(s): 30
available Level of Evidence
Duration of follow-up: 3 month Determination
☐ Not relevant to question Potential Level: II
Validated outcome measures used Downgraded Level: III
(list): VAS, ODI, SF36 Downgraded due to a
randomized cohort and values
Nonvalidated outcome measures in graph format but not
used (list): Click or tap here to explicitly listed
enter text.
Conclusions
Diagnosis made by: This paper provides evidence
☒ Clinical exam/history that: patients treated with
☐ Electromyography teriparatide demonstrate a
☐ Myelogram steady improvement in their
☒ MRI showing acute fx
676
☐ CT pain out to 3 months.
☐ CT/Myelogram
☒ Other: DEXA
Results/subgroup analysis
(relevant to question): patients
treated with VP or TPTD based on
patient preference. Both groups
had similar reductions in VAS at
all points.
Author conclusions (relevant to
question): In conclusion, the
conservative treatment strategy
with TPTD obtained similar
therapeutic effects but cost less
than PVP in the treatment of acute
OVCF, thus indicating a more
preferable therapeutic approach.
Meccariello L, Muzii VF, Falzarano G, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
et al. Dynamic corset versus three- Prognostic Study Design: Comparative ☐ Patients not enrolled at
point brace in the treatment of same point in their disease
osteoporotic compression fractures of Level II Stated objective of study: compare ☐ <80% follow-up
the thoracic and lumbar spine: a efficacy and safety of the two ☐ Follow-up not standardized
prospective, comparative study. Aging Explanation of failure to meet types of braces
Clin Exp Res. 2017;29(3):443-449. guideline inclusion criteria ☐ No validated outcome
doi:10.1007/s40520-016-0602-x (when applicable) measures used
Total number of patients in the
study: 140 ☐ Small sample size
☐ Level V (expert consensus) Number of patients in relevant ☐ Lacked subgroup analysis
subgroup(s): divided into two ☐ Diagnostic methods not
☐ Level IV in presence of groups and treated with either described.
higher quality studies dynamic corset or three-point ☐ Other: Click or tap here to
orthosis enter text.
☐ Subgroup analysis data not
available Duration of follow-up: 6 months Level of Evidence
Determination
Validated outcome measures used Potential Level: II
☐ Not relevant to question
(list): VAS, ODI, OLBPDQ Downgraded Level: Not
Downgraded
Nonvalidated outcome measures
used (list): ODI, radiological Conclusions
This paper provides evidence
Diagnosis made by: that: patients with acute
☒ Clinical exam/history OCVF treated with bracing
677
☐ Electromyography have improvement in pain
☒ Myelogram until 3 months after which,
it plateaus out to a 6-month
☐ MRI
measurement, independent
☒ CT of the type of brace worn.
☐ CT/Myelogram
☒ Other: radiograph, x-ray
Results/subgroup analysis
(relevant to question): there were
2 different bracing strategies
studied here. Pain scores at injury
were: 9.4; 1m - rigid brace(3PO):
baseline VAS 5.3 -> injury 9.4 ->
@ 1 month 7.6(5-10) and 7.3(5-9);
3m - -> @ 3 month 5.6(4-8) and ->
@ 6 month 5.6
SDO (corset): VAS baseline 5.6(3-
8); 6m - 4.3(8 -> on admission 9.6
-> @ 1 month 7.3 -> @ 3-6) and
month 4.3 -> @ 6 month 3.9(1-4)
– (p<0.05) [NB preinjury pain was
5.3(4-8)
Author conclusions (relevant to
question): Compared to three-
point orthosis, patients treated
with dynamic orthosis had a
greater reduction in pain
Movrin I. Adjacent level fracture after Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
osteoporotic vertebral compression Prognostic Study Design: Observational ☐ Patients not enrolled at
fracture: a nonrandomized same point in their disease
prospective study comparing balloon Level III Stated objective of study: analyze ☐ <80% follow-up
kyphoplasty with conservative the incidence and possible risk ☐ Follow-up not standardized
therapy. Wien Klin Wochenschr. Explanation of failure to meet factors of adjacent level fracture
2012;124(9-10):304-311. guideline inclusion criteria ☐ No validated outcome
comparing BK with CT
doi:10.1007/s00508-012-0167-4 (when applicable) measures used
Total number of patients in the ☐ Small sample size
☐ Level V (expert consensus) study: 107 ☐ Lacked subgroup analysis
Number of patients in relevant ☐ Diagnostic methods not
☐ Level IV in presence of subgroup(s): 61 described.
higher quality studies ☒ Other: control arm of non-
Duration of follow-up: 1 year randomized prospective
678
☐ Subgroup analysis data not Validated outcome measures used study…VAS > 5, selection
available (list): VAS bias Indirectness of evidence
☐ Not relevant to question Nonvalidated outcome measures Level of Evidence
used (list): radiology Determination
Potential Level: II
Diagnosis made by: Downgraded Level: III
☒ Clinical exam/history Downgraded due to non
☐ Electromyography randomized control arm and
presence of selection bias
☐ Myelogram
☒ MRI Conclusions
☒ CT This paper provides evidence
☐ CT/Myelogram that: pain improves over
☒ Other: radiograph, x-ray time with conservative care
but does not resolve it.
Results/subgroup analysis
(relevant to question): VAS 3.8+/-
.19 at 1 year for CT
Author conclusions (relevant to
question): These results indicated
that BK carries
a low risk of adjacent level
fractures. Lower BMD values
and altered biomechanics in the
treated area of the
spine due to resistant kyphosis are
possible predictive
factors for adjacent level fractures.
A positive effect of BK
over conventional treatment was
observed upon reduction
of the incidence of adjacent level
fracture, vertebral
morphology, and pain reduction.
Piazzolla A, Solarino G, Lamartina C, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
et al. Vertebral Bone Marrow Edema Prognostic Study Design: Observational ☐ Patients not enrolled at
(VBME) in Conservatively Treated same point in their disease
Acute Vertebral Compression Level II Stated objective of study: to ☐ <80% follow-up
Fractures (VCFs): Evolution and assess (1) the evolution of VBME ☐ Follow-up not standardized
Clinical Correlations. Spine (Phila Pa Explanation of failure to meet on conservatively managed VCFs
1976). 2015;40(14):E842-E848. guideline inclusion criteria ☐ No validated outcome
and (2) and relationship between
doi:10.1097/BRS.0000000000000973 (when applicable) measures used
☐ Small sample size
679
VBME and reduction and clinical ☐ Lacked subgroup analysis
☐ Level V (expert consensus) symptoms improvement. ☐ Diagnostic methods not
described.
☐ Level IV in presence of Total number of patients in the
☐ Other: Click or tap here to
higher quality studies study: 80
enter text.
Number of patients in relevant
☐ Subgroup analysis data not subgroup(s): 21 group 1, 59 group
Level of Evidence
2
available Determination
Potential Level: II
Duration of follow-up: 90 days
☐ Not relevant to question Downgraded Level: Not
Downgraded
Validated outcome measures used
(list): VAS, ODI
Conclusions
This paper provides evidence
Nonvalidated outcome measures
that: VAS improved over 90
used (list): Click or tap here to
days but remained above a
enter text.
mean value of 3 in adults
with OVCF treated without
Diagnosis made by:
augmentation or surgery.
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: x-ray
Results/subgroup analysis
(relevant to question): Q2 – pain
scores improve from group 1
(brace, bedrest): baseline VAS
7.5-> 30 d 7.1 -> 60 d 5.3 -> 90 d
3.6
group 2 (same + clodronate):
baseline VAS 7.9 at baseline to
7.7 at-> 30d and then 6.1 at7.7 ->
60d and6.1 -> 90d 4.8 at 90d. Q3
– cannot answer
Author conclusions (relevant to
question): in conservatively
managed A1 VCR, edema
decreases the first 3 months which
680
correlates with improvement in
clinical status
Van Meirhaeghe J, Bastian L, Boonen Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
S, et al. A randomized trial of balloon Prognostic Study Design: Observational ☐ Patients not enrolled at
kyphoplasty and nonsurgical same point in their disease
management for treating acute Level III Stated objective of study: to ☒ <80% follow-up
vertebral compression fractures: compare efficacy and safety of ☐ Follow-up not standardized
vertebral body kyphosis correction Explanation of failure to meet balloon kyphoplasty with NSM
and surgical parameters. Spine (Phila guideline inclusion criteria ☐ No validated outcome
during 24 months in patients with
Pa 1976). 2013;38(12):971-983. (when applicable) measures used
painful VCFs
doi:10.1097/BRS.0b013e31828e8e22 ☐ Small sample size
☐ Level V (expert consensus) Total number of patients in the ☐ Lacked subgroup analysis
Wardlaw D, Cummings SR, Van study: 300 ☐ Diagnostic methods not
Meirhaeghe J, et al. Efficacy and ☐ Level 3 in presence of higher Number of patients in relevant described.
safety of balloon kyphoplasty quality studies subgroup(s): 151 NSM, 149 NSM ☐ Other: Click or tap here to
compared with non-surgical care for enter text.
vertebral compression fracture ☐ Subgroup analysis data not Duration of follow-up: 24 months
(FREE): a randomised controlled trial. Level of Evidence
available
Lancet. 2009;373(9668):1016-1024. Validated outcome measures used Determination
doi:10.1016/S0140-6736(09)60010-6 (list): VAS, PCS, RMD, EQ5D,
☐ Not relevant to question Potential Level: II
EUroQOL Downgraded Level: III
Downgraded due to: < 80%
Nonvalidated outcome measures follow-up
used (list): Click or tap here to
enter text. Conclusions
This paper provides evidence
Diagnosis made by: that: pain improves over 24-
☐ Clinical exam/history month periods but the NSM
☐ Electromyography group had a mean VAS of
☐ Myelogram 3.65 (improved from 6.93).
☐ MRI
☐ CT
☐ CT/Myelogram
☐ Other: Click or tap here to
enter text.
Results/subgroup analysis
(relevant to question): VAS 6.93
at baseline to 3.65 atbaseline VAS
6.93 -> @ 1 month 5.48 -> @ 3
month 4.52 -> @ 6 months 4.35 ->
@ 12 month 3.79 -> @ 24 months
3.65
681
Author conclusions (relevant to
question): Compared with NSM,
BPK improves patient quality of
life and pain averaged during 24
months and results in better
improvement of index vertebral
body kyphotic angulation.
Venmans A, Klazen CA, Lohle PN, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Mali WP, van Rooij WJ. Natural Prognostic Study Design: Observational ☐ Patients not enrolled at
history of pain in patients with same point in their disease
conservatively treated osteoporotic Level II Stated objective of study: further ☐ <80% follow-up
vertebral compression fractures: analyzed the conservatively ☐ Follow-up not standardized
results from VERTOS II. AJNR Am J Explanation of failure to meet treated patients from VERTOS II,
Neuroradiol. 2012;33(3):519-521. guideline inclusion criteria ☐ No validated outcome
in particular the proportion of
doi:10.3174/ajnr.A2817 (when applicable) measures used
patients that developed chronic
back pain. ☐ Small sample size
☐ Level V (expert consensus) ☐ Lacked subgroup analysis
Total number of patients in the ☐ Diagnostic methods not
☐ Level IV in presence of study: 202 described.
higher quality studies Number of patients in relevant ☐ Other: VAS had to be 5+
subgroup(s): 95
☐ Subgroup analysis data not Level of Evidence
available Duration of follow-up: 1 year Determination
Potential Level: II
Validated outcome measures used Downgraded Level: Not
☐ Not relevant to question
(list): VAS Downgraded
Nonvalidated outcome measures Conclusions
used (list): Click or tap here to This paper provides evidence
enter text. that: less than 50% of adults
with OVCF treated without
Diagnosis made by: augmentation or surgery
☐ Clinical exam/history had a VAS less than 4 at 3
☐ Electromyography months and this improved
☐ Myelogram to 60% with VAS less than 3
at one year.
☐ MRI
☐ CT
☐ CT/Myelogram
☐ Other: Click or tap here to
enter text.
682
Results/subgroup analysis
(relevant to question): 60% of
patient has suff pain relief at 1
year with most achieving at 3
months; 40% of still had pain >4 at
1 year
Author conclusions (relevant to
question): In VERTOS II most
patients had sufficient relief of pain
during the first 3m. However, after
1yr, a substantial proportion of
patients still reported disabling
pain.
Natural History Question 3: For patients with acute osteoporotic vertebral compression fractures managed without augmentation or surgery, what is the
risk of persistent long-term (>6 months) pain?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Boonen S, Van Meirhaeghe J, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Bastian L, et al. Balloon Prognostic Study Design: Observational ☐ Patients not enrolled at same point in
kyphoplasty for the treatment of their disease
acute vertebral compression Level of Evidence: Stated objective of study: To compare ☒ <80% follow-up
fractures: 2-year results from a ☐I the effectiveness of kypoplasty with that ☐ Follow-up not standardized
randomized trial. J Bone Miner ☐ II of of standard nonsurgical management
☐ No validated outcome measures
Res. 2011;26(7):1627-1637.
☒ III of the treatment compare efficacy and
used
doi:10.1002/jbmr.364 safety of BKP to CT over 24 months. to
☐ IV ☐ Small sample size
compare the effectiveness of
kyphoplasty with that of conservative ☐ Lacked subgroup analysis
standard nonsurgical management for ☐ Diagnostic methods not described.
Explanation of failure to
the treatment in OCVFof acute vertebral ☒ Other: industry funded
meet guideline inclusion
fractures owing to osteoporosis. (This is
criteria
a report of 24 m data). Level of Evidence Determination
(when applicable)
Potential Level: II
Total number of patients in the study: Downgraded Level: III
☐ Level V (expert
300 Downgraded due to: <80% follow-up
consensus) Number of patients in relevant
subgroup(s): 151 BKP, 149 nonsurgical Conclusions relative to question
☐ Level IV in presence of This paper provides evidence that: 10%
higher quality studies Duration of follow-up: 24 months of adults with OVCF treated without
683
augmentation or surgery will still
☐ Subgroup analysis data Validated outcome measures used take opioids for pain at 2 years.
not available (list): SF-36 PCS, VAS, EuroQOL, SF-
36 subscales, RMDQ Likert scale
☐ Not relevant to question
Nonvalidated outcome measures used
(list): days of inactivity, likert scale of
satisfaction, days bedrest
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☐ Other:
Results/subgroup analysis (relevant to
question): 69/101 pt used pain meds
@ 12 months and 23/105 @ 24 months;
42.9% using opiods @ 6 months ->
33.7% @ 12 months -> 9.5% @ 24
months.
Author conclusions (relevant to
question): compared with nonsurgical
treatment, BKP rapidly reduces pain
and improves function, disability anmd
QOL over the course of 2 years without
increasing the risk of additional
vertebral fractures.
Du JP, Fan Y, Liu JJ, et al. The Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
analysis of MSTMOVCF (Multi- Prognostic Study Design: Observational ☐ Patients not enrolled at same point in
segment thoracolumbar mild their disease
osteoporotic fractures surgery or Level II Stated objective of study: To assess the ☐ <80% follow-up
conservative treatment) based on utility of the MSTMOVCF system to ☐ Follow-up not standardized
ASTLOF (the assessment direct care and to revise their system.
system of thoracolumbar ☐ No validated outcome measures
osteoporotic fracture). Sci Rep. used
684
2018;8(1):8185. Published 2018 Explanation of failure to Total number of patients in the study: ☐ Small sample size
May 29. doi:10.1038/s41598- meet guideline inclusion 470 ☐ Lacked subgroup analysis
018-26562-7 criteria Number of patients in relevant ☐ Diagnostic methods not described.
(when applicable) subgroup(s): 277 conservative , 193
surgery ☒ Other: selection bias in enrollment,
included burst fractures;
☐ Level V (expert
Duration of follow-up: 1 year multisegment OCVF; non-randomly
consensus)
assigned patient
☐ Level IV in presence of Validated outcome measures used
Level of Evidence Determination
higher quality studies (list): VAS, ODI, SF36
Potential Level: II
Nonvalidated outcome measures used Downgraded Level: Not Downgraded
☐ Subgroup analysis data
(list): imaging
not available Conclusions
Diagnosis made by: This paper provides evidence that:
☐ Not relevant to question treatment without augmentation or
☒ Clinical exam/history
surgery allows significant
☐ Electromyography improvement in both VAS and ODI.
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: xray, DEXA
Results/subgroup analysis (relevant to
question): Conservative group VAS
Post 3M 6.4+/- 1.8; Post 1y 4.6+/-1.3)
Author conclusions (relevant to
question): great short term clinical
results in patients undergoing surgery.
Hoshino M, Tsujio T, Terai H, et Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
al. Impact of initial conservative Prognostic Study Design: Observational ☒ Patients not enrolled at same point in
treatment interventions on the their disease
outcomes of patients with Level II Stated objective of study: To examine ☒ <80% follow-up
osteoporotic vertebral whether initial conservative treatment ☐ Follow-up not standardized
fractures. Spine (Phila Pa 1976). interventions for osteoporotic
2013;38(11):E641-E648. Explanation of failure to ☐ No validated outcome measures
vertebral fractures (OVF) influence
doi:10.1097/BRS.0b013e31828c meet guideline inclusion used
patient outcomes.
ed9d criteria ☐ Small sample size
(when applicable) Total number of patients in the study: ☐ Lacked subgroup analysis
362 ☐ Diagnostic methods not described.
☐ Other: Click or tap here to enter text.
685
☐ Level V (expert Number of patients in relevant
consensus) subgroup(s): n/a Level of Evidence Determination
Potential Level: II
☐ Level IV in presence of Duration of follow-up: 6 months Downgraded Level: Not Downgraded
higher quality studies
Validated outcome measures used Conclusions
☐ Subgroup analysis data (list): VAS, SF36, MMSE, PCS MCS This paper provides evidence that: this
others , % vertebral collapse paper provides Level II evidence that
not available
26% of adults with OVCF treated
Nonvalidated outcome measures used without augmentation or surgery will
☐ Not relevant to question (list): Japanese 4 ADL categories have persistent back pain at 6
months.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: x-ray, radiograph
Results/subgroup analysis (relevant to
question): Prolonged back pain in Click
or tap here to enter text. 93/362 (25.7%
of%) had VAS > 5 @ 6 months (mean
VAS 6.67 @ 6 months for these
patients. There); for others is MV
analysis of risk factors for prolonged
back pain, of which only middle column
injury and steroid use were significant.
Author conclusions (relevant to
question): treatment intervention
factors did not affect patient outcomes 6
months after OCVF
Iwata A, Kanayama M, Oha F, et Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
al. Is Bone Nonunion, Vertebral Prognostic Study Design: Case Series ☐ Patients not enrolled at same point in
Deformity, or Spinopelvic their disease
Malalignment the Best Level III Stated objective of study: The aim of ☐ <80% follow-up
Therapeutic Target for this study was to identify ☐ Follow-up not standardized
Amelioration of Low Back Pain Explanation of failure to independentrisk factors for residual low
☐ No validated outcome measures
After Osteoporotic Vertebral meet guideline inclusion back pain (LBP) following osteoporotic
Fracture?. Spine (Phila Pa 1976). criteria used
vertebral fracture (OVF)
686
2020;45(13):E760-E767. (when applicable) ☐ Small sample size
doi:10.1097/BRS.000000000000 Total number of patients in the study: ☐ Lacked subgroup analysis
3422 ☐ Level V (expert 67
☐ Diagnostic methods not described.
consensus) Number of patients in relevant
☐ Other: Click or tap here to enter text.
subgroup(s): LBP=36, non LBP=31
☒ Level IV in presence of Level of Evidence Determination
higher quality studies Duration of follow-up: 24 weeks
Potential Level: III
Validated outcome measures used Downgraded Level: Not Downgraded
☐ Subgroup analysis data
(list): VAS, ODI, RMDQ, VKA
not available Conclusions
Nonvalidated outcome measures used This paper provides evidence that:
☐ Not relevant to question approximately 26% of adults with
(list): spinopelvic alignment
OVCF treated without augmentation
Diagnosis made by: or surgery have persistent pain and
24% of patients had ODI LBP scores
☒ Clinical exam/history
> 40% at 6 months.
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: DEXA, X-ray
Results/subgroup analysis (relevant to
question): 24% had ODI LBP > 40% @
6 months, 39% by VAS and 39% by
RDQ, combined 53% @ 6
Author conclusions (relevant to
question): Although spinopelvic
malalignment is considered as a
preexisting factor for LBP, VKA
exacerbated by nonunion
predominantly led to LBP after a new
OVF. Each incidence of
OVF should be treated to limit further
morphological changes to
the fractured vertebra.
687
Klazen CA, Lohle PN, de Vries J, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
et al. Vertebroplasty versus Prognostic Study Design: Observational ☐ Patients not enrolled at same point in
conservative treatment in acute their disease
osteoporotic vertebral Level II Stated objective of study: to clarify ☒ <80% follow-up
compression fractures (Vertos II): whether vertebroplasty has the ☐ Follow-up not standardized
an open-label randomised additional value compared with
trial. Lancet. Explanation of failure to ☐ No validated outcome measures
optimum pain treatment in patients with
2010;376(9746):1085-1092. meet guideline inclusion used
acute vertebral fractures
doi:10.1016/S0140- criteria ☐ Small sample size
6736(10)60954-3 (when applicable) Total number of patients in the study: ☒ Lacked subgroup analysis
202 ☐ Diagnostic methods not described.
☐ Level V (expert Number of patients in relevant ☒ Other: selection bias, VAS had to be
consensus) subgroup(s): 101 assigned to PV and 5+
101 assigned to conservative Maybe not a limitation but less
☐ Level IV in presence of generalizable
higher quality studies Duration of follow-up: 1 year
Level of Evidence Determination
☐ Subgroup analysis data Validated outcome measures used Potential Level: II
not available (list): VAS, EQ5D , RMD Downgraded Level: Not Downgraded
☐ Not relevant to question Nonvalidated outcome measures used Conclusions
(list): QUALEFFO<cost-effectiveness This paper provides evidence that: a
select group of patients with OVCF
Diagnosis made by: who underwent vertebroplasty
☒ Clinical exam/history improved more quickly and to a
☐ Electromyography greater magnitude than OVCF
☐ Myelogram patients who did not have this
procedure. Some patients in either
☒ MRI
group continued to have persistent
☐ CT pain, although the vertebroplasty
☐ CT/Myelogram group had less pain overall.
☒ Other: DEXA, radiograph
Results/subgroup analysis (relevant to
question): baseline VAS 7.5 -> 4.8 @ 1
month -> 3.8 @ 1 year; 3 months to
plateau; 115.6 days until plateau in
significant improvement
Author conclusions (relevant to
question): none
Klazen CA, Verhaar HJ, Lohle Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
PN, et al. Clinical course of pain Prognostic Study Design: Observational
688
in acute osteoporotic vertebral ☐ Patients not enrolled at same point in
compression fractures. J Vasc Level II Stated objective of study: The authors their disease
Interv Radiol. 2010;21(9):1405- prospectively determined the natural ☒ <80% follow-up
1409. course of pain in patients with
☒ Follow-up not standardized
doi:10.1016/j.jvir.2010.05.018 Explanation of failure to conservatively treated acute
meet guideline inclusion osteoporotic vertebral compression ☐ No validated outcome measures
criteria fractures (VCF). In addition, the type of used
(when applicable) conservative therapy that thesepatients ☐ Small sample size
received was assessed ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic methods not described.
consensus) Total number of patients in the study: ☒ Other: not MRI confirmed, selection
49 process was restricted to conservative
☐ Level IV in presence of Number of patients in relevant tx, not really bracing
higher quality studies subgroup(s): n/a
Level of Evidence Determination
Duration of follow-up: 23 months
☐ Subgroup analysis data Potential Level: I
not available Downgraded Level: II
Validated outcome measures used Downgraded due to inclusion criteria,
(list): VAS selection bias and < 80% followup
☐ Not relevant to question
Nonvalidated outcome measures used Conclusions
(list): Click or tap here to enter text. This paper provides evidence that:
approximately 1/3 of adults with
Diagnosis made by: OVCF treated without augmentation
☒☐ Clinical exam/history or surgery have persistent pain after
☐ Electromyography 6 months and up to 23 months.
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: radiograph and back pain
less than 2 weeks , xray
Results/subgroup analysis (relevant to
question): 63% of patients had
significant pain relief at 6 months and
69% at 23 months
Author conclusions (relevant to
question): The natural fracture
healing, in terms of pain relief, of an
acute, osteo-porotic VCF mainly took
place within the first 6 months. In view
689
of the high percentage (31%) of
patients with chronic pain caused by an
acute VCF with conservative therapy
only, minimally invasive techniques
should be considered
Meccariello L, Muzii VF, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Falzarano G, et al. Dynamic Prognostic Study Design: Comparative ☐ Patients not enrolled at same point in
corset versus three-point brace in their disease
the treatment of osteoporotic Level II Stated objective of study: compare ☐ <80% follow-up
compression fractures of the efficacy and safety of the two types of ☐ Follow-up not standardized
thoracic and lumbar spine: a Explanation of failure to braces
prospective, comparative meet guideline inclusion ☐ No validated outcome measures
study. Aging Clin Exp Res. criteria used
Total number of patients in the study:
2017;29(3):443-449. (when applicable) 140 ☐ Small sample size
doi:10.1007/s40520-016-0602-x Number of patients in relevant ☐ Lacked subgroup analysis
☐ Level V (expert subgroup(s): divided into two groups ☐ Diagnostic methods not described.
consensus) and treated with either dynamic corset ☐ Other: Click or tap here to enter text.
or three-point orthosis
☐ Level IV in presence of Level of Evidence Determination
higher quality studies Duration of follow-up: 6 months Potential Level: II
Downgraded Level: Not Downgraded
☐ Subgroup analysis data Validated outcome measures used
not available (list): VAS, ODI, OLBPDQ Conclusions
This paper provides evidence that:
Nonvalidated outcome measures used treating OVCF with a dynamic
☐ Not relevant to question
(list): radiological orthosis had a slightly higher VAS
improvement compared to a more
Diagnosis made by: rigid brace at 3 and 6 months,
☒ Clinical exam/history although both brace groups
☐ Electromyography continued to have some pain.
☒ Myelogram
☐ MRI
☒ CT
☐ CT/Myelogram
☒ Other: radiograph, x-ray
Results/subgroup analysis (relevant to
question): there were 2 different
bracing strategies studied here. Pain
scores at injury were: 9.4; 1m - rigid
brace(3PO): baseline VAS 5.3 -> injury
9.4 -> @ 1 month 7.6(5-10) and 7.3(5-
690
9); 3m - -> @ 3 month 5.6(4-8) and ->
@ 6 month 5.6
SDO (corset): VAS baseline 5.6(3-8);
6m - 4.3(8 -> on admission 9.6 -> @ 1
month 7.3 -> @ 3-6) and month 4.3 ->
@ 6 month 3.9(1-4) – (p<0.05) [NB
preinjury pain was 5.3(4-8)
Author conclusions (relevant to
question): Compared to three-point
orthosis, patients treated with dynamic
orthosis had a greater reduction in pain
Venmans A, Klazen CA, Lohle Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
PN, Mali WP, van Rooij WJ. Prognostic Study Design: Observational ☒ Patients not enrolled at same point in
Natural history of pain in patients their disease
with conservatively treated Level II Stated objective of study: further ☐ <80% follow-up
osteoporotic vertebral analyzed the conservatively treated ☐ Follow-up not standardized
compression fractures: results Explanation of failure to patients from VERTOS II, in particular
from VERTOS II. AJNR Am J meet guideline inclusion ☐ No validated outcome measures
the proportion of patients that
Neuroradiol. 2012;33(3):519-521. criteria used
developed chronic back pain.
doi:10.3174/ajnr.A2817 (when applicable) ☐ Small sample size
Total number of patients in the study: ☐ Lacked subgroup analysis
☐ Level V (expert 202 ☐ Diagnostic methods not described.
consensus) Number of patients in relevant ☐ Other: VAS had to be 5+
subgroup(s): 95
☐ Level IV in presence of Level of Evidence Determination
higher quality studies Duration of follow-up: 1 year Potential Level: II
Downgraded Level: Not Downgraded
☐ Subgroup analysis data Validated outcome measures used
not available (list): VAS Conclusions
This paper provides evidence that: 40%
☐ Not relevant to question Nonvalidated outcome measures used of adults with OVCF treated without
(list): Click or tap here to enter text. augmentation or surgery still have
significant pain (VAS >4) at 1 year.
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter text.
691
Results/subgroup analysis (relevant to
question): 60% of patient has suff pain
relief at 1 year with most achieving at 3
months; 40% of still had pain >4 at 1
year
Author conclusions (relevant to
question): In VERTOS II most patients
had sufficient relief of pain during the
first 3m. However, after 1yr, a
substantial proportion of patients still
reported disabling pain.
Yasuda H, Hoshino M, Tsujio T, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
et al. Difference of clinical course Prognostic Study Design: Observational ☐ Patients not enrolled at same point in
between cases with bone union their disease
and those with delayed union Level III Stated objective of study: to determine ☒ <80% follow-up
following osteoporotic vertebral how delayed union following OVCF ☐ Follow-up not standardized
fractures. Arch Osteoporos. Explanation of failure to influences the condition of patients in a
2017;13(1):3. Published 2017 meet guideline inclusion ☐ No validated outcome measures
prospective multicenter cohort study
Dec 28. doi:10.1007/s11657-017- criteria used
0411-7 (when applicable) Total number of patients in the study: ☐ Small sample size
324 ☐ Lacked subgroup analysis
☐ Level V (expert Number of patients in relevant ☐ Diagnostic methods not described.
consensus) subgroup(s): 280 in the union group ☐ Other: Click or tap here to enter text.
and 44 into delayed union group
☐ in presence of higher Level of Evidence Determination
quality studies Duration of follow-up: 6 months Potential Level: II
Downgraded Level: III
☐ Subgroup analysis data Validated outcome measures used Downgraded due to <80% follow-up
not available (list): VAS, SF-36, MMSE
Conclusions
☐ Not relevant to question Nonvalidated outcome measures used This paper provides evidence that:
(list): approximately 10-15% of patients in
both groups remained in severe pain
Diagnosis made by: at 6 months.
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: radiograph, xray
692
Results/subgroup analysis (relevant to
question): VAS 8.3+/-2.0 to 3.0+/-2.5,
34 patients severe pain (>7) at 6
months
Author conclusions (relevant to
question): delayed union following OVF
causes prolonged pain, QOL
impairment, ADL impairment, cognitive
status deterioration and vertebral
collapse progression
Natural History Question 4: For patients with osteoporotic vertebral compression fractures, are rates of morbidity and mortality different for those
managed with augmentation or surgery versus those managed without?
Article (Alpha by Author) Level Description of study Conclusion
of evidence
Becker S, Pfeiffer KP, Ogon M. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Comparison of inpatient Prognostic Study Design: Comparative ☐ Patients not enrolled at same
treatment costs after balloon point in their disease
kyphoplasty and non-surgical Level II Stated objective of study: to look at ☐ <80% follow-up
treatment of vertebral body the hospital treatment costs after ☒ Follow-up not standardized
compression fractures. Eur Spine BKP and conservative treatment in
J. 2011;20(8):1259-1264. Explanation of failure to meet ☐ No validated outcome
patients with OCVF
doi:10.1007/s00586-011-1692-y guideline inclusion criteria measures used
(when applicable) Total number of patients in the ☐ Small sample size
study: 245 ☐ Lacked subgroup analysis
☐ Level V (expert consensus) Number of patients in relevant ☒ Diagnostic methods not
subgroup(s): 245: 135 BKP and described.
☐ Level IV in presence of higher 110 control ☒ Other: no personal
quality studies identifiers, so a statistical
Duration of follow-up: 2002-2006?? method used to match patients
☐ Subgroup analysis data not 4 years max (2.93+/- 1.4 control to their date of death?
available and 2.56 +/- 0.96 yrs BKP2.93+/-
1.40 in non-surgical group and Level of Evidence
2.56+/-0.96 in BKP group 4 years Determination
☐ Not relevant to question
Potential Level: II
Validated outcome measures used Downgraded Level: III
(list): mortality
693
Nonvalidated outcome measures Downgraded due to unclear
used (list): Click or tap here to enter methodology and diagnostic
text. criteria
Diagnosis made by: Conclusions
☐ Clinical exam/history This paper provides evidence
☐ Electromyography that: there is no difference in
mortality between BKP or
☐ Myelogram
conservative care.
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: ICD 10 codes
Results/subgroup analysis (relevant
to question): 6.7% of BKP vs 9.9%
of control
Author conclusions (relevant to
question): Patients with OCVF
after BKP had fewer readmission
and shorter LOS but no difference
in DRG score (mortality)
Blasco J, Garcia A, Manzanera Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
LSR, et al. Randomized trial Prognostic Study Design: Observational ☐ Patients not enrolled at same
comparing vertebroplasty and point in their disease
conservative treatment analyzing Level III Stated objective of study: to ☒ <80% follow-up
pain relief and quality of life on compare the effects of VP vs ☐ Follow-up not standardized
the long term basis. Explanation of failure to meet conservative approach on quality of
CardioVascular and guideline inclusion criteria ☐ No validated outcome
life and pain relief in patients with
Interventional Radiology. (when applicable) measures used
painful OVF and analyze secondary
2010;33:182-183. adverse effects and the ☐ Small sample size
☐ Level V (expert consensus) development of new fractures in ☐ Lacked subgroup analysis
both treatments groups ☐ Diagnostic methods not
☐ Level IV in presence of higher described.
quality studies Total number of patients in the ☒ Other: no values for 6 month
study: 125 and 12 month VAS, control
☐ Subgroup analysis data not Number of patients in group
available relevant subgroup(s): 64 VP, 61 CT
Level of Evidence
☐ Not relevant to question Determination
Duration of follow-up:12 months Potential Level: II
Downgraded Level: III
694
Validated outcome measures used Downgraded due to <80%
(list): Qualeffo-41, VAS follow-up and values not listed
Nonvalidated outcome measures Conclusions relative to question
used (list): analgesic consumption, This paper provides evidence
clinical complications, radiological that: there are more clinical
vertebral fractures new fractures in the VP group
than the group treated
Diagnosis made by: without augmentation or
☒ Clinical exam/history surgery, however there is no
☐ Electromyography difference in mortality.
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: bone scan or MRI,
DEXA, radiograph
Results/subgroup analysis (relevant
to question): pain reduction on
VAS significantly greater in VP
group at 2Baseline VAS 6.31 ->
3.07 @ 2months , QOL measures
only statistically improved @ 6
months. Difference was NS at all
other time points. Figure A. \
Author conclusions (relevant to
question): VP and conservative
treatment both associated with
significant improvement in pain and
QOL.
Boonen S, Van Meirhaeghe J, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Bastian L, et al. Balloon Prognostic Study Design: Observational ☐ Patients not enrolled at same
kyphoplasty for the treatment of point in their disease
acute vertebral compression Level III Stated objective of study: To ☒ <80% follow-up
fractures: 2-year results from a compare the effectiveness of ☐ Follow-up not standardized
randomized trial. J Bone Miner Explanation of failure to meet kyphoplasty with that of standard
Res. 2011;26(7):1627-1637. guideline inclusion criteria ☐ No validated outcome
nonsurgical management of the
doi:10.1002/jbmr.364 (when applicable) measures used
treatment compare efficacy and
safety of BKP to CT over 24 ☐ Small sample size
☐ Level V (expert consensus) months. ☐ Lacked subgroup analysis
695
☐ Diagnostic methods not
☐ Level IV in presence of higher Total number of patients in the described.
quality studies study: 300 ☒ Other: industry funded
Number of patients in
☐ Subgroup analysis data not relevant subgroup(s): 151 BKP, 149 Level of Evidence
available nonsurgical Determination
Work group conclusions
Duration of follow-up: 24 months
☐ Not relevant to question
Potential Level: II
Validated outcome measures used Downgraded Level: III
(list): SF-36 PCS, VAS, EuroQOL, Downgraded due to: less than
SF-36 subscales, RMDQ Likert 80% follow-up
scale
Conclusions relative to question
Nonvalidated outcome measures This paper provides evidence
used (list): days of inactivity, likert that: patients receiving
scale of satisfaction, days bedrest kyphoplasty compared to
treatment without augmentation
Diagnosis made by: or surgery have small, but
☒ Clinical exam/history statistically significant
☐ Electromyography improvement in EQ5D scores,
☐ Myelogram back pain, SF-36 bodily pain
☒ MRI and patient satisfaction at 2
years post-intervention without
☒ CT
an increase in mortality,
☐ CT/Myelogram adjacent vertebral fractures or
☐ Other: other adverse events. The
number of outcome measures
Results/subgroup analysis (relevant showing statistically significant
to question): 69/101 pt used pain differences decreases with tim
meds @ 12 months and 23/105 @
24 months; 42.9% using opioids @
6 months -> 33.7% @ 12 months ->
9.5% @ 24 months.
Author conclusions (relevant to
question): compared with
nonsurgical treatment, BKP rapidly
reduces pain and improves
function, disability and QOL over
the course of 2 years without
increasing the risk of additional
vertebral fractures.
696
Chen AT, Cohen DB, Skolasky Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
RL. Impact of nonoperative Prognostic ☒ Patients not enrolled at same
treatment, vertebroplasty, and Study Design: Comparative point in their disease
kyphoplasty on survival and Level III ☐ <80% follow-up
morbidity after vertebral Stated objective of study: To ☐ Follow-up not standardized
compression fracture in the Explanation of failure to meet Compare survival rates for
medicare population. J Bone guideline inclusion criteria ☐ No validated outcome
Medicare patients with new VCF
Joint Surg Am (when applicable) measures used
that have been acutely treated with
2013;95(19):1729–1736. VP, KP, or non-op ☐ Small sample size
☐ Level V (expert consensus) ☐ Lacked subgroup analysis
. Total number of patients in the ☐ Diagnostic methods not
☐ Level IV in presence of higher study: 68,752 described.
quality studies ☒Other: using criteria to
Number of patients in relevant estimate new onset OVCF
☐ Subgroup analysis data not subgroup(s): 38,249
available Level of Evidence
Duration of follow-up: 3-yr survival Determination
☐ Not relevant to question Potential Level: III
Validated outcome measures used Downgraded Level: Not
(list): survival rate, Downgraded
hospital stay, length of stay,
hospital charges, Conclusions
complications, and This paper provides evidence
subsequent procedures that: there is a lower 3-year
survival rate in the group
Nonvalidated outcome measures treated without augmentation
used (list): N/A or surgery compared to
vertebroplasty or kyphoplasty
Diagnosis made by: although this may be due to
☐ Clinical exam/history selection bias.
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: ICD 9 codes, Claims data
, chart review, diagnostic
codes/charges
Results/subgroup analysis (relevant
to question): Higher mortality rates
in conservative group even after
adjusted. Higher complications and
697
readmission (61.9% vs 52.4% VS
vs 35.2% KP) in conservative
groups as well. Higher risk of
pneumonia in VB and nonop
groups; VB group higher DVT/PE
vs KP lowest
Author conclusions (relevant to
question): Vertebral augmentation
procedures appear to be
associated with longer patient
survival than nonoperative
treatment does. Kyphoplasty tends
to have a more striking association
with survival than vertebroplasty
does, but it is costly
and may have a higher rate of
subsequent vertebral compression
fracture. These provocative findings
may reflect selection
bias and should be addressed in a
prospective, direct comparison of
methods to treat vertebral
compression fractures
Diamond TH, Bryant C, Browne Type of evidence: Prognostic ☒ Prospective ☐ Retrospective Critique of methodology:
L, Clark WA. Clinical outcomes Study Design: Observational ☒ Patients not enrolled at same
after acute osteoporotic vertebral Level III point in their disease (dx criteria
fractures: a 2-year non- Stated objective of study: To unclear)
randomised trial comparing Explanation of failure to meet assess the safety and efficacy of ☐ <80% follow-up
percutaneous vertebroplasty with guideline inclusion criteria percutaneous vertebroplasty for the ☐ Follow-up not standardized
conservative therapy. Med J (when applicable) treatment of acute osteoporotic
☐ No validated outcome
Aust. 2006;184(3):113-117. vertebral fractures.
measures used
doi:10.5694/j.1326- ☐ Level V (expert consensus)
5377.2006.tb00148.x ☒Small sample size
Total number of patients in the
☐ Level IV in presence of higher study: 126 ☐ Lacked subgroup analysis
quality studies ☒ Diagnostic methods not
Number of patients in described.
☐ Subgroup analysis data not relevant subgroup(s): 38 by ☒ Other: selection bias?
available conservative therapy and 88 PV Patients who declined VP were
control group; no statistical
Duration of follow-up: 24 months comparison between time
☐ Not relevant to question
intervals
698
Validated outcome measures used Level of Evidence
(list) VAS, level of function (Barthel Determination
index) , pain score Potential Level: II
Downgraded Level: III
Nonvalidated outcome measures Downgraded due to: unclear
used (list): number of hospital days, diagnostic criteria and selection
vertebral morphometry via XR, new bias
fx, recurrent pain
Conclusions
Diagnosis made by: This paper provides evidence
☒ Clinical exam/history that: the mortality rate is the
same for OVCF treated with
☐ Electromyography
vertebroplasty compared to
☐ Myelogram treated without augmentation
☒ MRI or surgery, although there is a
☐ CT benefit out to 6 weeks with
respect to pain and physical
☐ CT/Myelogram
function favoring
☒ Other: unclear, imaging criteria vertebroplasty.
of acute fracture activity
Results/subgroup analysis (relevant
to question): VAS 19 @ 24 hrs ->
7@6weeks ->4@6-12 months and
3 @ 24 months, 85% improvement
in pain score at 24 months with
conservative therapy
Author conclusions (relevant to
question): The analgesic benefit of
percutaneous vertebroplasty and
the low complication rates suggest
that it is a useful therapy for acute
painful osteoporotic vertebral
fractures
Du JP, Fan Y, Liu JJ, et al. The Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
analysis of MSTMOVCF (Multi- Prognostic Study Design: Observational ☐ Patients not enrolled at same
segment thoracolumbar mild point in their disease
osteoporotic fractures surgery or Level II Stated objective of study: To ☐ <80% follow-up
conservative treatment) based on assess the utility of the ☐ Follow-up not standardized
ASTLOF (the assessment MSTMOVCF system to direct care
system of thoracolumbar Explanation of failure to meet ☐ No validated outcome
and to revise their system.
osteoporotic fracture). Sci Rep. guideline inclusion criteria measures used
2018;8(1):8185. Published 2018 (when applicable) ☐ Small sample size
699
May 29. doi:10.1038/s41598- Total number of patients in the ☐ Lacked subgroup analysis
018-26562-7 ☐ Level V (expert consensus) study: 470 ☐ Diagnostic methods not
Number of patients in described.
☐ Level IV in presence of higher relevant subgroup(s): 277 ☒ Other: selection bias in
quality studies conservative , 193 surgery
enrollment, included burst
fractures; multisegment
☐ Subgroup analysis data not Duration of follow-up: 1 year
OCVF; non-randomly
available assigned patient
Validated outcome measures used
(list): VAS, ODI, SF36
☐ Not relevant to question Level of Evidence Determination
Potential Level: II
Nonvalidated outcome measures
Downgraded Level: Not
used (list): imaging
Downgraded
Diagnosis made by:
Conclusions
☒ Clinical exam/history This paper provides evidence
☐ Electromyography that: the non-operative group
☐ Myelogram had 9.2% complications
☒ MRI (pneumonia, UTI, bedsores, PE)
☒ CT vs 10.9% cement leak in the
☐ CT/Myelogram operative group. Both groups
had similar adjacent fracture
☒ Other: x-ray, DEXA rates.
Results/subgroup analysis (relevant
to question): Conservative group
VAS Post 3M 6.4+/- 1.8; Post 1y
4.6+/-1.3)
Author conclusions (relevant to
question): great short-term clinical
results in patients undergoing
surgery.
Edidin AA, Ong KL, Lau E, Kurtz Type of evidence: Prognostic ☐ Prospective ☒ Retrospective Critique of methodology:
SM. Morbidity and Mortality After ☐ Patients not enrolled at same
Vertebral Fractures: Comparison Level IV Study Design: Case Series point in their disease
of Vertebral Augmentation and ☐ <80% follow-up
Nonoperative Management in the Explanation of failure to meet Stated objective of study: compare ☐ Follow-up not standardized
Medicare Population. Spine guideline inclusion criteria M&M for VCF with CT, BKP, VP
(Phila Pa 1976). (when applicable) ☐ No validated outcome
2015;40(15):1228-1241. measures used
Total number of patients in the
doi:10.1097/BRS.000000000000 ☐ Level V (expert consensus) study: 1,038,956 ☐ Small sample size
0992 ☐ Lacked subgroup analysis
700
☐ Level IV in presence of higher Number of patients in ☐ Diagnostic methods not
quality studies relevant subgroup(s): 141343 BKP, described.
75364 VP, 822249 nonop ☒ Other: ICD 9 claims based
☐ Subgroup analysis data not data
available Duration of follow-up: 4 years
Level of Evidence
☐ Not relevant to question Validated outcome measures used Determination
(list): Survival & Morbidity DVT, Potential Level: IV
UTI based on ICD coding Downgraded Level: Not
Downgraded
Nonvalidated outcome measures
used (list): mortality Conclusions
This paper provides evidence
Diagnosis made by: that: non-operative treatment
☐ Clinical exam/history has 55% and 25% higher
☐ Electromyography adjusted risk of mortality than
☐ Myelogram BKP and VP (only
☐ MRI comparative data was
☐ CT available).
☐ CT/Myelogram
☒ Other: ICD 9 codes, claims data
Results/subgroup analysis (relevant
to question): nonoperated cohort
had significantly higher adjusted
risks of pneumonia, myocardial
infarction/cardiac complications,
deep venous thrombosis (DVT),
and urinary tract infection (UTI)
than the BKP cohort at 4 years. For
the propensity-matched group,
the corresponding AHRs were 1.15
( P < 0.001), 1.09
( P < 0.001), 1.04 ( P = 0.001), and
1.10 ( P < 0.001). On the
contrary, the nonoperated patient
cohort had lower adjusted
risks of subsequent
augmentation/fusion, subsequent
augmentation, and
pulmonary/respiratory
complications at
701
4 years. When comparing
nonmatched and matched patients
in the nonoperated and VP cohorts
after 4 years of follow-up, patients
in the nonoperated cohort were
found to have a
higher adjusted risk of UTI than
patients in the VP cohort. On the
contrary, the nonoperated patient
cohort had lower adjusted risks of
subsequent augmentation/fusion,
subsequent augmentation,
pulmonary/respiratory
complications, and pulmonary
embolism at 4 years
Author conclusions (relevant to
question): VCF patients in the
Medicare population who received
vertebral augmentation therapies,
specifically BKP and VP,
experienced lower mortality and
overall morbidity than VCF patients
who received conservative
management
Gerling MC, Eubanks JD, Patel Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
R, Whang PG, Bohlman HH, Ahn Prognostic Study Design: Case Control ☐ Patients not enrolled at same
NU. Cement augmentation of point in their disease
refractory osteoporotic vertebral Level III Stated objective of study: To ☐ <80% follow-up
compression fractures: compare survivorship after cement ☐ Follow-up not standardized
survivorship analysis. Spine augmentation of refractory
(Phila Pa 1976). Explanation of failure to meet ☐ No validated outcome
osteoporotic vertebral compression
2011;36(19):E1266-E1269. guideline inclusion criteria measures used
fractures (OVCFs) with traditional
doi:10.1097/BRS.0b013e31820a (when applicable) inpatient pain management and ☐ Small sample size
0b3f bracing. ☐ Lacked subgroup analysis
☐ Level V (expert consensus) ☐ Diagnostic methods not
Total number of patients in the described.
☐ Level IV in presence of higher study: 175 ☒ Other: what is the definition
quality studies of refractory?, no values just HR
Number of patients in
☐ Subgroup analysis data not relevant subgroup(s): 46 VP and
available 129 control Level of Evidence
Determination
702
☐ Not relevant to question Duration of follow-up: Click or tap Potential Level: III
here to enter text. Downgraded Level: Not
Downgraded
Validated outcome measures used
(list): survival Conclusions
This paper provides evidence
Nonvalidated outcome measures that: augmentation had
used (list): Click significant improvement in
survival compared to controls
Diagnosis made by: treated without augmentation
☐ Clinical exam/history or surgery.
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: chart/imaging review
Results/subgroup analysis (relevant
to question): controlling for
significant predictors, the estimated
hazard ratio associated with
cementation was 0.10 (95% CI =
0.02–0.43; P = 0.002) for year 1,
0.15 (95% CI = 0.02–1.12; P =
0.064) for year 2, and 0.95 (95% CI
= 0.32–2.79; P = 0.919) for
subsequent follow-up.
Author conclusions (relevant to
question): Cement augmentation of
refractory OVCF improves survival
for up to 2 years when compared
with conservative pain
management
Kim YC, Bok DH, Chang HG, et Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
al. Increased sagittal vertical axis Prognostic Study Design: Observational ☒ Patients not enrolled at same
is associated with less effective Comparative point in their disease
control of acute pain following Level III ☐ <80% follow-up
vertebroplasty. Bone Joint Res. Stated objective of study: to identify ☐ Follow-up not standardized
2016;5(11):544-551. Explanation of failure to meet the pre-op prognostic factors
doi:10.1302/2046-3758.511.BJR- guideline inclusion criteria ☐ No validated outcome
related to the effect of
2016-0135.R1 (when applicable) measures used
vertebroplasty on acute pain control
☐ Small sample size
703
using a cohort of surgically and ☐ Lacked subgroup analysis
☐ Level V (expert consensus) non-surgically managed patients ☐ Diagnostic methods not
described.
☐ Level IV in presence of higher Total number of patients in the ☒ Other: odd methodology; pts
quality studies study: 342
who did not improve at 3 weeks
Number of patients in
were then given choice of
☐ Subgroup analysis data not relevant subgroup(s): 222
vertebroplasty; 35% crossover
available
Duration of follow-up: 12 weeks
Level of Evidence
☐ Not relevant to question Validated outcome measures used
Determination
Potential Level: II
(list): McGill Pain Map, VAS
Downgraded Level: III
Downgraded due to the patients
Nonvalidated outcome measures
not being enrolled at the same
used (list): Click or tap here to enter
point in their disease and
text.
selection bias. For example,
patients who did not improve
Diagnosis made by:
after three weeks were given a
☒ Clinical exam/history choice of the vertebroplasty
☐ Electromyography treatment.
☐ Myelogram
☒ MRI Conclusions
☐ CT This paper provides evidence
that: the interventional group
☐ CT/Myelogram
had a 24.2% risk of cement
☒ Other: DEXA leakage. No difference in
medical complications
Results/subgroup analysis (relevant occurred between groups
to question): patients underwent 3 (5.4% non-operative vs 5%
wks of conservative treatment. intervention).
Patients not satisfied could elect for
VP. VP significant better at 4VAS
@ diagnosis 6.6 -> 4.5 @ 3 weeks -
> 3.5 @ 4 weeks -> 2.9@ 6 weeks
and 6 weeks, but same as
conservative at2.0@ 12 weeks.
Author conclusions (relevant to
question): In conclusion, for the
patients with single-level acute
osteoporotic
vertebral compression fracture, ve
rtebroplasty was more effective for
acute pain control than
704
conservative
treatment regardless of age, b
mI, medical comorbidity, presen
ce of previous fracture, pain
duration,
bone mineral density, degree of v
ertebral body compression, canal
encroachment, and kyphotic Cob
b angle.
Klezl Z, Bhangoo N, Phillips J, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Swamy G, Calthorpe D, Prognostic Study Design: Case Control ☐ Patients not enrolled at same
Bommireddy R. Social point in their disease
implications of balloon Level III Stated objective of study: to assess ☐ <80% follow-up
kyphoplasty: prospective study the social and functional ☐ Follow-up not standardized
from a single UK centre. Eur consequences of BKP
Spine J. 2012;21(9):1880-1886. Explanation of failure to meet ☐ No validated outcome
doi:10.1007/s00586-012-2262-7 guideline inclusion criteria measures used
Total number of patients in the
Duplicate: Also in OVCF NH1 (when applicable) study: 118 ☐ Small sample size
Number of patients in ☐ Lacked subgroup analysis
☐ Level V (expert consensus) relevant subgroup(s): 63 BKP and ☐ Diagnostic methods not
55 control described.
☐ Level IV in presence of higher ☒ Other: control group historic
quality studies Duration of follow-up: 1 year retro group,
☐ Subgroup analysis data not Validated outcome measures used Level of Evidence
available (list): mortality Determination
Potential Level: III
☐ Not relevant to question Nonvalidated outcome measures Downgraded Level: Not
used (list): Click or tap here to enter Downgraded
text.
Conclusions
Diagnosis made by: This paper provides evidence
☒ Clinical exam/history that: patients who had BKP for
☐ Electromyography OVCF had a lower mortality
☐ Myelogram rate at 3 months compared to
a historical control group
☒ MRI
treated without augmentation
☐ CT or surgery.
☐ CT/Myelogram
☒ Other: xray
Results/subgroup analysis (relevant
to question): After BKP, 11/53 had
social drift down and 6 (11%) died.
705
27/51 treated conservatively had a
downward social drift and 11 died
(21.6%) deaths in control were
statistically higher by 3 months,
Author conclusions (relevant to
question): BKP may contribute to
reduced mortality compared to
conservative management
Lange A, Kasperk C, Alvares L, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Sauermann S, Braun S. Survival Prognostic Study Design: Case Control ☐ Patients not enrolled at same
and cost comparison of point in their disease
kyphoplasty and percutaneous Level III Stated objective of study: examine ☐ <80% follow-up
vertebroplasty using German survival and treatment costs for ☐ Follow-up not standardized
claims data. Spine (Phila Pa Explanation of failure to meet patients with OVCF treated by VA
1976). 2014;39(4):318-326. guideline inclusion criteria ☐ No validated outcome
or CT in Germany
doi:10.1097/BRS.000000000000 (when applicable) measures used
0135 Total number of patients in the ☐ Small sample size
☐ Level V (expert consensus) study: 3607 ☐ Lacked subgroup analysis
Number of patients in ☐ Diagnostic methods not
☐ Level IV in presence of higher relevant subgroup(s): 157 – VP, described.
quality studies 441 – BKP, 3009 - conservative ☒ Other: insurer database
☐ Subgroup analysis data not Duration of follow-up: 2005-2010 Level of Evidence
available 60m5 years Determination
Potential Level: III
Validated outcome measures used Downgraded Level: Not
☐ Not relevant to question
(list): Click or tap here to enter text. Downgraded
Nonvalidated outcome measures Conclusions
used (list): survival This paper provides evidence
that: patients undergoing
Diagnosis made by: vertebral augmentation had a
☐ Clinical exam/history slightly lower death rate
☐ Electromyography compared to a matched
☐ Myelogram control group over 5 years.
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: ICD 10, claims data
Results/subgroup analysis (relevant
to question): At 60 months,
706
operated cohort had higher
adjusted survival rate 65.5% at up
to 4 years compared to 51.9% in
non-operated. Adjusting for
covariates operated were 69.9%
compared 53.8% in non-operated
Author conclusions (relevant to
question): The evidence from this
study suggests that the risk of
mortality for patients with
osteoporosis who had vertebral
fracture and underwent NSM is
signifi cantly higher than that for
operated patients after 5 years of
follow-up
Lavelle WF, Khaleel MA, Cheney Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
R, Demers E, Carl AL. Effect of Prognostic Study Design: Case Control ☐ Patients not enrolled at same
kyphoplasty on survival after point in their disease
vertebral compression Level III Stated objective of study: to ☐ <80% follow-up
fractures. Spine J. 2008;8(5):763- determine if KP improves survival ☐ Follow-up not standardized
769. after OCVF
doi:10.1016/j.spinee.2007.05.013 Explanation of failure to meet ☐ No validated outcome
guideline inclusion criteria measures used
Total number of patients in the
(when applicable) study: 184 ☐ Small sample size
Number of patients in ☐ Lacked subgroup analysis
☐ Level V (expert consensus) relevant subgroup(s): 94 – BKP, 90 ☐ Diagnostic methods not
- conservative described.
☐ Level IV in presence of higher ☐ Other: Click or tap here to
quality studies Duration of follow-up: 2000-2004 to enter text.
2006until close of study (Sept
☐ Subgroup analysis data not 2006), study reviewed patients Level of Evidence
available back to June 20006 years Determination
Potential Level: III
Validated outcome measures used Downgraded Level: Not
☐ Not relevant to question
(list): death Downgraded
Nonvalidated outcome measures Conclusions
used (list): Click or tap here to enter This paper provides evidence
text. that: mortality was comparable
between kyphoplasty patients
Diagnosis made by: and the control group once
☒ Clinical exam/history adjusted
☐ Electromyography
707
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: radiograph & bone scan
Results/subgroup analysis (relevant
to question): 38/94 BKP died vs
26/90 control; once controlled for
variables not significant.. age
adjusted mortality 35.3/1000
ptyears in control vs 40.1/1000 pts
years for KP
Author conclusions (relevant to
question): Kyphoplasty did not
seem to effect the survival of
patients with a vertebral
compression
fracture.
Levy H, Seydafkan S, Rice JD, Type of evidence: Prognostic ☐ Prospective ☒Retrospective Critique of methodology:
Easley KA, Tangpricha V. ☒ Patients not enrolled at same
Comparative efficacy of Level IV Study Design: Case Control point in their disease
vertebroplasty, kyphoplasty, and ☐ <80% follow-up
medical therapy for vertebral Explanation of failure to meetStated objective of study: to ☐ Follow-up not standardized
fractures on survival and guideline inclusion criteria examine the survival rate and
prevention of recurrent fractures. (when applicable) ☐ No validated outcome
recurrent fracture rate after surgical
Endocr Pract 2012;18(4):499– measures used
therapy, medical therapy or both
507. ☐ Level V (expert consensus) ☐ Small sample size
Total number of patients in the ☐ Lacked subgroup analysis
☐ Level IV in presence of higher study: 250 ☐ Diagnostic methods not
quality studies Number of patients in described.
relevant subgroup(s): 149 117 ☒ Other: baseline different
☐ Subgroup analysis data not groups, younger patients in
available Duration of follow-up: 10 years non-op, not clear duration of
f/u
☐ Not relevant to question Validated outcome measures used
(list): survival rate, refracture rate Level of Evidence
Determination
Nonvalidated outcome measures Potential Level: III
used (list): Click or tap here to enter Downgraded Level: IV
text.
708
Diagnosis made by: Downgraded due to different
☐ Clinical exam/history times of enrollment for disease
☐ Electromyography for comparative component.
☐ Myelogram
Conclusions
☐ MRI This paper provides evidence
☐ CT that: adults with OVCF treated
☐ CT/Myelogram without augmentation or
☒☐ Other: ICD 9 and CPT, chart surgery have a 6% refracture
review rate and a 24.8% mortality
rate.
Results/subgroup analysis (relevant
to question):
There was no significant difference
in the cumulative survival rates
among the 4 study groups nor
between the treatment groups.
There was, how-ever, a significant
difference in the cumulative
refracture-free rates among the 4
study groups (P<.0001). Recurrent
fracture-free rates were highest in
the group that received no
treatment. The 2-year cumulative
refracture-free rates were 95.9%,
84.8%, 81.7%, and 68.5%,
respectively, for the no treatment,
medical therapy only, surgical
treatment only, and medical plus
surgical therapy groups. Recurrent
fracture-free rates were significantly
different for patients who received
surgical or medical or surgical plus
medical therapy (P = .0007), with
patients in the medical plus surgical
group having the shortest time to
refracture, although these patients
may have been sicker and more
frail than the other groups.
Author conclusions (relevant to
question): surgical treatment with
vertebroplasty or kyphoplasty did
not decrease recurrent vertebral
709
fractures in patients presenting with
an initial vertebral fracture. Medical
and surgical therapies together may
shorten the time to refracture, but
the observed elevated risk may be
due to other confounding factors.
We found no difference in survival
in patients undergoing kyphoplasty
or vertebroplasty in comparison
with medical or no treatment
groups.
Lin JH, Chien LN, Tsai WL, Chen Type of evidence: Prognostic ☐ Prospective ☒ Retrospective Critique of methodology:
LY, Chiang YH, Hsieh YC. Early ☒ Patients not enrolled at same
vertebroplasty associated with a Level IV Study Design: Comparative point in their disease
lower risk of mortality and ☐ <80% follow-up
respiratory failure in aged Stated objective of study: to ☐ Follow-up not standardized
patients with painful vertebral Explanation of failure to meet elucidate the benefits of an early
☐ No validated outcome
compression fractures: a guideline inclusion criteria VP intervention in aged patients
population-based cohort study in (when applicable) measures used
with a PVCF by comparing the risks
Taiwan. Spine J ☐ Small sample size
of mortality and respiratory-related
2017;17(9):1310–1318 ☐ Level V (expert consensus) morbidity based on the population- ☐ Lacked subgroup analysis
based propensity score matched ☐ Diagnostic methods not
☐ Level IV in presence of higher cohort . described.
quality studies ☒ Other: patients > 70,
Total number of patients in the treatment within 3 months,
☐ Subgroup analysis data not study: 10,785
available Number of patients in Level of Evidence
relevant subgroup(s): 1773 VP, Determination
☐ Not relevant to question 5324 non-VP Potential Level: III
Downgraded Level: IV
Duration of follow-up: 1 year Downgraded due to possible
crossover of patients and
Validated outcome measures used unclear intervention.
(list): death, pneumonia and
respiratory complications
Nonvalidated outcome measures Conclusions
used (list): Click or tap here to enter This paper provides evidence
text. that: in adults with OVCF
treated without augmentation
Diagnosis made by: or surgery the risk of
☐ Clinical exam/history mortality was 389 over 61427
☐ Electromyography person-months observed.
☐ Myelogram
710
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Taiwan registry, claims
data
Results/subgroup analysis (relevant
to question): The incidences of
death at 1 year of VP and non-VP
patients were 0.46 (95% confidence
interval [CI]: 0.38–0.56) and 0.63
(95% CI: 0.57–0.70) per 100
person-months, respectively. We
observed a hazard ratio (HR) of
1.39 (95% CI: 1.09–1.78, p=.008)
when comparing non-VP to VP
patients. This phenomenon was
seen when estimating the benefits
of respiratory failure (HR: 1.46;95%
CI: 1.04–2.05, p=.028)
Author conclusions (relevant to
question): VP was associated with
lower risks of mortality and
respiratory failure in aged patients
with a PVCF. VP should be
considered a priority for the aged
patients with a PVCF requiring
admission and analgesics
McCullough BJ, Comstock BA, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Deyo RA, Kreuter W, Jarvik JG. Prognostic Study Design: Case Control ☐ Patients not enrolled at same
Major medical outcomes with point in their disease
spinal augmentation vs Level III Stated objective of study: to ☐ <80% follow-up
conservative therapy. JAMA compare major medical outcomes ☐ Follow-up not standardized
Intern Med. 2013;173(16):1514- Explanation of failure to meet following treatment of OCVF with
1521. guideline inclusion criteria ☐ No validated outcome
spinal augmentation or
doi:10.1001/jamainternmed.2013. (when applicable) measures used
conservative therapy
8725 ☐ Small sample size
☐ Level V (expert consensus) Total number of patients in the ☐ Lacked subgroup analysis
study: 115851 + 10541 ☐ Diagnostic methods not
☐ Level IV in presence of higher Number of patients in described.
quality studies relevant subgroup(s): 10,541 aug, ☐ Other: Click or tap here to
115,851 CT enter text.
711
☐ Subgroup analysis data not
available Duration of follow-up: 30 day and 1 Level of Evidence
year Determination
☐ Not relevant to question Potential Level: III
Validated outcome measures used Downgraded Level: Not
(list): Mortality, major medical Downgraded
complications
Conclusions
Nonvalidated outcome measures This paper provides evidence
used (list): Click or tap here to enter that: through the use of
text. Medicare data, patients with
OVCF treated without
Diagnosis made by: augmentation or surgery
☐ Clinical exam/history experience a mortality rate of
☐ Electromyography 6.7% and an incidence of
major medical complication of
☐ Myelogram
28.9% at 1 year following
☐ MRI OCVF.
☐ CT
☐ CT/Myelogram
☒ Other: ICD 9 , claims data
Results/subgroup analysis (relevant
to question): 30 d: augmentation
0.4% vs control 1.5% and 1 year:
5.2% vs 6.7% but diminished with
propensity score adjustment 0.3%
vs 0.6% @ 30 days and 5.2% vs
5.6% at 1 year (no longer stat
sign)
Author conclusions (relevant to
question): after accounting for
selection bias, spinal augmentation
did not improve mortality or major
medical outcomes
Ong KL, Beall DP, Frohbergh M, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Lau E, Hirsch JA. Were VCF Prognostic Study Design: Case Control ☐ Patients not enrolled at same
patients at higher risk of mortality point in their disease
following the 2009 publication of Level III Stated objective of study: to ☐ <80% follow-up
the vertebroplasty "sham" determine the utilization of BKP/VP ☐ Follow-up not standardized
trials?. Osteoporos Int. in the US elderly population
712
2018;29(2):375-383. Explanation of failure to meet Total number of patients in the ☐ No validated outcome
doi:10.1007/s00198-017-4281-z guideline inclusion criteria study: 2,129,769 measures used
(when applicable) Number of patients in ☐ Small sample size
relevant subgroup(s): 261,756 BKP,
☐ Lacked subgroup analysis
☐ Level V (expert consensus) 117,232 VP
☐ Diagnostic methods not
described.
☐ Level IV in presence of higher Duration of follow-up: 1 year10yr9
years data ☒ Other: different timing
quality studies
Validated outcome measures used Level of Evidence
☐ Subgroup analysis data not Determination
(list): mortality
available Potential Level: III
Nonvalidated outcome measures Downgraded Level: Not
☐ Not relevant to question used (list): Click or tap here to enter Downgraded
text.
Conclusions
Diagnosis made by: This paper provides evidence
☐ Clinical exam/history that: augmentation was
associated with a lower
☐ Electromyography
mortality at 10 years.
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: ICD 9, Medicare data
Results/subgroup analysis (relevant
to question): propensity adjusted
mortality risk for VCF patients was
4% greater in 2010-2014 vs 2005-
2009, with 10 year risk overall to
cohort of 85.1%
BKP and VP had 19% lower
propensity-adjusted 10 year
mortality rate compared non-surg,
BKP 13% lower than VP cohort
Author conclusions (relevant to
question): Changes in treatment
patterns following the 2009 VP
publications led to fewer
augmentation procedures. In turn
the 5 year period following 2009
713
was associated with elevated
mortality risk in VCF patients.
Zampini JM, White AP, McGuire Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
KJ. Comparison of 5766 vertebral Prognostic Study Design: Case Control ☐ Patients not enrolled at same
compression fractures treated point in their disease
with or without kyphoplasty. Clin Level of Evidence: Stated objective of study: To ☐ <80% follow-up
Orthop Relat Res. ☐I evaluate complications, mortality, ☐ Follow-up not standardized
2010;468(7):1773-1780. ☐ II posthospital disposition and ☐ No validated outcome
doi:10.1007/s11999-010-1279-7
☐ III treatment costs of BKP with NSM in
measures used
a Nationwide Inpatient Sample
☒ IV ☐ Small sample size
Database
☐ Lacked subgroup analysis
Total number of patients in the ☐ Diagnostic methods not
Explanation of failure to meet
study: 5766 described.
guideline inclusion criteria
(when applicable)
Number of patients in relevant ☒ Other: differences between
subgroup(s): 15.3% BKP; 84.7% cohorts of age, gender,
NSM location,
☐ Level V (expert consensus)
Duration of follow-up: N/A Level of Evidence
☐ Level IV in presence of higher Determination
quality studies Validated outcome measures used Work group conclusions
(list): death, mortality Potential Level: III
☐ Subgroup analysis data not Downgraded Level: IV
available Nonvalidated outcome measures Downgraded due to differences
used (list): Click or tap here to enter between cohorts of age, gender,
☐ Not relevant to question text. location
Diagnosis made by: Conclusions relative to question
☐ Clinical exam/history This paper provides evidence
☐ Electromyography that: non-operative treatment
☐ Myelogram of OCVF was associated with
a 1.6% rate of mortality, 1%
☐ MRI
overall complication risk and
☐ CT 3.4% risk of pneumonia.
☐ CT/Myelogram
☒ Other: ICD 9
Results/subgroup analysis (relevant
to question): mortality: BKP –
0.3%; NSM – 1.6% (p=0.003).
There was no difference in
complications
714
Author conclusions (relevant to
question): Kyphoplasty for
treatment of VCF in well selected
patients may accelerate the return
of independent patient function as
indicated by improved measures of
hospital discharge.
Natural History Question 5: For patients with osteoporotic vertebral compression fractures managed without augmentation or surgery, are there specific
variables that increase the risk for re-fracture of the same or other vertebral levels?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Diamond TH, Bryant C, Browne Type of evidence: Prognostic ☒ Prospective ☐ Retrospective Critique of methodology:
L, Clark WA. Clinical outcomes Study Design: Observational ☒ Patients not enrolled at same
after acute osteoporotic vertebral Level III point in their disease (dx criteria
fractures: a 2-year non- Stated objective of study: To unclear)
randomised trial comparing Explanation of failure to meet assess the safety and efficacy of ☐ <80% follow-up
percutaneous vertebroplasty with guideline inclusion criteria percutaneous vertebroplasty for the ☐ Follow-up not standardized
conservative therapy. Med J (when applicable) treatment of acute osteoporotic
☐ No validated outcome
Aust. 2006;184(3):113-117. vertebral fractures.
measures used
doi:10.5694/j.1326- ☐ Level V (expert consensus)
5377.2006.tb00148.x ☒Small sample size
Total number of patients in the
☐ Level IV in presence of higher study: 126 ☐ Lacked subgroup analysis
quality studies ☒ Diagnostic methods not
Number of patients in described.
☐ Subgroup analysis data not relevant subgroup(s): 38 by ☒ Other: selection bias?
available conservative therapy and 88 PV Patients who declined VP were
control group; no statistical
Duration of follow-up: 24 months comparison between time
☐ Not relevant to question
intervals
Validated outcome measures used
(list) VAS, level of function (Barthel Level of Evidence
index) , pain score Determination
Potential Level: II
Nonvalidated outcome measures Downgraded Level: III
used (list): number of hospital Downgraded due to: unclear
days, vertebral morphometry via diagnostic criteria and selection
XR, new fx, recurrent pain bias
715
Diagnosis made by:
☒ Clinical exam/history Conclusions
☐ Electromyography This paper provides evidence
that: new fractures were found
☐ Myelogram
in 24% of patients for both VP
☒ MRI
and non-operative groups
☐ CT with no specific risk factors
☐ CT/Myelogram identified.
☒ Other: unclear, imaging criteria
of acute fracture activity
Results/subgroup analysis
(relevant to question): VAS 19 @
24 hrs -> 7@6weeks ->4@6-12
months and 3 @ 24 months, 85%
improvement in pain score at 24
months with conservative therapy
Author conclusions (relevant to
question): The analgesic benefit of
percutaneous vertebroplasty and
the low complication rates suggest
that it is a useful therapy for acute
painful osteoporotic vertebral
fractures
Faloon MJ, Ruoff M, Deshpande Type of evidence: Prognostic ☐ Prospective ☒ Retrospective Critique of methodology:
C, et al. Risk Factors Associated Study Design: Case Control ☐ Patients not enrolled at same
with Adjacent and Remote- Level Level III point in their disease
Pathologic Vertebral Stated objective of study: to ☐ <80% follow-up
Compression Fracture Following Explanation of failure to meet compare rates of adjacent and ☐ Follow-up not standardized
Balloon Kyphoplasty: 2-Year guideline inclusion criteria remote fractures in osteoporotic
☐ No validated outcome
Follow-Up Comparison Versus (when applicable) patients treated with either
Conservative Treatment. J Long measures used
kyphoplasty or conservative care
Term Eff Med Implants. ☐ Level V (expert consensus) ☐ Small sample size
2015;25(4):313-319. Total number of patients in the ☐ Lacked subgroup analysis
doi:10.1615/jlongtermeffmedimpl ☐ Level IV in presence of higher study: 258 ☐ Diagnostic methods not
ants.2015013971 quality studies Number of patients in described.
relevant subgroup(s): 121 treated ☐ Other: Click or tap here to
☐ Subgroup analysis data not nonoperatively and 137 underwent enter text.
available BK with polymethylmethacrylate
cement augmentation Level of Evidence
Determination
716
☐ Not relevant to question Duration of follow-up: 2yr minimum Potential Level: III
(Range 2-6 years) Downgraded Level: Not
Downgraded
Validated outcome measures used
(list): Mantel-Haensezl-Cochran Conclusions
test This paper provides evidence
Nonvalidated outcome measures that: the refracture rate was
used (list): Click or tap here to approximately 50%; DM,
enter text. smoking, NSAIDS all
increased secondary fracture
Diagnosis made by: risk; and there were no risk
☐ Clinical exam/history factors in the multivariate
☐ Electromyography analysis in adults treated
without augmentation or
☐ Myelogram
surgery.
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: x-ray, bone scan
Results/subgroup analysis
(relevant to question): 61.3% of
nonop patients had a new fracture,
risk factors included DM, smoking,
NSAIDs use in univariate but
nothing in multivariate
Author conclusions (relevant to
question): Patients in the
current series treated with
nonoperative, conservative
management had a 2.28 times
greater risk for a
subsequent VCF than patients
treated with balloon
kyphoplasty and PMMA
augmentation.
Lindsay R, Silverman SL, Cooper Type of evidence: Prognostic ☐ Prospective ☒Retrospective Critique of methodology:
C, et al. Risk of new vertebral Study Design: ☐ Patients not enrolled at same
fracture in the year following a Level III point in their disease
☐ <80% follow-up
717
fracture. JAMA. 2001;285(3):320- Stated objective of study: to ☐ Follow-up not standardized
323. doi:10.1001/jama.285.3.320 Explanation of failure to meet determine the incidence of further ☐ No validated outcome
guideline inclusion criteria vertebral fracture in the year measures used
(when applicable) following a vertebral fracture
☐ Small sample size
☐ Lacked subgroup analysis
☐ Level V (expert consensus) Total number of patients in the
study: 2725 ☐ Diagnostic methods not
described.
☐ Level IV in presence of higher
quality studies Number of patients in relevant ☐ Other:
subgroup(s): 381
Level of Evidence
☐ Subgroup analysis data not
Duration of follow-up: 12 monthsDetermination
available
Potential Level: III
Validated outcome measures used Downgraded Level: Not
☐ Not relevant to question (list): downgraded
Downgraded due to:
Nonvalidated outcome measures
used (list): Conclusions
This paper provides evidence
Diagnosis made by: that: there is a 19.2% risk of
☐ Clinical exam/history developing new fractures
☐ Electromyography after OVCF
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☐ Other:
Results/subgroup analysis (relevant
to question):
Author conclusions (relevant to
question): the risk of new vertebral
fracture was 19.2%
Yamauchi K, Adachi A, Type of evidence: Prognostic ☐ Prospective ☒ Retrospective Critique of methodology:
Kameyama M, et al. A risk factor Study Design: Case Control ☐ Patients not enrolled at same
associated with subsequent new Level III point in their disease
vertebral compression fracture Stated objective of study: This ☒ <80% follow-up
after conservative therapy for study aimed to determine the ☐ Follow-up not standardized
patients with vertebral Explanation of failure to meet factors independently associated
compression fracture: a guideline inclusion criteria ☐ No validated outcome
with the subsequent vertebral
retrospective observational (when applicable) measures used
compression fracture (VCF) after
study. Arch Osteoporos. hospital conservative therapy in ☐ Small sample size
718
2020;15(1):9. Published 2020 ☐ Level V (expert consensus) patients with new fragility VCFs and ☐ Lacked subgroup analysis
Jan 3. doi:10.1007/s11657-019- parameters related with functional ☐ Diagnostic methods not
0679-x ☐ Level IV in presence of higher recovery in the acute period described.
quality studies ☐ Other: 216/328 f/u @ 9
Total number of patients in the
months
study: 328
☐ Subgroup analysis data not
available Level of Evidence
Number of patients in relevant
Determination
subgroup(s): 216/328
☐ Not relevant to question Potential Level: II
Downgraded Level: III
Duration of follow-up: 9 months
Downgraded due to less than
80% follow-up
Validated outcome measures used
(list): radiographs
Conclusions
This paper provides evidence
Nonvalidated outcome measures
that: low lumbar BMD, low FIM
used (list): FIM, pain intensity
score, and low segmental
Diagnosis made by:
Cobb angle demonstrated an
☒ Clinical exam/history increased risk of subsequent
☐ Electromyography fractures in adults treated
☐ Myelogram without augmentation or
☒ MRI surgery.
☐ CT
☐ CT/Myelogram
☒ Other: x-ray, radiograph
Results/subgroup analysis (relevant
to question): lumbar BMD, FIm
(functional independence measure)
recovery,L/ S BMD lower in fracture
vs non, FIM recovery ratio and
segmental Cobb at 2 months ;
37/216 had angle independently
associated w subsequent
fractures
Author conclusions (relevant to
question): lower lumbar BMD
value, worse functional recovery in
the acute period and vertebral body
collapse already observed at
hospitalization were independently
associated with subsequent new
719
VCF after conservative hospital
therapy for patients with new
fragility VCFs.
720
Cost Effectiveness Section
Question 1: In the treatment of osteoporotic vertebral compression fractures, what is the comparative cost-effectiveness of
a. Medical therapy alone vs.
b. Vertebral augmentation vs.
c. Thermal ablation, radiofrequency ablation or cryoablation with or without augmentation vs.
d. Operative fusion/fixation?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Fritzell P, Ohlin A, Borgström F. Cost- Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
effectiveness of balloon kyphoplasty Economic and Decision ☐ No validated outcome
versus standard medical treatment in Analysis Study Design: RCT measures used
patients with osteoporotic vertebral ☐ Small sample size
compression fracture: a Swedish Level II Stated objective of study: To assess ☐ Lacked subgroup analysis
multicenter randomized controlled trial the cost-effectiveness of balloon
with 2-year follow-up. Spine (Phila Pa ☐ No sensible alternatives
kyphoplasty (BKP) compared with
1976). 2011;36(26):2243-2251. Explanation of failure to utilized
standard medical treatment (control)
doi:10.1097/BRS.0b013e3182322d0f meet guideline inclusion in patients with acute/subacute ( < 3 ☐ No sensible costs utilized
criteria months) vertebral compression ☐ Limited alternatives and
(when applicable) fracture (VCF) due to osteoporosis costs
☐ Poor estimates
☐ Level V (expert Total number of patients in the ☐ No sensitivity analysis
consensus) study: 63 performed
Number of patients in ☐ Other: Click or tap here to
☐ Level IV in presence of relevant subgroup(s): BKP 32, enter text.
higher quality studies control 31
Level of Evidence
☐ Subgroup analysis data Consecutively assigned? Yes Determination
not available Potential Level: II
Duration of follow-up: 2 years Downgraded Level: Not
☐ Not relevant to question Downgraded
Validated outcome measures used
(list): EQ-5D, QALY Conclusions
This paper provides evidence
Nonvalidated outcome measures that: based upon a wiliness to
used (list): Click or tap here to enter pay of US$50,000 cost/QALY
text. gained, BKP was not shown
to be cost effective, however
Measures of cost effectiveness the sensitivity analyses
used: QALY suggest significant
uncertainty
721
☒ Quality Adjusted Life Year
(QALY)
Used to compare: BKP vs control
groupsClick or tap here to
enter text.
☒ EQ-5D
Used to compare: Click or tap
here to enter text.
☐ SF-6D
Used to compare: Click or tap
here to enter text.
☒ Incremental Cost-Effectiveness
Ratio (ICER)
Used to compare: Click or tap
here to enter text.
☐ Other: Click or tap here to enter
text.
Used to compare: Click or tap
here to enter text.
Sensible costs and alternatives?
Costs based upon hospital’s billing
systems and a patient ‘cost diary’,
yes
Values obtained from:
☐ many studies
☒ limited studies
Sensitivity analyses performed:
☒ Multiway analysis
☐ One way analysis
☐ Other: Click or tap here to enter
text.
☐ None
Results (including specific data on
value measures assessed and
comparison made between
treatments): cost/QALY gained by
using BKP was $134,043, sensitivity
analysis resulted in $54,416 gained
722
Author conclusions (relative to
question): it was not possible
to demonstrate that BKP was cost-
effective compared with standard
medical treatment in patients treated
for an acute/subacute vertebral
fracture due to osteoporosis.
Author perspective:
Physician/Researcher
Svedbom A, Alvares L, Cooper C, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Marsh D, Ström O. Balloon Economic and Decision ☐ No validated outcome
kyphoplasty compared to Analysis Study Design: Comparative measures used
vertebroplasty and nonsurgical ☐ Small sample size
management in patients hospitalised Level II Stated objective of study: The ☐ Lacked subgroup analysis
with acute osteoporotic vertebral objective of the model is to estimate
compression fracture: a UK cost- Explanation of failure to ☐ No sensible alternatives
the cost effectiveness of BKP
effectiveness analysis. Osteoporos meet guideline inclusion utilized
compared to NSM and PVP in
Int. 2013;24(1):355-367. criteria patients hospitalized with acute ☐ No sensible costs utilized
doi:10.1007/s00198-012-2102-y (when applicable) OVCF ☐ Limited alternatives and
costs
☐ Level V (expert Total number of patients in the ☒ Poor estimates
consensus) study: Click or tap here to enter text. ☐ No sensitivity analysis
performed
☐ Level IV in presence of Number of patients in ☐ Other: Click or tap here to
higher quality studies relevant subgroup(s): Click or tap enter text.
here to enter text.
☐ Subgroup analysis data Level of Evidence
not available Consecutively assigned? Choose an Determination
item. Potential Level: I
☐ Not relevant to question Downgraded Level: II
Duration of follow-up: 24m6 month Downgraded due to poor
cycle estimates
Validated outcome measures used Conclusions
(list): QALY Click or tap here to This paper provides evidence
enter text. that: the BKP may be cost-
effective compared to PVP
Nonvalidated outcome measures and NMS for hospitalized
used (list): Click or tap here to enter patients with OCVF, but
text. significant variability exists.
723
Measures of cost effectiveness
used:
☒ Quality Adjusted Life Year
(QALY)
Used to compare: BKP vs control
Click or tap here to enter text.
☒ EQ-5D
Used to compare: Click or tap here
to enter text.
☐ SF-6D
Used to compare: Click or tap here
to enter text.
☒ Incremental Cost-Effectiveness
Ratio (ICER)
Used to compare: Click or tap here
to enter text.
☐ Other: Click or tap here to enter
text.
Used to compare: Click or tap here
to enter text.
Sensible costs and alternatives?
Click or tap here to enter text.
Values obtained from:
☒ many studies
☐ limited studies
Sensitivity analyses performed:
☐ Multiway analysis
☒ One way analysis
☐ Other: Click or tap here to enter
text.
☐ None
Results (including specific data on
value measures assessed and
comparison made between
treatments): Incremental cost per
QALY for BKP was GBP 2,706 and
GBP 15,982 compared to NSM and
PVP, respectively
724
Author conclusions (relative to
question): BKP may be a cost-
effective strategy for the treatment
of patients hospitalized with acute
OVCF in the UK compared to NSM
and PVP.
Author perspective: Other
Takahashi S, Hoshino M, Yasuda H, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
et al. Cost-effectiveness of Balloon Economic and Decision ☐ No validated outcome
Kyphoplasty for Patients With Analysis Study Design: Comparative measures used
Acute/Subacute Osteoporotic ☐ Small sample size
Vertebral Fractures in the Super- Level III Stated objective of study: to reveal ☐ Lacked subgroup analysis
Aging Japanese Society. Spine (Phila the cost-effectiveness of VAP in
Pa 1976). 2019;44(5):E298-E305. Explanation of failure to ☐ No sensible alternatives
Japan
doi:10.1097/BRS.0000000000002829 meet guideline inclusion utilized
criteria Total number of patients in the ☐ No sensible costs utilized
(when applicable) study: 624116 ☐ Limited alternatives and
Number of patients in relevant costs
☐ Level V (expert subgroup(s): BKP – 116; NSM 458 ☐ Poor estimates
consensus) ☐ No sensitivity analysis
Consecutively assigned? Yes performed
☐ Level IV in presence of ☐ Other: Click or tap here to
higher quality studies Duration of follow-up: 6m enter text.
☐ Subgroup analysis data Validated outcome measures used Level of Evidence
not available (list): QALY Click or tap here to Determination
enter text. Potential Level: II
☐ Not relevant to question Downgraded Level: III
Nonvalidated outcome measures Downgraded due to analysis
used (list): Click or tap here to enter based on modeling, and based
text. on limited alternatives and
costs. Multiway sensitivity
Measures of cost effectiveness analyses were not performed.
used:
☒ Quality Adjusted Life Year Conclusions
(QALY) This paper provides evidence
Used to compare: Click or tap here that: BKP is cost effective in
to enter text. this modeling study,
☐ EQ-5D particularly for people under
80 years in Japan
725
Used to compare: Click or tap here
to enter text.
☒ SF-6D
Used to compare: Click or tap here
to enter text.
☐ Incremental Cost-Effectiveness
Ratio (ICER)
Used to compare: Click or tap here
to enter text.
☐ Other: Click or tap here to enter
text.
Used to compare: Click or tap here
to enter text.
Sensible costs and alternatives?
Click or tap here to enter text.
Values obtained from:
☒ many studies
☒ limited studies
Sensitivity analyses performed:
☐ Multiway analysis
☒ One way analysis
☐ Other: Click or tap here to enter
text.
☐ None
Results (including specific data on
value measures assessed and
comparison made between
treatments): BKP has an ICER of
GBP 29,832/QALY at 3yrs and GBP
16,368/QALY at 20yrs compared to
NSM
Author conclusions (relative to
question): BKP is a cost- effective
treatment option for OVF in Japan.
Author perspective: Choose an item.
726
Clinical Diagnosis Section
Clinical Diagnosis Question 1: Which elements (individual or combination) of a history, symptoms, and/or physical examination are most sensitive and
specific for identifying a patient with an acute osteoporotic vertebral compression fracture?
Article Level Description of study Conclusion
(Alpha by Author) of Evidence
Jin H, Ma X, Liu Y, et al. Type of Evidence: Diagnostic ☒ Prospective ☐ Retrospective Critique of methodology
Back Pain-Inducing Study Design: Observational ☒Nonconsecutive patients
Test, a Novel and Level II ☐ Small sample size
Sensitive Screening Stated objective of study: To determine ☒Nonmasked reviewers
Test for Painful diagnostic value of a novel clinical test ☐ No universally-applied gold
Osteoporotic Vertebral Explanation of failure to meet guideline (back-pain inducing test, BPIT), to
Fractures: A inclusion criteria standard
detect painful vertebral fractures (VFs)
Prospective Clinical (when applicable) in back pain populations at risk of ☐ No consistently applied gold
Study. J Bone Miner osteoporosis. standard
Res. 2020;35(3):488- ☐ Level V (expert consensus) ☐ Poor reference standard/no gold
497. Diagnostic test(s) studied: standard applied
doi:10.1002/jbmr.3912 ☐ Level IV in presence of higher ☒ Clinical exam/history ☐ Lacked subgroup analysis
quality studies ☐ Electromyography ☒Other: high prevalence of VCF in
☐ Myelogram population
☐ Subgroup analysis data not available ☐ MRI
☐ CT Level of Evidence Determination
☐ Not relevant to question
☐ CT/Myelogram Potential Level: I
☒ Other: A novel test (back-pain Downgraded Level: II
inducing test-BPIT), BMD Downgraded due to nonconsecutive
patients, nonmasked reviewers, and
Compared to: high prevalence of VCF in
☐ Clinical exam/history population.
☐ Electromyography
☐ Myelogram Conclusions
This study provides evidence that:
☒ MRI
the back pain-inducing test (BPIT)
☐ CT is a potentially effective screening
☐ CT/Myelogram test to detect painful VFs in
☐ Other: patients with back pain with a
high sensitivity and specificity.
Gold standard used? ☒ Yes ☐ No
If so, what was the gold standard? MRI
727
Number of patients: 510
Consecutively assigned? No
Results/subgroup analysis (relevant to
question): The sensitivity, specificity,
and accuracy of the BPIT for
identifying painful VFswere
99.1%(95%CI, 97.5%to 99.8%),
67.9%(95% CI, 60.4%to 74.5%), and
89.0%, respectively. The positive and
negative predictive valueswere
86.6%(95%CI, 82.9%to 89.6%) and
97.4% (95% CI, 92.6% to 99.3%),
respectively. Cutoff NRS scores for
lying supine, rolling over, and sitting up
were 3, 0, and 2, respectively. The
corresponding area under the receiver
operating characteristic curves
(AUROCs) of each movement was
0.898 (95% CI, 0.868 to 0.922), 0.884
(95%CI, 0.854 to 0.911), and 0.910
(95%CI, 0.882 to 0.933), respectively.
Author conclusions (relative to
question): In summary, the BPIT is a
potentially effective screening test to
detect painful VFs in the back-pain
population at risk of osteoporosis,
although the high prevalence of VFs in
the present study
partially limited the external validity of
the BPIT’s predictive value
in the general population.
Langdon J, Way A, Type of Evidence: Diagnostic ☒ Prospective ☐ Retrospective Critique of methodology
Heaton S, Bernard J, Study Design: Observational ☐ Nonconsecutive patients
Molloy S. Vertebral Level II ☒ Small sample size
compression fractures-- Stated objective of study: The aim of ☒ Nonmasked reviewers
new clinical signs to aid Explanation of failure to meet guideline this study was to evaluate these two
diagnosis. Ann R Coll inclusion criteria ☐ No universally-applied gold
clinical signs (closed fist percussion
Surg Engl. (when applicable) standard
and supine signs) to determine how
2010;92(2):163-166. effective they are at predicting a ☐ No consistently applied gold
doi:10.1308/003588410 ☐ Level V (expert consensus) symptomatic osteoporotic vertebral standard
X12518836440162 compression fracture. ☐ Poor reference standard/no gold
standard applied
728
☐ Level IV in presence of higher ☐ Lacked subgroup analysis
quality studies Diagnostic test(s) studied: ☒ Other: Selection bias
☒ Clinical exam/history
☐ Subgroup analysis data not available ☐ Electromyography Level of Evidence Determination
☐ Myelogram Potential Level: I
☐ Not relevant to question ☐ MRI Downgraded Level: II
Reason for downgrade: selection
☐ CT
bias and nonmasked reviewers
☐ CT/Myelogram
☒ Other: closed fist percussion Conclusions
This study provides evidence that:
Compared to: positive closed-fist percussion
☐ Clinical exam/history sign and supine sign are sensitive
☐ Electromyography and specific indicators of the
☐ Myelogram presence of a symptomatic VCF.
☒ MRI
☐ CT
☐ CT/Myelogram
☐ Other:
Gold standard used? ☒ Yes ☐ No
If so, what was the gold standard? MRI
Number of patients: 83 (78 included in
study)
Consecutively assigned? Yes
Results/subgroup analysis (relevant to
question): Of the 78 patients who were
included in this study, 48 were
found to have an acute or chronic, but
non-healed, vertebral
compression fracture on their MR
scan. In addition,
three patients were found to have
sacral pressure sores due
to sleeping in a chair at night.
Forty-five patients were positive for
closed-fist percussion.
Forty-two of these patients had an
acute fracture on
729
their MR scan. However, there were
six patients who were
negative for closed-fist percussion, but
who had an acute
fracture on the scan. The sensitivity of
this sign was 87.5%,
and the specificity was 90% (Table 1).
Forty-one patients were unable to lie
flat and 39 of these
had an acute fracture on their MR
scan. However, there
were nine patients who were
comfortably able to lie supine,
but who had an acute fracture on their
scan. The sensitivity
of this sign was 81.25%, and the
specificity was 93.33%
Author conclusions (relative to
question): These two clinical signs are
useful adjuncts in the diagnostic
evaluation of symptomatic osteoporotic
vertebral compression fractures, as
either a positive closed-fist percussion
sign or a positive supine sign is a
reliable indicator of the presence of a
symptomatic vertebral compression
fracture.
730
Yang Y, Wang B, Fei Q, Type of Evidence: Diagnostic ☒ Prospective ☐ Retrospective Critique of methodology
et al. Validation of an Study Design: Observational ☒Nonconsecutive patients
osteoporosis self- Level III ☐ Small sample size
assessment tool to Stated objective of study: This study ☐Nonmasked reviewers
identify primary Explanation of failure to meet guideline aimed to validate the effectiveness of
osteoporosis and new inclusion criteria ☐ No universally-applied gold
the Osteoporosis Self-assessment
osteoporotic vertebral (when applicable) standard
Tool for Asians (OSTA) in identifying
fractures in postmenopausal women at increased ☐ No consistently applied gold
postmenopausal ☐ Level V (expert consensus) risk of primary osteoporosis and standard
Chinese women in painful new osteoporotic vertebral ☐ Poor reference standard/no gold
Beijing. BMC ☐ Level IV in presence of higher fractures in a large Han Chinese standard applied
Musculoskelet Disord. quality studies population in Beijing. ☐ Lacked subgroup analysis
2013;14:271. Published ☐ Other: Click or tap here to enter
2013 Sep 22.
☐ Subgroup analysis data not available Diagnostic test(s) studied: text.
doi:10.1186/1471-2474- ☐ Clinical exam/history
14-271 ☐ Electromyography Level of Evidence Determination
☐ Not relevant to question
☐ Myelogram Potential Level: III
☐ MRI Downgraded Level: Not Downgraded
☐ CT
☐ CT/Myelogram Conclusions
☒ Other: The OSTA score: was This study provides evidence that: in
calculated based on age and body the Han Chinese population, the
weight using the following formula: OSTA index may be a useful test
[body weight (kg) − age to identify individuals at risk for
(year)] × 0.2 acute painful vertebral
compression fracture.
Compared to:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☐ Other:
Gold standard used? ☒ Yes ☐ No
If so, what was the gold standard? MRI
Number of patients: 1201 (173 with
VF, 1028 healthy)
731
Consecutively assigned? No
Results/subgroup analysis (relevant to
question): Of the study subjects,
29.3% had osteoporosis, and the
prevalence of osteoporosis increased
progressively
with age. The areas under the ROC
curves of the OSTA index (cutoff = -1)
to identify osteoporosis in the femoral
neck, total hip, and lumbar spine were
0.824, 0.824, and 0.776, respectively.
The sensitivity and specificity of the
OSTA index (cutoff = -1) to identify
osteoporosis in healthy women were
66% and 76%, respectively. With
regard to
painful new vertebral fractures, the
area under the ROC curve relating the
OSTA index (cutoff = -1) to new
vertebral
fractures was 0.812. Sensitivity and
specificity values of 82%
and 67%, respectively, were obtained
with an OSTA cut-off
value ≤ −1. The area under the ROC
curve relating the
OSTA index to new vertebral fractures
was 0.70.
Author conclusions (relative to
question): The OSTA may be a simple
and effective tool for identifying the risk
of osteoporosis and new painful
osteoporotic vertebral fractures in Han
Chinese women.
732
Medical Treatment Section
Medical Treatment Question 1: How do non-pharmacologic treatments (e.g., bracing, physical therapy, acupuncture, massage,
cannabis, exercise, etc.) compare in terms of reducing severity and duration of pain and disability in osteoporotic vertebral compression fractures?
Article Level Description of study Conclusion
(Alpha by Author) of Evidence
Kato T, Inose H, Type of evidence: Therapeutic ☒ Prospective ☐ Retrospective Critique of methodology:
Ichimura S, et al. ☒ Nonconsecutive patients
Comparison of Rigid Level II Study Design: Comparative ☐ Nonrandomized
and Soft-Brace
☒ Nonmasked reviewers
Treatments for Acute Stated objective of study: To
Osteoporotic Vertebral Explanation of failure to meet guideline ☒ Nonmasked patients
clarify and compare the preventive
Compression Fracture: inclusion criteria effect of the different brace treatments ☐ No validated outcome measures
A Prospective, (when applicable) on the deformity of the vertebral body used
Randomized, and other clinical results in patients ☐ Small sample size
Multicenter Study. J Clin ☐ Level V (expert consensus) with vertebral compression fractures ☐ <80% follow-up
Med. 2019;8(2):198. ☐ Lacked subgroup analysis
Published 2019 Feb 6. ☐ Level IV in presence of higher quality Type of treatment(s): rigid brace ☐ Diagnostic method not stated
doi:10.3390/jcm802019 studies versus soft brace ☐ Other: Click or tap here to enter
8
text.
☐ Subgroup analysis data not available Total number of patients: 284
randomized Level of Evidence Determination
Number of patients in relevant
☐ Not relevant to question Potential Level: II
subgroup(s): 141 patients were Downgraded Level: Not
assigned to the rigid-brace group, Downgraded
whereas 143 patients were assigned to
the soft-brace group Conclusions
This paper provides evidence that:
Consecutively assigned? No in women with acute OVCFs
treated with either a rigid custom-
Duration of follow-up: 48 weeks. made back support or soft
support, there was no significant
Validated outcome measures used difference in clinical and
(list): European Quality of Life-5 radiographic outcomes at 48
Dimensions (EQ-5D), visual analog weeks.
scale (VAS) for lower back pain,
Japanese Orthopaedic Association
Back Pain Evaluation Questionnaire
(JOABPEQ), Anterior vertebral body
compression percentage at 48 weeks.
733
Nonvalidated outcome measures used
(list): Anterior vertebral body
compression percentage (AVBCP),
brace compliance, use of analgesics,
Japanese Orthopaedic Association
Back Pain Evaluation Questionnaire
(JOABPEQ).
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Radiographs, X-ray
Results/subgroup analysis: There
were no statistically significant
differences in the primary outcome and
secondary outcome measures
between groups.
Author conclusions: We found that the
12-week rigid-brace treatment for
acute vertebral compression fractures
did
not result in statistically greater
prevention of spinal deformity, better
QOL, or lesser back pain than soft-
brace treatment at 48 weeks.
Therefore, the routine use of a custom-
made rigid brace for acute vertebral
compression fractures is not justified.
Li M, Law SW, Cheng J, Type of evidence: Therapeutic ☒ Prospective ☐ Retrospective Critique of methodology:
Kee HM, Wong MS. A ☒ Nonconsecutive patients
comparison study on the Level III Study Design: Comparative ☐ Nonrandomized
efficacy of SpinoMed® ☒ Nonmasked reviewers
and soft lumbar orthosis Stated objective of study: To compare
for osteoporotic Explanation of failure to meet guideline the efficacy of SpinoMed® and soft ☒ Nonmasked patients
vertebral inclusion criteria lumbar orthosis at the subacute stage ☐ No validated outcome measures
fracture. Prosthet Orthot (when applicable) (the second and third weeks of disease used
Int. 2015;39(4):270-276. ☐ Small sample size
734
doi:10.1177/030936461 ☐ Level V (expert consensus) onset) of the patients with osteoporotic ☐ <80% follow-up
4528204 vertebral fracture. ☒ Lacked subgroup analysis
☐ Level IV in presence of higher quality ☒ Diagnostic method not stated
Type of treatment(s): SpinoMed vs
studies
soft lumbar orthosis. ☐ Other: Click or tap here to enter
text.
☐ Subgroup analysis data not available
Total number of patients: 51
Number of patients in relevant
☐ Not relevant to question subgroup(s): soft lumbar orthosis Level of Evidence Determination
(control group, n = 24) and SpinoMed® Potential Level: II
(test group, n = 27) Downgraded Level: III
Downgraded due to: nonconsecutive
Consecutively assigned? No and nonmasked patients,
nonmasked reviewers, lack of
Duration of follow-up: after 3 weeks of subgroup analysis, and the
orthotic treatment
diagnostic method not being stated
Validated outcome measures used
(list): The pain level was assessed by Conclusions
This paper provides evidence that:
obtaining verbally feedback in 10-point
scale in female patients with acute
scoring, VAS, FIM-motor, Elderly OVCF treated either with a soft
mobility scale, Modified Ambulation lumbar orthosis vs. a specific
category, thoracic kyphosis angle orthosis made of metal with soft
padding after three weeks, there
Nonvalidated outcome measures used was no difference in clinical
(list): functional mobility level was outcomes.
estimated with Functional
Independence Measure-motor Scores,
Elderly Mobility Scale, and Modified
Functional Ambulation Category,
thoracic kyphosis angle, Verbal 10-
point scale pain scoring
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Radiographs, x-ray
735
Results/subgroup analysis: : Both
groups showed significant reduction in
the patients’ pain level and limitations
of daily life (p
< 0.05). The effect of the two types of
spinal orthoses on the pain level
reduction and functional mobility level
gain did
not show significant difference (p >
0.05) at the subacute stage.
Author conclusions: The effect of the
two types of spinal orthoses on the
pain level reduction and functional
mobility level gain did not show
significant difference (p > 0.05) at the
subacute stage. Their long-term effects
require further study to confirm while
the
patients’ compliance should also be
monitored.
Meccariello L, Muzii VF, Type of evidence: Therapeutic ☒ Prospective ☐ Retrospective Critique of methodology:
Falzarano G, et al. ☐ Nonconsecutive patients
Dynamic corset versus Level II Study Design: Comparative ☒ Nonrandomized
three-point brace in the
☒ Nonmasked reviewers
treatment of Stated objective of study: To compare
osteoporotic Explanation of failure to meet guideline the efficacy and safety of two types of ☒ Nonmasked patients
compression fractures inclusion criteria brace in treating osteoporotic vertebral ☐ No validated outcome measures
of the thoracic and (when applicable) fractures. used
lumbar spine: a ☐ Small sample size
prospective, ☐ Level V (expert consensus) Type of treatment(s): three-point ☐ <80% follow-up
comparative orthosis or dynamic corset ☐ Lacked subgroup analysis
study. Aging Clin Exp ☐ Level IV in presence of higher ☐ Diagnostic method not stated
Res. 2017;29(3):443- Total number of patients: n=140
quality studies ☐ Other: Click or tap here to enter
449. Number of patients in relevant
doi:10.1007/s40520- text.
☐ Subgroup analysis data not available subgroup(s):n=72 3PO, n=68 SDO
016-0602-x
Level of Evidence Determination
Consecutively assigned? Yes
☐ Not relevant to question Potential Level: II
Downgraded Level: Not Downgraded
Duration of follow-up: 6 months.
Validated outcome measures used Conclusions
(list): Visual Analogue Scale (VAS) This paper provides evidence that:
and Oswestry Low Back Pain,
736
Disability Questionnaire (OLBPDQ), in patients with acute back pain
ODI, measure of forced expiratory due to acute OVCF, a dynamic
volume in the 1 second, Regional corset produced statistically
kyphosis angle, Delmas index, and significant better clinical
height of the fractured vertebral body outcomes than a three-point
were also measured on x-ray. brace.
Nonvalidated outcome measures used
(list): Forced expiratory volume in 1
second, Regional kyphosis angle,
Delmas Index and height of fractured
vertebral body, measurement of forced
expiratory volume, Record of
complications.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Radiographs, X-Ray.
Results/subgroup analysis: At the 3-
and 6-month follow-ups, there was a
significant difference (p < 0.05) in pain,
disability, and respiration in favor of the
dynamic orthosis group. At 6-month
follow-up, there was no significant
difference (p > 0.05)
in all the radiological parameters
between groups. Complications were
reported for 28 patients in the three-
point orthosis group, and for eight
patients in the dynamic corset group (p
< 0.05).
Author conclusions: Compared to
three-point orthosis, patients treated
with dynamic orthosis had a greater
reduction in pain and a greater
improvement in quality of life and
737
respiratory function, with equal
effectiveness in stabilizing the fracture,
and
fewer complications.
Palmer S, Barnett S, Type of evidence: Therapeutic ☒ Prospective ☐ Retrospective Critique of methodology:
Cramp M, Berry A, ☒ Nonconsecutive patients
Thomas A, Clark EM. Level III Study Design: RCT ☐ Nonrandomized
Effects of postural
☒ Nonmasked reviewers
taping on pain, function Stated objective of study: To
and quality of life Explanation of failure to meet guideline investigate the effects of postural ☒ Nonmasked patients
following osteoporotic inclusion criteria taping on pain, function and quality of ☐ No validated outcome measures
vertebral fractures-A (when applicable) life when used in addition to usual used
feasibility care. ☒ Small sample size
trial. Musculoskeletal ☐ Level V (expert consensus) ☐ <80% follow-up
Care. 2018;16(3):345- Type of treatment(s): Adhesive ☐ Lacked subgroup analysis
352. ☐ Level IV in presence of higher quality postural taping device at home vs ☐ Diagnostic method not stated
doi:10.1002/msc.1350 studies usual care (control). ☐ Other: Click or tap here to enter
2/8/22: Include. Note:
Starts as Level II d/t text.
☐ Subgroup analysis data not available Total number of patients: 24
lesser quality RCT and Number of patients in relevant
downgraded d/t very Level of Evidence Determination
subgroup(s): Control (n = 11), Taping Potential Level: II
small sample size. ☐ Not relevant to question
(n = 13) Downgraded Level: III
Downgraded due to nonconsecutive
Consecutively assigned? No and nonmasked patients,
nonmasked reviewers, and a small
Duration of follow-up: 4 weeks sample size
Validated outcome measures used Conclusions
(list): Pain at rest and on movement This paper provides evidence that:
(visual analogue scales [VASs]), and the use of taping device has
function and quality of life (Quality of potential to improve pain and
Life Questionnaire of the European function in patients with OVCF as
Foundation for Osteoporosis compared to usual care.
[QUALEFFO]), QUALEFFO-41
Nonvalidated outcome measures used
(list): Click or tap here to enter text.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
738
☐ CT/Myelogram
☒ Other: Algorithm‐based qualitative
(ABQ) method of identifying OVF from
spinal radiographs, x-ray;
Rheumatologist trained to identify in
ABQ method, Radiographs
Results/subgroup analysis: Twenty‐
four participants completed the trial
(taping, n = 13; control, n = 11).
Groups were comparable in age,
although the control group contained
more men (n = 3 versus n = 0) and
scored slightly lower on most outcome
measures at baseline. Descriptive
analysis favored the taping group for
most outcome measures. Effect sizes
were small to medium (0.37, 0.45 and
0.66 for VAS rest, VAS movement and
QUALEFFO, respectively).
Author conclusions: The taping device
demonstrated potential to improve pain
and function. However, the findings
need to be replicated in an
appropriately powered study. The
study procedures were largely
acceptable. A more extensive pilot trial
is recommended prior to a definitive
trial.
Weerink LB, Folbert EC, Type of evidence: Therapeutic ☐ Prospective ☒ Retrospective Critique of methodology:
Kraai M, Smit RS, ☒ Nonconsecutive patients
Hegeman JH, van der Level IV Study Design: Case Series ☒ Nonrandomized
Velde D. Thoracolumbar
☒ Nonmasked reviewers
spine fractures in the Stated objective of study: The aim of
geriatric fracture center: Explanation of failure to meet guideline this study is to evaluate the ☒ Nonmasked patients
early ambulation leads inclusion criteria conservative treatment of elderly ☒ No validated outcome measures
to good results on short (when applicable) patients with a vertebral fracture. used
term and is a successful ☐ Small sample size
and safe alternative ☐ Level V (expert consensus) Type of treatment(s): Early Ambulation ☒ <80% follow-up
compared to and Immobilization ☒ Lacked subgroup analysis
immobilization in elderly ☐ Level IV in presence of higher quality ☐ Diagnostic method not stated
patients with two- studies Total number of patients: n=106
column vertebral
739
fractures. Geriatr Orthop ☐ Subgroup analysis data not available Number of patients in relevant ☐ Other: highly variable treatment
Surg Rehabil. subgroup(s): Treatment at admission regimen
2014;5(2):43-49. ☒ Not relevant to question n=73 immobilization, n= 31 early
doi:10.1177/215145851 ambulation. Definitive treatment n=11 Level of Evidence Determination
4524053. immobilization, n=91 early Potential Level: III
mobilization. Downgraded Level: IV
Downgraded due to nonconsecutive,
Consecutively assigned? No nonmasked, and nonrandomized
patients, nonmasked reviewers, less
Duration of follow-up: 6 weeks and 3 than 80% follow-up, lack of subgroup
months analysis, and no validated outcome
measures being used
Validated outcome measures used
(list): CCI; New Mobility Score; neuro Conclusions
exam This paper provides evidence that:
early mobilization of older adults
Nonvalidated outcome measures used with acute OVCF results in
(list): New Mobility Score, Type of functional outcomes comparable
treatment, involvement of middle to immobilization at 3 months
column, compression rate of vertebral follow up with less risk of
body, diameter of spinal canal, existing complications.
comorbidities, level of mobility at
admission
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Radiographs
Results/subgroup analysis: We
included 106 patients with 143
vertebral fractures, of which 61
patients were evaluated
after 3 months. In our population, 53%
of the patients had a fracture involving
both middle and anterior columns. The
majority of
the patients functioned sufficiently 6
weeks and 3 months after admission.
740
Analysis showed that age <80 years is
an independent
predictor of a sufficient level of
functioning after 6 weeks
Author conclusions: The nonoperative
treatment of elderly patients with a
vertebral fracture leads to a sufficient
level of functioning 6 weeks and 3
months after admission. only age <80
years was independent predictor for a
sufficient level of functioning 6 weeks
after admission. The level of
functioning at 6 weeks predicts the
level of functioning 3 months after
admission. There was no difference in
function between patiens treated with
early ambulation vs immobilization.
Where immobilization may lead to
complications, early ambulation was
not
associated with new complications or
neurological damage. Based on these
advantages, the treatment of elderly
patients with a
fracture involving both middle and
anterior columns may be altered from
immobilization to mobilization in the
future.
Medical Treatment Question 2: Do restrictions on patient activity alter outcomes in patients with acute osteoporotic vertebral compression fractures?
Article Level Description of study Conclusion
(Alpha by Author) of Evidence
Weerink LB, Folbert EC, Type of evidence: Therapeutic ☐ Prospective ☒ Retrospective Critique of methodology:
Kraai M, Smit RS, ☒ Nonconsecutive patients
Hegeman JH, van der Level IV Study Design: Case Series ☒ Nonrandomized
Velde D. Thoracolumbar
☒ Nonmasked reviewers
spine fractures in the Stated objective of study: The aim of
geriatric fracture center: Explanation of failure to meet guideline this study is to evaluate the ☒ Nonmasked patients
early ambulation leads to inclusion criteria conservative treatment of elderly ☒ No validated outcome measures
good results on short (when applicable) patients with a vertebral fracture. used
741
term and is a successful ☐ Small sample size
and safe alternative ☐ Level V (expert consensus) Type of treatment(s): Early Ambulation ☒ <80% follow-up
compared to and Immobilization
☒ Lacked subgroup analysis
immobilization in elderly
☐ Level IV in presence of higher ☐ Diagnostic method not stated
patients with two-column Total number of patients: n=106
vertebral
quality studies
Number of patients in relevant ☐ Other: highly variable treatment
fractures. Geriatr Orthop subgroup(s): Treatment at admission regimen
Surg Rehabil. ☐ Subgroup analysis data not n=73 immobilization, n= 31 early
2014;5(2):43-49. available ambulation. Definitive treatment n=11 Level of Evidence Determination
doi:10.1177/2151458514 immobilization, n=91 early mobilization. Potential Level: III
524053. ☒ Not relevant to question Downgraded Level: IV
Consecutively assigned? No Downgraded due to nonconsecutive,
nonmasked, and nonrandomized
Duration of follow-up: 6 weeks and 3 patients, nonmasked reviewers, less
months than 80% follow-up, lack of subgroup
analysis, and no validated outcome
Validated outcome measures used (list): measures being used
CCI; New Mobility Score; neuro exam
Conclusions
Nonvalidated outcome measures used This paper provides evidence that:
(list): New Mobility Score, Type of immobilization and early
treatment, involvement of middle ambulation leads to similar
column, compression rate of vertebral outcomes in older adults with two-
body, diameter of spinal canal, existing column vertebral fractures.
comorbidities, level of mobility at
admission
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Radiographs
Results/subgroup analysis: We
included 106 patients with 143 vertebral
fractures, of which 61 patients were
evaluated
after 3 months. In our population, 53%
of the patients had a fracture involving
both middle and anterior columns. The
742
majority of
the patients functioned sufficiently 6
weeks and 3 months after admission.
Analysis showed that age <80 years is
an independent
predictor of a sufficient level of
functioning after 6 weeks
Author conclusions: The nonoperative
treatment of elderly patients with a
vertebral fracture leads to a sufficient
level of functioning 6 weeks and 3
months after admission. In our
population, only age <80 years is an
independent predictor for a sufficient
level of functioning 6 weeks after
admission. The level of functioning at 6
weeks predicts the level of functioning 3
months after admission. On
comparison, the level of functioning
after early ambulation is equal to the
level of functioning after immobilization.
Where immobilization may lead to
complications, early ambulation was
not
associated with new complications or
neurological damage. Based on these
advantages, the treatment of elderly
patients with a
fracture involving both middle and
anterior columns may be altered from
immobilization to mobilization in the
future.
Medical Treatment Question 3: Which pharmacologic treatments are effective in improving outcomes in acute osteoporotic vertebral compression
fractures?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Armingeat T, Brondino R, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Pham T, Legré V, Therapeutic ☒ Nonconsecutive patients
Lafforgue P. Intravenous
743
pamidronate for pain Level II Study Design: RCT ☐ Nonrandomized
relief in recent ☐ Nonmasked reviewers
osteoporotic vertebral Explanation of failure to Stated objective of study: To compare IV ☐ Nonmasked patients
compression fracture: a meet guideline inclusion pamidronate and placebo for pain relief in recent
randomized double-blind criteria OVCF ☐ No validated outcome
controlled (when applicable) measures used
study. Osteoporos Int. Type of treatment(s): intravenous pamidronate ☒ Small sample size
2006;17(11):1659-1665. ☐ Level V (expert vs placebo (isotonic saline solution) ☐ <80% follow-up
doi:10.1007/s00198-006- consensus) ☒ Lacked subgroup analysis
0169-z Total number of patients: 32 ☐ Diagnostic method not stated
☐ Level IV in presence Number of patients in relevant subgroup(s):n=15 ☐ Other:
of higher quality studies pamidronate, n=16 control
Level of Evidence Determination
Consecutively assigned? No
☐ Subgroup analysis Potential Level: I
data not available Downgraded Level: II
Duration of follow-up: 30 days Downgraded due to small sample
☐ Not relevant to Validated outcome measures used (list): VAS,
size
question Schober index, clinical parameters Conclusions
This paper provides evidence that:
Nonvalidated outcome measures used (list): Pts IV pamidronate is effective and
overall assessment of improvement, mobility well tolerated for treating acute
index, Schober index and finger–ground OVCF.
distance, Classification as “50% responders” or
“20% responders” (patients with at least 50% or
20% improvement relative to initial pain)
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: DXA, ap/lat xray, Radiographs, bone
scintigraphy
Results/subgroup analysis: Thirty-one
patients were evaluated at day 7 and 26 patients
at day
30. VAS pain decreased significantly in both
groups at day
7 (placebo −23 mm, pamidronate −42 mm,
p<0.01). The
744
difference in pain scores between groups was
−23.25 mm
(confidence interval (CI) [−42.3; −4.2], p=0.018)
at day 7
and −26 mm at day 30 (p=0.03), in favor of
pamidronate.
At day 7, there were 4 versus 12 “50%
responders,”
respectively, in the placebo and in the
pamidronate groups
(likelihood ratio: 8.372; p=0.004) and 9 versus 14
“20%
responders” (likelihood ratio: 4.038; p=0.044). At
day 30,
there were 5 versus 10 “50% responders,”
respectively, in
the placebo and in the pamidronate groups, and
7 versus 11
“20% responders.” Patients’ overall assessment
of improvement
at day 7 was 37±26 mm in the placebo group
and 59±
30 mm in the pamidronate group (p=0.019), and
42±26 mm
and 72±21 mm at day 30 (p=0.07). The two
groups did not
differ significantly at days 7 and 30 for supine
pain,
Schober index, or finger–ground distance. No
significant
adverse reaction related to treatment occurred.
Author conclusions: Pamidronate provides rapid
and sustained pain relief in patients with acute
painful osteoporotic VCF and is
well tolerated. Further investigations are needed
to better
define the place of pamidronate in the
management of painful recent osteoporotic
collapse.
Combe B, Cohen C, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Aubin F. Equivalence of Therapeutic ☒ Nonconsecutive patients
nasal spray and Study Design: RCT ☐ Nonrandomized
Level II
subcutaneous ☐ Nonmasked reviewers
745
formulations of salmon Explanation of failure to Stated objective of study: To assess the efficacy ☐ Nonmasked patients
calcitonin. Calcif Tissue meet guideline inclusion and safety of nasal spray and subcutaneous ☐ No validated outcome
Int 1997;61:10-5 criteria (when applicable) injection of salmon calcitonin. measures used
☐ Small sample size
☐ Level V (expert Type of treatment(s): Nasal spray and
☐ <80% follow-up
consensus) subcutaneous calcitonin
☒ Lacked subgroup analysis
Total number of patients: 204 ☐ Diagnostic method not stated
☐ Level IV in presence
☒ Other: Xray based diagnosis.
of higher quality studies
Number of patients in relevant subgroup(s): 102 No real control group (placebo).
The study based on the
☐ Subgroup analysis Consecutively assigned? No assumption that salmon calcitonin
data not available is effective in functional
Duration of follow-up: 30 days improvement.
☐ Not relevant to
question Validated outcome measures used (list): The Level of Evidence Determination
main efficacy criterion was spontaneous pain Potential Level: I
measured by VAS Downgraded Level: II
Nonvalidated outcome measures used (list): Conclusions
number of days until pain relief occurred, the This paper provides evidence
amount of acetaminophen used between days 1 that: subcutaneous and
and 15, and between days 15 and 30, intranasal calcitonin produce
vertebral stiffness as measured by the hand- comparable effects in pain
to-floor distance at each of the three visits, and reduction in patients with acute
the global pain relief assessments by patients OVF.
and investigators on days 15 and 30
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X-Rays
. Results/subgroup analysis: Both forms of SCT
were efficient with a significant decrease in
spontaneous pain in both groups. The repeated
measures analysis of variance showed a
significant decrease in pain with time (time effect,
P 4 .0001), but no treatment effect (P 4 .71) and
746
no treatment × time interaction (P 4 .84). NSCT
and SCSCT are equivalent in terms of pain
improvement. The comparison of the results on
day 30 by means of a Student’s t test showed no
statistically significant difference between the two
forms
Author conclusions: In conclusion, a 30-day
course with 200 IU/day of INSCT demonstrated
an equivalence with a 30-day course with 50
IU/day of SCSCT. Safety of this new
formulation proved to be comparable to the
parenteral form
Choi JH, Kang HD, Park Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
JH, Gu BS, Jung SK, Oh Therapeutic ☒ Nonconsecutive patients
SH. The Efficacy of Study Design: Case Series ☒ Nonrandomized
Fentanyl Transdermal Level IV
Stated objective of study: To determine the ☒ Nonmasked reviewers
Patch as the First-Line
Explanation of failure to success rate of conservative treatment method ☒ Nonmasked patients
Medicine for the
meet guideline inclusion for VCF and to find its prognostic factor. ☐ No validated outcome
Conservative Treatment
criteria (when applicable) measures used
of Osteoporotic Type of treatment(s): Low dose (12.5 -25 ug)
Compression ☐ Level V (expert fentanyl transdermal patch, at least 3-month ☐ Small sample size
Fracture. Korean J consensus) corset brace application, tramadol 37.5 ☐ <80% follow-up
Neurotrauma. mg/acetaminophen 325 mg combination tablet or ☒ Lacked subgroup analysis
2017;13(2):130-136. ☐ Diagnostic method not stated
☐ Level IV in presence an acetaminophen 250 mg, ibuprofen 200 mg
doi:10.13004/kjnt.2017.1
of higher quality studies and codeine phosphate 10 mg combination ☐ Other:
3.2.130 tablet (PRN)
☐ Subgroup analysis
data not available Level of Evidence Determination
Potential Level: IV
Total number of patients: 75 patients (22 male,
Downgraded Level: Not
☐ Not relevant to 53 female)
Downgraded
question
Number of patients in relevant subgroup(s): 57
favorable, 18 unfavorable
Conclusions
Consecutively assigned? No This paper provides evidence that:
in patients with acute OVCF,
Duration of follow-up: 12 months low dose (12.5 μg) fentanyl
patch may improve pain
Validated outcome measures used (list): short control.
form SF-36, NRS; SF-36; , SF-36 (12 months),
747
Nonvalidated outcome measures used (list):
radiology x-ray, Hospital stay, duration to return
to usual activity, dose of used patch, Odom’s
criteria, and radiological outcomes such as
compression rate and Cobb angle.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: DXA
Results/subgroup analysis: Among 75 patients,
the clinical outcome of 57 (76%) was favorable,
but that of 18 (24%) was unfavorable, which
included 12 unsatisfied patients and 6 patients
undertaken PVP at a different hospital. There
were no differences in baseline cllinical or
demographic characteristics between the two
groups.
In the clinical outcome, NRS at 6 and 12 months
and Odom’s criteria at 12 months were
significantly different between the favorable and
unfavorable groups
In the radiological outcome, the compression
rate increased until 1 month and stable at
subsequent time points. There was no significant
difference in radiographic outcomes between the
two groups.
Regarding hospital stay, return to activity of daily
living (ADL), patch use duration, and the dose of
the patch used, only the dose of the patch used
showed a statistically significant difference
between the favorable and unfavorable groups
748
(p=0.001)
There were no adverse events.
Author conclusions: The only statistically
significant affecting factor for an unfavorable
outcome was the use of a higher dose fentanyl
patch. Our data inferred that the
unresponsiveness to a low-dose fentanyl patch
could be helpful to select patients necessary for
percutaneous vertebroplasty or kyphoplasty.
Ikeda S, Nakamura E, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Narusawa K, et al. Therapeutic ☐ Nonconsecutive patients
Comparison of once- Study Design: RCT ☐ Nonrandomized
weekly teriparatide and Level I ☐ Nonmasked reviewers
Stated objective of study: To compare weekly
alendronate against new
teriparatide with alendronate in their inhibition of ☐ Nonmasked patients
osteoporotic vertebral Explanation of failure to
fractures at week 12. J meet guideline inclusion
vertebral collapse, effects on delayed union, pain ☐ No validated outcome
relief, and improvement of quality of life (QOL) in measures used
Bone Miner Metab. criteria
2020;38(1):44-53. (when applicable)
women with new osteoporotic vertebral fractures ☐ Small sample size
within 1 week after onset of the fracture.
doi:10.1007/s00774-019- ☐ <80% follow-up
01023-x ☐ Level V (expert Type of treatment(s): injection of 56.5 μg of ☐ Lacked subgroup analysis
consensus) TPTD (Teribone®, AsahiKasei Pharma ☐ Diagnostic method not stated
Corporation, Tokyo, Japan) once per week ☒ Other: Some patients had xray-
☐ Level IV in presence (TPTD group) or the group treated with ALN (oral based diagnosis.
of higher quality studies dose of 35 mg/week) (ALN group).
Total number of patients: 96
☐ Subgroup analysis Level of Evidence Determination
Number of patients in relevant subgroup(s): n=48 Potential Level: I
data not available
teriparatide vs n=48 alendronate Downgraded Level: Not
☐ Not relevant to Downgraded
Consecutively assigned? Yes
question
Duration of follow-up: 12 weeks Conclusions
This paper provides evidence
that: in patients with new
Validated outcome measures used (list):VAS, OVCFs, weekly teriparatide is
EuroQol5 superior to alendronate in
improving QOL at 12 weeks.
Nonvalidated outcome measures used vertebral
collapse; +/- delayed union, BMD, Radiological
parameters (Vertebral collapse ratios [height at
749
the anterior border/height at the posterior border
(A/P) and central height/height at the posterior
border (C/P)], wedge angle (WA), and kyphosis
angle (KA), Non union
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Radiographs, x-ray
Results/subgroup analysis: Vertebral collapse
progressed over time in both groups, with no
significant difference between the groups. Pain
on rising from lying position, turning over in bed,
and resting in the lying position improved over
time in both groups, with no significant difference
between them. There were no significant
differences in increase in BMD and delayed
union. QOL in the teriparatide group showed
significant improvement in comparison with that
in the alendronate group at week 12. The
weekly formulation of teriparatide may have
improved components of QOL other than pain at
week 12.
Author conclusions: The effects of the weekly
formulation of TPTD on inhibition of vertebral
collapse, improvement in BMD, promotion of
bone union, and relief of pain were comparable
to the effects of ALN in female patients who
sustained new osteoporotic vertebral fractures
within 1 week. However, the TPTD group
showed significant improvement in QOL at week
12 com‐pared with the ALN group, which may
reflect the improvement of components of QOL
other than pain.
750
Laroche M, Cantogrel S, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Jamard B, et al. Therapeutic ☒ Nonconsecutive patients
Comparison of the Study Design: RCT ☐ Nonrandomized
analgesic efficacy of Level II
☐ Nonmasked reviewers
pamidronate and Stated objective of study: To compare the
☐ Nonmasked patients
synthetic human Explanation of failure to analgesic efficacy of IV pamidronate and
calcitonin in osteoporotic meet guideline inclusion ☐ No validated outcome
synthetic human calcitonin for recent painful
vertebral fractures: a criteria benign VCF measures used
double-blind controlled (when applicable) ☒ Small sample size
study. Clin Rheumatol. ☐ Level V (expert Type of treatment(s): Patients received either ☐ <80% follow-up
2006;25(5):683-686. consensus) PAM (1 mg/kg) ☒ Lacked subgroup analysis
doi:10.1007/s10067-005- or synthetic human CT (1.5 mg) as an ☐ Diagnostic method not stated
0159-0 ☐ Level IV in presence intravenous infusion. ☒ Other: short follow up; Has no
of higher quality studies real control group (no treatment)
Total number of patients: n=27
☐ Subgroup analysis Number of patients in relevant subgroup(s): n=14
Level of Evidence Determination
data not available pamidronate, n=13 calcitonin
Potential Level: I
Downgraded Level: II
Consecutively assigned? No
☐ Not relevant to Downgraded due to small sample
question size
Duration of follow-up: 30 days
Conclusions
Validated outcome measures used (list): VAS,
This paper provides evidence that:
disability rating scale for back pain (EIFEL scale)
in the treatment of pain in
patient with acute OVCF, there
Nonvalidated outcome measures used (list):
is no difference in short-term
outcome between single
Diagnosis made by:
infusions of pamidronate vs
☒ Clinical exam/history calcitonin.
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: bone scan, x0ray, Bone scintigraphy,
increased uptake on scintigraphy with
technetium-99m
pyrophosphate
751
Results/subgroup analysis:
There was no significant difference in pain,
functional
disability or analgesic use between the two
groups of
patients at any assessment time.Both groups
improved over time.
Author conclusions: No advantage of PAM over
CT in a single intravenous infusion for the
treatment of painful recent benign vertebral
compression. Since CT is ten times
less costly, its use should be preferred.
Lyritis GP, Ioannidis GV, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Karachalios T, et al. Therapeutic ☒ Nonconsecutive patients
Analgesic effect of Study Design: RCT ☐ Nonrandomized
salmon calcitonin Level II
☐ Nonmasked reviewers
suppositories in patients Stated objective of study: To evaluate the
☐ Nonmasked patients
with acute pain due to Explanation of failure to analgesic efficacy of calcitonin suppositories
recent osteoporotic meet guideline inclusion ☐ No validated outcome
(200 IU) in comparison with bed rest and
vertebral crush fractures: criteria paracetamol as a rescue analgesic measures used
a prospective double- (when applicable) ☒ Small sample size
blind, randomized, Type of treatment(s): One calcitonin (200 IU) or ☐ <80% follow-up
placebo-controlled ☐ Level V (expert placebo suppository once a day for 28 days. All ☒ Lacked subgroup analysis
clinical study. Clin J Pain. consensus) patients were allowed to take paracetamol tablet ☐ Diagnostic method not stated
1999;15(4):284-289. (500 mg) with max dose of 6 tablets daily ☐ Other: Click or tap here to enter
doi:10.1097/00002508- ☐ Level IV in presence text.
199912000-00004 of higher quality studies Total number of patients: 40
Number of patients in relevant subgroup(s): n= Level of Evidence Determination
☐ Subgroup analysis 20 calcitonin vs n=20 placebo Potential Level: I
data not available Downgraded Level: II
Consecutively assigned? No Downgraded due to
☐ Not relevant to nonconsecutive, small sample
Duration of follow-up: 28 days size
question
Validated outcome measures used (list):VAS Conclusions
This paper provides evidence that:
Nonvalidated outcome measures used (list): pain in patients with acute OVCF,
meter device - direct pressure on fracture, salmon calcitonin suppositories
may improve pain and allow
752
biochemical urine and plasma, Blood and urinary earlier mobilization than
parameters. placebo treated patients.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X-ray
Results/subgroup analysis: All calcitonin-treated
patients experienced an overall statistically
significant (all p values < 0.001) decrease of
spinal pain as assessed by the VAS and the pain
meter device. Pain relief allowed for early
mobilization and the gradual restoration of the
locomotive functions in the calcitonin-treated
group. Placebo-treated patients remained in bed
for almost the whole of the observation period. At
the end of the study (28th day), fasting
osteocalcin, hydroxyproline/creatinine, and
calcium/creatinine ratio values were statistically
significantly (all p values < 0.001), lower in the
calcitonin-treated than in the placebo-treated
patients. In the placebo group these values
showed a gradual increase. In the calcitonin-
treated group side effects mainly included
dizziness and enteric irritation caused by the
suppositories. Enteric irritation was also present
in the placebo-treated group.
Author conclusions: Salmon calcitonin
suppositories caused a dramatic decrease in
spinal pain in patients with acute OVF and
influenced the early mobilization and gradual
restoration of their locomotor functions.
Lyritis GP, Paspati I, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Karachalios T, Ioakimidis Therapeutic ☒ Nonconsecutive patients
753
D, Skarantavos G, Lyritis Study Design: RCT ☐ Nonrandomized
PG. Pain relief from nasal Level II ☐ Nonmasked reviewers
salmon calcitonin in Stated objective of study: This clinical, double-
☐ Nonmasked patients
osteoporotic vertebral Explanation of failure to blind controlled study evaluates the efficacy of
☐ No validated outcome
crush fractures. A double meet guideline inclusion nasal salmon calcitonin in relieving post-fracture
blind, placebo-controlled criteria pain for early mobilization. measures used
clinical study. Acta (when applicable) ☐ Small sample size
Orthop Scand Suppl. Type of treatment(s): Salmon calcitonin nasal ☐ <80% follow-up
1997;275:112-114. ☐ Level V (expert spray (200 IU) vs placebo nasal spray ☒ Lacked subgroup analysis
doi:10.1080/17453674.19 consensus) administered daily for 28 days. Patient were ☐ Diagnostic method not stated
97.11744761 permitted to take paracetamol (.5 g) as a rescue ☒ Other: xray based fx diagnosis
☐ Level IV in presence analgesic up to 6 tablets daily.
of higher quality studies Level of Evidence Determination
Total number of patients: n=100
Potential Level: I
Number of patients in relevant subgroup(s): n=50
☐ Subgroup analysis Downgraded Level: II
calcitonin, n=50 placebo
data not available Downgraded due to
nonconsecutive patients
Consecutively assigned? No
☐ Not relevant to
question Conclusions
Duration of follow-up: 28 days
This paper provides evidence that:
in patients with painful acute
Validated outcome measures used (list): VAS,
OVCFs, nasal salmon calcitonin
may provide significant pain
Nonvalidated outcome measures used (: Fasting
relief and promote earlier
urine calcium/creatinine and
mobilization.
hydroxyproline/creatinine ratios on the second
voind urine labs, Bone resorption, fasting urine
Ca/Cr, RBC, hematocrit, hemoglobin, WBC,
platelets, ESR, total bilirubin, SzgOT, SGPT
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☐☒ Other: x-ray, Radiographs
754
Results/subgroup analysis: Pain was reduced
dramatically in the group receiving calcitonin (p ~
0.001). The analgesic effect of nasal calcitonin
was negatively associated to the number of
paracetamol tablets requested by the patients
(p ~ 0.001). Pain rating on the VAS, showed that
the
most patients were gradually able to gain full
mobility
after the first week of calcitonin treatment
The number of patients who remained bedridden
was
significantly greater in the placebo group at all
time
points than in the calcitonin group
. Nasal salmon calcitonin was well-tolerated by
all
patients. Mild symptoms, mainly headache, were
reported
in only 6 cases. No interruption of treatment
was necessary.
Author conclusions: In conclusion, nasal salmon
calcitonin in a daily dose of 200 IU had an
adequate analgesic effect and
facilitated mobilization.
Lyritis GP, Tsakalakos N, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Magiasis B, Karachalios Therapeutic ☒ Nonconsecutive patients
T, Yiatzides A, Tsekoura Study Design: RCT ☐ Nonrandomized
M. Analgesic effect of Level II
☐ Nonmasked reviewers
salmon calcitonin in Stated objective of study: To evaluate the
☐ Nonmasked patients
osteoporotic vertebral Explanation of failure to efficacy of salmon
fractures: a double-blind meet guideline inclusion ☐ No validated outcome
calcitonin injections, particularly facilitation of
placebo-controlled criteria early mobilization measures used
clinical study. Calcif (when applicable) ☐ Small sample size
Tissue Int. Type of treatment(s): Salmon calcitonin (100 IU) ☐ <80% follow-up
1991;49(6):369-372. ☐ Level V (expert or placebo intramuscular injections were given ☒ Lacked subgroup analysis
doi:10.1007/BF02555844 consensus) daily for 14 days. Patients were allowed to take ☐ Diagnostic method not stated
paracetamol (500 mg) tablets as additional ☐ Other: Click or tap here to enter
☐ Level IV in presence analgesic.
text.
of higher quality studies
755
Total number of patients: n=56 Level of Evidence Determination
☐ Subgroup analysis Number of patients in relevant subgroup(s): n=28 Potential Level: I
data not available salmon calcitonin injection, n=28 placebo Downgraded Level: II
injection Downgraded due to
☐ Not relevant to nonconsecutive patients
question Consecutively assigned? No
Conclusions
Duration of follow-up: 14 days This paper provides evidence that:
in patients with acute OVCF,
Validated outcome measures used (list): VAS injectable calcitonin provided
(bedrest, sitting, standing, walking) significant pain relief and
allowed earlier mobilization.
Nonvalidated outcome measures used (list):
Blood and urine samples were taken from all
patients on days 0, 2, 5, and 14. The following
laboratory test values were determined: serum
calcium, phosphate, alkaline phosphatase,
SGOT, SGPT, creatinine, sodium, potassium,
bilirubin and urea and urinary hydroxyproline and
calcium. Side effects were recorded
daily, and the tolerability of the calcitonin or
placebo treatment was evaluated as follows: 3 =
very good, 2 = good, 1 = poor, 0 = not tolerated.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: x-ray, Radiographs
Results/subgroup analysis: The results showed
a significant (P < 0.001) difference in pain
intensity between
the calcitonin group and the placebo group. This
beneficial
effect was generally apparent from the second
day of treatment
756
onward, and over the following 2 weeks, the
patients
were able to sit and stand, and gradually started
to walk
again. A significant decrease in urinary
hydroxyproline and
urinary calcium was also noted in the calcitonin
group.
Author conclusions: It is concluded that
calcitonin exerts a beneficial effect on back pain
following a vertebral crush fracture.
Ma Y, Wu X, Xiao X, et Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
al. Effects of teriparatide Therapeutic ☒ Nonconsecutive patients
versus percutaneous Study Design: Case Series ☒ Nonrandomized
vertebroplasty on pain Level III
☒ Nonmasked reviewers
relief, quality of life and Stated objective of study: To compare the 3-
☒ Nonmasked patients
cost-effectiveness in Explanation of failure to month
postmenopausal females meet guideline inclusion ☐ No validated outcome
therapeutic effects of teriparatide (TPTD) and
with acute osteoporotic criteria vertebroplasty (PVP) on acute OVCFs, aiming to measures used
vertebral compression (when applicable) evaluate the utility of this new conservative ☐ Small sample size
fracture: A prospective treatment strategy. ☐ <80% follow-up
cohort study. Bone. ☐ Level V (expert ☐ Lacked subgroup analysis
2020;131:115154. consensus) Type of treatment(s): Teriparatide (TPTD 20ug ☐ Diagnostic method not stated
doi:10.1016/j.bone.2019. subcutaneous injections once daily) vs ☒ Other: selection bias
115154 ☐ Level IV in presence percutaneous vertebroplasty (PVP) plus
of higher quality studies alendronate (70 mg orally once weekly). Both Level of Evidence Determination
groups were administered with .6mg Caltrate and Potential Level: II
☐ Subgroup analysis 500 IU Vitamin D3 per day. Downgraded Level: III
data not available Downgraded due to selection bias
Total number of patients: n=60
Number of patients in relevant subgroup(s): n=30
☐ Not relevant to Conclusions
TPTD vs PVP (plus alendronate) This paper provides evidence that:
question
in patients with OVCF,
Consecutively assigned? No teriparatide produces
significant improvement in pain
Duration of follow-up: 3 months and QoL at 3 months
comparable to alendronate plus
Validated outcome measures used (list): SF-36, PVP and may be more cost
VAS, ODI effective.
757
Nonvalidated outcome measures used ): Direct
medical cost
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: DXA
Results/subgroup analysis: Both treatments with
TPTD and PVP significantly and similarly
improved the patients' health quality,
with reduced visual analogue and ODI scores at
the end of the first and third months. PVP was
more effective in
reducing pain at the early time point (1 week, p <
0.05). 24 of 27 patients who were rescanned with
magnetic
resonance imaging in the TPTD group showed
bone healing. The mid-vertebral height was
increased by PVP
(p < 0.05) but not by TPTD. The cost of TPTD
treatment was 21,868.61 ± 167.05 RMB per
capita, while the
cost for PVP treatment was 33,265.95 ± 1491.11
RMB per capita (p < 0.05).
Author conclusions: TPTD conservative
treatment obtained similar therapeutic effects but
cost less than PVP in terms of treating acute
OVCF.
Min HK, Ahn JH, Ha KY, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
et al. Effects of anti- Therapeutic ☒ Nonconsecutive patients
osteoporosis medications Study Design: Comparative ☒ Nonrandomized
on radiological and Level III
☒ Nonmasked reviewers
clinical results after acute Stated objective of study: To elucidate the effects
☒ Nonmasked patients
osteoporotic spinal of different anti-osteoporosis medications on
758
fractures: a retrospective Explanation of failure to radiological and clinical outcomes after acute ☐ No validated outcome
analysis of prospectively meet guideline inclusion OSFs measures used
designed criteria ☒ Small sample size
study. Osteoporos Int. (when applicable) Type of treatment(s): No anti-osteoporotic
☐ <80% follow-up
2019;30(11):2249-2256. treatment vs anti-resorptive bisphosphonates vs
☐ Lacked subgroup analysis
doi:10.1007/s00198-019- ☐ Level V (expert daily anabolic PTH (teriparatide 20ug). Standard
05125-0 conservative treatment included 1 week of bed ☒ Diagnostic method not stated
consensus)
rest and pain control using NSAIDs and muscle ☒ Other: not clear endpoint
☐ Level IV in presence relaxants. After this period, tolerable ambulation analysis; how "acute fracture
of higher quality studies was permitted with soft brace. defined not clear; did not specify
male/female numbers; selection
Total number of patients: 132 bias; Duration of follow up not
☐ Subgroup analysis
Number of patients in relevant subgroup(s): n=39 specified? Dosage of
data not available
(no anti-osteoporosis medication), n=66 bisphosphonates not specified?
(bisphosphonates), n=27 (parathyroid hormone)
☐ Not relevant to Level of Evidence Determination
question Consecutively assigned? No Potential Level: III
Downgraded Level: Not
Duration of follow-up: 3 months Downgraded
Validated outcome measures used (list): ODI, Conclusions
NRS, Pain (numerical rating scale). This paper provides evidence that:
teriparatide may improve
Nonvalidated outcome measures used : fracture healing and produce
radiological parameters (height and local better clinical outcomes
kyphosis, BMD, magnetic resonance (MR) compared to bisphosphonate.
classification, occurrence of intravertebral cleft
(IVC))
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: xray, BMD, radiographs, DXA
Results/subgroup analysis: IVC sign was
observed in 30 patients. The rate of IVC sign
759
was lower in group III (teriparatide)(7.4%) than
that in group I (20.5%) or group II (30.3%),
although the difference was not statistically
significant. Moreover, the degree of NRS
improvement was better in group III than that in
group I or group II (5.7 vs. 3.1 vs. 3.5, p <
0.001)..
Author conclusions: Different anti-osteoporosis
medications presented different clinical and
radiological results after acute OSFs. The use of
anabolic agent significantly enhanced fracture
healing, reduced progressive collapse, and
presented better clinical outcomes. Proper
selection of medication might improve initial
management of acute OSFs.
Pun KK, Chan LW. Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Analgesic effect of Therapeutic ☒ Nonconsecutive patients
intranasal salmon Study Design: RCT ☐ Nonrandomized
calcitonin in the treatment Level II
☐ Nonmasked reviewers
of osteoporotic vertebral Stated objective of study: To evaluate the
☐ Nonmasked patients
fractures. Clin Ther. Explanation of failure to intranasal administration of salmon calcitonin in
1989;11(2):205-209. meet guideline inclusion ☐ No validated outcome
the treatment of osteoporotic fractures of the
criteria spine measures used
(when applicable) ☒ Small sample size
Type of treatment(s): Salmon calcitonin, ☐ <80% follow-up
☐ Level V (expert administered intranasally ☐ Lacked subgroup analysis
consensus) (200 IV per day) or placebo. ☐ Diagnostic method not stated
☒ Other: X-ray based diagnosis.
☐ Level IV in presence Total number of patients: 18
of higher quality studies Number of patients in relevant subgroup(s): n=9
Level of Evidence Determination
salmon calcitonin, n=9 placebo
Potential Level: I
☐ Subgroup analysis Downgraded Level: II
data not available Consecutively assigned? No
Downgraded due to
nonconsecutive patients and small
Duration of follow-up: 4 weeks
☐ Not relevant to sample size
question
Validated outcome measures used (list): VAS
Conclusions
This paper provides evidence
that: in patients with acute
VCFs, daily intranasal
760
Nonvalidated outcome measures used : A simple calcitonin significantly reduces
subjective pain scale and consumption of pain and analgesic
analgesic drugs. consumption in comparison to
placebo treated patients.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Radiograph, x-ray
Results/subgroup analysis: A significant
decrease in bone pain was observed after seven
days by the nine patients receiving salmon
calcitonin in comparison to no change in the
placebo group.. The intensity of pain decreased
with time in patients in both groups; however,
patients treated with salmon calcitonin had
significantly
lower pain scores throughout the 28-day
assessment. The calcitonin group demonstrated
a statistically significant reduction in the daily
consumption of analgesic drugs in comparison to
the placebo group throughout the study.). No
significant side effects were reported by either
group during the four week
treatment
Author conclusions: When compared with
placebo, intranasal salmon calcitonin significantly
relieved pain and occasioned a decrease in the
consumption of analgesic drugs. No major side-
effects were reported by the patients under study
Rovetta G, Maggiani G, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Molfetta L, Monteforte P. Therapeutic ☐ Nonconsecutive patients
One-month follow-up of Study Design: Comparative ☒ Nonrandomized
patients treated by Level III
☒ Nonmasked reviewers
intravenous clodronate
☒ Nonmasked patients
761
for acute pain induced by Explanation of failure to Stated objective of study: the aims of the study ☐ No validated outcome
osteoporotic vertebral meet guideline inclusion were to compare the group taking disodium- measures used
fracture. Drugs Exp Clin criteria clodronate with a group taking acetaminophen ☒ Small sample size
Res. 2001;27(2):77-81. (when applicable) and to evaluate the correlation between pain
☐ <80% follow-up
duration and intensity
☐ Lacked subgroup analysis
☐ Level V (expert
Type of treatment(s): Disodium clodronate 300 ☐ Diagnostic method not stated
consensus)
mg vs acetaminophen 3 gr. ☐ Other: Click or tap here to
☐ Level IV in presence enter text.
of higher quality studies Total number of patients: 30
Number of patients in relevant subgroup(s): n=15 Level of Evidence Determination
IV disodium-clodronate, n=15 acetaminophen
☐ Subgroup analysis Potential Level: II
data not available Downgraded Level: III
Consecutively assigned? Yes Downgraded due to small sample
☐ Not relevant to size
Duration of follow-up: 2 months.
question
Conclusions
Validated outcome measures used (list): VAS This paper provides evidence that:
in patients with acute VCF, IV
Nonvalidated outcome measures used (: clodronate may produce
significant reduction of pain in
Diagnosis made by: comparison to acetaminophen.
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: xray, Radiographs
Results/subgroup analysis: Differences in pain
scores were not significant between groups
during days 1-14 but were significantly improved
in clodronate patients up to day 48. significant up
to day 48,
Author conclusions: The use of disodium -
clodronate was associated with a reduction in the
number of days the patients experienced severe
pain, which suggests that disodium-clodronate
762
may be a first line drug in the treatment of recent
VCF
Rovetta G, Monteforte P, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Balestra V. Intravenous Therapeutic ☐ Nonconsecutive patients
clodronate for acute pain Study Design: Comparative ☒ Nonrandomized
induced by osteoporotic Level III
☒ Nonmasked reviewers
vertebral fracture. Drugs Stated objective of study: To assess the effect of
☒ Nonmasked patients
Exp Clin Res. Explanation of failure to IV disodium clodronate (300 mg) on the three
2000;26(1):25-30. meet guideline inclusion ☐ No validated outcome
pain conditions (at rest, on pressure, on motion)
criteria associated with recent osteoporotic vertebral measures used
(when applicable) fractures. ☒ Small sample size
☐ <80% follow-up
. ☐ Level V (expert Type of treatment(s): IV disodium clodronate ☐ Lacked subgroup analysis
consensus) (300 mg in 500ml of saline for 3h daily for 5 days ☐ Diagnostic method not stated
over 2 weeks) vs paracetamol (1 g for a total of 3 ☒ Other: Xray based diagnosis.
☐ Level IV in presence g daily)
of higher quality studies Level of Evidence Determination
Total number of patients: 30
Potential Level: II
☐ Subgroup analysis Number of patients in relevant subgroup(s): n=15
Downgraded Level: III
data not available disodium clodronate, n=15 paracetamol
Downgraded due to small sample
size
Consecutively assigned? Yes
☒ Not relevant to
question Conclusions
Duration of follow-up: 30 days
This paper provides evidence that:
in patients with acute VCF, IV
Validated outcome measures used (list): VAS
clodronate may produce
significant reduction of pain in
Nonvalidated outcome measures used (list):
comparison to acetaminophen.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Radiographs
Results/subgroup analysis: Higher remission
rate (on motion, at rest and on pressure) in
763
patients receiving disodium clodronate IV than in
that receiving paracetamol.
Author conclusions: The treatment of highly
painful vertebral fractures with IV disodium
clodronate is more effective in producing gradual
pain remission than paracetamol.
Shigenobu K, Hashimoto Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
T, Kanayama M, Ohha H, Therapeutic ☒ Nonconsecutive patients
Yamane S. The efficacy Study Design: RCT ☐ Nonrandomized
of osteoporotic treatment Level II
☒ Nonmasked reviewers
in patients with new Stated objective of study: The objective of this
☒ Nonmasked patients
spinal vertebral Explanation of failure to study was to investigate post fracture pain and
compression fracture meet guideline inclusion ☐ No validated outcome
QOL when administering bisphosphonate (BP) or
pain, ADL, QOL, bone criteria weekly teriparatide(W-TPTD) to patients with measures used
metabolism and fracture- (when applicable) new spinal compression fractures and who have ☐ Small sample size
healing - In comparison completed a patient questionnaire. ☐ <80% follow-up
with weekly teriparatide ☐ Level V (expert ☐ Lacked subgroup analysis
with consensus) Type of treatment(s): bisphosphonate or ☐ Diagnostic method not stated
bisphosphonate. Bone teriparatide weekly ☐ Other: Click or tap here to enter
Rep. 2019;11:100217. ☐ Level IV in presence text.
Published 2019 Jul 25. of higher quality studies Total number of patients: 43
doi:10.1016/j.bonr.2019.1 Number of patients in relevant subgroup(s): n=24 Level of Evidence Determination
00217.
☐ Subgroup analysis BP vs n=19 W-TPTD Potential Level: I
data not available Downgraded Level: II
Consecutively assigned? No Downgraded due to
☐ Not relevant to nonconsecutive patients
Duration of follow-up: 24 weeks
question
Conclusions
Validated outcome measures used (list): VAS, This paper provides evidence that:
RDQ, EQ-5D in patients with acute VCFs,
weekly teriparatide is superior
Nonvalidated outcome measures used (list): to bisphosphonates in
fracture healing, BMD improving early rate of fracture
healing, pain, and quality of life.
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
764
☐ CT
☐ CT/Myelogram
☒ Other: x-ray
Results/subgroup analysis:
The W-TPTD group demonstrated significantly
greater improvement in RMDQ scores in
comparison to BP treated patients. The EuroQol
5 dimensions (EQ-5D) and visual analogue scale
(VAS)
scores significantly improved over time in both
groups (p < 0.05).
The fracture-healing rate was observed in 45%
of the BP group and 73% of the W-TPTD group
at Week 12,
and a statistically significant higher fracture-
healing rate was obtained in the W-TPTD group
compared to the BP
group (p < 0.05).
.
Author conclusions: Weekly TPTD and BP both
reduced
back pain. TPTD improved QOL and fracture
healing faster than BP.
Tanaka S, Yoshida A, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Kono S, Ito M. Therapeutic ☒ Nonconsecutive patients
Effectiveness of Study Design: RCT ☐ Nonrandomized
monotherapy and Level II
☒ Nonmasked reviewers
combined therapy with Stated objective of study: To clarify the effects
☒ Nonmasked patients
calcitonin and minodronic of monotherapy, and combination therapy, with a
acid hydrate, a Explanation of failure to ☐ No validated outcome
bisphosphonate (minodronic acid hydrate), and
bisphosphonate, for early meet guideline inclusion calcitonin (elcatonin), which is effective for the measures used
treatment in patients with criteria alleviation of pain due to vertebral fractures in ☐ Small sample size
new vertebral fractures: (when applicable) osteoporotic patients ☐ <80% follow-up
An open-label, ☐ Lacked subgroup analysis
randomized, parallel- ☐ Level V (expert Type of treatment(s): Compared 3 treatment ☐ Diagnostic method not stated
group study. J Orthop consensus) groups: patients received either intramuscular ☐ Other: Click or tap here to enter
Sci. 2017;22(3):536-541. injections (IM) of EL (Elcitonin® at a dose of 20 text.
doi:10.1016/j.jos.2016.12 units weekly (EL group), an oral administration of
.021 MIN a dose of 1 mg daily (MIN group), or a
765
☐ Level IV in presence combination of these two drugs (EL + MIN Level of Evidence Determination
of higher quality studies group). Potential Level: I
Downgraded Level: II
☐ Subgroup analysis Total number of patients: 51 Downgraded due to
data not available Number of patients in relevant subgroup(s): EL nonconsecutive patients
group 16, MIN group 17, EL + MIN group 18.
Conclusions
☐ Not relevant to
Consecutively assigned? No This paper provides evidence that:
question
in patients with osteoporosis
Duration of follow-up: 6 mo and acute VCFs, the
combination of calcitonin and
Validated outcome measures used (list): minodronic acid produced both
BMD,VAS, TRACP-5b better pain relief than either
monotherapy.
Nonvalidated outcome measures used
(list)Inhibition of bone resorption based on
changes in TRACP-5b levels; percent changes in
BMD of the L2eL4 vertebrae, total hip and
femoral neck; and percent change in advanced
hip assessment (AHA) parameters, TRACPP-5b
levels, Change in BMD and AHA parameters
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☐☒ Other: BMD; TRACP-5b, X-ray,
Radiographs
Results/subgroup analysis: Elcatonin
monotherapy showed some alleviation of pain
immediately after any vertebral fractures,
which was more than in the minodronic acid
hydrate monotherapy group. In addition, the
minodronic
acid hydrate monotherapy group experienced
more effective inhibited bone resorption than the
766
elcatonin monotherapy group. In the combination
therapy, the efficacy for alleviating pain and
inhibiting bone resorption was equivalent to the
effect observed in the elcatonin and monodromic
acid hydrate
monotherapy groups respectively, with further
improved values of bone mineral density
observed in the
femoral neck and lumbar vertebrae, and in
parameters of advanced hip assessment
compared with both monotherapy groups.
Author conclusions: Combination therapy with
elcatonin and minodronic acid hydrate appears
to be an effective treatment for osteoporosis
patients with lower back pain, caused by fresh
vertebral fractures
Tanaka S, Yoshida A, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Kono S, Oguma T, Therapeutic ☒ Nonconsecutive patients
Hasegawa K, Ito M. Study Design: RCT ☐ Nonrandomized
Effectiveness of elcatonin Level of Evidence:
☒ Nonmasked reviewers
for alleviating pain and ☐I Stated objective of study: the objective of this
☒ Nonmasked patients
inhibiting bone resorption ☒ II study was to compare the changes in pain, ADL,
in patients with ☐ No validated outcome
☐ III QOL, bone resorption, BMD, and fracture
osteoporotic vertebral healing for patients with new vertebral measures used
☐ IV ☐ Small sample size
fractures. J Bone Miner fractures who were given intramuscular (IM)
Metab. 2017;35(5):544- injections of elcatonin and those who were given ☐ <80% follow-up
553. doi:10.1007/s00774-
Explanation of failure to
an NSAID in combination with a VD3 analogue. ☐ Lacked subgroup analysis
016-0791-6 ☐ Diagnostic method not stated
meet guideline inclusion
Type of treatment(s): One group received ☐ Other: Click or tap here to enter
criteria
intramuscular
(when applicable) text.
(IM) injections of elcatonin (Elcatonin; Asahi
Kasei
☐ Level V (expert Level of Evidence Determination
Pharma Corporation, Tokyo, Japan) at a dose of
consensus) Work group conclusions
20 units
Potential Level: I
weekly (elcatonin IM group). The control group
☐ Level IV in presence received
Downgraded Level: II
of higher quality studies Downgraded due to
an oral NSAID (etodolac; 200 mg, twice daily) in
nonconsecutive patients
combination
☐ Subgroup analysis with an active VD3 analogue (alfacalcidol; 0.5
Conclusions relative to question
data not available
767
μg, OVCF Med Q3: This paper
☐ Not relevant to once daily) (NSAID + VD3 group). provides evidence that:
question in patients with acute VCFs
Total number of patients: n=107 Calcitonin was superior to
Number of patients in relevant subgroup(s): n=53 relieving pain to an NSAID after
elcatonin vs n=54 NSAID +VD3 2 weeks and led to better QOL
and ability to perform ADLs at 1
Consecutively assigned? No and 3 months.
Duration of follow-up: 6 months
Validated outcome measures used (list): VAS,
ADL, RDQ and QoL
Nonvalidated outcome measures used : BMD
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: x-ray, Radiographs
Results/subgroup analysis: The elcatonin
IM group had significantly higher QOL score at 2
weeks
and later, and significantly lower VAS and ADL
scores than those in the NSAID + VD3 group at
1 month and later.
Author conclusions: In patients with new
vertebral fractures, elcatonin was shown to
alleviate pain as effectively as a combined
NSAID + VD3 regimen immediately after starting
the
treatment, and more effectively in the later
stages, thereby
improving ADL and QOL..
768
Tetsunaga T, Tetsunaga Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
T, Nishida K, et al. Therapeutic ☒ Nonconsecutive patients
Denosumab and Study Design: Comparative ☒ Nonrandomized
alendronate treatment in Level III
☒ Nonmasked reviewers
patients with back pain Stated objective of study: To analyze the effects
☒ Nonmasked patients
due to fresh osteoporotic Explanation of failure to of antiresorptive osteoporosis pharmacotherapy
vertebral fractures. J meet guideline inclusion ☐ No validated outcome
on pain relief in patients with fresh vertebral
Orthop Sci. criteria fracture. measures used
2017;22(2):230-236. (when applicable) ☐ Small sample size
doi:10.1016/j.jos.2016.11 Type of treatment(s): Denosomab (60mg ☐ <80% follow-up
.017 ☐ Level V (expert subcutaneously every 6 months) with calcium ☐ Lacked subgroup analysis
consensus) carbonate and vitamin D supplements vs ☐ Diagnostic method not stated
. alendronate (35 mg orally every week for 6 ☐ Other: Click or tap here to enter
☐ Level IV in presence months. All patients wore lumbosacral brace for
text.
of higher quality studies 3 months.
☐ Subgroup analysis Total number of patients: n=80
Level of Evidence Determination
data not available Number of patients in relevant subgroup(s): n=40
Potential Level: III
denosomab, n=40 alendronate
Downgraded Level: Not
☐ Not relevant to Downgraded
Consecutively assigned? No
question
Conclusions
Duration of follow-up: 6 months
This paper provides evidence that:
in patients with acute OVCFs,
Validated outcome measures used ( VF
denosumab provides faster
pain relief than alendronate and
Nonvalidated outcome measures used (list):
avoided catastrophizing at 6
Duration of back pain, BMD, serum type 1
months.
collagen cross-linked
N-telopeptide (NTX), and serum N-terminal
propeptide of type 1 collagen (P1NP), incidence
of further vertebral fractures, adverse effects
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
769
☒ Other: X-ray, Radiographs
Results/subgroup analysis: Pain relief was
obtained at a mean of 3.3 weeks with
denosumab and 5.4 weeks with
alendronate.. The incidence of further vertebral
fractures was 5% with
denosumab and 10% with alendronate. Adverse
event rates were similar between groups.
Author conclusions: Denosumab enabled earlier
pain relief than alendronate
Tu PH, Liu ZH, Lee ST, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Chen JF. Treatment of Therapeutic ☒ Nonconsecutive patients
repeated and multiple Study Design: Case Series ☒ Nonrandomized
new-onset osteoporotic Level IV
☒ Nonmasked reviewers
vertebral compression Stated objective of study: To assess the short
☒ Nonmasked patients
fractures with Explanation of failure to term and long-term efficacy of treatment with
teriparatide. J Clin meet guideline inclusion ☐ No validated outcome
teriparatide for patients with osteoporosis who
Neurosci. criteria have repeated and multiple new-onset painful measures used
2012;19(4):532-535. (when applicable) VCF and if teriparatide prevents new ☒ Small sample size
doi:10.1016/j.jocn.2011.0 compression fractures ☐ <80% follow-up
4.048 ☐ Level V (expert ☐ Lacked subgroup analysis
consensus) Type of treatment(s): 20 ug teriparatide ☐ Diagnostic method not stated
subcutaneously injected once daily with ☒ Other: No control
☐ Level IV in presence combined oral medication including 1000 mg
of higher quality studies calcium supplement and 400 IU vitamin D per
Level of Evidence Determination
day for 12 months
Potential Level: IV
☐ Subgroup analysis Downgraded Level: Not
data not available Total number of patients: n=28
Downgraded
Number of patients in relevant subgroup(s): Only
one group
☐ Not relevant to Conclusions
question This paper provides evidence that:
Consecutively assigned? No
teriparatide may decrease pain,
function, and improve quality of
Duration of follow-up: 18 months
life in patients with new onset
Validated outcome measures used (list): , VAS,
VCFs.
JOA
Nonvalidated outcome measures used (list):
BMD,
770
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter text.
Results/subgroup analysis: VAS pain scores
were significantly reduced from baseline at 1,6,
and 12 months. The JOA scores were also
significantly improved at all time points from
baselineli . Fourteen patients were free from
analgesics after teriparatide was administered for
four months, and all patients were free from
analgesics after teriparatide was administered for
six months. Three patients had full JOA scores
after teriparatide was administered for six
months.
Author conclusions: Teriparatide can be used in
patients who have repeated and multiple new
onset painful VCF to avoid repeated
vertebroplasty. They should continue for at least
6 months to ensure it is effective.
Zhao Y, Xue R, Shi N, et Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
al. Aggravation of spinal Therapeutic ☐ Nonconsecutive patients
cord compromise Study Design: Comparative ☐ Nonrandomized
following new Level II
☒ Nonmasked reviewers
osteoporotic vertebral Stated objective of study: Compare the
☒ Nonmasked patients
compression fracture Explanation of failure to preventive effects of teriparatide and alendronate
prevented by teriparatide meet guideline inclusion ☐ No validated outcome
on aggravation of spinal cord compromise
in patients with surgical criteria following new unstable OVCF in patients with measures used
contraindications. Osteop (when applicable) surgical contraindications. ☒ Small sample size
oros Int. ☐ <80% follow-up
2016;27(11):3309-3317. ☐ Level V (expert Type of treatment(s): Teriparatide (20 ug once ☐ Lacked subgroup analysis
consensus) daily by self-administered subcutaneous injection ☐ Diagnostic method not stated
771
doi:10.1007/s00198-016- vs alendronate oral 70 mg tablet once weekly. ☒ Other: Patients and physicians
3651-2 ☐ Level IV in presence Both groups received daily supplements of are note blinded to the open-label
of higher quality studies calcium (600 or 1200 mg) and vitamin D (800 study; Not clear if the patients had
IU). All patients supported with thoracolumbar spinal cord
☐ Subgroup analysis brace for 3 months and were encouraged to compression/improvement in
data not available adopt complete bed rest for 1-2 months. mJOA score may not be related to
the medications/surgical
Total number of patients: n=49
☐ Not relevant to contraindications is a relative term
Number of patients in relevant subgroup(s): n=24
question
teriparatide, n25 alendronate= Level of Evidence Determination
Potential Level: II
Consecutively assigned? Yes Downgraded Level: Not
Downgraded
Duration of follow-up: 12 months
Conclusions
Validated outcome measures used (list): mJOA This paper provides evidence that:
(neurological status), VAS in patients with acute, unstable
OVCFs with neurological
Nonvalidated outcome measures used (list): deficits, teriparatide is superior
BMD, bone turnover. Kyphotic angles, anterior to alendronate in reducing pain,
bone heights, diameters of spinal canal, incident improving neurological
new fractures, and serum markers of bone outcomes and reducing fracture
resorption and bone formation risk.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: DEXA
Results/subgroup analysis: In the teriparatide
group, mean mJOA score increased significantly
between baseline and month 6 (P< .01) and did
not differ significantly between month 6 and
month 12 (P= .08). The mean recovery rate was
63.5 % (range, 33.3–100 %) at final follow-up.
Patients with sphincter dysfunction and trunk
772
sensory deficit had complete relie. All patients
had improvement, but not complete relief, in both
sensory and
motor functions in the lower extremities.
In the alendronate group, mean mJOA score
decreased significantly between baseline and
month 6 (P < .01) and between
month 6 and month 12 (P=.02). Mean recovery
rate
was −30.8 % (range, −20 to −66.7 %) at final
follow-up
Patients with sphincter dysfunction and trunk
sensory
deficit experienced either no relief or
aggravation.
Deficits in sensory and motor functions of the
lower extremities
were aggravated.
Significant decreases in VAS scores between
baseline and
month 6 (P< .01in both groups) and significant
increases in
VAS scores between month 6 and month 12
were seen in both
groups (P < .01 for both). VAS score was similar
between
groups at baseline (P = .95) but was significantly
lower in
the teriparatide group than in the alendronate
group at month
6 (P<.01) and month 12 (P< .01) (
Author conclusions: In pts with neurological
deficits following new unstable OVCF and with
surgical contraindications, teriparatide was better
than alendronate at improving the BMD and the
bone turnover parameters, as well as preventing
aggravation of spinal cord compromise.
Zheng H, Li H, Zhang J, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
et al. The effect of Therapeutic ☒ Nonconsecutive patients
zoledronic acid combined Study Design: Comparative ☐ Nonrandomized
773
with percutaneous Level III ☐ Nonmasked reviewers
kyphoplasty on the Stated objective of study: To investigate the ☐ Nonmasked patients
treatment of osteoporotic Explanation of failure to clinical efficacy of zoledronic acid combined with
☐ No validated outcome
vertebral body meet guideline inclusion percutaneous kyphoplasty on the treatment of
measures used
compression fractures in criteria OVCF
☐ Small sample size
patients. Journal of (when applicable)
Biomaterials and Tissue Type of treatment(s): PKP alone and PKP plus ☐ <80% follow-up
Engineering. ☐ Level V (expert ZA ☐ Lacked subgroup analysis
2019;9(7):1008-1013. consensus) ☐ Diagnostic method not stated
Total number of patients: 102 ☐ Other: Click or tap here to enter
☐ Level IV in presence Number of patients in relevant subgroup(s): text.
of higher quality studies Group A PK only; Group B PK and zoledronic
acid (48 and 54) Level of Evidence Determination
☐ Subgroup analysis Potential Level: III
Consecutively assigned? No Downgraded Level: Not
data not available
Downgraded
Duration of follow-up: 12 months
☐ Not relevant to
question Conclusions
Validated outcome measures used VAS This paper provides evidence that:
in in patients with acute OVCFs,
Nonvalidated outcome measures usedBMD,CTX the addition of Zoledronate
(list): Click or tap here to enter text. after a PKP significantly
improves pain, reduces risk of
Diagnosis made by: recurrent fracture at 1, 3, 6, and
☒ Clinical exam/history 12 months reduces risk of
☐ Electromyography recurrent fracture at 1, 3, 6, and
☐ Myelogram 12 months.
☒ MRI
☒ CT
☐ CT/Myelogram
☐☒ Other: Radiographs
Results/subgroup analysis: The result showed
that preoperative and postoperative VAS scores
after 1, 3, 6, and 12 months in group B (PBP +
ZA) were significantly lower than group A (PKP
alone) while the BMD in group B was higher than
that in group A
774
Author conclusions: zoledronic acid, combined
with percutaneous kyphoplasty can improve the
therapeutic efficacy of OVCF after surgery, which
provides new insights for the further treatment of
OVCF in clinical practice.
Medical Treatment Question 4: Does spinal manipulative treatment improve outcomes for patients with acute osteoporotic vertebral compression
fractures?
A systematic review of the literature yielded no studies to adequately address this question.
Medical Treatment Question 5: In patients presenting with symptomatic acute osteoporotic vertebral compression fractures, does medical treatment of the
underlying bone loss improve long-term outcomes such as reduction in risk of future fragility fractures?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Craig SJ, Youssef PP, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Vaile JH, Sullivan L, Therapeutic ☒ Nonconsecutive patients
Bleasel JF. Intravenous Study Design: Comparative ☒ Nonrandomized
zoledronic acid and oral Level IV ☒ Nonmasked reviewers
alendronate in patients Stated objective of study: To compare the
with a low trauma ☒ Nonmasked patients
safety and effectiveness of IV zoledronic acid
fracture: experience from Explanation of failure to and oral alendronate in osteoporotic patients ☒ No validated outcome measures used
an osteoporosis meet guideline inclusion following a low trauma fracture ☐ Small sample size
clinic. Intern Med J. criteria ☐ <80% follow-up
2011;41(2):186-190. (when applicable) Type of treatment(s): Patients were treated ☐ Lacked subgroup analysis
doi:10.1111/j.1445- with either an infusion of 4 mg ZOL or ALN 70 ☒ Diagnostic method not stated
5994.2010.02198.x ☐ Level V (expert mg weekly. Some patients were also ☒ Other: Selection bias
consensus) prescribed vitamin D and/or calcium
supplements, depending on their baseline 25- Level of Evidence Determination
☐ Level IV in presence hydroxy vitamin D3 level and reported Potential Level: III
of higher quality studies calcium intake. Downgraded Level: IV
775
☐ Subgroup analysis Total number of patients: 169 Downgraded due to nonconsecutive, no
data not available Number of patients in relevant subgroup(s): validated outcome measures, diagnostic
There were 70 patients in the ZOL group and method not stated
☐ Not relevant to 99 patients in the ALN group
question Conclusions
Consecutively assigned? No This paper provides evidence that: in
patients with osteoporosis and an
Duration of follow-up: 12 months acute VCF, patients with OVCF treated
with ALN had significantly fewer
Validated outcome measures used (list): fractures at one year compared to ZOL.
BMD, Subsequent fractures
Nonvalidated outcome measures used (list):
The percentage
change in absolute BMD at both lumbar spine
and total
hip, and the occurrence of new major
osteoporotic fractures
(hip, clinical spine, shoulder and forearm).
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Radiographs, X rays
Results/subgroup analysis: There was a
significant improvement in absolute BMD for
both groups at the lumbar spine and total hip
. There was a statistically significant
increase in the number of major osteoporotic
fractures in the ZOL group compared to the
ALN group.
Author conclusions: ZOL and ALN both
produce a significant increase in BMD and
are well tolerated in patients with
osteoporotic, low trauma fractures. Yearly
ZOL provides a safe,
776
convenient alternative to weekly oral
bisphosphonates.
Tu PH, Liu ZH, Lee ST, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Chen JF. Treatment of Therapeutic ☒ Nonconsecutive patients
repeated and multiple Study Design: Case Series ☒ Nonrandomized
new-onset osteoporotic Level IV ☒ Nonmasked reviewers
vertebral compression Stated objective of study: To assess the short
fractures with Explanation of failure to ☒ Nonmasked patients
term and long-term efficacy of treatment with
teriparatide. J Clin meet guideline inclusion teriparatide for patients with osteoporosis ☐ No validated outcome measures used
Neurosci. criteria who have repeated and multiple new-onset ☒ Small sample size
2012;19(4):532-535. (when applicable) painful VCF and if teriparatide prevents new ☐ <80% follow-up
doi:10.1016/j.jocn.2011.0 compression fractures ☐ Lacked subgroup analysis
4.048 ☐ Level V (expert ☐ Diagnostic method not stated
consensus) Type of treatment(s): 20 ug teriparatide ☒ Other: No control
subcutaneously injected once daily with
☐ Level IV in presence combined oral medication including 1000 mg Level of Evidence Determination
of higher quality studies calcium supplement and 400 IU vitamin D per Work group conclusions
day for 12 months Potential Level: IV
☐ Subgroup analysis Downgraded Level: Not Downgraded
data not available Total number of patients: n=28
Number of patients in relevant subgroup(s): Conclusions
Only one group
☐ Not relevant to
question OVCF Med Q5: This paper provides
Consecutively assigned? No evidence that:
in patients with repeated and acute
Duration of follow-up: 18 months VCFs, teriparatide may reduce the risk
Validated outcome measures used (list): , for future fractures and need for
VAS, JOA percutaneous vertebroplasty.
Nonvalidated outcome measures used (list):
BMD
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter text.
Results/subgroup analysis: mm).VAS
decreased signiificantly from baseline with
777
teriparatide at 2,6, and 12 months of
treaatment.Similarly, increases in JOA score
were seen at all time points. Fourteen
patients were free from analgesics after
teriparatide was administered for four
months, and all patients were free from
analgesics after teriparatide was
administered for six months. Three patients
had full JOA scores after teriparatide was
administered for six months.
.
Author conclusions: Teriparatide can be
used in patients who have repeated and
multiple new onset painful VCF to avoid
repeated vertebroplasty. They should
continue for at least 6 months to ensure it is
effective.
Zhao Y, Xue R, Shi N, et Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
al. Aggravation of spinal Therapeutic ☐ Nonconsecutive patients
cord compromise Study Design: Comparative ☐ Nonrandomized
following new Level II
Stated objective of study: Compare the ☒ Nonmasked reviewers
osteoporotic vertebral
Explanation of failure to preventive effects of teriparatide and ☒ Nonmasked patients
compression fracture
meet guideline inclusion alendronate on aggravation of spinal cord ☐ No validated outcome measures used
prevented by teriparatide
criteria compromise following new unstable OVCF in
in patients with surgical ☒ Small sample size
(when applicable) patients with surgical contraindications.
contraindications. Osteop ☐ <80% follow-up
oros Int.
☐ Level V (expert Type of treatment(s): Teriparatide (20 ug ☐ Lacked subgroup analysis
2016;27(11):3309-3317. once daily by self-administered subcutaneous ☐ Diagnostic method not stated
consensus)
doi:10.1007/s00198-016- injection vs alendronate oral 70 mg tablet ☒ Other: Patients and physicians are note
3651-2 once weekly. Both groups received daily
☐ Level IV in presence blinded to the open-label study; Not clear
supplements of calcium (600 or 1200 mg) if the patients had spinal cord
of higher quality studies
and vitamin D (800 IU). All patients compression/improvement in mJOA score
supported with thoracolumbar brace for 3
☐ Subgroup analysis may not be related to the
months and were encouraged to adopt medications/surgical contraindications is a
data not available
complete bed rest for 1-2 months. relative term
☐ Not relevant to
Level of Evidence Determination
question
Total number of patients: n=49 Potential Level: II
Number of patients in relevant subgroup(s): Downgraded Level: Not Downgraded
n=24 teriparatide, n25 alendronate=
Conclusions
778
This paper provides evidence that:
teriparatide is superior to alendronate
Consecutively assigned? Yes at 12 months in reducing the risk of
new fractures in patients with unstable
Duration of follow-up: 12 months
acute OVCFs.
Validated outcome measures used (list):
mJOA (neurological status), VAS
Nonvalidated outcome measures used (list):
BMD, bone turnover. Kyphotic angles,
anterior bone heights, diameters of spinal
canal, incident new fractures, and serum
markers of bone resorption and bone
formation
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: DEXA
Results/subgroup analysis: In the teriparatide
group, mean mJOA score increased
significantly between baseline and month 6
(P< .01) and did not differ significantly
between month 6 and month 12 (P= .08). The
mean recovery rate was 63.5 % (range, 33.3–
100 %) at final follow-up. Patients with
sphincter dysfunction and trunk sensory
deficit had complete relief (Table 4). All
patients had improvement, but not complete
relief, in both sensory and
motor functions in the lower extremities.
In the alendronate group, mean mJOA score
decreased significantly between baseline and
month 6 (P < .01) and between
month 6 and month 12 (P=.02). Mean
779
recovery rate
was −30.8 % (range, −20 to −66.7 %) at final
follow-up
Patients with sphincter dysfunction and trunk
sensory
deficit experienced either no relief or
aggravation.
Deficits in sensory and motor functions of the
lower extremities
were aggravated.
Significant decreases in VAS scores between
baseline and
month 6 (P< .01in both groups) and
significant increases in
VAS scores between month 6 and month 12
were seen in both
groups (P < .01 for both). VAS score was
similar between
groups at baseline (P = .95) but was
significantly lower in
the teriparatide group than in the alendronate
group at month
6 (P<.01) and month 12 (P< .01) (
Author conclusions: In pts with neurological
deficits following new unstable OVCF and
with surgical contraindications, teriparatide
was better than alendronate at improving the
BMD and the bone turnover parameters, as
well as preventing aggravation of spinal cord
compromise.
Zheng H, Li H, Zhang J, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
et al. The effect of Therapeutic ☒ Nonconsecutive patients
zoledronic acid combined Study Design: Comparative ☐ Nonrandomized
with percutaneous Level III
☐ Nonmasked reviewers
kyphoplasty on the Stated objective of study: To investigate the
☐ Nonmasked patients
treatment of osteoporotic clinical efficacy of zoledronic acid combined
vertebral body Explanation of failure to ☐ No validated outcome measures used
with percutaneous kyphoplasty on the
compression fractures in meet guideline inclusion treatment of OVCF ☐ Small sample size
patients. Journal of criteria ☐ <80% follow-up
Biomaterials and Tissue (when applicable) Type of treatment(s): PKP alone and PKP ☐ Lacked subgroup analysis
plus ZA ☐ Diagnostic method not stated
780
Engineering. ☐ Level V (expert ☐ Other: Click or tap here to enter text.
2019;9(7):1008-1013. consensus) Total number of patients: 102
Number of patients in relevant subgroup(s): Level of Evidence Determination
☐ Level IV in presence Group A PK only; Group B PK and zoledronic Potential Level: III
of higher quality studies acid (48 and 54) Downgraded Level: Not Downgraded
Consecutively assigned? No
☐ Subgroup analysis Conclusions
data not available This paper provides evidence that:
Duration of follow-up: 12 months in patients with acute OVCFs, in
☐ Not relevant to addition to PVP, Z significantly
Validated outcome measures used (list): reduced recurring fracture risk and
question VAS, BMD, TRACP 5b, CTX increased BMD.
Nonvalidated outcome measures used (list):
N/A
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☐☒ Other: Radiographs
Results/subgroup analysis: The result
showed that preoperative and postoperative
VAS scores after 1, 3, 6, and 12 months in
group B (PBP + ZA) were significantly lower
than group A (PKP alone ) while the BMD in
group B was higher than that in group A
Author conclusions: zoledronic acid,
combined with percutaneous kyphoplasty can
improve the therapeutic efficacy of OVCF
after surgery, which provides new insights for
the further treatment of OVCF in clinical
practice.
781
Medical Treatment Question 6: Does the involvement of multiple specialties in clinical management change the outcomes of acute osteoporotic vertebral
compression fractures?
A systematic review of the literature yielded no studies to adequately address this question.
782
Imaging Section
Imaging Question 1: Which imaging modalities and findings are most sensitive and specific for the accurate diagnosis of symptomatic osteoporotic vertebral
compression fractures?
Article Level Description of study Conclusion
(Alpha by Author) of Evidence
Chen YJ, Lo DF, Chang CH, Chen Type of Evidence: ☐ Prospective ☒ Retrospective Critique of methodology
HT, Hsu HC. The value of dynamic Diagnostic Study Design: Case Series ☐ Nonconsecutive patients
radiographs in diagnosing painful ☒ Small sample size
vertebrae in osteoporotic Level II Stated objective of study: The ☒ Nonmasked reviewers
compression fractures. AJNR Am J purpose of this study was to discover ☐ No universally-applied gold
Neuroradiol. 2011;32(1):121-124. Explanation of failure to the diagnostic value of dynamic
doi:10.3174/ajnr.A2233 meet guideline inclusion radiographs and the percentage of standard
criteria mobile vertebrae in painful VCFs. ☐ No consistently applied gold
(when applicable) standard
Diagnostic test(s) studied: ☐ Poor reference standard/no
☐ Level V (expert ☒ Clinical exam/history gold standard applied
consensus) ☐ Electromyography ☐ Lacked subgroup analysis
☐ Myelogram ☐ Other: Click or tap here to
☐ Level IV in presence of enter text.
☒ MRI
higher quality studies
☐ CT Level of Evidence
☐ Subgroup analysis data ☐ CT/Myelogram Determination
not available ☒ Other: Preprocedural upright AP Potential Level: II
& lateral rays. Preprocedural sitting Downgraded Level: Not
☐ Not relevant to question focused lateral xrays, and supine Downgraded
cross-table lateral xrays focused on
the index vertebral body with a Conclusions
bolster 10 cm. in height placed This study provides evidence
beneath it, dynamic radiographs. that: dynamic upright and
stress supine x-rays are
Compared to: helpful to diagnose acute
☐ Clinical exam/history painful vertebral fractures.
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
783
Gold standard used? ☒ Yes ☒
No
If so, what was the gold standard?
VP result at 1 month F/U, MRI
Number of patients: 105 pts.
Consecutively assigned? Yes
Results/subgroup analysis (relevant
to question): (1) Postprocedure
VAS decreased from 8.9 to 1.8
(P>.001)at 1 month F/U. (2)
Kyphotic angle: Average sitting
lateral xray vs supine lateral +bolster
xray improved from 18.18 +/-8.22
degrees to 7.52 +/-7.25 degrees.
The average difference between
sitting and supine+ bolster was
10.67 +/- 6.67degrees (range -2 to -
27 degrees) P<.001. Anterior VBH:
Increased from 13.53 +/- 6.80mm
sitting to 22.01+/- 6.13mm (range
6.09 - 38.53mm) supine+bolster.
The average vertebral body height
increase was 8.48 +/- 5.36 mm
(range -1.17 to 24.04 mm)
P<.001. (3) Of the 144 edematous
vertebral body fxs. 126 were mobile,
18 were not mobile. In all 105
treated pts. 104 had at least 1
mobile fx. One pt. had a single
nonmobile L5 fx. (4) Sensitivity of
dynamic radiographs in diagnosing
the painful vertebrae in pts. with
severe pain is 0.87.
Author conclusions (relative to
question): Dynamic (sitting and
supine with bolster) radiographs can
be valuable in diagnosing painful
vertebrae in VCFs. The sensitivity
was 0.88 in this study.
784
Karam M, Lavelle WF, Cheney R. The Type of Evidence: ☐ Prospective ☒ Retrospective Critique of methodology
role of bone scintigraphy in treatment Diagnostic Study Design: Case Series ☐ Nonconsecutive patients
planning, and predicting pain relief ☐ Small sample size
after kyphoplasty. Nucl Med Commun. Level II Stated objective of study: To ☒Nonmasked reviewers
2008;29(3):247-253. determine the accuracy of bone
doi:10.1097/MNM.0b013e3282f30598 Explanation of failure to ☐ No universally-applied gold
scanning in patient selection,
meet guideline inclusion standard
planning treatment and predicting
criteria response to kyphoplasty. ☐ No consistently applied gold
(when applicable) standard
Diagnostic test(s) studied: ☒ Poor reference standard/no
☐ Level V (expert ☐ Clinical exam/history gold standard applied
consensus) ☐ Electromyography ☐ Lacked subgroup analysis
☐ Myelogram ☒ Other: Spectrum bias
☐ Level IV in presence of
☐ MRI
higher quality studies
☐ CT Level of Evidence
☐ Subgroup analysis data ☐ CT/Myelogram Determination
not available ☒ Other: Bone scan; xrays Potential Level: II
Downgraded Level: Not
☐ Not relevant to question Compared to: Downgraded
☒ Clinical exam/history
☐ Electromyography Conclusions
This study provides evidence
☐ Myelogram
that: positive bone scans will
☐ MRI reliably predict a painful
☐ CT vertebral level that will
☐ CT/Myelogram respond favorably to KP.
☒ Other: (1) Response to KP
(excellent, intermediate and poor)
based on questionnaire determined
by surgeon. (2) Bone scan and xrays
within 4 weeks of TX analyzed by 2
nuclear medicine physicians, x-ray.
Gold standard used? ☒ Yes ☒
No
If so, what was the gold standard?
KP
Number of patients: 60 pts.
Consecutively assigned? Yes
785
Results/subgroup analysis (relevant
to question): 1 Group A: 53/60
patients managed by xray and bone
scan. Group B: 7/60 patients
managed by x ray.
2). Suboptimal results were found in
11/53 group A and 7/7 group B. 3)
High rate of incorrect level selection
in group B 3/7. 4). Total of 12
patients (20%) x ray showed multiple
fractures where bone scan showed
only one level of acute fracture. (
Author conclusions (relative to
question): Bone scanning is an
excellent predictor of response to
kyphoplasty and decreases the
number of vertebrae to be
treated as suggested by plain
radiographs. Preoperative
scintigraphy is recommended to
avoid incorrect selection
of treatment level.
Kaup M, Wichmann JL, Scholtz JE, et Type of Evidence: ☐ Prospective ☒ Retrospective Critique of methodology
al. Dual-Energy CT-based Display of Diagnostic Study Design: Comparative ☐ Nonconsecutive patients
Bone Marrow Edema in Osteoporotic ☒ Small sample size
Vertebral Compression Fractures: Level III Stated objective of study: To ☐ Nonmasked reviewers
Impact on Diagnostic Accuracy of evaluate whether a dual-energy (DE)
Radiologists with Varying Levels of Explanation of failure to ☒ No universally-applied gold
computed tomographic (CT) virtual
Experience in Correlation to MR meet guideline inclusion standard
noncalcium technique can improve
Imaging. Radiology. 2016;280(2):510- criteria the detection rate of acute ☐ No consistently applied gold
519. doi:10.1148/radiol.2016150472 (when applicable) thoracolumbar vertebral compressi standard
on fractures in patients with os- ☒ Poor reference standard/no
☐ Level V (expert teoporosis compared with that at gold standard applied
consensus) magnetic resonance (MR) imaging ☐ Lacked subgroup analysis
☐ Other: Click or tap here to
☐ Level IV in presence of Diagnostic test(s) studied: enter text.
higher quality studies ☒ Clinical exam/history
☐ Electromyography
☐ Subgroup analysis data ☐ Myelogram Level of Evidence
Determination
not available ☒ MRI
Potential Level: III
☒ CT
☐ Not relevant to question
786
☐ CT/Myelogram Downgraded Level: Not
☒ Other: DXA, T<-2.5; DE CT Downgraded
Compared to: Conclusions
This study provides evidence
☐ Clinical exam/history
that: the sensitivity,
☐ Electromyography specificity, accuracy, PPV and
☐ Myelogram NPV of detecting vertebral
☒ MRI bone marrow edema is closer
☒ CT to MRI with dual-energy CT
☐ CT/Myelogram compared to conventional CT.
☒ Other: DE CT
Gold standard used? ☒ Yes ☐
No
If so, what was the gold standard?
MRI
Number of patients: 49 pts.
Consecutively assigned? Yes
Results/subgroup analysis (relevant
to question): 1). Diagnosis of fresh
(acute) fracture improved for all
readers with the use of Dual energe
CT compared to CT alone. 2). There
was a gradient of accuracy in the
level of reader experience. 3) using
the DE CT, the potential referral for
additional MR imaging decreased by
36%-87%.
Author conclusions (relative to
question): The DE CT–
based virtual noncalcium techniqu
e may enable depic-
tion of bone marrow edema in th
oracolumbar vertebral compres-
sion fractures in patients with ost
eoporosis, with good accordance
with MR imaging when images are
read by experienced radiologists.
787
Although less experienced readers
improved their diagnostic perfor-
mance to some degree, the exper
ienced reader’s diagnostic perfor-
mance approached that with MR
imaging.
Li YB, Zheng X, Wang R, et al. Type of Evidence: ☒ Prospective ☐Retrospective Critique of methodology
SPECT-CT versus MRI in localizing Diagnostic Study Design: Case Series ☒ Nonconsecutive patients
active lesions in patients with ☒ Small sample size
osteoporotic vertebral compression Level III Stated objective of study: This study ☒ Nonmasked reviewers
fractures. Nucl Med Commun. aimed to evaluate the difference
2018;39(7):610-617. Explanation of failure to ☐ No universally-applied gold
andconsistency between single-
doi:10.1097/MNM.000000000000085 meet guideline inclusion standard
photon emission
7 criteria computedtomography-computed ☐ No consistently applied gold
(when applicable) tomography (SPECT-CT) and MRI standard
indiagnosing osteoporotic vertebral ☐ Poor reference standard/no
☐ Level V (expert compression fractures(OVCFs) and gold standard applied
consensus) identifying active lesions. ☐ Lacked subgroup analysis
☐ Other: Click or tap here to
☐ Level IV in presence of Diagnostic test(s) studied: enter text.
higher quality studies ☐ Clinical exam/history
☐ Electromyography Level of Evidence
☐ Subgroup analysis data ☐ Myelogram Determination
Potential Level: III
not available ☒ MRI
Downgraded Level: Not
☒ CT Downgraded
☒ Not relevant to question
☐ CT/Myelogram
☒ Other: spect Conclusions
This study provides evidence
Compared to: that: SPECT CT have been
☐ Clinical exam/history useful in the diagnosis of
☐ Electromyography OVCF.
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: spect
Gold standard used? ☒ Yes ☐
No
If so, what was the gold standard?
MRI
788
Number of patients: 46
Consecutively assigned? No
Results/subgroup analysis (relevant
to question): Total of 77 vertebral
bodies were treated with PKP in 46
patients. MRI showed 79 levels of
fresh (acute) fractures. SPECT CT
showed 83 levels.
Pairedt-testevaluation showed that
PKP was effective, suggesting
thatthe affected sites were
determined accurately
(P<0.05).Furthermore, theκ-statistics
indicated that these two methods
were highly consistent (P<0.05) and
the McNemar test indicated that the
efficacy of these two diagnostic
methods was closely correlated
(P>0.05). Indifferent stages of
fractures, especially the acute
phase, the consistency of SPECT-
CT and MRI in the diagnosis of fresh
OVCFs was high.
Author conclusions (relative to
question): SPECT-CT is the
preferred method for imaging
diagnosis when patients with
suspected OVCFs have
contraindications to MRI, particularly
for patients with acute fractures.
Marongiu G, Congia S, Verona M, Type of Evidence: ☐ Prospective ☒ Retrospective Critique of methodology
Lombardo M, Podda D, Capone A. Diagnostic Study Design: Case Series ☒ Nonconsecutive patients
The impact of magnetic resonance ☐ Small sample size
imaging in the diagnostic and Level I Stated objective of study: Quantify ☐ Nonmasked reviewers
classification process of osteoporotic the misdiagnosis rate of OVCF’s and
vertebral fractures. Injury. 2018;49 Explanation of failure to ☐ No universally-applied gold
analyse the impact of MRI on early
Suppl 3:S26-S31. meet guideline inclusion standard
diagnosis and classification,
doi:10.1016/j.injury.2018.10.006 criteria compared to standard radiographs ☐ No consistently applied gold
(when applicable) alone. standard
☒ Poor reference standard/no
gold standard applied
789
☐ Level V (expert Diagnostic test(s) studied: ☐ Lacked subgroup analysis
consensus) ☒ Clinical exam/history ☐ Other: Click or tap here to
☐ Electromyography enter text.
☐ Level IV in presence of ☐ Myelogram
higher quality studies ☒ MRI
Level of Evidence
☐ CT
☐ Subgroup analysis data Determination
☐ CT/Myelogram Potential Level: I
not available
☒ Other: Xrays] Downgraded Level: Not
☐ Not relevant to question Downgraded
Compared to:
☒ Clinical exam/history Conclusions
☐ Electromyography This study provides evidence
☐ Myelogram that: radiographs have low
☒ MRI sensitivity and specificity and
accuracy for diagnosing
☐ CT
acute symptomatic OVCF.
☐ CT/Myelogram
☒ Other: plains xray
Gold standard used? ☒ Yes ☐
No
If so, what was the gold standard?
MRI, within 7 days of hospitalization.
Axial T2-w. Sagittal T1-w and STIR.
Xray
Number of patients: 173 pts w/ fx on
xray. 208 total fxs on xray
Consecutively assigned? Yes
Results/subgroup analysis (relevant
to question): In total of 216 patients,
Radiograph showed 208 fractures in
the thoracolumbar spine, and MIR
showed 216 fractures. MRI showed
19 bone bruise that were noted as
unremarkable on radiograph. There
were also 93 fractures on radiograph
that were old fratures. Post MRI
showed change in diagnosis in 90 of
173 patients with diagnositic
discordance of 52%.
790
Author conclusions (relative to
question): the extensive use of MRI
imaging allows better accuracy
in the diagnostic process and in the
classification assessment, compared
to conventional radiographs.
Further investigation should provide
additional information about the
impact of early MRI on treatment
and management of elderly patients
with suspected OVFs, including the
decision to hospitalize or not,
and how it could affect clinical
outcome and social costs
Niimi R, Kono T, Nishihara A, et al. Type of Evidence: ☐ Prospective ☒Retrospective Critique of methodology
Efficacy of the dynamic radiographs Diagnostic Study Design: Case Series ☒ Nonconsecutive patients
for diagnosing acute osteoporotic ☐ Small sample size
vertebral fractures. Osteoporos Int. Level III Stated objective of study: we ☒ Nonmasked reviewers
2014;25(2):605-612. analyzed the diagnostic accuracy of ☐ No universally-applied gold
doi:10.1007/s00198-013-2456-9 Explanation of failure to comparative supine and sitting
meet guideline inclusion standard
lateral radiographs for diagnosing
criteria acute OVFs and evaluated their ☐ No consistently applied gold
(when applicable) efficacy for predicting any standard
subsequent reduction in vertebral ☐ Poor reference standard/no
☐ Level V (expert height. gold standard applied
consensus) ☐ Lacked subgroup analysis
Diagnostic test(s) studied: ☐ Other: Click or tap here to
☐ Level IV in presence of ☐ Clinical exam/history enter text.
higher quality studies ☐ Electromyography
☐ Myelogram
☐ Subgroup analysis data ☐ MRI Level of Evidence
not available Determination
☐ CT Potential Level: II
☐ CT/Myelogram Downgraded Level: III
☒Not relevant to question
☒ Other: supine lateral xrays Downgraded due
compared with sitting lateral xrays. to: nonconsecutive patients and
Vertebrae w/height changes nonmasked reviewers
diagnosed as acute OVCF’s;
diagnosed by orthopedic surgeons, Conclusions
dynamic radiographs. This study provides evidence
that: acute symptomatic OVCF
Compared to: can be diagnosed two thirds
☐ Clinical exam/history
791
☐ Electromyography of the time with dynamic
☐ Myelogram mobility on x-ray.
☒ MRI
☐ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Gold standard used? ☒ Yes ☐
No
If so, what was the gold standard?
MRI within 3 days, assessors
blinded
Number of patients: 403 pts. w/472
OVCF’s ;< 3weeks after injury, or
onset or onset of symptoms. The
dynamic mobility of 472 painful
OVCF DX by MRI was assessed by
changes in vertebral body height
from supine to sitting xrays.
Consecutively assigned? YesNo
Results/subgroup analysis (relevant
to question):
Diagnosis from radiographs for acute
fractures in supine, sitting and
dynamic postitions were compared
to MRI.
The sensitivity/specificity/PPV/NPV
for the three positions were are
follows:
39.6/94.4/14.0/94.0;
43.0/94.3/42.6/94.4;
66.3/95.9/61.4/96.6
Of the 472 acute OVFs diagnosed,
313 (66 %)exhibited vertebral
mobility on supine lateral and
sittinglateral radiographs.
Author conclusions (relative to
question): Dynamic radiographs
792
provide a convenientway to identify
acute OVFs.
Zhao QM, Gu XF, Liu ZT, Cheng L. Type of Evidence: ☒ Prospective ☐ Retrospective Critique of methodology
The Value of Radionuclide Bone Diagnostic Study Design: Case Series ☒ Nonconsecutive patients
Imaging in Defining Fresh Fractures ObservationalComparative ☒ Small sample size
Among Osteoporotic Vertebral Level III ☒ Nonmasked reviewers
Compression Fractures. J Craniofac Stated objective of study: Evaluate
Surg. 2016;27(3):745-748. Explanation of failure to ☐ No universally-applied gold
the value of raionuclide bone
doi:10.1097/SCS.0000000000002594 meet guideline inclusion standard
imaging in the diagnosis of fresh
criteria OVCF’s. ☐ No consistently applied gold
(when applicable) standard
Diagnostic test(s) studied: ☐ Poor reference standard/no
☐ Level V (expert ☒ Clinical exam/history gold standard applied
consensus) ☐ Electromyography ☐ Lacked subgroup analysis
☐ Myelogram ☐ Other: Click or tap here to
☐ Level IV in presence of enter text.
☒ MRI
higher quality studies
☐ CT
☐ Subgroup analysis data ☐ CT/Myelogram Level of Evidence
not available ☒ Other: bone scan, scintigraphy, d Determination
radionuclide bone Potential Level: II
☐ Not relevant to question imaging Downgraded Level: III
Downgraded due to: small
Compared to: sample size, nonconsecutive
☒ Clinical exam/history patients, and nonmasked
☐ Electromyography reviewers.
☐ Myelogram
Conclusions
☒ MRI This study provides evidence
☐ CT that: a bone scan is highly
☐ CT/Myelogram accurate in detecting OVCF
☒ Other: VA, d radionuclide bone compared to an MRI.
imaging
Gold standard used? ☒ Yes ☐
No
If so, what was the gold standard?
VA, Clinical F/U, MRI.
Number of patients: 39 pts
Consecutively assigned? No
793
Results/subgroup analysis (relevant
to question): Detecting acute
vertebral fracture was found as
92.1% *82/89) in radionuclide bone
imaging and 93.3% (83/89) in MRI.
One patient had positive bone scan
and negative MRI, Two patients had
positive MRI and negative bone
scan.
A kappa test showed good
consistency between the 2 methods
for detecting the affected
vertebrae (Kappa ¼ 0.751, P <
0.01).
Author conclusions (relative to
question): Radionuclide bone
imaging
is as sensitive as MRI in the
diagnosis of fresh osteoporotic
vertebral compression fracture,
making it an effective method
for detecting affected vertebrae for
percutaneous vertebroplasty
Imaging Question 2: Which imaging findings stratify the acuity of osteoporotic vertebral compression fractures?
Article Level Description of study Conclusion
(Alpha by Author) of Evidence
Kaup M, Wichmann JL, Scholtz JE, et Type of Evidence: ☐ Prospective ☒ Retrospective Critique of methodology
al. Dual-Energy CT-based Display of Diagnostic Study Design: Comparative ☐ Nonconsecutive patients
Bone Marrow Edema in Osteoporotic ☒ Small sample size
Vertebral Compression Fractures: Level III Stated objective of study: To ☐ Nonmasked reviewers
Impact on Diagnostic Accuracy of evaluate whether a dual-energy (DE)
Radiologists with Varying Levels of Explanation of failure to ☒ No universally-applied gold
computed tomographic (CT) virtual
Experience in Correlation to MR meet guideline inclusion standard
noncalcium technique can improve
Imaging. Radiology. 2016;280(2):510- criteria the detection rate of acute ☐ No consistently applied gold
519. doi:10.1148/radiol.2016150472 (when applicable) thoracolumbar vertebral standard
compression fractures in patients ☒ Poor reference standard/no
☐ Level V (expert with osteoporosis compared with gold standard applied
consensus) that at magnetic resonance (MR) ☐ Lacked subgroup analysis
794
imaging depending on the level of ☐ Other: Click or tap here to
☐ Level IV in presence of experience of the reading radiologist. enter text.
higher quality studies
Level of Evidence
☐ Subgroup analysis data Diagnostic test(s) studied: Determination
not available ☐ Clinical exam/history Potential Level: III
☐ Electromyography Downgraded Level: Not
☐ Not relevant to question ☐ Myelogram Downgraded
☐ MRI
Conclusions
☒ CT This study provides evidence
☐ CT/Myelogram that: bone marrow edema (as
☐☒Dual-energy CT virtual seen on virtual noncalcium
noncalcium technique DE CT) can improve detection
rates of new/acute thoraco-
Compared to: lumbar OVCF (and bone
☐ Clinical exam/history bruise) and help distinguish
☐ Electromyography from older fractures in
☐ Myelogram readers with experience with
DECT.
☒ MRI
☐ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Gold standard used? ☐ Yes ☒ No
If so, what was the gold standard?
MRIComparing CT to MRI (gold
standard)
Number of patients: 49 patients (62
fresh fractures, 52 old fractures)
Consecutively assigned? Yes
Results/subgroup analysis (relevant
to question):
528 vertebra were examined in 49
patients. Conventional CT and Duel
Energy CT were analyzed compared
to MRI. There were 5 readers.
795
For all 5 readers, accuracy of the DE
CT compared to conventional CT
incrased for all readers. (CT alone /
DECT). 0.61/0.83; 0.73/0.85;
0.81/0.92; 076/0.91; 0.81/0.95
The DECT accuracy of the reader
with least experience was in the
range of the CT alone for the most
experienced reader
Author conclusions (relative to
question): The DE CT–based virtual
noncalcium technique may enable
depiction of bone marrow edema in
thoracolumbar vertebral
compression fractures in patients
with osteoporosis, with good
accordance with MR imaging when
images are read by experienced
radiologists.
Lin HH, Chou PH, Wang ST, Yu JK, Type of Evidence: ☐ Prospective ☒ Retrospective Critique of methodology
Chang MC, Liu CL. Determination of Diagnostic Study Design: Comparative ☒ Nonconsecutive patients
the painful level in osteoporotic ☒ Small sample size
vertebral fractures--Retrospective Level III Stated objective of study: They ☒ Nonmasked reviewers
comparison between plain film, bone evaluated the findings of plain film
scan, and magnetic resonance Explanation of failure to ☒ No universally-applied gold
examination and the efficacy of bone
imaging. J Chin Med Assoc. meet guideline inclusion standard
scan and MRI to diagnose a painful
2015;78(12):714-718. criteria fracture, which is an acute fracture ☐ No consistently applied gold
doi:10.1016/j.jcma.2015.06.015 (when applicable) or chronic standard
nonunion fracture, in elderly patie ☐ Poor reference standard/no
☐ Level V (expert nts with osteoporotic vertebral gold standard applied
consensus) compression fracture.Stated ☐ Lacked subgroup analysis
objective of study: To evaluate and ☐ Other: Click or tap here to
☐ Level IV in presence of compare the findings between plain enter text.
higher quality studies film, bone scan, and MRI in the
diagnosis of new fracture in
☐ Subgroup analysis data osteoporotic vertebral fractures Level of Evidence
not available Stated objective of study: evaluated Determination
and compared the findings between Potential Level: III
plain film, bone scan, and magnetic Downgraded Level: Not
☐ Not relevant to question
resonance imaging (MRI) in the Downgraded
diagnosis of new fracture in
osteoporotic vertebral fractures. Conclusions
796
This study provides evidence
Diagnostic test(s) studied: that: vacuum sign cleft can be
☐ Clinical exam/history determined with equal
☐ Electromyography accuracy on plain x-ray or
bone scan (compared to MRI)
☐ Myelogram
especially for single-level
☒ MRI involvement. For multiple
☐ CT levels, confirmation testing
☐ CT/Myelogram with MRI is warranted.
☒ Other: routine x-rays/bone scan
Plain x-rays, bone scanX ray, bone
scanplain film + bone scan
Compared to:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Gold standard used? ☒ Yes ☒
No
If so, what was the gold standard?
MRI was used for confirmation
Number of patients: 52 patients52
who underwent plain X-ray, bone
scan and MRI52
Consecutively assigned? No
Results/subgroup analysis (relevant
to question):
Radiograph showed 79 compression
fractures. Of these, bone scan
showed 59 with increased uptate,
and MRI confirmed 45 fractures.
797
For signle level compression, the
bone scan and MRI had agreement
of 96.9% (31/32).
For multi level compression, the
bone scan and MRI agreement was
76.6%. The concordance of
radiograph and MRI was 31.9% and
bonescan to MRI was 53.5%
For vacuum cleft fractures, 15/15
(100%) agreement between bone
scan and MRI.
Author conclusions (relative to
question): For patients with single-
level compression fracture, the
painful level in osteoporotic vertebral
fractures can be determined by plain
film and bone scan testing. Vacuum
cleft sign noted on plain film may be
enough to localize the level of pain.
However, MRI testing is further
needed in multiple osteoporotic
vertebral fracture patients.
Schwaiger BJ, Gersing AS, Hammel Type of Evidence: ☐ Prospective ☒ Retrospective Critique of methodology
J, et al. Three-material decomposition Diagnostic Study Design: Comparative ☒ Nonconsecutive patients
with dual-layer spectral CT compared ☒ Small sample size
to MRI for the detection of bone Level III Stated objective of study: To assess ☐ Nonmasked reviewers
marrow edema in patients with acute whether bone marrow edema in
vertebral fractures. Skeletal Explanation of failure to ☒ No universally-applied gold
patients with acute vertebral
Radiology.47(11):1533-1540. meet guideline inclusion standard
fractures can be accurately
criteria diagnosed based on three-material ☐ No consistently applied gold
(when applicable) decomposition with dual-layer standard
spectral CT (DLCT). ☐ Poor reference standard/no
☐ Level V (expert gold standard applied
consensus) Diagnostic test(s) studied: ☐ Lacked subgroup analysis
☐ Clinical exam/history ☐ Other: Click or tap here to
☐ Level IV in presence of ☐ Electromyography enter text.
higher quality studies ☐ Myelogram
Level of Evidence
☐ MRI
☐ Subgroup analysis data Determination
☒ CT Potential Level: III
not available
798
☐ CT/Myelogram Downgraded Level: Not
☐ Not relevant to question ☒ Other: Duel-layer spectral CT Downgraded
scans
Conclusions
Compared to: This study provides evidence
that: bone marrow edema
☐ Clinical exam/history
detectionon dual-layer
☐ Electromyography spectral CT (DLCT) can be
☐ Myelogram achieved with near similar
☒ MRI accuracy as MRI in patients
☐ CT with thoracolumbar OVCF.
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Gold standard used? ☒ Yes ☒
No
If so, what was the gold standard?
MRI
Number of patients: 27
Consecutively assigned? YesNo
Choose an item.
Results/subgroup analysis (relevant
to question):
MRI vs conventional CT vs DLCT
results:
1. Acute fractures = 41 (70%) on
MRI (edema-like signal) vs 31/30
(conv CT) vs 38/39 (DLCT) [rad
1/rad 2)
-Conv CT: Sensitivity =73-76%;
Specficity =78-83%
-DLCT: Sensitivity= 93-95%; Sp. =
89%
-Increase in accuracy from conv CT
to DLCT: 76% to 92-93%
For non-acute fratures, seen as no-
edema like signal of MRI:
1. N for MRI = 18
2. N for Conv CT = 4/3 (radiologist
799
1/rad2)
3. N for DLCT = 16
Author conclusions (relative to
question): Material decomposition of
DLCT data substantially improved
accuracy for the diagnosis of acute
vertebral fractures, with a high
interreader agreement. This may
spare patients additional
examinations and facilitate the
diagnosis of vertebral fractures.
800
Interventional Treatment Section
Interventional Treatment Question 1: Do steroid and/or anesthetic injections improve outcomes in patients with acute osteoporotic vertebral compression
fractures?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Cheng Y, Wu X, Shi J, Jiang H. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Percutaneous Vertebroplasty and Therapeutic ☐ Nonconsecutive patients
Facet Blocking for Treating Back Study Design: Comparative ☐ Nonrandomized
Pain Caused by Osteoporotic Level III ☐ Nonmasked reviewers
Vertebral Compression Stated objective of study: purpose ☒ Nonmasked patients
Fracture. Pain Res Manag. of this retrospective study was to
2020;2020:5825317. Published 2020 Explanation of failure to meet compare the treatment effects of ☐ No validated outcome
Aug 11. doi:10.1155/2020/5825317 guideline inclusion criteria PVP and FB combined therapy with measures used
(when applicable) PVP alone in OVCFs patients ☐ Small sample size
☐ <80% follow-up
☐ Level V (expert Type of treatment(s): PVP vs PVP ☐ Lacked subgroup analysis
consensus) + FB ☐ Diagnostic method not
stated
☐ Level IV in presence of Total number of patients: 204 ☐ Other: Click or tap here to
higher quality studies Number of patients in enter text.
relevant subgroup(s): 125 group A
☐ Subgroup analysis data not vs 79 in group B Level of Evidence
available Determination
Consecutively assigned? Yes Potential Level: III
☐ Not relevant to question Downgraded Level: Not
Duration of follow-up: 12 months. Downgraded
Validated outcome measures used Conclusions
(list): VAS and ODI This paper provides evidence
that: facet blocks in addition
Nonvalidated outcome measures to PVP can offer more pain
used (list): X-ray findings , DEXA improvement up to 3 months
scan. after the procedure as
compared to PVP alone.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
801
☒ Other: X-ray
Results/subgroup analysis:
Group A (PVP) Group B (PVP+FB)
For both groups VAS significantly
decreased after intervention,
VAS at 1 day, 3 months, 12 month
(group A / group B)
4.7/3.2; 4.0/3.0/; 2.2/2.2
VAS showed greater improvement
at day 1 and 3 months for group B
compared to group A with no
differenct at 12 months.
Author conclusions: PVP and FB
combined therapy could provide
better pain relief than PVP alone in
short term after operation in
patients with OVCFs associated
back pains.
Wang B, Guo H, Yuan L, Huang D, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Zhang H, Hao D. A prospective Therapeutic ☐ Nonconsecutive patients
randomized controlled study Study Design: RCT ☐ Nonrandomized
comparing the pain relief in patients Level I ☒ Nonmasked reviewers
with osteoporotic vertebral Stated objective of study: To ☒ Nonmasked patients
compression fractures with the use of compare the clinical and
vertebroplasty or facet blocking. Eur Explanation of failure to meet radiological out- comes of patients ☐ No validated outcome
Spine J. 2016;25(11):3486-3494. guideline inclusion criteria undergoing percutaneous measures used
doi:10.1007/s00586-016-4425-4 (when applicable) vertebroplasty (PVP) versus those ☐ Small sample size
undergoing facet blocking (FB) for ☐ <80% follow-up
☐ Level V (expert severe pain due to osteoporotic ☐ Lacked subgroup analysis
consensus) vertebral compression fractures ☐ Diagnostic method not
(OVCFs). stated
☐ Level IV in presence of ☒ Other: First, a sham (fake
higher quality studies Type of treatment(s): PVP vs Facet procedure) control arm was
Blocks; Bilateral FB block with missing in the study design,
☐ Subgroup analysis data not mixture of prednisolone(125 mg:5 which prevented us from
available mL) and lidocaine (100 mg:5 mL) distinguishing the potential
was injectedunder fluoroscopic confounding placebo effect
monitoring
☐ Not relevant to question from the true efficacy of FB or
VP uni or bilateral
802
PVP. No medical comparison
Total number of patients: 217 vs. group
206
Number of patients in relevant Level of Evidence
subgroup(s):PVP group Determination
(100patients) or the FB group (106 Potential Level: I
patients) Downgraded Level: Not
Downgraded
Consecutively assigned? Yes
Conclusions
Duration of follow-up: 12 months This paper provides evidence
that: percutaneous
Validated outcome measures used vertebroplasty is superior to
(list): VAS, ODI and RMD, SF-36 facet block in short term pain
relief on functional outcome
Nonvalidated outcome measures up to 1-month post-
used (list): Standard questionnaires, procedure but no long-term
including additional questions difference.
related to pain treatment, hospital
stay, outpatient visits, and medical
aids.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☐ Other: dxa, Xray, BMD
Results/subgroup analysis:
The VAS, ODI, RMD were lower at
1 day and 1 week post intervention
for PVP compared to FB.
At 1, 3, 6, 12 months post
procedure, the scores were not
significantly different between the
two groups.
803
Author conclusions: PVP produced
better pain relief than FB in the
short term (B1 week). However, the
difference in pain- relief between
these two techniques was
insignificant in the long term (follow-
up between 1 month and 12 months
Interventional Treatment Question 2: What is the risk of treating multiple vertebral levels at one time, for patients with multi-level osteoporotic vertebral
compression fractures?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Chen L, Yang H, Tang T. Unilateral Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
versus bilateral balloon kyphoplasty Therapeutic ☐ Nonconsecutive patients
for multilevel osteoporotic vertebral Study Design: RCT ☐ Nonrandomized
compression fractures: a prospective Level II
☐ Nonmasked reviewers
study. Spine (Phila Pa 1976). Stated objective of study: To examine
2011;36(7):534-540. Explanation of failure to meet ☐ Nonmasked patients
and compare the safety and long-term
doi:10.1097/BRS.0b013e3181f99d7 guideline inclusion criteria
radiographic and clinical effects of ☐ No validated outcome measures
0 (when applicable) unilateral or bilateral balloon used
kyphoplasty to treat multilevel ☒ Small sample size
☐ Level V (expert consensus) symptomatic vertebral compression ☐ <80% follow-up
fractures ☒ Lacked subgroup analysis
☐ Level IV in presence of ☐ Diagnostic method not stated
higher quality studies Type of treatment(s): Unilateral or ☐ Other: Click or tap here to enter text.
bilateral kyphoplasty with Kyphon
☐ Subgroup analysis data not Level of Evidence Determination
available Total number of patients: 49 with 114 Potential Level: I
OVCF Downgraded Level: II
Number of patients in
☐ Not relevant to question Downgraded due to: Low sample size
relevant subgroup(s): 24 Unilateral, and lack of subgroup analysis.
25 bilateral
Conclusions
804
Consecutively assigned? Yes This paper provides evidence
that: multiple OVCF can be treated
Duration of follow-up: min. 2 years, simultaneously with a low risk of
mean 33.5 months significant adverse events. There
was no significant difference in
Validated outcome measures used clinical or radiological effects in
(list): VAS pain scores, and 36-Item patients undergoing multilevel,
Short Form Health Survey scores unilateral or bilateral kyphoplasty for
OVCF.
Nonvalidated outcome measures used
(list): Back disability instrument, back
dysfunction, kyphotic angle
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: x ray, Radiographs
Results/subgroup analysis:
Clinical outcome: VAS (pre / 2 weeks
/ final )
Unilateral: 7.8/2.7/3.1
Bilateral: 7.9/2.3/2.7
No final VAS significant difference
between the two groups.
Radiographic outcome:
Increase in anterior and middle
vertebral heights in both group with no
significant difference between the two
groups.
Author conclusions: Both unilateral
and bilateral kyphoplasty markedly
improve symptom-related clinical
effects of multilevel vertebral
compression fractures and result in
signifi cant vertebral height restoration
and kyphosis correction that remains
805
stable for at least 2 years after
treatment.
Ren HL, Jiang JM, Chen JT, Wang Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
JX. Risk factors of new symptomatic Therapeutic ☐ Nonconsecutive patients
vertebral compression fractures in Study Design: Case Series ☐ Nonrandomized
osteoporotic patients undergone Level IV
☒ Nonmasked reviewers
percutaneous vertebroplasty. Eur Stated objective of study: This study
Spine J. 2015;24(4):750-758. Explanation of failure to meet evaluated the risk factors of new ☐ Nonmasked patients
doi:10.1007/s00586-015-3786-4 guideline inclusion criteria vertebral compression fractures ☒ No validated outcome measures
(when applicable) (VCFs) following percu- taneous used
vertebroplasty (PVP) ☐ Small sample size
☐ Level V (expert consensus) ☐ <80% follow-up
Type of treatment(s): Percutaneous ☐ Lacked subgroup analysis
☐ Level IV in presence of vertebroplasty. ☐ Diagnostic method not stated
higher quality studies ☐ Other: Click or tap here to enter text.
Total number of patients: 182
☐ Subgroup analysis data not Number of patients in Level of Evidence Determination
available relevant subgroup(s): A total of 182 Potential Level: III
patients met the inclusion criteria; 102 Downgraded Level: Not Downgraded
had1-level fractures, 54 had 2-level
☐ Not relevant to question
fractures, and 26 hadC3- Conclusions
level fractures. This paper provides evidence that:
the incidence of new symptomatic
Consecutively assigned? Yes osteoporotic vertebral compression
fractures after percutaneous
Duration of follow-up: 24-50 months vertebroplasty was higher in
osteoporotic patients with initial
Validated outcome measures used multiple level fractures. The number
(list): New onset OVCF confirmed by of initial symptomatic fractures was
Xray and MRI, vert height and an important risk factor for new
kyphosis vertebral compression fractures.
However, whether the risk of onset of
Nonvalidated outcome measures used new fractures was a function of the
(list): Age, sex, bone, mineral density, number of levels involved initially or
body mass index, amount of bone specifically a result of the
cement, cement leakage into the disc, augmentation of these multiple levels
preoperative kyphosis, pre-operative fractures is unclear. No
degree of anterior vertebral intraoperative or postoperative
compression, pre-operative degree of cardiovascular or cerebrovascular
middle vertebral compression, events or pulmonary embolism
kyphosis correction, anterior vertebral events were reported in patients with
height restoration, middle vertebral multiple level fractures.
height restoration, and number of
806
initial symptomatic fracture levels
treated.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☒ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Xray, Radiographs
Results/subgroup analysis:
Of 182 patients with initial fractures for
treatment, 102 had one level fracture,
54 had 2 level fractures, 26 had >= 3
level fractures.
Incidence of new fractures were 9/102
(7.8%) in one level fracture group,
7/54 (11.1%) in two level fracture
group and 12/26 (26.9%) in >=3 level
fracture group.
28 new fractures occurred among all
patients. 21/28(78.6%) new fractures
occurred in non-adjacent and
6/28(21.4%) in adjacent vertebrae.
Author conclusions: The incidence of
new symptomatic VCFs after PVP
was higher in osteoporotic patients
with initial multiple-level fractures. The
number of initial symptomatic
fractures was
an important risk factor for new VCFs.
Zhai W, Jia Y, Wang J, et al. The Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
clinical effect of percutaneous Therapeutic ☒ Nonconsecutive patients
kyphoplasty for the treatment of Study Design: Case Series ☐ Nonrandomized
multiple osteoporotic vertebral Level IV ☒ Nonmasked reviewers
compression fractures and the
☐ Nonmasked patients
807
prevention of new vertebral Stated objective of study: to ☐ No validated outcome measures
fractures. Int J Clin Exp Med. Explanation of failure to meet investigate the clinical effect of used
2015;8(8):13473-13481. Published guideline inclusion criteria percutaneous kyphoplasty and the ☐ Small sample size
2015 Aug 15. (when applicable) precautions against adjacent vertebral
☐ <80% follow-up
refractures in the treatment of multiple
☐ Lacked subgroup analysis
☐ Level V (expert consensus) osteoporotic vertebral compression
fractures. ☐ Diagnostic method not stated
☐ Level IV in presence of ☐ Other: Click or tap here to enter text.
higher quality studies Type of treatment(s): kyphoplasty
Level of Evidence Determination
Total number of patients: 54 patients Potential Level: IV
☐ Subgroup analysis data not
Number of patients in Downgraded Level: Not Downgraded
available
relevant subgroup(s): (36- 2 levels,
16- 3 levels, 2- 4 levels) Conclusions
☐ Not relevant to question This paper provides evidence that: in
Consecutively assigned? No patients with OVCF percutaneous
kyphoplasty is safe and effective for
Duration of follow-up: 3-33 months multiple levels.
(mean 12)
Validated outcome measures used
(list): VAS, ODI
Nonvalidated outcome measures used
(list): Click or tap here to enter text.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xray, Radiographs
Results/subgroup analysis:
54 patients (128 vertebra) were
treated with PKP. Of the 128 vertebra
treated, there was cement leakage in
23 vertebra (2 into spinal canal
without symptoms, 3 into
intervertebral disc, 8 into paraspinal
808
soft tissue, 9 into paravertebral
vessels, 1 into puncture channel).
There were 8 patients with new
fractures post PKP, 3 in continguous
vertebfra and 5 in interval vertebra,
with incidence rate of 14.8%.
Author conclusions: percutaneous
kyphoplasty is safe and effective to
treat multiple osteoporotic vertebral
compression fractures. However, the
risk of new adjacent vertebral
fractures in the multiple osteoporotic
vertebral compression fractures is
higher than that in the single
osteoporotic vertebral compression
fracture. Timely and proper treatment
can reduce refractures
Zidan I, Fayed AA, Elwany A. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Multilevel Percutaneous Therapeutic ☒ Nonconsecutive patients
Vertebroplasty (More than Three Study Design: Case Series ☒ Nonrandomized
Levels) in the Management of Level IV
☒ Nonmasked reviewers
Osteoporotic Fractures. J Korean Stated objective of study: This study ☒ Nonmasked patients
Neurosurg Soc. 2018;61(6):700-706. Explanation of failure to meet was done to evaluate the usefulness
doi:10.3340/jkns.2017.0253 guideline inclusion criteria and safety of multilevel PV (more than ☒ No validated outcome measures
(when applicable) three vertebrae) in management of used
osteoporotic fractures ☒ Small sample size
☐ Level V (expert consensus) ☐ <80% follow-up
Type of treatment(s): Percutaneous ☐ Lacked subgroup analysis
☐ Level IV in presence of vertebroplasty ☐ Diagnostic method not stated
higher quality studies ☐ Other: Click or tap here to enter text.
Total number of patients: 40 (194
☐ Subgroup analysis data not levels) Level of Evidence Determination
available Number of patients in Potential Level: IV
relevant subgroup(s): 40 (16- 4 Downgraded Level: Not Downgraded
levels, 14- 5 levels, 10- 6 levels)
☐ Not relevant to question
Conclusions
Consecutively assigned? NoYes This paper provides evidence that:
Duration of follow-up: Mean 21.7 multilevel percutaneous
months (12-40) vertebroplasty for the treatment of
osteoporotic fractures is a safe and
successful procedure that can
809
Validated outcome measures used significantly reduce pain and
(list): VAS improve patient’s condition without a
significant morbidity. 10% developed
Nonvalidated outcome measures used new fracture requiring second
(list): Click or tap here to enter text. vertebroplasty. One patient
developed symptomatic pulmonary
Diagnosis made by: embolism with satisfactory recovery.
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xrays, Radiographs
Results/subgroup analysis:
Of the 40 patients with multi-level
treatment (more than 3 levels),
asymptomatic leakage occurred in 12
(30%) patients. One patient had
symptomatic pulmonary embolism.
Significant pain relief occurred in 36
(90%) patients.
4/40 (10%) had new fracture after
treatment which required additional
PKP.
Author conclusions:
Multilevel PV for the treatment of o
steoporotic fractures is a safe and
successful procedure that can signif
icantly reduce pain and improve
patient’s condition without a significant
morbidity. It is considered a cost
effective procedure allowing a rapid
restoration of patient mobility.
Interventional Treatment Question 3: Does vertebral augmentation improve outcomes in patients with acute osteoporotic vertebral compression fractures
compared to medical therapy?
810
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Balkarli H, Kilic M, Balkarli A, Erdogan M. An Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
evaluation of the functional and radiological Therapeutic ☒ Nonconsecutive patients
results of percutaneous vertebroplasty Study Design: Comparative ☒ Nonrandomized
versus conservative treatment for acute Level III
☒ Nonmasked reviewers
symptomatic osteoporotic spinal Stated objective of study: to
☒ Nonmasked patients
fractures. Injury. 2016;47(4):865-871. compare the results of the two
doi:10.1016/j.injury.2016.01.041 Explanation of failure to ☐ No validated outcome
different treatment regimens
meet guideline inclusion (percutaneous vertebroplasty (PV) measures used
criteria and conservative treatment (CT)) ☐ Small sample size
(when applicable) regarding to efficacy, quality of life, ☐ <80% follow-up
functional and radiological results ☐ Lacked subgroup
☐ Level V (expert in patients with acute osteoporotic analysis
consensus) vertebral compression fractures ☐ Diagnostic method not
(OVF). stated
☐ Level IV in presence of ☐ Other: Selection criteria
higher quality studies Type of treatment(s):
for PVP Vs CT ot stated
Percutaneous vertebroplasty or
☐ Subgroup analysis data conservative treatment
Level of Evidence
not available Determination
Total number of patients: 83
Potential Level: III
Number of patients in relevant
☐ Not relevant to question Downgraded Level: Not
subgroup(s): 46 -PVP and 37
Downgraded
medical
Conclusions
Consecutively assigned? YesNo
This paper provides
evidence that: vertebral
Duration of follow-up: 6 months
augmentation provides
improved pain control
Validated outcome measures used
and function for the
(list): VAS, ODI, Cobb’s angle,
acute/subacute period in
vertebral height
the first 3 months
following surgery but
Nonvalidated outcome measures
there is no long-term
used (list): radiographic eval, Mid-
difference in outcomes at
line vertebral corpus height and
6 months.
local sagittal Cobb’s angle
measured on lateral radiographs.
Diagnosis made by:
811
☒ Clinical exam/history
☐ Electromyography
☒ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xray, Radiographs
Results/subgroup analysis: When
VAS of the CT
group at the 1st and 3rd months
were compared with VAS scores of
the PVP group at the 1st and 3rd
months, the PVP group was
observed to be statistically
significant in reducing pain.
However, there was no statistical
difference between groups when
VAS at the 6th month were
compared (p = 0.614) There was a
significant decrease in ODI
score at the end of the 1st month in
the PVP group (p < 0.001). The
ODI scores were significantly lower
in the PVP group than the CT
group in the 1st and 3rd month
controls (p < 0.05). However, there
was no statistically significant
difference between treatment
groups when ODI scores of both
groups at the 6th month were
compared (p = 0.341)
There was an increase in LSCA
and a significant decrease
in MVCH in the CT group when the
6th month values were compared
with the PVP group (p < 0.05)
812
Author conclusions: Compared to
the CT group, PV provides a rapid
decrease of pain and an early
return to daily life activities.
Although improvement was
observed on the radiological
findings following treatment in the
PV group, PV may not enhance the
quality of life in patients with acute
OVF at 6th months follow up
813
Blasco J, Martinez-Ferrer A, Macho J, et al. Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Effect of vertebroplasty on pain relief, quality Therapeutic ☒ Nonconsecutive patients
of life, and the incidence of new vertebral Study Design: RCT ☐ Nonrandomized
fractures: a 12-month randomized follow-up, Level II
☒ Nonmasked reviewers
controlled trial. J Bone Miner Res. Stated objective of study: to
☒ Nonmasked patients
2012;27(5):1159-1166. compare the effects of VP versus
doi:10.1002/jbmr.1564’ Explanation of failure to ☐ No validated outcome
conservative treatment on the
meet guideline inclusion quality of life and pain in patients measures used
criteria with painful osteoporotic vertebral ☐ Small sample size
(when applicable) fractures new fractures and ☒ <80% follow-up
secondary adverse effects were ☐ Lacked subgroup
☐ Level V (expert also analyzed during a 12-month analysis
consensus) follow-up period ☐ Diagnostic method not
stated
☐ Level IV in presence of Type of treatment(s): Perc ☒ Other: no concealment
higher quality studies Vertebroplasty
Conservative therapy consisted of
Level of Evidence
☐ Subgroup analysis data analgesics with a standardized
Determination
not available format and nasal calcitonin (first
Potential Level: I
month). We offered rescue therapy
Downgraded Level: II
by intrathecal infusion (25mg
☐ Not relevant to question Downgraded due to:
fentanyl and 1.5 mgbupivacaine)
when treatment was ineffective
Conclusions
(VAS7) or onintolerance to drug
This paper provides
therapy.
evidence that:
Total number of patients: 125
vertebroplasty and
Number of patients in relevant
medical management
subgroup(s): 64 VP 61
provide similar
conservative
significant improvement
in pain and quality of life
Consecutively assigned? YesNo
in patients with painful
osteoporotic vertebral
Duration of follow-up: 1 year
fractures over a 1-year
follow up period with no
Validated outcome measures used
statistically significant
(list): Quality of Life Questionnaire
differences in mortality
of the European Foundation for
between the two groups.
Osteoporosis [Qualeffo-41] and
Vertebroplasty provided
pain (Visual Analogue Scale [VAS]
greater pain relief 2
months after treatment,
814
Nonvalidated outcome measures but was associated with
used (list): analgesic consumption, an increase in new
clinical complications, and vertebral fractures.
radiological vertebral fractures at Intrathecal infusion of
the same time points bupivacaine and fentanyl
was administered to
Diagnosis made by: patients if standard
☒ Clinical exam/history analgesic medications
☐ Electromyography were ineffective or not
tolerated in the
☐ Myelogram
conservative care group
☒ MRI
or pain improvement was
☒ CT inadequate in VP group.
☐ CT/Myelogram This rescue therapy was
☒ Other: Radiographs, bone required only in 3
densitometry, blood analysis patients in VP group
including bone metabolism compared to 15 in the CC
parameters, x-ray group
Results/subgroup analysis:
At 2 month the VAS score
improvement was greater in vP
group compared to CT group. AT
12 months the residual pain was
similar between the two groups.
Intrathecal bupivacaine and
fentanyl was given as rescue
therapy in 3 PV group and 15
medical therapy group.
The PV group had 2.78 fold more
new compression fractures
compared to the medical therapy
group.
Author conclusions: VP and
conservative treatment are both
associated with significant
improvement in pain and quality
of life in patients with painful
815
osteoporotic VF over a 1-year
follow-up period with no statistically
significant differences in
mortality between the two groups.
Patients treated with VP
showed greater pain relief 2
months after treatment, although it
was associated with an increase in
new VF.
816
Bornemann R, Hanna M, Kabir K, Goost H, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Wirtz DC, Pflugmacher R. Continuing Therapeutic ☐ Nonconsecutive patients
conservative care versus crossover to Study Design: Comparative ☒ Nonrandomized
radiofrequency kyphoplasty: a comparative Level II
☒ Nonmasked reviewers
effectiveness study on the treatment of Stated objective of study: Compare
☒ Nonmasked patients
vertebral body fractures. Eur Spine J. radiofrequency kyphoplasty to
2012;21(5):930-936. doi:10.1007/s00586- Explanation of failure to ☐ No validated outcome
conservative care and assess the
012-2148-8 meet guideline inclusion usual algorithm of starting all measures used
criteria patients on conservative carefor 6 ☒ Small sample size
(when applicable) weeks before offering surgery. ☐ <80% follow-up
☐ Lacked subgroup
☐ Level V (expert Type of treatment(s): analysis
consensus) Radiofrequency kyphoplasty and ☐ Diagnostic method not
conservative care. stated
☐ Level IV in presence of ☒ Other: No long term
higher quality studies Total number of patients: 67
follow up.
Number of patients in relevant
☐ Subgroup analysis data subgroup(s): 34 conservative
Level of Evidence
not available management, 33 surgical
Determination
Potential Level: II
Consecutively assigned? Yes
☐ Not relevant to question Downgraded Level: Not
Downgraded
Duration of follow-up: 12 weeks
Conclusions
Validated outcome measures used
This paper provides
(list): VAS and ODI
evidence that:
Nonvalidated outcome measures
vertebral augmentation
used (list): Click or tap here to
provides significant
enter text.
improvement in pain and
function for patients who
Diagnosis made by:
are unresponsive to 6
☒ Clinical exam/history weeks of medical
☐ Electromyography management.
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xray, Radiograph
817
Results/subgroup analysis: total of
67 patients and 100 fracture levels
all had medical management for 6
weeks. After 6 weeks, only 1 of 65
met criteria of clinical success.
After 12 weeks, in the medical
management group 5/38 met
criterial of clinical success with
medial VAS improvement of 1. The
kyphoplasty group showed 31/33
met the criteria for clinical success
with medial VAS improvement of 5.
Author conclusions: For the vast
majority of patients with a VAS C5,
conservative care did not provide
meaningful clinical improvement. In
contrast, nearly all patients who
under- went radiofrequency
kyphoplasty had rapid substantial
improvement. Surgery was clearly
much more effective than
conservative care and should be
offered to patients much sooner.
818
Colangelo D, Nasto LA, Genitiempo M, et al. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Kyphoplasty vs conservative treatment: a Therapeutic ☒ Nonconsecutive patients
case-control study in 110 post-menopausal Study Design: Case Control ☒ Nonrandomized
women population. Is kyphoplasty better Level III
☒ Nonmasked reviewers
than conservative treatment?. Eur Rev Med Stated objective of study: The aim
☒ Nonmasked patients
Pharmacol Sci. 2015;19(21):3998-4003. of this study is to compare effects
Explanation of failure to ☐ No validated outcome
in
meet guideline inclusion terms of recovery and quality of life measures used
criteria and to compare ☐ Small sample size
(when applicable) deformity prevention efficacy of ☐ <80% follow-up
kyphoplasty ☐ Lacked subgroup
☐ Level V (expert and conservative treatment in post- analysis
consensus) menopausal ☐ Diagnostic method not
women with an osteoporotic VCF stated
☐ Level IV in presence of and to provide ☐ Other: Click or tap here
higher quality studies an efficacy assessment of
to enter text.
kyphoplasty as compared
☐ Subgroup analysis data with standard conservative
Level of Evidence
not available treatment in
Determination
post-menopausal women
Potential Level: III
☐ Not relevant to question Downgraded Level: Not
Type of treatment(s): Kyphoplasty
Downgraded
compared to conservative care.
Conclusions
Total number of patients: 110
This paper provides
Number of patients in relevant
evidence that:
subgroup(s): 52 kyphoplasty 58
conservative
Kyphoplasty offers better
pain relief and functional
Consecutively assigned? YesNo
outcomes in short term
with effect waning at 12
Duration of follow-up: 12 months
months. Kyphoplasty,
performed early, can
Validated outcome measures used
improve segmental
(list): VAS, SF-12, and EQ5D
alignment.
Nonvalidated outcome measures
used (list):
Diagnosis made by:
☒ Clinical exam/history
819
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xrays
Results/subgroup analysis:
110 patients 52 kyphoplasty and 58
conservative treatement
At 1 months, VAS decreased 5.52
for kyphoplasty compared to 2.13
for conservative group. At 12
months, there was no statistically
significant difference between VAS
for the two groups.
EQ5D quality of life measurement
showed greater improvement in
kyphoplasty group. At 12 months
the quality of life score was similar
between the two groups.
The kyphoplasty group has slightly
greater improvement for physical
and mental schores measured by
SF-12 at 1 and 3 months.
Author conclusions: Kyphoplasty is
a modern minimal invasive surgery,
allowing faster recov- ery than
bracing treatment. It can avoid the
de- formity in kyphosis due to VCF.
In fact, the risk to develop a new
vertebral fracture after the first one
is very high.
820
Diamond TH, Bryant C, Browne L, Clark WA. Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Clinical outcomes after acute osteoporotic Therapeutic ☒ Nonconsecutive patients
vertebral fractures: a 2-year non-randomised Study Design: Comparative ☒ Nonrandomized
trial comparing percutaneous vertebroplasty Level II
☒ Nonmasked reviewers
with conservative therapy. Med J Aust. Stated objective of study: To
☒ Nonmasked patients
2006;184(3):113-117. doi:10.5694/j.1326- assess the safety and efficacy of
5377.2006.tb00148.x Explanation of failure to ☐ No validated outcome
percutaneous vertebroplasty for the
meet guideline inclusion treatment of acute osteoporotic measures used
criteria vertebral fractures. ☐ Small sample size
(when applicable) ☐ <80% follow-up
Type of treatment(s): ☐ Lacked subgroup
☐ Level V (expert Percutaneous vertebroplasty or analysis
consensus) conservative care. ☐ Diagnostic method not
stated
☐ Level IV in presence of Total number of patients: 126 ☐ Other: Click or tap here
higher quality studies Number of patients in relevant
to enter text.
subgroup(s): 88 VP, 38
☐ Subgroup analysis data conventional therapy
Level of Evidence
not available Determination
Consecutively assigned? YesNo
Potential Level: II
☐ Not relevant to question Downgraded Level: Not
Duration of follow-up: 2 years
Downgraded
Validated outcome measures used
Conclusions
(list): Fracture-related
This paper provides
complications, visual analoge pain
evidence that:
scale, and level of function with
vertebroplasty provided
Barthel Index
improved pain control
and function for first 6
Nonvalidated outcome measures
weeks.
used (list): LOS, death, rads
parameters, new fractures,
radiology and survival at 2 years
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
821
☐ CT/Myelogram
☒ Other: Xrays, Bone
densitometry and spinal
radiography
Results/subgroup analysis:
Within 24 hours, vertebroplasty
group showed 60% decrease in
pain scores and 29% improvement
in physical function, whereas
conservative group showed no
change. Up to 6 weeks lower pain
scores persisted for vertebroplasty
group. At 6-12 months and 24
months, there was no difference
between the two groups.
Vertebroplasty group had three
minor complications of fractured
pedicle and psoas muscle
hemorrhage.
40 new fractures occurred in 30
patients. There was no significant
differenc in the risk of new fractures
between the two groups.
Author conclusions: The analgesic
benefit of percutaneous
vertebroplasty and the low
complication rates suggest that it is
a useful therapy for acute painful
osteoporotic vertebral fractures
822
Diamond TH, Champion B, Clark WA. Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Management of acute osteoporotic vertebral Therapeutic ☐ Nonconsecutive patients
fractures: a nonrandomized trial comparing Study Design: Comparative ☒ Nonrandomized
percutaneous vertebroplasty with Level III
☒ Nonmasked reviewers
conservative therapy. Am J Med. Stated objective of study:determine
☒ Nonmasked patients
2003;114(4):257-265. doi:10.1016/s0002- whether percutaneous
9343(02)01524-3 Explanation of failure to ☐ No validated outcome
vertebroplasty—which involves the
meet guideline inclusion injection of cement to sta- bilize a measures used
criteria fractured vertebral body—may be ☐ Small sample size
(when applicable) an effective treatment for vertebral ☐ <80% follow-up
fracture. ☐ Lacked subgroup
☐ Level V (expert analysis
consensus) Type of treatment(s): ☐ Diagnostic method not
Percutaneous vertebroplasty or stated
☐ Level IV in presence of conservative care. ☒ Other: unequal group
higher quality studies sizes
Total number of patients: 79
☐ Subgroup analysis data Number of patients in relevant
Level of Evidence
not available subgroup(s): 55 VP, 24
Determination
conservative
Potential Level: II
☐ Not relevant to question Downgraded Level: III
Consecutively assigned? Yes
Downgraded due to
disparity in group sizes.
Duration of follow-up: 12 months
Conclusions
Validated outcome measures used
This paper provides
(list): VAS, Barthel index level of
evidence that:
function
Vertebroplasty is more
effective for pain relief
Nonvalidated outcome measures
and functional
used (list): Complications
improvement than
medical management
Diagnosis made by:
throughout the course of
☒ Clinical exam/history treatment with more
☐ Electromyography statistically significance
☐ Myelogram at 24 hours but less at 6
☒ MRI weeks.
☒ CT
☐ CT/Myelogram
823
☒ Other: Xrays, bone
densitometry
Results/subgroup analysis:
24 hours after vertebroplasty there
was 53% decrease in pain and
29% improvement in physical
function with no change in the
conservative group. 24% of
vertebroplasty group was able to
stop all analgesics compared to
none in the conservative group.
At 6 weeks and 6-12 months, the
cliical outcomes were similar in
both vertebroplasty and
conservative groups.
Author conclusions: When
compared with conservative
therapy, percutaneous
vertebroplasty results in prompt
pain relief and rapid rehabilitation.
In experienced hands, it is a safe
and effec- tive procedure for
treating acute osteoporotic
vertebral com- pression fractures
824
Faloon MJ, Ruoff M, Deshpande C, et al. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Risk Factors Associated with Adjacent and Therapeutic ☐ Nonconsecutive patients
Remote- Level Pathologic Vertebral Study Design: Comparative ☒ Nonrandomized
Compression Fracture Following Balloon Level III
☐ Nonmasked reviewers
Kyphoplasty: 2-Year Follow-Up Comparison Stated objective of study: Compare
☒ Nonmasked patients
Versus Conservative Treatment. J Long balloon kyphoplasty and
Term Eff Med Implants. 2015;25(4):313-319. Explanation of failure to ☒ No validated outcome
conservative care for vertebral
doi:10.1615/jlongtermeffmedimplants.20150 meet guideline inclusion compression fractures measures used
13971 criteria ☐ Small sample size
(when applicable) Type of treatment(s): Balloon ☐ <80% follow-up
kyphoplasty and conservative care. ☐ Lacked subgroup
☐ Level V (expert analysis
consensus) Total number of patients: 258 ☐ Diagnostic method not
Number of patients in relevant stated
☐ Level IV in presence of subgroup(s): 121 treated ☐ Other: Click or tap here
higher quality studies nonoperatively and 137 underwent
to enter text.
treatment
☐ Subgroup analysis data Level of Evidence
not available Consecutively assigned? Yes
Determination
Potential Level: III
Duration of follow-up: 2 years
☒ Not relevant to question Downgraded Level: Not
Downgraded
Validated outcome measures used
(list): Click or tap here to enter
Conclusions
text.
This paper provides
evidence that: patients
Nonvalidated outcome measures
treated with balloon
used (list): Secondary fracture rate
kyphoplasty had less
vertebral compression
Diagnosis made by:
fractures than those
☒ Clinical exam/history treated with medical
☐ Electromyography management.
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
825
Results/subgroup analysis: 121
patients had non operative
treatement and 131 patients had
kyphoplasty. Kyphoplasty group
was older and more diabetes and
more history of smoking. 57
patients in nonoperative group had
second fractures, and 36 patients
in the kyphoplasty group had
second fractures.
Author conclusions: Patients
treated with nonoperative,
conservative management had a
2.28 times greater risk for a
subsequent VCF than patients
treated with balloon kyphoplasty
and PMMA augmentation.
826
Farrokhi MR, Alibai E, Maghami Z. Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Randomized controlled trial of percutaneous Therapeutic ☒ Nonconsecutive patients
vertebroplasty versus optimal medical Study Design: RCT ☐ Nonrandomized
management for the relief of pain and Level I
☐ Nonmasked reviewers
disability in acute osteoporotic vertebral Stated objective of study: This
☒ Nonmasked patients
compression fractures. J Neurosurg Spine. randomized controlled trial
2011;14(5):561-569. Explanation of failure to ☐ No validated outcome
compared the efficacy of
doi:10.3171/2010.12.SPINE10286. meet guideline inclusion percutaneous vertebroplasty (PV) measures used
criteria versus optimal medical therapy ☐ Small sample size
(when applicable) (OMT) in controlling pain and ☐ <80% follow-up
improving the quality of life (QOL) ☐ Lacked subgroup
☐ Level V (expert in patients with VCFs. Efficacy was analysis
consensus) measured as the incidence of new ☐ Diagnostic method not
vertebral fractures after PV, stated
☐ Level IV in presence of restoration of vertebral body height ☐ Other: Click or tap here
higher quality studies (VBH), and correction of deformity=
to enter text.
☐ Subgroup analysis data Type of treatment(s):
Level of Evidence
not available Percutaneous vertebroplasty or
Determination
optimal medical therapy.
Potential Level: I
☐ Not relevant to question Downgraded Level: Not
Total number of patients: 82
Downgraded
Number of patients in relevant
subgroup(s): 40 patients under-
Conclusions
went PV and 42 received OMT
This paper provides
evidence that: compared
Consecutively assigned? Yes
to optimal medical
treatment, Percutaneous
Duration of follow-up: 36 months
vertebroplasty had
statistically significant
Validated outcome measures used
improvements in pain
(list): VAS, ODI, Vertebral body
relief and QOL that was
height, sagittal index.
maintained for 2 years
with sustained
Nonvalidated outcome measures
improvements in
used (list): Radiological evaluation
vertebral body height
to measure VBH and sagittal index
corrections in spine
deformity after 3 years,
Diagnosis made by:
and had fewer adjacent-
☒ Clinical exam/history level fractures.
☐ Electromyography
827
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xrays, Radiographs
Results/subgroup analysis:
82 patients were randomized into
the two groups. The VAS
decreased in the vertebroplsty
group from 8.4 to 3.3 at 1 week,
where for medical treatment group
it decreased from 7.22 to 6.4.
There was significant improvement
in QOL in vertebroplsty group
immediately after procedure
reaching maximum at 6 months,
with no significant improvement in
the medical treatment group.
Author conclusions: PV group had
statistically significant
improvements in visual analog
scale and QOL scores maintained
over 24 months, improved VBH
maintained over 36 months, and
fewer adjacent-level fractures
compared with the OMT group.
Jin C, Xu G, Weng D, Xie M, Qian Y. Impact Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
of Magnetic Resonance Imaging on Therapeutic ☐ Nonconsecutive patients
Treatment-Related Decision Making for Study Design: RCT ☐ Nonrandomized
Osteoporotic Vertebral Compression Level II
☒ Nonmasked reviewers
Fracture: A Prospective Randomized Stated objective of study: aim of
☒ Nonmasked patients
Trial. Med Sci Monit. 2018;24:50-57. this study was to analyze the
Published 2018 Jan 3. Explanation of failure to ☐ No validated outcome
impact and usefulness of
doi:10.12659/msm.905729 meet guideline inclusion characteristic signal change ofa measures used
criteria linear black signal on magnetic ☒ Small sample size
(when applicable) ☒ <80% follow-up
828
resonance imaging (MRI) on ☐ Lacked subgroup
. ☐ Level V (expert treatment-related decision making analysis
consensus) ☐ Diagnostic method not
Type of treatment(s): PKP, stated
☐ Level IV in presence of conservative
☐ Other: Click or tap here
higher quality studies to enter text.
Total number of patients: 41
Number of patients in relevant
☐ Subgroup analysis data Level of Evidence
subgroup(s): 24 treated with
not available Determination
vertebroplasty, 17 conservative
Potential Level: I
(bed rest, back brace, analgesic,
☐ Not relevant to question Downgraded Level: II
anti-osteoporosis
Downgraded due to: less
than 80% follow-up and
Consecutively assigned? Yes
method of randomization
was suboptimal.
Duration of follow-up: one year
Conclusions
Validated outcome measures used
This paper provides
(list): VAS, SF36]
evidence that: PKP
provides rapid
Nonvalidated outcome measures
meaningful durable relief
used (list): radiographic, Rate of
from pain due to
bone union.
osteoporotic vertebral
compression fractures.
Diagnosis made by:
PKP exceeds the relief
☒ Clinical exam/history from medical
☐ Electromyography management at all time
☒ Myelogram points over one year. The
☒ MRI kyphotic angle and
☐ CT anterior vertebral body
were statistically
☐ CT/Myelogram
significantly superior in
☒ Other: Xray, Radiographs
the PKP group.
Results/subgroup analysis:
VAS score was similar for both
groups pre treatment. Immediately
after treatment there was
significant decrease in VAS for the
PKP group compared to
conservative group (1.95 vs 7.64).
829
One week after treatemtent there
was continued difference in vAS
(1.7 vs 7.12). At three months
difference continued (0.92 vs 3.47).
One year after treatment VAS was
0.47 in PKP group and 2.29 in
conservative group.
One year after treatment the
physical function, physical health,
body pain measurements were
significant higher for the PKP group
compared to conservative group.
Author conclusions: patients with a
linear black signal detected on
MRI, the first-choice treatment
should be PKP rather than
conservative treatment
Klazen CA, Lohle PN, de Vries J, et al. Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Vertebroplasty versus conservative Therapeutic ☒ Nonconsecutive patients
treatment in acute osteoporotic vertebral Study Design: RCT ☐ Nonrandomized
compression fractures (Vertos II): an open- Level I
☒ Nonmasked reviewers
label randomised trial. Lancet. Stated objective of study: We
☒ Nonmasked patients
2010;376(9746):1085-1092. aimed to clarify whether
doi:10.1016/S0140-6736(10)60954-3 Explanation of failure to ☐ No validated outcome
vertebroplasty has additional value
meet guideline inclusion compared with optimum pain measures used
criteria treatment in patients with acute ☐ Small sample size
(when applicable) vertebral fractures. ☒ <80% follow-up
☐ Lacked subgroup
☐ Level V (expert Type of treatment(s): analysis
consensus) percutaneous vertebroplasty or ☐ Diagnostic method not
conservative treatment stated
☐ Level IV in presence of ☐ Other: Click or tap here
higher quality studies Total number of patients: 431
to enter text.
Number of patients in relevant
☐ Subgroup analysis data subgroup(s): 101 vertebroplasty,
Level of Evidence
not available 101 conservative treatment=
Determination
Potential Level: I
Consecutively assigned? No
☐ Not relevant to question
830
Downgraded Level: Not
Duration of follow-up: 1 year Downgraded
Validated outcome measures used Conclusions relative to
(list): VAS, EuroQol-5 dimensions question
(EQ-5D), RMD This paper provides
evidence that: vertebral
Nonvalidated outcome measures augmentation provided
used (list): Visual analoge superior pain relief out to
scale.Quality of Life Questionnaire 1 year in comparison to
of the European Foundation for medical management.
Osteoporosis, Roland Morris The study was funded by
Disability index. manufacturer of the
cement used for
Diagnosis made by: augmentation. The
☒ Clinical exam/history sponsors were reported
☐ Electromyography to not have a material
role in study design, data
☐ Myelogram
collection or reporting.
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xray
Results/subgroup analysis:
202 patients were randomized
equally to vertebroplasty and
conservative groups. Baseline
VAS was similar. Decrease in VAS
was significantly higher than
conservative grop at all timepoints.
VAS difference between
vertebroplasty vs conservative
group: 1 day (3.7 vs 6.7). 1 week
(3.5 vs 5.6). 1 month (2.5 vs 4.9).
3 months (2.5 vs 3.9). 6 months
(2.3 vs 3.9). 1 year (2.2 vs 3.7).
After vertebroplasty, medication
use was significantly reduced for
831
vertebroplasty group compared to
conservative treated group.
Author conclusions: In a subgroup
of patients with acute osteoporotic
vertebral compression fractures
and persistent pain, percutaneous
vertebroplasty is effective and safe.
Pain relief after vertebroplasty is
immediate, is sustained for at least
a year, and is signifi cantly greater
than that achieved with
conservative treatment, at an
acceptable cost.
Leali PT, Solla F, Maestretti G, Balsano M, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Doria C. Safety and efficacy of Therapeutic ☒ Nonconsecutive patients
vertebroplasty in the treatment of Study Design: RCT ☐ Nonrandomized
osteoporotic vertebral compression Level II
☒ Nonmasked reviewers
fractures: a prospective multicenter Stated objective of study: The
☒ Nonmasked patients
international randomized controlled purpose of this paper is to estimate
study. Clin Cases Miner Bone Metab. Explanation of failure to ☐ No validated outcome
cost-effectiveness of VP compared
2016;13(3):234-236. meet guideline inclusion to conservative care in terms of: measures used
doi:10.11138/ccmbm/2016.13.3.234 criteria pain reduction, qua-lity of life, ☐ Small sample size
(when applicable) complications, secondary fractures ☐ <80% follow-up
and mortality ☒ Lacked subgroup
☐ Level V (expert analysis
consensus) Type of treatment(s): ☐ Diagnostic method not
Vertebroplasty, conservative stated
☐ Level IV in presence of treatment ☒ Other: Lacked data
higher quality studies reporting
Total number of patients: 400
☐ Subgroup analysis data Number of patients in relevant
Level of Evidence
not available subgroup(s): 200 VP, 200
Determination
conservative
Potential Level: I
☐ Not relevant to question Downgraded Level: II
Consecutively assigned? No
Downgraded due to: Lack
of raw data reporting
Duration of follow-up: 1 year
Conclusions
Validated outcome measures used
This paper provides
(list): VAS, ODI
evidence that:
832
vertebroplasty offers
Nonvalidated outcome measures immediate but short-term
used (list): Click or tap here to pain relief and
enter text. improvement in
functional outcomes as
Diagnosis made by: compared to medical
☒ Clinical exam/history management.
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xrays, Bone Density
Results/subgroup analysis:
Immediately post vertebroplasty,
the VAS decreased rom 4.8 to 2.3
and the ODI decreased from 53.6%
to 31.7%. Conservatively treated
group had no immediate change in
VAS and ODI. AT 6 weeks and 3-6
months the outcomes were similar
for both groups.
Author conclusions: Pain relief and
improvement of mobility and func-
tion after PV is immediate and
significantly better in the shortterm
compared with non-surgical care
treatment.
Lee HM, Park SY, Lee SH, Suh SW, Hong Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
JY. Comparative analysis of clinical Therapeutic ☒ Nonconsecutive patients
outcomes in patients with osteoporotic Study Design: Comparative ☐ Nonrandomized
vertebral compression fractures (OVCFs): Level III
☐ Nonmasked reviewers
conservative treatment versus balloon Stated objective of study: To
☐ Nonmasked patients
kyphoplasty. Spine J. 2012;12(11):998-1005. compare the clinical outcomes of
doi:10.1016/j.spinee.2012.08.024. Explanation of failure to ☐ No validated outcome
patients with OVCF according to
3/31/22: Include meet guideline inclusion different treat-ment modalities and measures used
criteria identify clinical risk factors related ☐ Small sample size
(when applicable) ☐ <80% follow-up
833
to failure of conservative treatment ☐ Lacked subgroup
☐ Level V (expert of OVCF. analysis
consensus) ☐ Diagnostic method not
Type of treatment(s): Conservative stated
☐ Level IV in presence of care or conservative care plus
☐ Other: Click or tap here
higher quality studies kyphoplasty.
to enter text.
Total number of patients: 259
☐ Subgroup analysis data Level of Evidence
Number of patients in relevant
not available Determination
subgroup(s): 91 KP, 168
Potential Level: II
conservative treatment
☐ Not relevant to question Downgraded Level: III
Downgraded due to
Consecutively assigned? No
disparity in groups and
nonconsecutive patients.
Duration of follow-up: 12 months
Conclusions
Validated outcome measures used
This paper provides
(list): VAS and ODI
evidence that: medical
management is likely to
Nonvalidated outcome measures
fail in OVCF patients with
used (list): Bone mineral density,
severe osteoporosis,
body mass index, collapse rates,
older age, obesity and
and history of spine fractures.
higher degree of
collapse. KP improves
Diagnosis made by:
pain and functional
☒ Clinical exam/history outcomes for 1 month,
☐ Electromyography results thereafter being
☐ Myelogram comparable with medical
☒ MRI management.
☐ CT
☐ CT/Myelogram
☒ Other: Xray
Results/subgroup analysis:
VAS and ODI were significantly
lower for kyphoplasty group
compared to conservative group at
1 week and 1 month, with no
significant difference at 3, 6, 12
months.
834
Author conclusions: Both
treatments of OVCF showed
successful clinical results at the
end of the1-year follow-up period.
Kyphoplasty showed better
outcomes in the first month only.
Given theseresults, prompt
kyphoplasty should not be
indicated in the case of a patient
with OVCF that has no isk factors
for failure with conservative
treatment. Rather, a trial of
conservative, 3-week
treatmentwould be beneficial.
Li Y, Zhu J, Xie C. A comparative study of Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
percutaneous kyphoplasty and conservative Therapeutic ☒ Nonconsecutive patients
therapy on vertebral osteoporotic Study Design: RCT ☒ Nonrandomized
compression fractures in elderly patients. Level II
☒Nonmasked reviewers
International Journal of Clinical and Stated objective of study: To
☒ Nonmasked patients
Experimental Medicine. 2017;10(5):8139- Explanation of failure to compare the therapeutic efficacy of
8145. meet guideline inclusion ☐ No validated outcome
percutaneous kyphoplasty (PKP)
criteria with that of conserva- tive measures used
(when applicable) treatment in elderly patients with ☒ Small sample size
osteoporotic vertebral compression ☐ <80% follow-up
☐ Level V (expert fractures (OVCFs) ☐ Lacked subgroup
consensus) Type of treatment(s): analysis
Percutaneous kyphoplasty or ☒ Diagnostic method not
☐ Level IV in presence of conservative treatment. stated
higher quality studies ☐ Other: Click or tap here
Total number of patients: 80
to enter text.
☐ Subgroup analysis data Number of patients in relevant
not available subgroup(s): 40 with KP and 40
Level of Evidence
with conservative
Determination
☐ Not relevant to question Potential Level: I
Consecutively assigned? YesNo
Downgraded Level: II
Downgraded due to:
Duration of follow-up: 6 months
Unclear randomization, no
details of subgroup
analysis for controls.
835
Validated outcome measures used Conclusions
(list): Anterior vertebral height, This paper provides
Cobb angle, VAS, ODI evidence that: PKP
provides rapid durable
Nonvalidated outcome measures and statistically
used (list): radiographic, Vertebral significantly greater
height and Cobb angle of kyphosis improvements in pain
and function vs. medical
Diagnosis made by: management.
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☒ CT/Myelogram
☒ Other: Xray, Radiographs
Results/subgroup analysis:
Baseline VAS was similar (8.6 vs
8.43). At 3 days (2.1 vs 8.32), 1
week (3.8 vs 7.2), 1 month (2.64 vs
3.1), 3 month (1.42 vs 0.34), 6
month (1.02 vs 1.53), PKP group
showed greater decrease in VAS
compared to control group.
ODI showed significant decrese
compared to control group:
baseline (42.3 vs 41.3), 3 days
(20.2 vs 36.5), 1 week (18.5 vs
19.7), 1 month (15.1 vs 18.7), 3
months (14.2 vs 18.2)
Author conclusions: The PKP
treatment could provide immediate
pain relief for the patients and
takes the advantages of bringing
more signifi- cant improvements in
vertebral fracture restoration, better
836
correction in kyphosis and weight-
bearing capacity at an earlier
stage. However, although
conservative treatment might lead
to smaller trauma, it cannot bring
complete restoration in
compressed vertebral height and in
Cobb angle. Also, it was found to
have a high incidence of compli-
cations. In such cases, the patients’
quality of life warrants further
improvement.
Ma Y, Wu X, Xiao X, et al. Effects of Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
teriparatide versus percutaneous Therapeutic ☒ Nonconsecutive patients
vertebroplasty on pain relief, quality of life Study Design: Comparative ☒ Nonrandomized
and cost-effectiveness in postmenopausal Level III
☒ Nonmasked reviewers
females with acute osteoporotic vertebral Stated objective of study: In this
☒ Nonmasked patients
compression fracture: A prospective cohort study, we compared the 3-month
study. Bone. 2020;131:115154. Explanation of failure to ☐ No validated outcome
therapeutic effects of Teriparatide
doi:10.1016/j.bone.2019.115154 meet guideline inclusion and PVP on acute OVCFs, aiming measures used
criteria to evaluate ☒ Small sample size
(when applicable) the utility of this new conservative ☐ <80% follow-up
treatment strategy. ☐ Lacked subgroup
☐ Level V (expert analysis
consensus) Type of treatment(s): teriparatide ☐ Diagnostic method not
vs pvp stated
☐ Level IV in presence of ☒ Other: No long term
higher quality studies Total number of patients: 60
follow up.
Number of patients in relevant
☐ Subgroup analysis data subgroup(s): 30 each group
Level of Evidence
not available Determination
Consecutively assigned? YesNo
Potential Level: II
☐ Not relevant to question Downgraded Level: III
Duration of follow-up: 3 months
Downgraded due to: No
long term follow up, small
Validated outcome measures used
sample size,
(list): VAS, ODI, VBH, direct care
nonconsecutive patients,
costs, fracture healing on MRI
nonmasked patients,
nonmasked reviewers, and
Nonvalidated outcome measures
nonrandomization
used (list): Direct medical cost
837
Conclusions
Diagnosis made by: This paper provides
☒ Clinical exam/history evidence that:
☐ Electromyography percutaneous
vertebroplasty showed
☐ Myelogram
improved pain at 1 week
☒ MRI
compared to medical
☒ CT management with
☐ CT/Myelogram Teriparatide. The
☒ Other: Xray, BMD, difference was less at 1
Radiographs, DEXA bone mineral month and similar at 3
density. months.
Results/subgroup analysis:
60 patients were equally assigned
to PVP and medical therap with
TPTD.
Comparing VAS, PVP was more
effective at reducing pain at 1 week
post procedure compared to
medical therapy. The difference
was less at 1 month. At 3 month
the VAS was similar between the
two groups.
ODI decreased more for PVP at 1
week and was similar at 1 month
and 3 months.
Author conclusions: Conservative
treatment strategy with Teriparatide
resulted in similar therapeutic
effects with less cost than
percutaneous vertebroplasty for the
treatment of acute OVCF.
838
Macías-Hernández SI, Chávez-Arias DD, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Miranda-Duarte A, Coronado-Zarco R, Diez- Therapeutic ☒ Nonconsecutive patients
García MP. Percutaneous Vertebroplasty Study Design: Comparative ☒ Nonrandomized
Versus Conservative Treatment and Level III
☒ Nonmasked reviewers
Rehabilitation in Women with Vertebral Stated objective of study: to
☒ Nonmasked patients
Fractures due to Osteoporosis: A evaluate the pain
Prospective Comparative Study. Rev Invest Explanation of failure to ☐ No validated outcome
and function in women with
Clin. 2015;67(2):98-103. meet guideline inclusion vertebral fractures caused measures used
criteria by osteoporosis and treated with ☒ Small sample size
(when applicable) percutaneous vertebroplasty, ☐ <80% follow-up
compared with a group receiving ☐ Lacked subgroup
☐ Level V (expert conservative analysis
consensus) treatment under a rehabilitation ☐ Diagnostic method not
program stated
☒ Level IV in presence of protocol. ☐ Other: Click or tap here
higher quality studies to enter text.
Type of treatment(s): VP vs
☐ Subgroup analysis data conservative
Level of Evidence
not available Determination
Total number of patients: 31
Potential Level: II
Number of patients in relevant
☐ Not relevant to question Downgraded Level: III
subgroup(s): 13 with KP, 18
Downgraded due to small
conservative
sample size
Consecutively assigned? YesNo
Conclusions
This paper provides
Duration of follow-up: 1 year
evidence that: VP offers
immediate pain relief up
Validated outcome measures used
to 3 months after
(list): vas, odi
treatment but no long-
term difference as
Nonvalidated outcome measures
compared to structural
used (list): N/A
rehabilitation program
treatment.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
839
☐ CT/Myelogram
☒ Other: Xray, BMD
Results/subgroup analysis: At
baseline, VAS was 73.1 ± 28.36 in
the vertebroplasty group and 68.6 ±
36.1 mm in the conservative
treatment group (p = 0.632); at
three months it was 33.11 ± 10.1
vs. 42 ± 22.21 mm (p = 0.111); and
at 12 months, 32.3 ± 11.21 vs. 36.1
± 12.36 mm (p = 0.821). The ODI
at baseline was 83% in the
vertebroplasty group vs. 85% for
conservative management (p =
0.34); at three months, 36 vs. 39%
(p = 0.36); and at 12 months, 29.38
vs. 28.33% (p = 0.66).
Author conclusions: A
conservative, standardized
rehabilitation treatment program
has the same
therapeutic efficacy as
vertebroplasty.
Martikos K, Greggi T, Faldini C, Vommaro F, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Scarale A. Osteoporotic thoracolumbar Therapeutic ☒ Nonconsecutive patients
compression fractures: long-term Study Design: Comparative ☒ Nonrandomized
retrospective comparison between Level III
☒ Nonmasked reviewers
vertebroplasty and conservative Stated objective of study: To
☒ Nonmasked patients
treatment. Eur Spine J. 2018;27(Suppl compare long term clinical and
2):244-247. doi:10.1007/s00586-018-5605-1 Explanation of failure to ☐ No validated outcome
radiographic outcomes in
meet guideline inclusion osteoporotic vertebral compression measures used
criteria fractures of the thoracolumbar ☐ Small sample size
(when applicable) spine treated with conservative ☐ <80% follow-up
treatment and percutaneous ☐ Lacked subgroup
☐ Level V (expert vertebroplasty. analysis
consensus) ☐ Diagnostic method not
Type of treatment(s): VP and stated
conservative
840
☐ Level IV in presence of ☐ Other: Click or tap here
higher quality studies Total number of patients: 85 to enter text.
Number of patients in relevant
☐ Subgroup analysis data subgroup(s): CT (47 patients) and Level of Evidence
not available PV (38 patients) Determination
Potential Level: III
Consecutively assigned? YesNo
☐ Not relevant to question Downgraded Level: Not
Downgraded
Duration of follow-up: minimum
follow-up 2 years Conclusions
This paper provides
Validated outcome measures used evidence that: there was
(list): VAS, ODI, SF-36, vertebral no long-term difference
body Cobb’s angle, sagittal index in pain control or
function between
Nonvalidated outcome measures vertebral augmentation
used (list): radiographic, Sagittal and medical treatment 2
plane kyphosis 1 & 2 years following
treatment.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xray, Radiographs
Results/subgroup analysis:
47 patients had conservative
treatement and 38 patient had
percutaneous vertebroplasty.
Mean follow up of all patients were
2.8 years (min 2, max 3.8). At the
final followup time, there was no
difference in the VAS, ODI, SF36.
Note: there was only single follow
up at 2.8 years
841
Author conclusions: Percutaneous
vertebroplasty represents a safe
treatment for osteoporotic vertebral
compression fractures, although it
may be associated with a higher
incidence of adjacent fractures and
therefore worse thoracolumbar
kyphosis and long-term follow-up
than conservative treatment.
Masala S, Ciarrapico AM, Konda D, Vinicola Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
V, Mammucari M, Simonetti G. Cost- Therapeutic ☐ Nonconsecutive patients
effectiveness of percutaneous vertebroplasty Study Design: Comparative ☒ Nonrandomized
in osteoporotic vertebral fractures. Eur Spine Level III
☒ Nonmasked reviewers
J. 2008;17(9):1242-1250. Stated objective of study: assess
☒ Nonmasked patients
doi:10.1007/s00586-008-0708-8. Explanation of failure to cost effectiveness and efficacy of
meet guideline inclusion ☐ No validated outcome
VP
criteria measures used
(when applicable) Type of treatment(s): VP or ☐ Small sample size
conservative ☐ <80% follow-up
☐ Level V (expert ☐ Lacked subgroup
consensus) Total number of patients: 179 analysis
Number of patients in relevant ☐ Diagnostic method not
☐ Level IV in presence of subgroup(s): 58 VP, 95 medical stated
higher quality studies therapy ☐ Other: Click or tap here
to enter text.
☐ Subgroup analysis data Consecutively assigned? Yes
not available Level of Evidence
Duration of follow-up: 12 months
Determination
☒ Not relevant to question Potential Level: III
Validated outcome measures used
Downgraded Level: Not
(list): VAS pain scale, ALD scale,
Downgraded
hospital care costs
Conclusions
Nonvalidated outcome measures
This paper provides
used (list): Ambulation scale, ADL
evidence that:
scale
vertebroplasty improves
pain and function and is
Diagnosis made by:
cost-effective in the short
☒ Clinical exam/history term but loses the benefit
842
☐ Electromyography over medical treatment
☐ Myelogram over long term.
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Xray, Radiographs
Results/subgroup
analysis: Statistically significant
improvement in VAS, ambulation
scale and ADL Scale was observed
at 1 week and 3 and 12 months in
both groups. Improvement was
higher at 1 week and 3 months in
VP group but no difference
observed at 12 months.
Incidence of new vertebral
fractures was similar in both groups
during follow-up.
At 1 week VP was more cost-
effective than medical therapy on
all 3 outcomes, significant
difference on ambulation scale at 3
months. At 12 months VP was
more cost-effective but difference
was not statistically significant.
Author conclusions: Vertebroplasty
should be considered the treatment
of first choice in symptomatic acute
OVCF with refractory pain after a
short period of analgesic therapy.
843
Movrin I. Adjacent level fracture after Type of evidence: ☒Prospective ☐ Retrospective Critique of methodology:
osteoporotic vertebral compression fracture: Therapeutic ☐ Nonconsecutive patients
a nonrandomized prospective study Study Design: Comparative ☒ Nonrandomized
comparing balloon kyphoplasty with Level II
☒ Nonmasked reviewers
conservative therapy. Wien Klin Stated objective of study: The
☒ Nonmasked patients
Wochenschr. 2012;124(9-10):304-311. Explanation of failure to purpose of this prospective
doi:10.1007/s00508-012-0167-4 meet guideline inclusion ☐ No validated outcome
nonrand-omized comparative study
criteria was to analyze the incidence measures used
(when applicable) andpossible risk factors of adjacent ☒ Small sample size
level fracture coparing BK ☐ <80% follow-up
☐ Level V (expert withconservativetherapy. ☐ Lacked subgroup
consensus) analysis
Type of treatment(s): Balloon ☐ Diagnostic method not
☐ Level IV in presence of kyphoplasty or conservative stated
higher quality studies therapy ☐ Other: Click or tap here
to enter text.
☐ Subgroup analysis data Total number of patients: 107
not available Number of patients in relevant
Level of Evidence
subgroup(s): 46 BK and 61
Determination
conservative
☐ Not relevant to question Potential Level: II
Downgraded Level: Not
Consecutively assigned? Yes
Downgraded
Duration of follow-up: 1 year
Conclusions
This paper provides
Validated outcome measures used
evidence that:
(list): VAS
vertebral augmentation
with kyphoplasty
Nonvalidated outcome measures
improves pain and
used (list): Height of the fractured
function and may
vertebral body and kyphotic angle
decrease the rate of
adjacent OVCF
Diagnosis made by:
development 1 year
☒ Clinical exam/history following treatment.
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Radiograph
844
Results/subgroup analysis:
46 patients with BK and 61 patients
with conservative treatment.
After 1 year, VAS decreased to 2.0
for BK group and 3.8 for
conservative treated group.
lower rate of adjacent fracture in
BK copared to conservativel
treated group (6.5% vs 16.4%)
Author conclusions: Balloon
kyphoplasty and conservative
therapy had similar pain level
improvements at one year. Balloon
kyphoplasty has a low risk of
adjacent level fractures. The most
important factors for adjacent level
fractures after an osteoporotic
vertebral fracture are the degree of
osteoporosis and altered
biomechanics of the spine due to
local kyphosis.
Nakano M, Hirano N, Ishihara H, Kawaguchi Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Y, Watanabe H, Matsuura K. Calcium Therapeutic ☐ Nonconsecutive patients
phosphate cement-based vertebroplasty Study Design: Case Control ☒ Nonrandomized
compared with conservative treatment for Level III
☒ Nonmasked reviewers
osteoporotic compression fractures: a Stated objective of study: To
☒ Nonmasked patients
matched case-control study. J Neurosurg Explanation of failure to investigate the effects of calcium
Spine. 2006;4(2):110-117. meet guideline inclusion ☐ No validated outcome
phosphate cement (CPC)–based
doi:10.3171/spi.2006.4.2.110 criteria verte-broplasty on relief of pain and measures used
(when applicable) augmentation of the fractured ☒ Small sample size
vertebral body (VB), the authors ☐ <80% follow-up
☐ Level V (expert compared the results ofCPC- ☐ Lacked subgroup
consensus) assisted vertebroplasty with those analysis
of conservative treatment alone ☐ Diagnostic method not
☐ Level IV in presence of stated
higher quality studies ☐ Other: Click or tap here
to enter text.
845
☐ Subgroup analysis data Type of treatment(s):
not available Vertebroplasty Vs conservative Level of Evidence
treatment (brace, analgesics, cast) Determination
☐ Not relevant to question Potential Level: III
Total number of patients: 60 Downgraded Level: Not
Number of patients in relevant Downgraded
subgroup(s): 30 each
Conclusions
Consecutively assigned? Yes This paper provides
evidence that:
Duration of follow-up: Mean follow Percutaneous
up 17 months vertebroplasty provides
durable and statistically
Validated outcome measures used significantly greater
(list): VAS improvement in pain and
greater reduction in use of
Nonvalidated outcome measures analgesics compared to
used (list): deformity index, medical therapy.
kyphotic deformity- ratio of anterior
to posterior vertebral height
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xrays, Radiograph
Results/subgroup analysis:
VAS scores between
vertebroplasty/control were as
follows: preoperative (7.93/7.47), 6
months (0.7/ 2.57), 12 months
(0.67/1.97).
The mean duration of analgesic
requirement was 8.3 days for
846
vertebroplasty group and 62.2 days
for control group (p=0.0001)
Author conclusions: The authors
conclude that CPC-assisted
vertebroplasty provides better
clinical and radiological resultsthan
conservative treatment for primary
OVCF.
Oh Y, Lee B, Lee S, Kim J, Park J. Type of evidence: ☐Prospective ☒ Retrospective Critique of methodology:
Percutaneous Vertebroplasty versus Therapeutic ☒ Nonconsecutive patients
Conservative Treatment Using a Study Design: Comparative ☒ Nonrandomized
Transdermal Fentanyl Patch for Level III
☒ Nonmasked reviewers
Osteoporotic Vertebral Compression Stated objective of study:
☒ Nonmasked patients
Fractures. J Korean Neurosurg Soc. Explanation of failure to compared the safety and efficacy of
2019;62(5):594-602. meet guideline inclusion ☐ No validated outcome
conservative treatment with that of
doi:10.3340/jkns.2019.0086 criteria PVP for acute OVCFs. measures used
4/27/22: Include. (when applicable) ☐ Small sample size
Type of treatment(s): VP, medical ☐ <80% follow-up
☐ Level V (expert ☐ Lacked subgroup
consensus) Total number of patients: 131 analysis
Number of patients in relevant ☐ Diagnostic method not
☐ Level IV in presence of subgroup(s): 75 conservative, 56 stated
higher quality studies VP ☐ Other: Click or tap here
to enter text.
☐ Subgroup analysis data Consecutively assigned? No
not available Level of Evidence
Duration of follow-up: 12 months
Determination
☒ Not relevant to question Potential Level: III
Validated outcome measures used
Downgraded Level: Not
(list): VAS, kyphotic (vertebral
Downgraded
body wedge angle)
Conclusions
Nonvalidated outcome measures
This paper provides
used (list): radiographic
evidence that:
Compression rate (ratio of anterior
vertebroplasty provides
and posterior vertebral height),
greater immediate pain
reduction than a
Diagnosis made by:
Transdermal Fentanyl
☒ Clinical exam/history
847
☐ Electromyography patch. After one year,
☐ Myelogram pain relief was similar in
the two treatment groups.
☒ MRI
Vertebroplasty provided
☒ CT
superior vertebral
☐ CT/Myelogram segmental alignment.
☒ Other: Xray, Radiographs
Results/subgroup analysis: 131
patients with 56 vertebroplasty
(PVP), 75 transdermal fentenyl
patch (TFP).
VAS score vertebroplasty / fentanyl
patch: Baseline (7.3/ 7.8), 1 week
post vertebroplasty (3.4/ 5.8), 12
months (1.5/1.3).
The compression ration decreased
in the PVP group but increased in
the TFP group.
Author conclusions: We compared
clinical and radiological outcomes
between the TFP and PVP groups.
The immediate pain reduction
effect was superior in the PVP
group, but the final clinical outcome
was similar. Although the PVP
group had a better—preserved
compression rate than the TFP
group for 1 year, the development
of adjacent fractures was
significantly higher. Although TFPs
seemed to be beneficial in reducing
the failure rate of conservative
treatment, the possibility of side
effects (22.6%, 17 out of 75
patients, in this study) should be
carefully monitored
848
Rousing R, Hansen KL, Andersen MO, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Jespersen SM, Thomsen K, Lauritsen JM. Therapeutic ☐ Nonconsecutive patients
Twelve-months follow-up in forty-nine Study Design: RCT ☐ Nonrandomized
patients with acute/semiacute osteoporotic Level II
☒ Nonmasked reviewers
vertebral fractures treated conservatively or Stated objective of study:
☒ Nonmasked patients
with percutaneous vertebroplasty: a clinical Percutaneous vertebroplasty is
randomized study. Spine (Phila Pa 1976). Explanation of failure to ☐ No validated outcome
compared to conservative
2010;35(5):478-482. meet guideline inclusion treatment in patients with acute or measures used
doi:10.1097/BRS.0b013e3181b71bd1 criteria sub- acute osteoporotic vertebral ☐ Small sample size
(when applicable) fractures with respect topainto pain, ☐ <80% follow-up
physical and mental outcomes. The ☐ Lacked subgroup
☐ Level V (expert risk of vertebra lfractures vertebral analysis
consensus) fractures adjacent to treated levels ☐ Diagnostic method not
is assessed. stated
☐ Level IV in presence of ☐ Other: Click or tap here
higher quality studies Type of treatment(s): VP vs
to enter text.
conservative
☐ Subgroup analysis data Level of Evidence
not available Total number of patients: 49
Determination
Number of patients in relevant
Potential Level: I
subgroup(s): 25 with VP,patients in
☐ Not relevant to question Downgraded Level: II
the PVP group (19 females) and 24
Downgraded due to: small
patients in the conservative
sample size, some data
collected retrospectively
Consecutively assigned? No
Conclusions relative to
Duration of follow-up: 12 months
question
This paper provides
VAS, physical andmentalValidated
evidence that: PVP may
outcome assessment, Medical
provide immediate but
Outcome Short-Form 36(SF-36)
short-lasting pain relief
and Dallas Pain Questionnaire
and improvement in
(DPQ) weremeasures used.
functional outcomes after
FromNovember 2004, as a PhD-
acute and subacute
study was connected to the project,
OVCF than conservative
thestudy was supplemented with
care but mid to long term
EuroQol (EQ5D), Barthel, and
outcomes are similar.
amodified mini-mental state
examination (MMSE)
849
Nonvalidated outcome measures
used (list): Cobb angle and
vertebral height
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xrays, bone scan,
radiograph
Results/subgroup analysis:
For VAS, pain decreased in the
PVP group at 12 to 24 hours (7.9 to
2.0). At 1 month, there was
significant lower VAS in the PVP
group over conservative group. At
3 and 12 months, there was no
difference between the groups.
Author conclusions: PVP is a good
treatment for some patientswith
acute/subacute painful osteoporotic
vertebral frac-tures, but the majority
of fractures will heal after 8 to
12weeks of conservative treatment
with subsequent declinein pain.
The risk of new fractures needs
further research.
850
Tang H, Zhao J, Hao C. Osteoporotic Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
vertebral compression fractures: surgery Therapeutic ☒ Nonconsecutive patients
versus non-operative management. J Int Study Design: Comparative ☒ Nonrandomized
Med Res. 2011;39(4):1438-1447. Level III
☒ Nonmasked reviewers
doi:10.1177/147323001103900432 Stated objective of study: To
☒ Nonmasked patients
assess the efficiency and cost-
Explanation of failure to ☐ No validated outcome
effectiveness of PVP and PKP and
meet guideline inclusion compared with CMT in patients measures used
criteria with OVCF. ☐ Small sample size
(when applicable) ☐ <80% follow-up
Type of treatment(s): pvp vs kp vs ☐ Lacked subgroup
☐ Level V (expert medical analysis
consensus) ☐ Diagnostic method not
Total number of patients: 168 stated
☐ Level IV in presence of Number of patients in relevant ☐ Other: Click or tap here
higher quality studies subgroup(s): vertebroplasty (PVP;
to enter text.
n = 58), percutaneous kyphoplasty
☐ Subgroup analysis data (PKP; n = 55), or conservative
Level of Evidence
not available medical therapy (CMT; n = 55
Determination
Potential Level: III
Consecutively assigned? No
☐ Not relevant to question Downgraded Level: Not
Downgraded
Duration of follow-up: 12 months
Conclusions
Validated outcome measures used
This paper provides
(list): VAS, SF-12, anterior and
evidence that: vertebral
middle vertebral height, Cobb angle
augmentation procedures
may offer better pain
Nonvalidated outcome measures
relief and functional
used (list): Cobb angle
outcomes immediately as
compared to medical
Diagnosis made by:
management for OVCF
☒ Clinical exam/history with loss of effect in the
☐ Electromyography mid-term. PKP improves
☐ Myelogram segmental alignment but
☒ MRI is the most expensive
☒ CT treatment.
☐ CT/Myelogram
☒ Other: Xrays, BMD,
Radiographs
851
Results/subgroup analysis:
After cement augmentation (PVP or
PKP), mean VAS was significantly
lower compared to medical therapy
at 1 week. At 2 weeks, there was
no difference in VAS between the
two groups. At 6-12 months, the
mean VAS was stable for cement
augmentation group. But the VAS
rebounded signifigantly higher in
the medical therapy group.
The patient quality of life increased
significantly for cement
augmentation group, with medical
therapy group showing significantly
lower score.
Treatment times were shorter with
cement augmentation but costs
were lower with medical therapy.
The rate of secondary fractures in
follow up was greater with medical
therapy.
Author conclusions: PVP is a
better choice for the treatment of
OVCF compared with PKP or
conservative management.
Wang HK, Lu K, Liang CL, et al. Comparing Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
clinical outcomes following percutaneous Therapeutic ☐ Nonconsecutive patients
vertebroplasty with conservative therapy for Study Design: Comparative ☐ Nonrandomized
acute osteoporotic vertebral compression Level III
☐ Nonmasked reviewers
fractures. Pain Med. 2010;11(11):1659- Stated objective of study: Compare
☒ Nonmasked patients
1665. doi:10.1111/j.1526- the efficacy of percuta- neous
4637.2010.00959.x. Explanation of failure to ☐ No validated outcome
Vertebroplasty (PV) with
meet guideline inclusion conservative therapy for patients measures used
criteria with acute vertebral compression ☒ Small sample size
(when applicable) frac- tures. ☐ <80% follow-up
852
☐ Level V (expert Type of treatment(s): ☐ Lacked subgroup
consensus) Vertebroplasty or Conservative analysis
care. ☐ Diagnostic method not
☐ Level IV in presence of stated
Total number of patients: 55
higher quality studies ☒ Other: No intermediate
Number of patients in relevant
follow-up
subgroup(s): 32 PV, 23 medical
☐ Subgroup analysis data
not available Level of Evidence
Consecutively assigned? Yes
Determination
☐ Not relevant to question Potential Level: II
Duration of follow-up: 12 months
Downgraded Level: III
Downgraded due to: no
Validated outcome measures used
intermediate follow-up
(list): VAS, revised ODI
Conclusions
Nonvalidated outcome measures
This paper provides
used (list): physical functioning and
evidence that: vertebral
pain medication requirement were
augmentation provided
evaluated using a scoring system
improve pain control and
0-4, compression fractures
function up to 4 weeks
post-procedure but no
Diagnosis made by:
difference at 1 year. Pain
☒ Clinical exam/history relief and functional
☐ Electromyography outcomes may be
☐ Myelogram immediate and better
☒ MRI after PV than medical
☒ CT management in the short
term with no difference at
☐ CT/Myelogram
12 months.
☒ Other: Xrays, BMD,
Radiographs
Results/subgroup analysis:
Pain scores vertebroplsty /
conservative treatment; baseline
(7.5/7.1), 1 week (3.3/5.9), 4 weeks
(2.9/4.7), 12 months (2.3/3.2).
ODI scores
vertebroplasty/conservative
treatment: baseline (66.8/61.3), 1
853
week (42.8/54.4), 4 weeks
(37.4/46.4), 12 months 34.4/36.1)
Both PV and conservative therapy
showed pain reduction (P< 0.001),
improvements in physical
functioning (P< 0.001), and
decreased medication (P<0.001).
Decreased VAS were more
significant in the vertebroplasty
group at 1 (P< 0.001) and 4 weeks
(P< 0.001) but not at 12 months.
Improvements in physical
functioning were significant at 1 (P
< 0.001) and 4 weeks (P< 0.001).
Medication requirements were
lower in the Vertebroplasty group
compared to conservative therapy
group.
Author conclusions: Pain relief,
physical functioning improvement,
and medication requirement after
ver- tebroplasty are immediately
and significantly better when
compared with conservative
therapy.
Van Meirhaeghe J, Bastian L, Boonen S, et Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
al. A randomized trial of balloon kyphoplasty Therapeutic Study Design: Observational ☐ Patients not enrolled at
and nonsurgical management for treating same point in their disease
acute vertebral compression fractures: Level III Stated objective of study: to ☒ <80% follow-up
vertebral body kyphosis correction and compare efficacy and safety of ☐ Follow-up not
surgical parameters. Spine (Phila Pa 1976). Explanation of failure to balloon kyphoplasty with NSM standardized
2013;38(12):971-983. meet guideline inclusion during 24 months in patients with
doi:10.1097/BRS.0b013e31828e8e22 ☐ No validated outcome
criteria painful VCFs
measures used
(when applicable)
Wardlaw D, Cummings SR, Van Meirhaeghe Total number of patients in the ☐ Small sample size
J, et al. Efficacy and safety of balloon study: 300 ☐ Lacked subgroup
☐ Level V (expert analysis
kyphoplasty compared with non-surgical Number of patients in relevant
care for vertebral compression fracture consensus) ☐ Diagnostic methods not
subgroup(s): 151 NSM, 149 NSM
(FREE): a randomised controlled trial. described.
Duration of follow-up: 24 months
854
Lancet. 2009;373(9668):1016-1024. ☐ Level IV in presence of ☐ Other: Click or tap here
doi:10.1016/S0140-6736(09)60010-6 higher quality studies Validated outcome measures used to enter text.
(list): VAS, PCS, RMD, EQ5D,
EUroQOL Level of Evidence
☐ Subgroup analysis data
Determination
not available Nonvalidated outcome measures Potential Level: II
used (list): Click or tap here to Downgraded Level: III
☐ Not relevant to question enter text.
Conclusions
Diagnosis made by: This paper provides
☐ Clinical exam/history evidence that: clinical
☐ Electromyography outcome at two years is
☐ Myelogram better for BKP treated
☐ MRI patient group compared
☐ CT to non-surgical
☐ CT/Myelogram management patient
☐ Other: Click or tap here to enter group.
text.
This is an industry-
Results/subgroup analysis funded study, although
(relevant to question): industry had no input in
VAS BKP/NSM: baseline the analysis or
(6.79/6.93), 1 month (3.52/5.48), 3 presentation of the data.
months (2.93/4.52), 6 months
(2.73/4.35), 12 months (2.81/3.79),
24 months (2.82/3.65),
Author conclusions (relevant to
question): Compared with NSM,
BPK improves patient quality of life
and pain averaged during 24
months and results in better
improvement of index vertebral
body kyphotic angulation.
855
Yang EZ, Xu JG, Huang GZ, et al. Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Percutaneous Vertebroplasty Versus Therapeutic ☐ Nonconsecutive patients
Conservative Treatment in Aged Patients Study Design: RCT ☐ Nonrandomized
With Acute Osteoporotic Vertebral Level I
☐ Nonmasked reviewers
Compression Fractures: A Prospective Stated objective of study: we
☒ Nonmasked patients
Randomized Controlled Clinical Study. Spine Explanation of failure to determine whether percutaneous
(Phila Pa 1976). 2016;41(8):653-660. meet guideline inclusion ☐ No validated outcome
vertebroplasty (PVP) offers extra
doi:10.1097/BRS.0000000000001298 criteria benefits to aged patients with acute measures used
(when applicable) osteoporotic vertebral compression ☐ Small sample size
fractures (OVCFs) over ☐ <80% follow-up
☐ Level V (expert conservative therapy (CV). ☐ Lacked subgroup
consensus) analysis
Type of treatment(s): ☐ Diagnostic method not
☐ Level IV in presence of Percutaneous vertebroplasty or stated
higher quality studies conservative therapy. ☐ Other: Click or tap here
to enter text.
☐ Subgroup analysis data Total number of patients: 135
not available Number of patients in relevant
Level of Evidence
subgroup(s): 56 in PVP group; 51
Determination
in CV group
☐ Not relevant to question Potential Level: I
Downgraded Level: Not
Consecutively assigned? Yes
Downgraded
Duration of follow-up: 1 year
Conclusions
This paper provides
Validated outcome measures used
evidence that:
(list): VAS, ODI, QUAELFFCO
vertebral augmentation
resulted in improved pain
Nonvalidated outcome measures
control and function for
used (list): Satisfaction surveys.
first year post-procedure
for patients >70 years
Diagnosis made by:
with OVCF.
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xray, BMD, Radiograph
856
Results/subgroup
analysis:
Vertebroplsty compared to
conservative treatment showed
significant improvement in VAS,
ODI at 1 day, 1 week, 1 month, 3
month 6 month and 1 year. Both
groups had significant improvement
in VAS and ODI at 1 year
compared to baseline.
Author conclusions: In aged
patients with acute OVCF and
severepain, early vertebroplasty
yielded faster, better pain relief
andimproved functional outcomes,
which were maintained for 1 year.
Furthermore, it showed fewer
complications than conser-vative
treatment.
Yi X, Lu H, Tian F, et al. Recompression in Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
new levels after percutaneous vertebroplasty Therapeutic ☐ Nonconsecutive patients
and kyphoplasty compared with conservative Study Design: Comparative ☐ Nonrandomized
treatment. Arch Orthop Trauma Surg. Level II
☐ Nonmasked reviewers
2014;134(1):21-30. doi:10.1007/s00402-013- Stated objective of study: to
☒ Nonmasked patients
1886-3 investigate the incidence and
Explanation of failure to ☐ No validated outcome
associated risk factors of new
meet guideline inclusion symptomatic osteoporotic measures used
criteria vertebral compression fractures ☐ Small sample size
(when applicable) (OVCFs) in patients treated by ☐ <80% follow-up
percutaneous vertebroplasty ☐ Lacked subgroup
☐ Level V (expert (PVP) and kyphoplasty (PKP) analysis
consensus) versus conservative treatment, ☐ Diagnostic method not
and to elucidate our findings. stated
☐ Level IV in presence of ☐ Other: Click or tap here
higher quality studies Type of treatment(s):
to enter text.
Vertebroplasty, kyphoplasty, or
☐ Subgroup analysis data conservative treatment.
Level of Evidence
not available Determination
Total number of patients: 290
Potential Level: II
☐ Not relevant to question
857
Number of patients in relevant Downgraded Level: Not
subgroup(s): 90 vertebroplasty, 79 Downgraded
kyphoplasty, and 121 conservative
treatment. Conclusions
This paper provides
Consecutively assigned? Yes evidence that: treatment
with vertebroplasty or
Duration of follow-up: mean follow- kyphoplasty was not
up of 49.4 months (36–80 months) associated with
increased risk of
Validated outcome measures used additional fractures at
(list): VAS pain scale. new vertebral levels.
Adjacent segment
Nonvalidated outcome measures fractures appear earlier in
used (list): Telephone the treatment group,
questionnaires, clinical reexamine, although overall
and plain radiographs. additional fractures are
comparable.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Radiograph
Results/subgroup analysis:
Of the 290 patients 31 patients had
new symptomatic fractures.
Between the 169 cement
augmentation group and 121
conservative group there was no
significant statistical difference of
new fractures.
The adjacent fractures was
significantly higher than non
adjacent levels for cement
augmentation group.
858
The time interval of secondary
fracture was shorter for operative
group compared to conservative
group.
Author conclusions: Patients who
had experienced PVP/PKP were
not associated with an increased
risk of recompres-sion in new
levels. However, recompression
in new lev-els of PVP/PKP
group occurred much sooner
than that of conservative group
in the follow-up period. The
incidence of new vertebral
fractures observed at adjacent
levels was substantially higher
but no sooner than at distant
levels in PVP/PKP group. No
major risk factors involving new
OVCFs have been found in this
study and augmentation for
sandwich situation is not
necessary.
Interventional Treatment Question 4: Does mechanical device (an implant that includes more than a bone filler) improve outcomes in patients with
symptomatic osteoporotic vertebral compression fractures compared to medical care?
A systematic review of the literature yielded no studies to adequately address this question.
Interventional Treatment Question 5: Does the correction of vertebral height loss or segmental kyphosis during vertebral augmentation for symptomatic
osteoporotic vertebral compression fractures result in improved clinical outcomes?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Arabmotlagh M, Nikoleiski SC, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Schmidt S, Rauschmann M, Therapeutic
859
Rickert M, Fleege C. ☐ Nonconsecutive patients
Radiological evaluation of Level IV Study Design: Case Series ☒ Nonrandomized
kyphoplasty with an ☒ Nonmasked reviewers
intravertebral expander after Stated objective of study: To
osteoporotic vertebral fracture. J Explanation of failure to evaluate the efficacy of kyphoplasty ☒ Nonmasked patients
Orthop Res. 2019;37(2):457- meet guideline inclusion with the SpineJack to correct the ☐ No validated outcome measures
465. doi:10.1002/jor.24180. criteria kyphotic deformity and to analyze used
(when applicable) parameters affecting the restoration ☒ Small sample size
and maintenance of spinal ☐ <80% follow-up
☐ Level V (expert alignment. ☐ Lacked subgroup analysis
consensus) ☐ Diagnostic method not stated
Type of treatment(s): Kyphoplasty
☐ Other: Click or tap here to enter text.
☐ Level IV in presence of with intravertebral expander
higher quality studies (SpineJack)
Level of Evidence Determination
Potential Level: IV
Number of patients in relevant
☐ Subgroup analysis data Downgraded Level: Not Downgraded
subgroup(s): 42 patients/31
not available
completed follw-up; No subgroups
Conclusions
or control/comparison patients
☐ Not relevant to question This paper provides evidence that:
Consecutively assigned? Yes small correction of spine deformity
by kyphoplasty does not correlate
with improvement in pain.
Duration of follow-up: 12 months
Validated outcome measures used
(list): Kyphotic Angle, Vertebral
body height, VAS pain score
Nonvalidated outcome measures
used (list): The kyphosis angle was
significantly corrected from 13.4
degrees prior to kyphoplasty to
10.8 degrees (p < 0.01) after
surgery, but this correction was lost
at 12 months (13.3 degrees).
All patients, except for six with
adjacent vertebral fractures,
experienced significant pain
reduction (VAS 8.7 pre-operatively
and 2.0 at 12 months; p < 0.01),
and the pain was not affected by
the correction of the spinal
deformity or the loss of correction
in the follow-up period.
860
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Results/subgroup analysis:
Pain relief: VAS 8.7 baseline; 2.7
immediate (<0.01); 2.0 at 3 and 12
months (p<0.01)
VBH: 2.8 cm calculated pre
fracture; 1.5 post fracture, 1.9
immediate post procedure (<0.01);
1.8 12 monthspost but significantly
higher than pre procedure (<0.01)
KA: -1 degree pre procedure
calculated; 13.4 prior to kypho/post
fx; 10.8 immediate post procedure
((p<0.01);increased to 13.3 at 12
months /not significantly different
than pre kyphoplasty (p=0.6).
Significant correlation between
fracture mobility and correction of
VBH and KA, fracture mobility and
loss of KA correction and between
loss of correction at 12 months and
extent of correction (all p<0.01).
No correlation with age of the
fracture and pain improvement not
affected by change in KA at 12
months (p =0.02).
861
Author conclusions: Small
corrections of spinal deformities by
kyphoplasty or the loss of
correction over the follow up period
do not correlate with with pain
improvement. Furthermore, the
correction of the kyphotic deformity
, which is the main goal of
kyphoplasty, seems to have an
adverse effect on further
subsidence. The restoration of
spinal alignment by kyphoplasty is
mainly determined by the mobility
of the fracture prior to surger. Thus
the reduction of osteoporotic
vertebral body fractures can be
achieved more effectively by proper
positioning of the patient rather
than by the device used. However,
these conslusions are limited due
to the small number of patients
enrolled in our study and the short
postoperative period.
Bozkurt M, Kahilogullari G, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Ozdemir M, et al. Comparative Therapeutic ☐ Nonconsecutive patients
analysis of vertebroplasty and Study Design: Comparative ☒ Nonrandomized
kyphoplasty for osteoporotic Level III ☒ Nonmasked reviewers
vertebral compression Stated objective of study: To
fractures. Asian Spine J. ☒ Nonmasked patients
compare the efficacy and outcome
2014;8(1):27-34. Explanation of failure to of vertebroplasty compared with ☐ No validated outcome measures
doi:10.4184/asj.2014.8.1.27 meet guideline inclusion unipedicular and bipedicular used
criteria kyphoplasty for the treatment of ☐ Small sample size
(when applicable) osteoporotic vertebral compression ☐ <80% follow-up
fractures in terms of pain, ☐ Lacked subgroup analysis
☐ Level V (expert functional capacity and height ☐ Diagnostic method not stated
consensus) restoration rates. ☐ Other: Click or tap here to enter text.
☐ Level IV in presence of Type of treatment(s): Level of Evidence Determination
higher quality studies Vertebroplasty, Unipedicular Potential Level: III
kyphoplasty and bipedicular Downgraded Level: Not Downgraded
☐ Subgroup analysis data kyphoplasty
not available
Total number of patients: 296 (200 Conclusions
Kx and 96 Vx)
☐ Not relevant to question
862
Kyphoplasty = 116 unipedicular This paper provides evidence that:
and 84 bipedicular while the bipedicular kyphoplasty
procedure provides superior
Number of patients in relevant vertebral height restoration, both
subgroup(s): 116 unipedicular unipedicular and bipedicular
kyphoplasty, 84 bipedicular kyphoplasty and vertebroplasty
kyphoplasty, 96 vertebroplasty procedures provide effective pain
relief.
Consecutively assigned? Yes
Duration of follow-up:
Vertebroplasty = 42.9 months
Unipedicular Kypho = 23.88
months
Bipedicular Kypho= 23.44 months
Validated outcome measures used
(list): VAS, ODI, Height restoration,
Compression rate %
Nonvalidated outcome measures
used (list): Click or tap here to
enter text.
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☐☒ Other: Radiographs
Results/subgroup analysis:
VAS preoperative/first day/ 6
months/1year:
Vertebroplsty 8.3/2.8/2.96/2.78
Kyphoplasty(unipedicular)
8.3/2.76/2.85/2.84
Kyphoplasty (bi-pedicular)
8.27/2.70/2.79/2.66
ODI preoperative/6 months/1year
Vertebroplsty: 74342/35.31/26.56
863
Kypoplasty (unipedicular)
73.45/357/26.25
Kyphoplasty (bipedicular)
73.80/36.13/26.01
No stastically significant differene
between vertebroplasty / uni
pedicular kyphoplasty / bi pedicular
kyphoplasty for VAS and ODI
Height restoration
Vertebroplsty 24.16
Kyphoplsty unipedicular 24.25
Kyphoplsty bidedicular 37.05
Author conclusions: Vertebroplasty
and kyphoplasty are both effective
in providing pain relief and
improvement in functional capacity
and quality of life after the
procedure, but the bipedicular
kyphoplasty procedure has a
further advantage in terms of height
restoration when compared to
unipedicular kyphoplasty and
vertebroplasty procedures.
Chen B, Fan S, Zhao F. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Percutaneous balloon Therapeutic ☒ Nonconsecutive patients
kyphoplasty of osteoporotic Study Design: Comparative ☒ Nonrandomized
vertebral compression fractures Level III ☒ Nonmasked reviewers
with intravertebral cleft. Indian J Stated objective of study: To
Orthop. 2014;48(1):53-59. ☒ Nonmasked patients
investigate clinicoradiological
doi:10.4103/0019-5413.125498 Explanation of failure to characteristics of intravertebral cleft ☐ No validated outcome measures
meet guideline inclusion in OVCF and the effect on the used
criteria efficacy of percutaneous balloon ☐ Small sample size
(when applicable) kyphoplasty (PKP). ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Type of treatment(s): ☐ Diagnostic method not stated
consensus) Percutaneous ballon kyphoplasty ☐ Other: Click or tap here to enter text.
☐ Level IV in presence of Total number of patients: 183 Level of Evidence Determination
higher quality studies Number of patients in relevant Potential Level: III
subgroup(s): Group A: 139 OVCF Downgraded Level: Not Downgraded
864
☐ Subgroup analysis data without intravertebral cleft; Group
not available B: 44 OVCF with intravertebral cleft Conclusions
This paper provides evidence that:
☒ Not relevant to question Consecutively assigned? No restored height was statistically
significant in the cleft group but
Duration of follow-up: Unclear there was no significant difference in
pain relief or outcomes.
Validated outcome measures used
(list): VAS, ODI, vertebral body
height
Nonvalidated outcome measures
used (list): Leakage rate and type,
Pre and Post procedure VBH, Bone
cement infusion volumeClick or tap
here to enter text.
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Radiographs, Bone
density measurement
Results/subgroup
analysis: Significant difference
frequency distribution and cement
leakage type (p<0.05). No
significant difference infuision
volume and leakage rate (p<0.05)
Both groups postoperative height
significantly improved (p<0.05)
Restoration of height statistically
significant with cleft (p<0.05).
Preoperativ BAS and ODI in cleft
group significantly higher than
without cleft (p<0.05). Both
groups had significantly improved
pain relief after procedure (p<0.05)
but no significant difference in
865
postoperative VAS and ODI
between the 2 groups (P.0.05).
Author conclusions: Intravertebral
cleft exhibits specific clinical and
imaging s well as bone cement
formation characteristics.
Percutaneous balloon kyphoplasty
can effectively restore the affected
vertebral body height, alleviate
pain, and improve daily activity
function of patients,
Cheng J, Muheremu A, Zeng X, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Liu L, Liu Y, Chen Y. Therapeutic ☒Nonconsecutive patients
Percutaneous vertebroplasty vs Study Design: Comparative ☒Nonrandomized
balloon kyphoplasty in the Level III
☒Nonmasked reviewers
treatment of newly onset Stated objective of study: To
osteoporotic vertebral ☒Nonmasked patients
compare percutaneous
compression fractures: A Explanation of failure to vertebroplasty (VP) and balloon ☐ No validated outcome measures
retrospective cohort meet guideline inclusion kyphoplasty (BKP) for their used
study. Medicine (Baltimore). criteria effectiveness and safety in the ☐ Small sample size
2019;98(10):e14793. (when applicable) treatment of newly onset ☐ <80% follow-up
doi:10.1097/MD.000000000001 osteoporotic vertebral compression ☐ Lacked subgroup analysis
4793. ☐ Level V (expert fractures (VCF). ☐ Diagnostic method not stated
consensus) ☐ Other: Click or tap here to enter text.
Type of treatment(s):
☐ Level IV in presence of Vertebroplasty and Kyphoplasty Level of Evidence Determination
higher quality studies Potential Level: III
Total number of patients: 338 Downgraded Level: Not Downgraded
☐ Subgroup analysis data Number of patients in relevant
not available subgroup(s): 215 Vertebroplasty Conclusions
and 123 Kyphoplasty This paper provides evidence that:
☐ Not relevant to question there is no significant difference
Consecutively assigned? No between the two techniques in VAS
and ODI.
Duration of follow-up: 12 months
Validated outcome measures used
(list): VAS, ODI,
Nonvalidated outcome measures
used (list): Loss of vertebral body
height %, Restored vertebral height
, incidence of adjacent level fx,
866
incidence of cement leakage,
volume cement injected
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Radiographs
Results/subgroup analysis:
Kyphoplsty and vertebroplasty had
no significant difference between
the two groups for VAS and ODI
scores. Total cost higher for
kyphoplasty group.
Author conclusions: In the
treatment of OVCF, there are no
significant differences between VP
and BKP concerning the key
outcome parameters such as VAS
and ODI scores. Considering the
significantly less cost of VP than
BKP, we recommend prioritizing
VP over BKP for patients with
newly onset osteoporotic VCF.
Chi JE, Hsu JY, Chan R, Lo Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
WC, Chiang YH, Lin JH. Therapeutic ☐Nonconsecutive patients
Kyphoplasty with an Study Design: Comparative ☒Nonrandomized
intravertebral reduction device Level III ☒Nonmasked reviewers
for osteoporotic vertebral Stated objective of study: To
compression fractures with ☒Nonmasked patients
compare the radiological and
spinal canal encroachment. Explanation of failure to clinical outcomes of kyphoplasty ☐ No validated outcome measures
Formosan Journal of Surgery. meet guideline inclusion (KP) with intravertebral reduction used
2020;53(1):20-28. criteria device (IRD) and vertebroplasty ☒ Small sample size
(when applicable) (VP) for treating osteoporotic ☐ <80% follow-up
vertebral compression fracture ☐ Lacked subgroup analysis
☐ Level V (expert (OVCF)-associated spinal canal ☐ Diagnostic method not stated
consensus) encroachment (SCE). ☐ Other: Click or tap here to enter text.
867
☐ Level IV in presence of Type of treatment(s): Level of Evidence Determination
higher quality studies Vertebroplasty vs. Kyphoplasty with Potential Level: III
intravertebral reduction device Downgraded Level: Not Downgraded
☐ Subgroup analysis data
not available Total number of patients: 57 Conclusions
Number of patients in relevant This paper provides evidence that:
☐ Not relevant to question subgroup(s): 16 Kyphoplasty with kyphoplasty with a reduction device
IRD and 41 Vertebroplasty showed a significant difference in
height restoration and improved
Consecutively assigned? Yes kyphotic angle but no difference in
pain relief or outcomes.
Duration of follow-up: 12 months
required: actual KP/IRD: 20.7 mo;
VP: 30.9 mo
Validated outcome measures used
(list): VAS, ODI, EQ-5D-5L
Nonvalidated outcome measures
used (list): KA, Anterior, Middle and
Posterior Body Height (ABH. MBH,
PBH), Body Height Maintenance
Ratio, Height Restoration Ratio,
Cement leakage incidence, New
Neuro deficits, Postop
complications, Incidence rates of
cement leakage, Incidence rates of
adjacent fractures
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Results/subgroup
analysis: Compared with the VP
group, KA, ABH, MBH, and PBH
in the IRD group were
significantly greater after the
868
operation at postoperative 12
months (IRD vs. VP: KA −1.68° ±
6.02° vs. −10.34° ± 4.99°; ABH
2.06 ± 0.29 vs. 1.35 ± 0.26;
MBH 2.21 ± 0.51 vs. 1.21 ±
0.31; PBH 2.91 ± 0.62 vs. 2.11 ±
0.33 cm, P < 0.05). Significant
postoperative improvements were
observed in the VAS, ODI, and
EQ‐5D‐5 L in both groups; these
improvements were similar
between the two groups. No new
neurological deficits occurred, and
the incidence rates of cement
leakage into the SC were similar.
Author conclusions: KP with IRD
was associated with better body
heights and KA at least for 1
year for OVCF-associated SCE
with noninferior clinical outcomes to
VP.
Du J, Li X, Lin X. Kyphoplasty Type of evidence: ☒Prospective ☐ Retrospective Critique of methodology:
versus vertebroplasty in the Therapeutic ☒ Nonconsecutive patients
treatment of painful osteoporotic Study Design: Comparative ☒Nonrandomized
vertebral compression fractures: Level II
☒ Nonmasked reviewers
two-year follow-up in a Stated objective of study:
prospective controlled ☒ Nonmasked patients
Prospective study to compare the
study. Acta Orthop Belg. Explanation of failure to 2-year clinical and radiographic ☐ No validated outcome measures
2014;80(4):477-486. meet guideline inclusion outcomes of kyphoplasty and used
criteria vertebroplasty in the treatment of ☐ Small sample size
(when applicable) painful osteoporotic VCFs, and to ☒<80% follow-up
investigate if either of kyphoplasty ☐ Lacked subgroup analysis
☐ Level V (expert or vertebroplasty provides a better ☐ Diagnostic method not stated
consensus) treatment outcome than the other ☒ Other: < 805 f/uin VP group
procedure. (73%)Click or tap here to enter text.
☐ Level IV in presence of
higher quality studies Type of treatment(s): Kyphoplasty Level of Evidence Determination
and Vertebroplasty Potential Level: II
☐ Subgroup analysis data Downgraded Level: Not Downgraded
not available Total number of patients: 112
initially (60 in KP; 52 in VP)-->26 Conclusions relative to question
(23.3%) lost to f/u--> Final N=86
☐ Not relevant to question This paper provides evidence that:
(44KP, 42 VP) there is no difference between KP
869
Number of patients in relevant and VP in VAS and ODI
subgroup(s): 44 Kyphoplasty/42 improvement.
Vertebroplasty
Consecutively assigned? No
Duration of follow-up: Min f/u 2
years (mean/range N/A)
-f/u rate: 73.3% in KP vs 80.8% in
VP
Validated outcome measures used
(list): VAS, ODI, KA, VBH
(McKiernan technique) anterior,
middle and posterior vertebral
height
Nonvalidated outcome measures
used (list): Cement leakage, New
VCFs based on change in height
>10%, satisfaction rate
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Bone scan if no MRI,
Lateral radiographs
Results/subgroup
analysis: Significant pain reduction
in both groups post procedure
(VAS) and better maintained for 2
years with no statistical difference
between 2 groups at all f/u time
intervals. Both groups significant
improved function (ODI) immediate
and at 24 months with no
difference between 2 groups at any
time interval. Mean anterior, middle
and posterior height significantly
870
increased in both groups with no
difference between immediate post
op or final results. However,
postoperative increase of VBH in
each dimension was higher in
kyphoplasty group than VP group
(p<0.05) and difference more
remarkable for anterior and middle
VBH. At final f/u,81.8% in
kyphoplasty group and 47.6% in Vp
group had more than 10%
resolutrion ofheight in at least
dimension measure
(p=0.004).Greater rduction in post
op KA in KP than VP group at
every f/u time point with 77.3% KP
group and 52.4% VP group having
more than 5 degree reduction in KA
(p=0.001) BUT there was no
substantial correlation between
change in KA and clinical outcome
(p>0.05).
No procedural related adverse
event. Cement leak 11.4% KP and
31.0% VP.(p=0.011). No significant
difference in new symptomatic VCF
between the 2 groups.Satisfaction
rate 81.8% KP and 78.6% VP
which was not significant difference
between 2 groups (p=0.571).
Author conclusions: Kyphoplasty
and vertebroplasty achieved similar
improvement of clinical outcomes
and patient satisfaction at 2 years
after surgery, albeit KP had more
ability to markedly reduce vertebral
deformity and resulted in less
cement leaks compared to VP.
Gan M, Zou J, Song D, Zhu X, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Wang G, Yang H. Is balloon Therapeutic ☒ Nonconsecutive patients
kyphoplasty better than Study Design: Comparative ☒ Nonrandomized
percutaneous vertebroplasty for Level III
☒☐ Nonmasked reviewers
osteoporotic vertebral
871
biconcave-shaped Stated objective of study: To ☒☐ Nonmasked patients
fractures?. Acta Radiol. Explanation of failure to compare the effect and safety of ☐ No validated outcome measures
2014;55(8):985-991. meet guideline inclusion PV and BKP in treating used
doi:10.1177/0284185113511603 criteria osteoporotic vertebral biconcave-
☒ Small sample size
(when applicable) shaped fractures.
☐ <80% follow-up
☐ Level V (expert Type of treatment(s): ☐ Lacked subgroup analysis
consensus) Vertebroplasty, Balloon ☐ Diagnostic method not stated
Kyphoplasty ☐ Other: Click or tap here to enter text.
☐ Level IV in presence of
higher quality studies Total number of patients: 79 Level of Evidence Determination
patients Potential Level: III
Number of patients in relevant Downgraded Level: Not Downgraded
☐ Subgroup analysis data
subgroup(s): 38 PV and 41 BKP
not available
Conclusions
Consecutively assigned? No This paper provides evidence that: KP
☐ Not relevant to question
was superior in restoration of middle
Duration of follow-up: mean 41.4 vertebral height, however VAS and
+/- 3.6 PV and 43.5 +/- 4.1 months ODI improvements were similar in
BKP KP and VP.
Validated outcome measures used
(list): VAS, ODI, Cobb’s angle,
VBH (anterior and middle), kyphotic
angle
Nonvalidated outcome measures
used (list): refracture rates, cement
leakage, disc leakage,
extravasation
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Radiographs
Results/subgroup analysis:
For both kyphoplasty and
vertebroplasty the mean VAS and
872
ODI improved significantly and
sustained at final follow up.
Kyphoplasty was more effective in
middle vertebral height restoration.
There was no difference in anterior
vertebral height restoration.
Author conclusions: Both PV and
BKP achieved similar
improvements in pain and
functional outcomes for the
treatment of osteoporotic vertebral
biconcave-shaped fractures. BKP
had a significant advantage over
PV in terms of the restoration of the
middle VBH and fewer cement
leakages than PV.
Hu KZ, Chen SC, Xu L. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Comparison of percutaneous Therapeutic ☒ Nonconsecutive patients
balloon dilation kyphoplasty and Study Design: Comparative ☒ Nonrandomized
percutaneous vertebroplasty in Level III
☒ Nonmasked reviewers
treatment for thoracolumbar Stated objective of study: To
vertebral compression Explanation of failure to ☒ Nonmasked patients
compare the clinical efficacy of
fractures. Eur Rev Med meet guideline inclusion PKP and PVP in the treatment of ☐ No validated outcome measures
Pharmacol Sci. 2018;22(1 criteria osteoporotic thoracolumbar used
Suppl):96-102. (when applicable) vertebral compression fractures ☐ Small sample size
doi:10.26355/eurrev_201807_15 ☐ <80% follow-up
370 ☐ Level V (expert Type of treatment(s): Kyphoplasty, ☐ Lacked subgroup analysis
consensus) Vertebroplasty ☐ Diagnostic method not stated
☐ Other: Click or tap here to enter text.
☐ Level IV in presence of Total number of patients: 161
higher quality studies Number of patients in relevant Level of Evidence Determination
subgroup(s): 91 PKP and 70 PVP Potential Level: III
☐ Subgroup analysis data Downgraded Level: Not Downgraded
not available Consecutively assigned? No
Conclusions
Duration of follow-up: mean 2.1
☐ Not relevant to question This paper provides evidence that:
year (range 1-3 years) kyphoplasty is superior to
vertebroplasty in restoration of
Validated outcome measures used vertebral height, cobb angle
(list): VAS, ODI, Cobb’s angle, correction, pain, and function in
anterior VBH patients with osteoporotic vertebral
compression fractures.
873
Nonvalidated outcome measures
used (list): hospitalization time,
operation-related index (including
blood loss, bone cement injection,
surgical time and intraoperative
fluoroscopy), bedrest time, cement
leakage, secondary fractures
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: X-ray, BMD
Results/subgroup analysis:
For both kyphoplsty and
vertebroplsty the post operative
VAS, ODI, cobbs angle, vertebral
anterior height, quality of life were
dramatically improved. There was
significant difference between the
two groups for posterior vertebral
height, cobbs angle, and quality of
life was higher in kyphoplsty than
vertebroplasty.
Author conclusions: The clinical
effects of both PKP and PVP in the
treatment of OVCFs are good, of
which the reductive and analgesic
effect of PKP is superior to that of
PVP and the former has less
leakage of cement, higher safety
and fewer complications.
Kim KH, Kuh SU, Chin DK, et al. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Kyphoplasty versus Therapeutic ☒ Nonconsecutive patients
vertebroplasty: restoration of Study Design: Comparative ☒ Nonrandomized
vertebral body height and Level III
☒ Nonmasked reviewers
correction of kyphotic deformity
☒ Nonmasked patients
874
with special attention to the Stated objective of study: We ☐ No validated outcome measures
shape of the fractured Explanation of failure to analyzed kyphosis correction, used
vertebrae. J Spinal Disord Tech. meet guideline inclusion vertebral height restoration, and ☐ Small sample size
2012;25(6):338-344. criteria bone cement leakage in patients
☐ <80% follow-up
doi:10.1097/BSD.0b013e31822 (when applicable) treated by VP and KP to compare
4a6e6 the effectiveness of VP and KP for ☐ Lacked subgroup analysis
☐ Level V (expert treatment of OVCFs. ☐ Diagnostic method not stated
consensus) ☐ Other: Click or tap here to enter text.
Type of treatment(s): Kyphoplasty,
☐ Level IV in presence of Vertebroplasty Level of Evidence Determination
higher quality studies Potential Level: III
Total number of patients: 103 Downgraded Level: Not Downgraded
Number of patients in relevant
☐ Subgroup analysis data
subgroup(s): VP (n = 58) or KP (n = Conclusions
not available
45) This paper provides evidence that: KP
had advantages in middle vertebral
☐ Not relevant to question Consecutively assigned? No height restoration and cement
leakage, but for pain relief it was
Duration of follow-up: KP (26.8 similar to VP.
months), VP (23.9 months)
Validated outcome measures used
(list): Radiological: VBH, kyphotic
cobb angle; 2) PRO: VAS
Nonvalidated outcome measures
used (list): Click or tap here to
enter text.
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Whole body bone scan
Results/subgroup analysis: KP
significantly better than VP for
middle VBH restoration and
preventing cement leakage for all
shape fxs (p<0.05). KP more
effective in anterior VBH
875
restoration and kyphosis correction
in both flat and wedge shaped
fractures (p<0.05). Posterior VBH
was not restored in either KP or VP
groups. Clinical outcomes (VAS)
not different between KP and VP
(P>0.05) Results/subgroup
analysis: There were no significant
differences in kyphosis correction
using postoperative and
preoperative Cobb angles between
VCF and VCF+1 measuring
methods (Tables 3–5).
However, there was no statistically
significant difference of remote and
adjacent segment fracture between
KP and VP groups in all fracture
shapes.
Author conclusions: KP yielded
good results for kyphotic deformity
correction for W-shape fractures
compared with F-shape and V-
shape fractures. KP had additional
advantages in middle vertebral
height restoration and cement
leakage prevention in V-shape
fractures.
Lin JH, Wang SH, Lin EY, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Chiang YH. Better Height Therapeutic ☒ Nonconsecutive patients
Restoration, Greater Kyphosis Study Design: Comparative ☒ Nonrandomized
Correction, and Fewer Level III
☐ Nonmasked reviewers
Refractures of Cemented Stated objective of study:
Vertebrae by Using an Explanation of failure to ☒ Nonmasked patients
compared the radiologic and
Intravertebral Reduction Device: meet guideline inclusion clinical ☐ No validated outcome measures
a 1-Year Follow-up Study. World criteria outcomes of kyphoplasty with used
Neurosurg. 2016;90:391-396. (when applicable) intravertebral reduction ☐ Small sample size
doi:10.1016/j.wneu.2016.03.009 device (IRD) and vertebroplasty ☐ <80% follow-up
☐ Level V (expert (VP) in treating osteoporotic ☐ Lacked subgroup analysis
consensus) vertebral compression fractures ☐ Diagnostic method not stated
(OVCFs). ☐ Other: Click or tap here to enter text.
☐ Level IV in presence of
higher quality studies Level of Evidence Determination
876
Type of treatment(s): Potential Level: III
☐ Subgroup analysis data Vertebroplasty, Kyphoplasty with Downgraded Level: Not Downgraded
not available Intravertebral Reduction Device
Conclusions
☐ Not relevant to question Total number of patients: 75 This paper provides evidence tha KP
Number of patients in relevant was superior in height restoration
subgroup(s): 36 Kyphoplasty with and kyphosis correction, however
IRD and 39 VP pain improvement was similar in KP
and VP.
Consecutively assigned? No
Duration of follow-up: 1 year (12
months)
Validated outcome measures used
(list): VAS, anterior and middle
VBH for % restoration, KA
Nonvalidated outcome measures
used (list): Complications, cement
leakage, new fracture
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: BMD, Radiographs,
xrClick or tap here to enter text.
Results/subgroup analysis: No
significant differences between 2
groups preop. No significant
difference VAS score pre or post
op between 2 groups. The mean
KA was significantly better in KP
with IRD than VP except at 1 week.
The mean KA restoration was
significantly better in KP than VP at
all time points. Anterior VBH did
not differ in either group although
the anterior VBH restoration was
877
significantly better in KP than VP.
Mean middle VBH, middle VBH
restoration and refracture rates
were significantlt better in KP with
IRD than with VP. No significant
difference adjacent or non adjacent
fractures in 2 groups or
complications.
Author conclusions: Our findings
reveal significantly more efficient
height restoration and kyphosis
correction and fewer refractures in
the KP with IRD group. IRD may
not increase the risk of adjacent or
nonadjacent fractures.
Liu JT, Liao WJ, Tan WC, et al. Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Balloon kyphoplasty versus Therapeutic ☒ Nonconsecutive patients
vertebroplaty for treatment of Study Design: Comparative ☐ Nonrandomized
osteoporotic vertebral Level II
☒ Nonmasked reviewers
compression fracture: A Stated objective of study: To this
prosperctive, comprarative, and ☒ Nonmasked patients
to gauge the radiological and
randomized clinical study. Explanation of failure to clinical outcomes of balloon ☐ No validated outcome measures
Osteoporos Int 2010;21:359– meet guideline inclusion kyphoplasty versus vertebroplasty. used
64. criteria ☐ Small sample size
(when applicable) Type of treatment(s): ☐ <80% follow-up
Vertebroplasty versus Kyphoplasty ☐ Lacked subgroup analysis
☐ Level V (expert ☒ Diagnostic method not stated
consensus) Total number of patients: 100100 ☐ Other: Click or tap here to enter text.
cases of VCF
☐ Level IV in presence of Number of patients in Level of Evidence Determination
higher quality studies relevant subgroup(s): 50 Potential Level: II
vertebroplasty and 50 kyphoplasty Downgraded Level: Not Downgraded
☐ Subgroup analysis data
not available Consecutively assigned? No Conclusions
This paper provides evidence that:
☐ Not relevant to question Duration of follow-up: 6 months6 kyphoplasty did have a significant
months improvement in height over
. vertebroplasty but this made no
difference in pain.
Validated outcome measures used
(list): VAS
878
Nonvalidated outcome measures
used (list): .Vertebral body height,
kyphotic wedge angle
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒☐ Other: Not specified
Results/subgroup analysis:
Compared to the vertebroplasty
group, the kyphoplasty group
required longer operation time and
a greater amount of PMMA. To
patient's in the kyphoplasty group
pad adjacent segment
fractures. Vertebral body height
and kyphotic angle of the thoracic
and lumbar spine were improved in
the kyphoplasty group
(p<0.001). VAS pain scores did
not differ significantly between the
treatment groups.
Author conclusions: In terms of
clinical outcome there was little
difference between the treatment
groups. Thus with the higher cost
of kyphotic balloon procedure, we
recommend vertebroplasty over
kyphoplasty for the treatment of
osteoporotic VCFs.
Palmowski Y, Balmer S, Bürger Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
J, Schömig F, Hu Z, Pumberger Therapeutic ☒ Nonconsecutive patients
M. Influence of operative timing Study Design: Comparative ☒ Nonrandomized
on the early post-operative Level III
☒ Nonmasked reviewers
radiological and clinical outcome Stated objective of study: To clarify
after kyphoplasty. Eur Spine J. ☐ Nonmasked patients
the relationship between operative
2020;29(10):2560-2567. timing and the early post-operative ☐ No validated outcome measures
used
879
doi:10.1007/s00586-020-06491- Explanation of failure to radiological and clinical outcome ☐ Small sample size
8 meet guideline inclusion after kyphoplasty. ☐ <80% follow-up
criteria ☐ Lacked subgroup analysis
(when applicable) Type of treatment(s): KP
☐ Diagnostic method not stated
☐ Level V (expert Total number of patients: 230 (out ☐ Other: Click or tap here to enter text.
consensus) of 492)
Number of patients in Level of Evidence Determination
Potential Level: III
☐ Level IV in presence of relevant subgroup(s): 100 with
acute, 91 with subacute and 39 Downgraded Level: Not Downgraded
higher quality studies
with chronic fractures. Divided into
three groups based on the interval Conclusions
☐ Subgroup analysis data This paper provides evidence that:
between fracture and surgery-->
not available optimal correction of fracture-related
1. Acute [< 2 weeks]
2. Subacute [2–6 weeks] or local kyphosis improves if
☐ Not relevant to question 3. Chronic [6–51 weeks] kyphoplasty is performed within 6-
weeks after fracture onset. After 6-
Consecutively assigned? No weeks, correction of the local
kyphosis attributed to the fracture
Duration of follow-up: 2 days significantly decreases. VAS was not
(immediate postop.) significantly different between
groups, but medication use
Validated outcome measures used decreased in acute and subacute
(list): groups, but not statistically different
1. Radiographic metrics: VBH, local from the non-acute group.
kyphotic angle (LKA)
2. Clinical outcomes: VAS at rest
and in motion.
Nonvalidated outcome measures
used (list):
1. Analgesic use based on WHO
Analgesic Ladder (non-opioids;
non-opioids + weak opioids; non-
opioids + strong opioids)
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
880
☒ Other: X-rays
Results/subgroup analysis:
1. Radiological Outcomes:
All groups acute/subacute/chronic
had significant post operative
improvement in anterior and middle
VBH.
2. Clinical Outcomes:
Analgesic usage:
-In patients with acute fractures,
the use of analgesics
according to the WHO pain ladder
was significantly reduced
2 days post-operatively (Z-score
−2.2; p = 0.027) and at the
time of discharge (Z-score −3.3; p
= 0.001).
-In the subacute group, there was a
trend towards less use of
analgesics 2 days post-operatively,
which was not significant (Z-score
−1.6; p = 0.118). At time of
discharge, the use of analgesics
was also significantly lower than
preoperatively in the subacute
group (Z-score −3.2; p = 0.001).
-For patients with chronic fractures,
there was a trend towards a lower
use of analgesics 2 days post-
operatively (Z-score −1.4; p =
0.177) and at discharge (Z-score
−0.5; p = 0.642), which was less
pronounced than in the other two
groups and did not reach
significance
In summary, the use of analgesics
significantly decreased post-
operatively in the acute and
subacute groups, but did not
significantly change in the chronic
881
group.
Author conclusions: a better
correction
of fracture-related kyphotic
deformation is possible
if kyphoplasty is performed within 6
weeks after injury
compared to surgery after > 6
weeks. Therefore, we suggest
aiming for a final decision upon
conservative or surgical
treatment during that period.
However, if patients present
with older fractures, kyphoplasty
should still be considered
as an option because significant
pain reduction and vertebral
height restoration are possible
even after longer periods.
Park HT, Lee CB, Ha JH, Choi Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
SJ, Kim MS, Ha JM. Results of Therapeutic ☒ Nonconsecutive patients
kyphoplasty according to the Study Design: Comparative ☒ Nonrandomized
operative timing. Current Level III
☒ Nonmasked reviewers
Orthopaedic Practice. Stated objective of study: to
2010;21(5):489-493. Explanation of failure to ☒ Nonmasked patients
measure spinal deformity and
meet guideline inclusion pain scores before and after ☐ No validated outcome measures
criteria treatment with balloon kyphoplasty used
(when applicable) performed within 2 weeks or 2 ☒ Small sample size
weeks after fracture. ☐ <80% follow-up
☐ Level V (expert ☐ Lacked subgroup analysis
consensus) Type of treatment(s): KP ☐ Diagnostic method not stated
☐ Other: Click or tap here to enter text.
☐ Level IV in presence of Total number of patients: 40 female
higher quality studies patients Level of Evidence Determination
Number of patients in Potential Level: III
☐ Subgroup analysis data relevant subgroup(s): Downgraded Level: Not Downgraded
not available Group 1: N=20 ~ KP within 2
weeks after fracture occurrence Conclusions
☐ Not relevant to question Group 2: N=20 ~ KP more than 2 This paper provides evidence that: KP
weeks after fracture occurrence performed within 2 weeks of fracture
onset in female patients with single-
Consecutively assigned? No level OVCF provides better
882
restoration of VBH and improvement
Duration of follow-up: Mean f/u: 12- in Cobb angle. However, timing of
months; Range: 6-24 months intervention does not seem to impact
self-reported back pain at 3-month
Validated outcome measures used follow-up.
(list):
1. Radiographic metrics: Vertebral
Body Height (VBH) restoration
(anterior; middle); Restoration rate;
change in Cobb angle
2. Clinical: VAS Back pain
Nonvalidated outcome measures
used (list): Fractured vertebral
height ð%Þ, Height restoration
ð%Þ, Restoration rate ð%Þ
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X rays
Results/subgroup analysis:
Radiological outcomes:
1. VBH: Patients undergoing early
intervention (Group 1 <2 weeks)
had significantly higher anterior
[22.6% vs 12.9%; p=0.012] and
middle VBH restoration [25.3% vs
17.9%; p=0.015] compared to
Group 2 (>2 weeks)
2. Restoration rate (RR): Patients
in group 1 had higher RR in both
the anterior [46.2% vs 28.2%;
p=0.005] and middle [52.6% vs
36.6%; p=0.008] portion compared
to Group 2.
883
3. Change in Cobb angle: Group 1
had higher degree of changes in
the Cobb angle (8.8 vs 4.2;
p=0.025) compared to Group 2.
Clinical Outcomes: At 3-months
postoperatively, no difference was
noted in the VAS scores across the
groups (Group 1: 2.75 vs 2.85 in
Group 2; p=0.797].
Author conclusions: Vertebral
height restoration was better
achieved within 2 weeks of the
fracture occurrence. It seems
reasonable that patients presenting
with an acute vertebral
compression fracture and
substantial kyphosis might be best
managed with earlier intervention in
attempting to maximize
improvement in kyphosis
correction.
Röllinghoff M, Siewe J, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Zarghooni K, et al. Therapeutic ☒Nonconsecutive patients
Effectiveness, security and Study Design: Comparative ☒Nonrandomized
height restoration on fresh Level III
☒Nonmasked reviewers
compression fractures--a Stated objective of study: The aim
comparative prospective study ☒Nonmasked patients
of our tudy is to compare
of vertebroplasty and Explanation of failure to vertebroplasty and kyphoplasty as ☐ No validated outcome measures
kyphoplasty. Minim Invasive meet guideline inclusion to their effectiveness, safety, used
Neurosurg. 2009;52(5-6):233- criteria restorartion of VBH and to discuss ☐ Small sample size
237. doi:10.1055/s-0029- (when applicable) the complication rates in both ☐ <80% follow-up
1243631 procedures. Moreover with our ☐ Lacked subgroup analysis
☐ Level V (expert data we want to assist in reducing ☐ Diagnostic method not stated
consensus) the rate of serious complications in ☐ Other: Click or tap here to enter text.
both minimally invasive
☐ Level IV in presence of percutaneous fracture procedures. Level of Evidence Determination
higher quality studies Potential Level: II
Type of treatment(s): Kyphoplasty, Downgraded Level: III
☐ Subgroup analysis data Vetrberoplasty Downgraded due to: methodology
not available
884
Total number of patients: 90 (8 Conclusions
☐ Not relevant to question died, 2 lost to follow-up) This paper provides evidence that:
Number of patients in relevant there was no difference in QoL or
subgroup(s): 104 Vertebral Bodies pain improvement between both
treated, 51 VP and 53 KP procedues. Vertebral body height
was significantly better in KP.
Consecutively assigned? No
Duration of follow-up: 1 year
Validated outcome measures used
(list): VAS, ODI, vertebral height
restoration, kyphosis angle
Nonvalidated outcome measures
used (list): Cement leakage
volume, Adjacent level fracture,
VBH restoration, KA, anterior and
posterior edge height.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: conventional lateral or
A/P X-rays, CT and/or MRI
scanning.
Results/subgroup analysis: Both
VP and KP had a significant
decrease in VAS post op and
further significant improvement at
1 year.ODI was also significantly
reduced in both groups post op and
significantly further at 1 year.
There was no significant difference
in VAS or ODI improvement
between the 2 groups. Mean VBH
was significantly raised in both
groups. At 1 year follow-up there
was mean 1.4 mm loss of mean
885
VBH in VP and a mean of of 0.7
mm in KP. There was no statistical
difference concerning anterior
/posterior edge height restoration
and KA between the 2 groups.
Asymptomatic cement leakage in
25.3% VP and 22.6% KP although
2 VP had leakage into canal
requiring surgery. 4 adjacent
fractures in VP 7.8%) and 7 after
KP (13.2%)..
Author conclusions: This study
compares VP and KP with regard
to their effectiveness, safety and
restoration of VBH, and
complications. There were no
differences between the groups
with regard to QOL and pain
improvement, but the rate of
serious complications was higher
after vertebroplasty. Mean VBH
restoration at 1 year was
significantly higher(p<0.05) in the
KP group. It remains to be seen in
future long-term studies whether or
not restoration of VBH has an
effect on the clinical result.
Schofer MD, Efe T, Timmesfeld Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
N, Kortmann HR, Quante M. Therapeutic ☒ Nonconsecutive patients
Comparison of kyphoplasty and Study Design: Comparative ☒ Nonrandomized
vertebroplasty in the treatment Level of Evidence:
☒ Nonmasked reviewers
of fresh vertebral compression ☐I Stated objective of study: Compare ☒ Nonmasked patients
fractures. Arch Orthop Trauma ☐ II VP and KP treatment results and
Surg. 2009;129:1391– 9. ☐ No validated outcome measures
☒ III complications
used
☐ IV ☒ Small sample size
Type of treatment(s): Kyphoplasty
versus Vertebroplasty ☐ <80% follow-up
Explanation of failure to ☐ Lacked subgroup analysis
meet guideline inclusion
Total number of patients: 60 ☐ Diagnostic method not stated
Number of patients in relevant ☐ Other: Click or tap here to enter text.
criteria
subgroup(s): 30 Vertebroplasty/30
(when applicable)
Kyphoplasty Level of Evidence Determination
Work group conclusions
886
☐ Level V (expert Consecutively assigned? No Potential Level: II
consensus) Downgraded Level: III
Duration of follow-up: Average 13.5 Downgraded due to small sample size,
☐ Level IV in presence of +/- 6.9 months in Kyphoplasty nonconsecutive, nonrandomized,
higher quality studies group and 13.7 +/- 7.1 in nonmasked
Vertebroplasty group
☐ Subgroup analysis data Conclusions relative to question
Validated outcome measures used This paper provides evidence that:
not available
(list): VAS, mean SF-36 kyphoplasty did have a significant
improvement in height over
☐ Not relevant to question Nonvalidated outcome measures vertebroplasty but this made no
used (list): Angle of kyphosis, difference in pain and function.
cement leakage
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Radiographs
Results/subgroup analysis:
K
Clinical follow up at preoperative /
one day post surgery / later follow
up average 13.5 months for
kyphoplsty and 13.7 months for
vertebroplsty.
VAS kyphoplasty: 8.2/3.2/2.6
VAS vertebroplsty: 8.3/3.0/2.8
Angle of kyphosis more
pronounced in kyphoplsty group.
Kyphoplasty: 12.5/6.6/7.1 degrees
Vertebdroplsty: 11.4/9.3/10.4
Author conclusions: The two
surgical procedures were both
followed by significant pain relief,
and the quality of life was similar
regardless of the procedure used.
887
Sun G, Jin P, Li M, Liu XW, Li Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
FD. Height restoration and Therapeutic ☐ Nonconsecutive patients
wedge angle correction effects Study Design: Comparative ☒ Nonrandomized
of percutaneous vertebroplasty: Level III ☒ Nonmasked reviewers
association with intraosseous Stated objective of study: To
clefts. Eur Radiol. ☒ Nonmasked patients
evaluate effects of vertebroplasty
2011;21(12):2597-2603. Explanation of failure to on restora- tion of vertebral body ☐ No validated outcome measures
doi:10.1007/s00330-011-2218-z meet guideline inclusion height and wedge angle and relief used
criteria from pain in patients with ☐ Small sample size
(when applicable) osteoporotic compression ☐ <80% follow-up
. fractures. ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not stated
consensus) Type of treatment(s): ☐ Other: Click or tap here to enter text.
Percutaneous vertebroplasty
☐ Level IV in presence of Level of Evidence Determination
higher quality studies Total number of patients: 156 (232 Potential Level: III
levels) Downgraded Level: Not Downgraded
☐ Subgroup analysis data Number of patients in relevant
not available subgroup(s): 49 with cleft and 107 Conclusions
without This paper provides evidence that:
☐ Not relevant to question while height and wedge angle may
Consecutively assigned? YesNo be improved in patients with
vertebral cleft, compared to without
Duration of follow-up: 12 months cleft, there was no significant
difference in pain relief.
Validated outcome measures used
(list): Numerical Pain score VBH,
KA, height, wedge angle, NRS
Nonvalidated outcome measures
used (list): Amount cement injected
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: For all patients, digital
radiography and MR imaging were
888
performed in 1–13 days preceding
vertebroplasty.
Results/subgroup analysis: No
significant difference in amount of
cement used between the 2
groups. There was a significant
gain of most compressed vertical
height rate and reduction in wedge
angle at a whole patient level
analysis. However, with a
vertebra-by-vetrbera level analysis,
in the non-cleft group, both VBH
and wwedge angle showed no
significant change when values of
the preprocedure were compared
to values of the post-procedure by
using a paired sample t test
(P=0.11, and p=0.16). A significant
gain of the compressed vertical
height rate (P<0.001) and a
reduction in wedge angle (P,0.01)
were observed in the cleff group.
Pain releief was not significantly
different between the 2 groups
(p>0.05) with both groups
experiencing a significant reduction
in pain..
Author conclusions: Most patients
experienced pain relief after VP.
After VP, the height and wedge
angle were significantly improved in
the cleft group (p<0.01), with no
significant improvement in the non-
cleft group (p>0.05).
Zapałowicz K, Radek M. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Percutaneous balloon Therapeutic ☒Nonconsecutive patients
kyphoplasty in the treatment of Study Design: Case Series ☒Nonrandomized
painful vertebral compression Level IV
☒Nonmasked reviewers
fractures: effect on local Stated objective of study: The aim
kyphosis and one-year ☒Nonmasked patients
of the study was to determine the
outcomes in pain and effectiveness of percutaneous ☐ No validated outcome measures
disability. Neurol Neurochir Pol. used
889
2015;49(1):11-15. Explanation of failure to balloon kyphoplasty for treatment ☒Small sample size
doi:10.1016/j.pjnns.2014.11.005 meet guideline inclusion of compressive vertebral fracture. ☐ <80% follow-up
criteria ☐ Lacked subgroup analysis
(when applicable) Type of treatment(s): Ballooon
. kyphoplasty ☐ Diagnostic method not stated
☐ Level V (expert ☐ Other: Click or tap here to enter text.
consensus) Total number of patients: 24
patients, 58 fractures Level of Evidence Determination
Potential Level: IV
☐ Level IV in presence of Number of patients in relevant
subgroup(s): Click or tap here to Downgraded Level: Not Downgraded
higher quality studies
enter text.
Conclusions
☐ Subgroup analysis data This paper provides evidence that: the
Consecutively assigned? No
not available correction of local kyphosis with
Duration of follow-up: 12 months kyphoplasty had no effect on pain
☐ Not relevant to question relief or disability.
Validated outcome measures used
(list): VAS, ODI, KA
Nonvalidated outcome measures
used (list): Cement volume
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: A total of 58 fractured
vertebrae (29 thoracic, 29 lumbar)
were treated. Fractures were
diagnosed by X-ray films,
computed tomography (CT) or
magnetic resonance image (MRI)
Results/subgroup analysis:
Mean VAS decreased from
preoperative 6.54 to 1.25 at
discharge, and 0.26 at 12 months.
ODI was 50% / 1 month 21% /
follow up 10%
890
Local kyphosis reduction:
30 (51.7%) vertebrae and change
ranging from 2-10 degreres (mean
4,.3 degrees). In nine (37.5%)
pateints BKP reduced LK in
allaugmented vertebrae, in seven
(29.2%) reduced LK in fraction of
augmented vertebrae, in eight
(33.3%) no significant reduction of
LK.
Author conclusions: Rapid
significant pain relief after KP
followed long-term pain release
and disability reduction obtained in
all patients was most probably the
result of vertebral augmentation,
The correction of local kyphosis
had no influence on the outcome.
Zhou X, Meng X, Zhu H, Zhu Y, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Yuan W. Early versus late Therapeutic ☒ Nonconsecutive patients
percutaneous kyphoplasty for Study Design: Comparative ☒ Nonrandomized
treating osteoporotic vertebral Level III ☒ Nonmasked reviewers
compression fracture: A Stated objective of study: To find
retrospective study. Clin Neurol Explanation of failure to ☒ Nonmasked patients
out whether surgical timing could
Neurosurg. 2019;180:101-105. meet guideline inclusion affect the clinical and radiological ☐ No validated outcome measures
doi:10.1016/j.clineuro.2019.03.0 criteria outcomes in OVCF patients used
29 (when applicable) undergoing PKP ☒ Small sample size
☐ <80% follow-up
☐ Level V (expert Type of treatment(s): PKP ☐ Lacked subgroup analysis
consensus) ☐ Diagnostic method not stated
Total number of patients: 62 ☐ Other: Click or tap here to enter text.
☐ Level IV in presence of patients
higher quality studies Number of patients in Level of Evidence Determination
relevant subgroup(s): Potential Level: III
☐ Subgroup analysis data Group A: N=36 (58 vertebrae); Downgraded Level: Not Downgraded
not available procedure <4 weeks
Group B: N=26 (40 vertebrae); Conclusions
procedure >4 weeks
☐ Not relevant to question This paper provides evidence that:
early kyphoplasty less than 4 weeks
Consecutively assigned? No after fracture onset provides better
height restoration and lower rate of
Duration of follow-up: 6 months subsequent fracture compared to
PKP after 4 weeks. Clinical outcomes
891
Validated outcome measures used in terms of VAS and ODI at follow-up
(list): 1. Clinical Outcomes: VAS, are comparable.
ODI
2. Radiological outcomes: height
restored rate (HRR); local kyphosis
angle
Nonvalidated outcome measures
used (list): Height restoration rate
Diagnosis made by:
☐☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X-rays
Results/subgroup analysis:
Clinical outcomes;
VAS and ODI had no stastical
difference between the two groups
at baselin, post surgery and 6
months follow up.
Height restoration:
Group A: 17.5/10.5
Group B: 7.2/3.6
No significant difference between
the two groups
Kyphotic angle
(preoperative/post operative/6
month follow up)
Group A: -12.7/-7.3/-11.4
Group B: -17.6/+14.4/-16.1
There was significant difference
between the two groups an all
times for the kyphosis angle.
892
Author conclusions: Both surgical
timings of PKP showed similar
outcomes in terms of the VAS and
ODI. Early PKP could result in
better restoration of vertebral body
height and reduced rate of
subsequent fracture compared to
late PKP.
Interventional Treatment Question 6: For patients with symptomatic acute osteoporotic vertebral compression fractures, what is the optimal timing for
vertebral augmentation?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Diamond T, Clark W, Bird P, Gonski P, Type of evidence: ☒ Prospective ☐ Critique of methodology:
Barnes E, Gebski V. Early vertebroplasty Therapeutic Retrospective ☒ Nonconsecutive patients
within 3 weeks of fracture for acute painful ☐ Nonrandomized
vertebral osteoporotic fractures: subgroup Level I Study Design: RCT ☐ Nonmasked reviewers
analysis of the VAPOUR trial and review
☐ Nonmasked patients
of the literature. Eur Spine J. Stated objective of study:
2020;29(7):1606-1613. Explanation of failure to ☐ No validated outcome measures
To assess the safety and
doi:10.1007/s00586-020-06362-2. meet guideline inclusion efficacy of early used
criteria vertebroplasty for acute ☐ Small sample size
(when applicable) painful vertebral ☐ <80% follow-up
osteoporotic fractures ☐ Lacked subgroup analysis
☐ Level V (expert within 3 weeks of fracture ☐ Diagnostic method not stated
consensus) onset in the VAPOUR ☐ Other: Click or tap here to enter
study.
text.
☐ Level IV in presence of
higher quality studies Type of treatment(s): VP
Level of Evidence Determination
Potential Level: I
☐ Subgroup analysis data Total number of patients:
Downgraded Level: Not
not available 93 patients
Downgraded
Number of patients in
relevant subgroup(s):
☐ Not relevant to question Conclusions
46 in the Vertebroplasty (V)
This paper provides evidence that
group:
early vertebroplasty done within ≤
47 in the placebo (P) group
3 weeks of fracture onset shows
clinically important benefits in
893
Consecutively assigned? terms of lower NRS pain scores
No and lower RMDQ at up to six
months.
Duration of follow-up: 6
months for final
assessment
- 86 patients (93%)
completed follow-up at 14
days
and 78 (84%) the final
assessment at 6 months
Validated outcome
measures used (list):
1. NRS Pain (primary
outcome)
2. RMDQ Score (secondary
outcome measure)
3. EQ-5D Score
4. QUALEFFO score
Nonvalidated outcome
measures used (list):
Radiographic metrics: VH
loss
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X-rays
Results/subgroup
analysis: In total, 86
patients (41V, 45P)
completed the 14-day
questionnaire.
894
PRIMARY OUTCOME:
NRS pain scores
-The proportion of patients
with reduction in pain from
severe (NRS ≥ 7/10 was an
inclusion requirement) to
mild (NRS < 4) at 14 days
was 21 (51%) V-group and
9 (20%) in the P-group
(between-group difference
31 percentage points, 95%
CI 12–50; p = 0.002).
-At 1 month, 39% more
patients reported low pain
scores in the vertebroplasty
than placebo group.
SECONDARY OUTCOME
measure: RMDQ
-Early vertebroplasty
provided greater reductions
in mean NRS pain and
Roland–Morris Disability.
Mean NRS pain and
RMDQ scores from 3 days
through 6 months
favoured vertebroplasty
over placebo
Radiographic metrics:
-Baseline mean fracture
height loss was similar in
both
groups (Table 1). At 6
months, the mean height
loss was
25% ± 11 in the V-group
and 67% ± 15 in the C-
group (between-group
895
difference 42 percentage
points, (CI 35–49).p=
0.0001).
Author conclusions:
Analysis of this patient
subgroup from the
VAPOUR trial, in the
context of other
randomized trial evidence,
suggests clinically
significant benefits from
early vertebroplasty if
performed within 3 weeks
of fracture.
Erkan S, Ozalp TR, Yercan HS, Okcu G. Type of evidence: ☒ Prospective ☐ Critique of methodology:
Does timing matter in performing Therapeutic Retrospective ☐ Nonconsecutive patients
kyphoplasty? Acute versus chronic ☒ Nonrandomized
compression fractures. Acta Orthop Belg. Level III Study Design: ☒ Nonmasked reviewers
2009;75(3):396-404. Comparative
☐ Nonmasked patients
Explanation of failure to ☐ No validated outcome measures
Stated objective of study:
meet guideline inclusion To compare the clinical used
criteria outcomes, the ☒ Small sample size
(when applicable) radiographic outcomes and ☐ <80% follow-up
the complication rates of ☐ Lacked subgroup analysis
☐ Level V (expert symptomatic acute (< 10 ☐ Diagnostic method not stated
consensus) weeks) and chronic (> 16 ☒ Other: Poor statistical methods,
weeks) osteoporotic
especially no adjusted regression
☐ Level IV in presence of vertebral compression
analysis to their dataset.
higher quality studies fractures (VCFs) treated
with kyphoplasty.
Level of Evidence Determination
☐ Subgroup analysis data Potential Level: II
not available Type of treatment(s): KP
Downgraded Level: III
Downgraded due to:
Total number of patients:
☐ Not relevant to question nonrandomization, nonmasked
28 patients (with 52 OVCF)
reviewers, small sample size, and
Number of patients in
poor statistical methods especially
relevant subgroup(s):
no adjusted regression analysis to
1. Acute fracture group
the study data set.
896
(<10 weeks): N=15
2. Chronic fracture group Conclusions relative to question
(>16 weeks): N=13 This paper provides evidence that
the timing of kyphoplasty that is
Consecutively assigned? up to 2.5 months after injury has
Yes more favorable outcomes
compared to non-acute fractures.
Duration of follow-up:
average follow-up was
24 months, ranging from 14
to 28 months.
Validated outcome
measures used (list):
1. ODI for back pain
2. VAS for pain
asssessment
3. Radiological outcomes:
Vertebral Height (VH)
restoration, local kyphosis
(Cobb angle), Global
sagittal alignment, Dynamic
fracture mobility
(spontaneous reduction)
Nonvalidated outcome
measures used (list):
1. Patient satisfaction
scale:
-Fully satisfied (pain absent
at all times ; unimpaired
activities of daily living), or
-satisfied slight pain
requiring no medication
and occurring
no more than once a day ;
minimal impairment in daily
activities) or
-unsatisfied (pain occurring
more than once a day,
requiring medication ;
897
changes in daily activities).
2. Medication usage: Rated
as Zero or occasional
(once per day) or Regular
(more than once a day)
3. Complications: Cement
leakge, adjacent-level
fractures
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X-ray films
Results/subgroup
analysis:
[A] Validated Outcome
measures--
1. VAS and ODI:
At 6-weeks f/u, patients in
the acute group had
statistically higher mean
percent improvement
compared to their baseline
preop values for ODI (54%
vs 44%; p<0.05) and VAS
(59% vs 48%; p<0.05) than
the chronic group.
When comparing
respective preop baseline
group values for ODI and
VAS at 18-month follow-up,
statistically significant
898
improvement was noted in
both the groups.
-For acute group, this
transplates to a +36%
(p<0.001) and +42%
(p<0.001) improvement in
mean ODI and VAS values
respectively at 18-month f/u
(when gauged against their
preop baseline values)
-For chronic group, this
translates to a +32%
(p<0.001) and +37%
improvement in mean ODI
and VAS values
respectively at 18-month f/u
(when gauged against their
preop baseline values).
However, when comparing
percent improvement in
acute vs chronic group at
18-month, no statistical
difference was noted in the
mean percent improvement
in ODI or VAS. This
resonated at 12-week, 6
months and 12 months as
well.
2. Radiological Outcomes:
-VH: The mean height
restoration was 42% for the
acute VCFs and 29% for
the chronic VCFs at the 6-
week follow-up. However,
these
percentages decreased to
36% and 22% at the 18-
month follow-up. 7% of the
acute and 21% of the
899
chronic fractures had
important loss of height
restoration. The mean
height restoration for the
acute group was
significantly higher than
that of the chronic group at
all follow-ups (p < 0.05).
-Local kyphosis angle
(Cobb angle): The Cobb
angle improved from 22.2º
± 4.7° preoperatively to
9.7º ± 3.2° in the acute
fracture group versus from
24.6º ± 5.3° preoperatively
to 17.4º ± 3.7° for
the chronic group at the 18-
month follow-up. This
improvement was
significantly greater in the
acute group than in the
chronic group at all follow-
ups (p < 0.05).
-Global sagittal alignment:
the mean distance between
the plumb line and the
posterior superior corner of
the sacrum improved, but
not significantly, from 83 ±
7 mm preoperatively to 74
± 6 mm in the acute group
(p > 0.05) and from 97 ± 9
mm preoperatively to 86 ±
7 mm in the chronic group
(p > 0.05) at the 18-month
follow-up. The chronic
group performed better, but
the difference was not
significant (p > 0.05).
900
-Dynamic fracture mobility :
positioning the patients
prone on the
operating table provided a
significant spontaneous
correction, before inflation
of the balloons : height
improved significantly with
22% (range, 2%-32%) and
10% (range, 0%–21%) in
the acute and chronic
group, respectively.
Similarly, the local kyphosis
angle improved by 6.2° ±
3.7° (range, 3° to 14°) and
4.6° ± 2.8° (range, 1° to 8°)
in the acute and chronic
group, respectively. The
acute group did better, and
the difference was
significant (p < 0.05).
[B] Non-validated
Outcomes--
1. Patients’ satisfaction:
-89% of the patients in the
acute group were
completely satisfied or
simply satisfied at the 18
months follow-up, and 86%
in the
chronic group (p < 0.001).
Again, the acute group did
better at all follow-ups, but
the difference was not
significant (p > 0.05).
2. Medication usage:
-Decreased significantly in
both the acute and the
901
chronic fracture groups at
all follow-up periods (p
<0.05). The number of
patients using medication
was always lower in the
acute group than in the
chronic VCF group, but the
difference was only
significant at 6 and 12
weeks (p < 0.05).
3. Complications:
-Cement leakage: Higher
occurrence of cement
leakage in the acute group
(10%; n=3) than the
chronic group (4%; n=1)
-Adjacent level fractures:
Lower in the acute group
(13%; n=2) compared to
the chronic group (30%;
n=4)
Author conclusions:
Kyphoplasty improves
clinical and radiological
outcomes in patients
having either acute
(< 10 weeks) or chronic (>
16 weeks) VCFs. The
outcomes are mostly better
in the acute group, but
not always significantly.
This means that timing of
kyphoplasty really matters,
although the difference
between acute and chronic
fractures is more
striking from a radiological
view-point than from a
902
clinical view-point.
Controlled studies
(kyphoplasty
versus natural history) are
needed to establish the
real value of the procedure.
Minamide A, Maeda T, Yamada H, et al. Type of evidence: ☐ Prospective ☒ Critique of methodology:
Early versus delayed kyphoplasty for Therapeutic Retrospective ☒ Nonconsecutive patients
thoracolumbar osteoporotic vertebral ☒ Nonrandomized
fractures: The effect of timing on clinical Level III Study Design: ☒ Nonmasked reviewers
and radiographic outcomes and Comparative
☒ Nonmasked patients
subsequent compression fractures. Clin
Neurol Neurosurg. 2018;173:176-181. Explanation of failure to ☐ No validated outcome measures
Stated objective of study:
doi:10.1016/j.clineuro.2018.07.019 meet guideline inclusion To determine the effect of used
criteria timing of ☒ Small sample size
(when applicable) intervention with ☐ <80% follow-up
percutaneous balloon ☐ Lacked subgroup analysis
☐ Level V (expert kyphoplasty (BKP) for OVF ☐ Diagnostic method not stated
consensus) on clinical and radiographic ☐ Other: Click or tap here to enter
outcomes
text.
☐ Level IV in presence of
higher quality studies Type of treatment(s): BKP
Level of Evidence Determination
Potential Level: III
☐ Subgroup analysis data Total number of patients:
Downgraded Level: Not
not available 51 patients
Downgraded
Number of patients in
relevant subgroup(s): 2
☐ Not relevant to question Conclusions
groups based on timing of
This paper provides evidence that
BKP:
patients undergoing early KP
1. Early (< 4 weeks): n=32
have better radiological and
2. Late (> 4 weeks): n=19
clinical outcomes at 1.2 years
follow up.
Consecutively assigned?
No
Duration of follow-up: Mean
f/u: 1.2 years
Validated outcome
measures used (list):
NPRS, kyphosis angle,
903
vertebral height
1. Numeric Pain Rating
Score (NPRS) for low back
pain (LBP): Pain relief----
>reduction ≥3 points and
valuation<3 points)
2. Radiographic metrics:
Local kyphosis angle, VBH
Nonvalidated outcome
measures used (list): Click
or tap here to enter
text.Adjacent segment
fracture; length of hospital
stay (LOS)
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X-rays, Bone
Scan
Results/subgroup
analysis:
Clinical Outcomes:
1. NPRS: At final follow up,
the mean NPRS score in
the early intervention group
was significantly lower than
that of the late group
[2.6+/-0.8 vs 3.3 +/- 0.8;
p=0.002].
2. LOS: Postoperative
hospital stay for the early
904
group was significantly
shorter than that of late
group as well (p < 0.05)
Radiographic Outcomes:
1. Local kyphosis at final
follow-up was significantly
greater in the late group
(−28.4°+/-10) than in the
early group (−9.5°+/-6.9; p
< 0.001). However, there
was no significant
difference in local kyphosis
between preoperative
measurement and final
follow-up in the early (10.1
+/- 8.1 vs 9.5 +/-6.9;
p=0.741) or late cohort
(27.6 +/-7.0 vs 28.4 +/-
10.0; p=0.794).
Others:
The occurrence of adjacent
vertebral deformity was
significantly
higher in the late cohort
compared to the early
group [6/19 vs 3/32;
p=0.040]. No difference
was noted in the
development of new
vertebral fracture (excludes
adjacent fractures) across
the groups [2/32 vs 2/19;
p=0.623]
Author conclusions: BKP is
able to prevent progressive
collapse and kyphosis after
905
OVF, but not effectively
restore alignment, and as a
result, patients who
undergo early BKP (< 4
weeks) demonstrate better
alignment, better LBP
scores, and reduced rates
of subsequent fracture at
an average of 1.2 years
following treatment.
Son S, Lee SG, Kim WK, Park CW, Yoo Type of evidence: ☐ Prospective ☒ Critique of methodology:
CJ. Early Vertebroplasty versus Delayed Therapeutic Retrospective ☒ Nonconsecutive patients
Vertebroplasty for Acute Osteoporotic ☒ Nonrandomized
Compression Fracture : Are the Results of Level III Study Design: ☒ Nonmasked reviewers
the Two Surgical Strategies the Same?. J Comparative
☐ Nonmasked patients
Korean Neurosurg Soc. 2014;56(3):211-
217. doi:10.3340/jkns.2014.56.3.211 Explanation of failure to ☐ No validated outcome measures
Stated objective of study:
meet guideline inclusion To compare outcomes of used
criteria two surgical strategies ☒ Small sample size
(when applicable) (early vs delayed VP) for ☐ <80% follow-up
the treatment of single-level ☐ Lacked subgroup analysis
☐ Level V (expert acute OVCF in the ☐ Diagnostic method not stated
consensus) thoracolumbar junction ☐ Other: Click or tap here to enter
(T12-L2) to determine
text.
☐ Level IV in presence of whether timing of surgery
higher quality studies had an impact on outcome
Level of Evidence Determination
and cost-effectiveness.
Potential Level: III
☐ Subgroup analysis data Downgraded Level: Not
not available Type of treatment(s): VP
Downgraded
Total number of patients:
☐ Not relevant to question Conclusions
50 patients, single level
This paper provides evidence that:
Number of patients in
patients undergoing early VP (<2
relevant subgroup(s):
weeks) have better pain control in
1. Early VP (EVP) group:
the immediate postop duration,
23 (<2 weeks)
have lower chance of cement
2. Delayed VP (DVP)
leakage, and incur shorter
group: 27 (2-6 weeks?)
hospital stay when compared to
VP performed within 2-6 weeks.
Consecutively assigned?
No
906
Duration of follow-up:
minimum 1 year
Validated outcome
measures used (list):
(VAS) for low back pain,
the Oswestry Disability
Index (ODI), and Odom’s
criteria.
Nonvalidated outcome
measures used (list):
1. Cement leakage
2. Radiological outcomes:
VB collapse; segmental
kyphosis
3. Hospital stay duration
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: X-rays
Results/subgroup
analysis:
Clinical Outcomes:
1. Final clinical outcome
including VAS (p=0.703),
Oswestry Disability Index
[(At day-1 f/u: 46.1±14.0 in
EVP vs 45.7±8.0 in DVP;
p=0.766) and (Final f/u:
EVP: 29.3±15.0 vs
27.3±10.7 in DVP;
p=0.578)], and Odom’s
907
criteria (p=0.217 at day 1;
p=0.318 at final f/u) did not
differ across the 2 groups.
-However, immediate
improvement of the VAS
after vertebroplasty was
greater in the EVP group
(5.1±1.3 vs 4.0±1.0;
p=0.002) compared to DVP
group.
2. The proportion of cement
leakage was lower in the
EVPG (30.4%) than in the
DVPG (59.3%, p=0.039).
In addition,
semiquantitative grade of
cement interdigitation was
significantly more favorable
in the EVPG than in the
DVPG (p=0.003).
Radiological Outcomes:
Final vertebral body
collapse and segmental
kyphosis did not differ
significantly between the
two groups.
Others:
-Proportion of patients with
new compression fracture
was comparable between
the two groups (8.7% in
EVP vs 7.4% in DVP)
-The mean duration of
hospital stay was
significantly longer in the
DVPG (17.5±4.2) than in
the EVPG (10.8± 5.1,
p=0.001).
908
Author conclusions: Our
findings suggest that EVP
achieves a better
immediate surgical effect
with more favorable cost-
effectiveness.
Takahashi S, Hoshino M, Terai H, et al. Type of evidence: ☒ Prospective ☐ Critique of methodology:
Differences in short-term clinical and Therapeutic Retrospective ☐ Nonconsecutive patients
radiological outcomes depending on ☒ Nonrandomized
timing of balloon kyphoplasty for painful Level II Study Design: ☒ Nonmasked reviewers
osteoporotic vertebral fracture. J Orthop Comparative
☒ Nonmasked patients
Sci. 2018;23(1):51-56.
doi:10.1016/j.jos.2017.09.019 Explanation of failure to ☐ No validated outcome measures
Stated objective of study:
meet guideline inclusion To investigate differences used
criteria in the surgical outcomes of ☒ Small sample size
(when applicable) OVFs according to the ☐ <80% follow-up
timing of balloon ☐ Lacked subgroup analysis
☐ Level V (expert kyphoplasty (early: <=2 ☐ Diagnostic method not stated
consensus) months vs late > 2 months) ☐ Other: Click or tap here to enter
text.
☐ Level IV in presence of Type of treatment(s): BKP
higher quality studies Level of Evidence Determination
Total number of patients:
Potential Level: II
☐ Subgroup analysis data 72 patients
Downgraded Level: Not
not available Number of patients in
Downgraded
relevant subgroup(s):
1. Early <=2 months: n=27
☐ Not relevant to question Conclusions
(38%)
This paper provides evidence that:
2. Late > 2 months: n =45
patients over 65 years old with
OVCF and undergoing BKP within
Consecutively assigned?
2 months have significantly lower
Yes
back pain scores at final follow-
up (after 6-months) compared to
Duration of follow-up:
those after 2 months.
Atleast 6 months (mean:
6.5 months in early vs 7.6
months in the late group)
Validated outcome
measures used (list): VAS
909
Back pain
Radiographic metrics
(kyphotic angle; Anterior
VBH)
Nonvalidated outcome
measures used (list):
Complications (cement
leakage, cement
dislodgement, ASD, New
fracture, reoperation)
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: X-rays
Results/subgroup
analysis:
VAS for early group 19.9
was lower than the late
group 30.4
Kyphotic angle was greater
in the late group 16.3 than
the early group 12.4
Complications of cement
leakage, cement
dislodgement, ASD, new
fractures, reoperation was
similar between early and
late group.
910
Author conclusions:
Vertebral height and
kyphotic angle before and
after balloon kyphoplasty
were greater in patients
who underwent
kyphoplasty within 2
months after onset, and the
VAS score for low back
pain at final follow-up was
better. Our results support
kyphoplasty within 2
months.
Yang CC, Chien JT, Tsai TY, Yeh KT, Lee Type of evidence: ☐ Prospective ☒ Critique of methodology:
RP, Wu WT. Earlier Vertebroplasty for Therapeutic Retrospective ☒ Nonconsecutive patients
Osteoporotic Thoracolumbar Compression ☒ Nonrandomized
Fracture May Minimize the Subsequent Level III Study Design: ☒ Nonmasked reviewers
Development of Adjacent Fractures: A Comparative
☒ Nonmasked patients
Retrospective Study. Pain Physician.
2018;21(5):E483-E491. Explanation of failure to ☐ No validated outcome measures
Stated objective of study:
meet guideline inclusion To compare the incidence used
criteria of AVF among patients who ☐ Small sample size
(when applicable) received early PVP (≤ 30 ☒ <80% follow-up
days after symptom onset, ☐ Lacked subgroup analysis
☐ Level V (expert EPVP) or late PVP (> 30 ☐ Diagnostic method not stated
consensus) days after symptom onset, ☐ Other: Click or tap here to enter
LPVP) in the thoracolumbar
text.
☐ Level IV in presence of region (T10 to L2) after a 1-
higher quality studies year follow up
Level of Evidence Determination
Potential Level: III
☐ Subgroup analysis data Type of treatment(s):
Downgraded Level: Not
not available VPPVP
Downgraded
Total number of patients:
☐ Not relevant to question Conclusions
124 (out of 225 reviewed;
This paper provides evidence that:
40 patients did not
PVP performed after 4 weeks of
complete 1-year f/u)
fracture onset is associated with
Number of patients in
increased hazards for adjacent
relevant subgroup(s):
vertebral fractures at 1-year
1. EPVP group: n=78
postop. Early PVP is associated
2. LPVP group: n=46
with higher percentage of
911
improvement in postop VAS
Consecutively assigned? scores compared to their preop
No values.
Duration of follow-up:
minimum 1 year
Validated outcome
measures used (list):
1. VAS
2. RADIOGRAPHIC
metrics
Nonvalidated outcome
measures used (list): 1.
Adjacent vertebral fracture
(AVF)
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X-rays
Results/subgroup
analysis:
AVF developed in 14.1% of
EPVP and 39.1% of LPVP
groups.
Cox regression showed
increased risk of AVF for
the LPVP with adjusted
hazard ratio of 6.08
VAS was more improved in
the EPVP (8.2 to 3.6)
912
compared to LPVP (6.5 to
3.3)
Author conclusions:
Compared with later
interventions, PVP
performed within 30 days
after fracture development
may be associated with a
lower risk of adjacent
fractures in the
thoracolumbar region.
Interventional Taetment Question 7: Does vertebral augmentation improve clinical outcomes in patients with back pain and an intravertebral cleft on
imaging of chronic osteoporotic vertebral compression fractures?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Ha KY, Lee JS, Kim KW, Chon JS. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Percutaneous vertebroplasty for vertebral Therapeutic ☐ Nonconsecutive patients
compression fractures with and without Study Design: Comparative ☒ Nonrandomized
intravertebral clefts. J Bone Joint Surg Br. Level III ☒ Nonmasked reviewers
2006;88:629-633. Stated objective of study: To compare the ☐ Nonmasked patients
clinical and radiological
Explanation of failure to meet results of percutaneous vertebroplasty ☐ No validated outcome
guideline inclusion criteria (PV) in patients with osteoporotic vertebral measures used
(when applicable) compression fractures with or without an ☒ Small sample size
intravertebral cleft ☐ <80% follow-up
☐ Level V (expert consensus) ☐ Lacked subgroup
Type of treatment(s): PV analysis
☐ Level IV in presence of ☐ Diagnostic method not
higher quality studies Total number of patients: N=51 pts with 58 stated
fractures (out of the 54 patients with ☐ Other: Click or tap here
☐ Subgroup analysis data not OVCFs treated with PV; 2 lost to f/u and 1 to enter text.
available dead)
Level of Evidence
☐ Not relevant to question Number of patients in Determination
relevant subgroup(s): Potential Level: III
Group 1: 39 pts (46 vertebrae) without IV Downgraded Level: Not
cleft Downgraded
Group 2: 12 pts (12 vertebrae) with IV cleft
913
Conclusions
Consecutively assigned? Yes This paper provides
evidence that:
Duration of follow-up: minimum 2 years vertebroplasty is a
valuable option in
Validated outcome measures used (list): patients w/ osteoporotic
ODI, VAS, kyphotic angle, vertebral height vertebral compression
fractures with or without
intravertebral cleft with
Nonvalidated outcome measures used higher instance of
(list): cement leakage; bone resorption; cement related
adjacent vertebral fractures complications in patients
with clefts.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Bone scan; X-rays
Results/subgroup analysis: The ODI and
VAS scores in both groups improved after
treatment,
Group 1 = 75.1 (preop) vs 38.7 (3 mo
postop) vs 37.3 (final f/u)
Group 2 = 79.9 (preop) vs 48.5 (3 mo
postop) vs 55.4 (final f/u)
-VAS
Group 1 = 8.3 (preop) vs 4.2 (postop) vs
3.5 (final f/u)
Group 2 = 9.4 (preop) vs 4.5 (postop) vs
5.9 (final f/u)
-There was a greater initial correction of
the kyphosis in group 2 than in group 1,
914
Author conclusions: Percutaneous
vertebroplasty is an effective treatment for
osteoporotic compression
fractures with or without an intravertebral
cleft. Nonetheless, higher rates of
complications related to the cement must
be recognized in patients in the presence
of an intravertebral cleft
Interventional Treatment Question 8: Are there specific characteristics of the fracture or the patient that influence outcomes in patients with osteoporotic
compression fractures undergoing vertebral augmentation?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Ahashash M, Shousha M, Barakat AS, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Boehm H. Effects of Therapeutic ☒ Nonconsecutive patients
Polymethylmethacrylate Cement Study Design: RCT ☐ Nonrandomized
Viscosity and Bone Porosity on Cement Level II
☐ Nonmasked reviewers
Leakage and New Vertebral Fractures Stated objective of study: To evaluate
☐ Nonmasked patients
After Percutaneous Vertebroplasty: A the effect of bone cement viscosity as
Prospective Study. Global Spine J. Explanation of failure to ☐ No validated outcome
well as of bone porosity on cement
2019;9(7):754-760. meet guideline inclusion leakage during vertebroplasty and to measures used
doi:10.1177/2192568219830327 criteria analyze the occurrence of new ☐ Small sample size
(when applicable) vertebral fractures after the procedure ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Type of treatment(s): Percutaneous ☐ Diagnostic method not
consensus) Vertebroplasty (high-viscosity cement stated
vs low-viscosity cement) ☒ Other: Lacks robust
☐ Level IV in presence of statistical applications
higher quality studies Total number of patients: 60
including adjusted regression
Number of patients in relevant
analysis-->thus, the so called
☐ Subgroup analysis data subgroup(s): n=30 in each of the
“factors” [low T-scores, low-
not available groups (thus total 60 patients overall)
viscous cement, multiple
-Group A: High-viscosity cement [37
fractures at presentation] are
vertebral bodies augmented in 30
☐ Not relevant to question not TRULY risk factors or
patients]
association. Rather
-Group B: low-viscosity cement [36
observations.
vertebral bodies augmented in 30
patients]
Level of Evidence
Determination
915
Consecutively assigned? No Potential Level: I
Downgraded Level: II
Duration of follow-up: All 60 patients Downgraded due to:
followed-up for a minimum of 2-years nonconsecutive patients and
lacking of robust statistical
Validated outcome measures used applications including
(list): adjusted regression
1. Clinical Outcomes (PROs)
-VAS (preop, postop (day 1, at 3mo, at Conclusions
1-yr and 2-yr) This paper provides evidence
-ODI (preop, postop (day 1, at 3mo, at that: proportion of patients
1-yr and 2-yr) incurring cement leakage
post vertebroplasty is
Nonvalidated outcome measures used higher in those with lower
(list): : T-score and those injected
1. Cement leakage (location- disc with low-viscous cement
space, epidural space, paravertebral and patients with multiple
areas, peripheral veins) fractures at presentation
2. Occurrence of a new vertebral body (preop) were noted to have
fracture during f/u higher rates of new
fractures postoperatively.
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: DEXA, X-rays
Results/subgroup analysis:
Group A High viscosity, B Low
viscosity.
Group A had leakage in 9/37 levels.
Group B had leakage in 20/36 levels.
Difference between two groups was
stastically significant.
916
There was no ODI or VAS difference in
groups who had leakage vs no
leakage.
14 new fracxtures occurred, 10 in
group A and 4 in group B. Result did
not reach statistical significance.
Author conclusions:
-The clinical outcome of vertebroplasty
was not influenced by cement
viscosity. However, lower cement
viscosity
and higher degree of osteoporosis
were found to be significant risk factors
for cement leakage. Furthermore, the
number of
vertebral body fractures on
presentation was a predictor for the
occurrence of new fractures
postoperatively
Alvarez L, Pérez-Higueras A, Granizo Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
JJ, de Miguel I, Quiñones D, Rossi RE. Therapeutic ☒ Nonconsecutive patients
Predictors of outcomes of percutaneous Study Design: Comparative ☒ Nonrandomized
vertebroplasty for osteoporotic vertebral Level III
☐ Nonmasked reviewers
fractures. Spine (Phila Pa 1976). Stated objective of study: To
☐ Nonmasked patients
2005;30(1):87-92. determine the factors affecting the
doi:10.1097/00007632-200501010- Explanation of failure to ☐ No validated outcome
outcome of percutaneous
00016 meet guideline inclusion vertebroplasty for the treatment of measures used
criteria persistent painful osteoporotic ☐ Small sample size
(when applicable) fractures ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Type of treatment(s): Percutaneous ☐ Diagnostic method not
consensus) vertebroplasty (PV) stated
☒ Other: Some author
☐ Level IV in presence of Total number of patients: 260 patients
conclusions are based on
higher quality studies (278 PV procedures at 423 vertebral
univariate analysis. Table 3
levels)
basically depicts the crux of
☐ Subgroup analysis data Number of patients in relevant
the study findings.
not available subgroup(s): Click or tap here to enter
text.
917
☐ Not relevant to question Level of Evidence
Consecutively assigned? No Determination
Potential Level: II
Duration of follow-up: Mean f/u: 12 Downgraded Level: III
months; range= 3-weeks to 96 months Downgraded due to:
Nonconsecutive patients,
Validated outcome measures used nonrandomized, and some
(list): author conclusions were
1.Postprocedural “Favorable” VAS based on univariate analysis
(defined as VAS 0 to 3 at discharge
and at 3-week f/u= “marked-to- Conclusions
complete pain relief”) was the outcome This paper provides evidence
of interest [compared to a reference that: ASA grade-I and
value of “unfavorable” VAS (postop vertebral height loss <70%
VAS 4 to 10)] are associated with lower
-Postop “FAVORABLE” VAS was the odds of postoperative VAS
binary outcome of interest score equal or higher than
4.
Nonvalidated outcome measures used
(list):
1. Patient satisfaction and if they would
undergo future procedure for another
compression fracture
2. Complications
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Results/subgroup analysis:
1. Favorable outcome after VP was
noted in 187 procedures (67.2%).
-In multivariabe analysis, the study
notes vertebral height loss <70% [OR:
918
0.096;; 95% CI: 0.03-0.27; p<0.001]
and an ASA grade-I [OR: 0.28; 95%
CI: 0.11-0.68; P=0.005 to be
associated with lower odds of having
unfavorbable outcome (VAS 4 to 10).
Even though “evident” signal changes
on MRI was associated with lower
odds [OR: 0.01] of developing
“unfavorable” outcome, the
relationship did not attain statistical
significance [p=0.685; Table 3].
2. 84.6% patients “satisfied with the
result of thei surgery” and 82.4%
mentioned they would “repeat the
procedure”.
3. Complications in 6.8% patients
(n=19) with most common being
transitory radicular pain (4.3%; n=12).
4. Cement leaks in 72% vertebrae
treated.
-Three patients (1%) had cement into
the canal, 16.7% had a leakage into
the disc, 17% in the lumbar venous
plexus, and 50.9% had
polymethylmethacrylate into the
epidural veins
Author conclusions: Appropriate
patient selection is essential
for achieving clinical success. Better
results can be expected
in patients with an American Society of
Anesthesiologists score of I and when
the level managed is confirmed
by magnetic resonance imaging and
the vertebral body height loss is less
than 70%.
919
Bae JS, Park JH, Kim KJ, Kim HS, Jang Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
IT. Analysis of Risk Factors for Therapeutic ☒ Nonconsecutive patients
Secondary New Vertebral Compression Study Design: Comparative ☒ Nonrandomized
Fracture Following Percutaneous Level III
☐ Nonmasked reviewers
Vertebroplasty in Patients with Stated objective of study: To analyze
☐ Nonmasked patients
Osteoporosis. World risk factors for secondary new
Neurosurgery.99:387-394. Explanation of failure to ☒ No validated outcome
vertebral compression fractures
meet guideline inclusion (SNVCFs) after percutaneous measures used
criteria vertebroplasty in patients with ☐ Small sample size
(when applicable) osteoporosis. ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Type of treatment(s): Percutaneous ☐ Diagnostic method not
consensus) vertebroplasty stated
☐ Other: Click or tap here to
☐ Level IV in presence of Total number of patients: 293 patients
enter text.
higher quality studies (336 affected vertebral levels)
Number of patients in relevant
Level of Evidence
☐ Subgroup analysis data subgroup(s):
Determination
not available 1. Patients who experienced SNVCF
Potential Level: III
2. Patients without SNVCF
Downgraded Level: Not
☐ Not relevant to question Downgraded
Consecutively assigned? No
Conclusions
Duration of follow-up: 36 months +/-
This paper provides evidence
18.6
that: patients developing
secondary new vertebral
Validated outcome measures used
compression fracture
(list): Click or tap here to enter text.
(SNVCF) after PV have
lower bone mineral content
Nonvalidated outcome measures used
(BMC) and cement leakage
(list):
compared to those not
1. SNVCF (and factors associated with
developing SNVCF.
it)
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
920
☐ CT/Myelogram
☒ Other: X-rays, Quantitative CT for
osteoporosis to examine bone mineral
content (BMC)
Results/subgroup analysis: Overall,
11.6% (n=34) patients experienced
SNVCF.
-Patients that developed SNVCF had
lower BMC compared to those not
developing SNVCF (26.8 vs 44.4 mg;
p<0.01). [Table 3]
-Higher proportion of SNVCF were
noted in patients with cement leakage
compared to those with no cement
leakge (19.5% vs 7.9%; p=0.04)
-No difference in the mean segmental
kyphosis angle was noted across the 2
groups (p=0.64)
Author conclusions: Poor bone
mineral content can be a
predictive factor of SNVCFs. To
prevent SNVCFs, bone cement should
be injected as evenly as possible into
the vertebral body. Bone cement
leakage into the disc space should be
avoided
Bayram S, Akgul T, Adiyaman AE, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Karalar S, Dolen D, Aydoseli A. Effect of Therapeutic ☐ Nonconsecutive patients
Sarcopenia on Mortality after Study Design: Comparative ☒ Nonrandomized
Percutaneous Vertebral Augmentation Level III
☐ Nonmasked reviewers
Treatment for Osteoporotic Vertebral Stated objective of study: To evaluate
☐ Nonmasked patients
Compression Fractures in Elderly whether central sarcopenia,
Patients: A Retrospective Cohort Study. Explanation of failure to ☒ No validated outcome
as measured by psoas cross-sectional
World Neurosurgery.138:e354-e360. meet guideline inclusion area on admission imaging, measures used
criteria is associated with outcomes in patients ☐ Small sample size
(when applicable) with VCFs managed with ☐ <80% follow-up
percutaneous vertebral augmentation ☐ Lacked subgroup analysis
☐ Level V (expert treatment ☐ Diagnostic method not
consensus) stated
921
Type of treatment(s): Percutaneous ☐ Other: Click or tap here to
☐ Level IV in presence of vertebral augmentation (VP or KP) enter text.
higher quality studies
Total number of patients: 103 Level of Evidence
☐ Subgroup analysis data Number of patients in relevant Determination
not available subgroup(s): Potential Level: III
1. Low Psoas:Lumbar vertebral index Downgraded Level: Not
(PLVI <0.603): 51
☐ Not relevant to question Downgraded
2. High PLVI (>=0.603): 52
Conclusions
Consecutively assigned? Yes This paper provides evidence
that increasing age, ASA
Duration of follow-up: score and sarcopenia (PLVI
Mean f/u or survival: 48.28 +/- 38.67 value) are associated with
months increased risk of mortality
Median f/u or survical: 31.33 mo in patients with OVCF
undergoing vertebral
Validated outcome measures used augmentation.
(list): Click or tap here to enter text.
Nonvalidated outcome measures used
(list): 1. Survival (and factors
associated with it)
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Click or tap here to enter
text.
Results/subgroup analysis:
The survival rates at 1 month, 6
months, and 1 year after surgery were
99%, 94.1%, and 88.4%, respectively.
Overall, mortality rate was 21.4%
(n=22). Significant differences in
922
mortality was noted across patients
with low PVLI versus high PLVI (43.1%
vs 0%; p=0.001)
Multivariate analysis noted Age
(p<0.001), PLVI value (p=0.001), ASA
score (p=0.001) were associated with
a poor overall survival.
-There is a significant correlation
between sarcopenia and postoperative
mortality after vertebral augmentation
procedure in patients with VCFs.
Author conclusions: Significant
correlation between sarcopenia and
postoperative mortality after vertebral
augmentation procedure in patients
with VCFs
Borensztein M, Camino Willhuber GO, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Posadas Martinez ML, Gruenberg M, Therapeutic ☐ Nonconsecutive patients
Sola CA, Velan O. Analysis of Risk Study Design: Case Control ☒ Nonrandomized
Factors for New Vertebral Fracture After Level III
☐ Nonmasked reviewers
Percutaneous Vertebroplasty. Global Stated objective of study: To evaluate
☐ Nonmasked patients
Spine J. 2018;8(5):446-452. epidemiological
doi:10.1177/2192568217732988 Explanation of failure to ☐ No validated outcome
and technical variables in patients who
meet guideline inclusion suffered a new VCF measures used
criteria requiring a new PV in comparison with ☒ Small sample size
(when applicable) a control group ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Type of treatment(s): Percutaneous ☐ Diagnostic method not
consensus) vertebroplasty (PV) stated
☐ Other: Click or tap here to
☐ Level IV in presence of Total number of patients: 90
enter text.
higher quality studies Number of patients in relevant
subgroup(s):
Level of Evidence
☐ Subgroup analysis data 1. Cases= 30 consecutive patients
Determination
not available with new VCF that required another
Potential Level: III
vertebroplasty during the 1st-year after
Downgraded Level: Not
index procedure
☐ Not relevant to question Downgraded
2. Controls= 60 that had no new VCF
923
within 1st-year after VP; controls were
matched for age (+/-5 years) and level Conclusions
(thoracic, lumbar) This paper provides evidence
that: higher segmental
Consecutively assigned? Yes kyphotic angle and cement
volume are associated with
Duration of follow-up: 1-year development of new VCFs
within 1-year after index
Validated outcome measures used VP.
(list): Click or tap here to enter text.
Nonvalidated outcome measures used
(list): 1. Incidence of new VCF and
factors associated with it.
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X-rays
Results/subgroup analysis:
The incidence of new VCF was 8.5%
(95% CI: 6.4% to 10.9%) after 1-year
follow-up.
-Univariate analysis noted age [OR:
0.82; 95% CI: 0.4 – 0.9; P=0.03] as a
risk factor of developing symptomatic
new VCF within 1-st year after index
VP. However, it did not reach
statistical significance on multivariate
analysis.
-In multivariate analyses, kyphosis
(OR: 1.18; 95% CI: 1.1 to 1.3;
p=0.011) and cement volume
percentage (OR: 1.12; 95% CI: 1.0-
1.2; P=0.008) as signigicant variables
924
associated with new VCF within 1-year
after index VP.
Author conclusions: Increased cement
percentage injected and a higher
kyphosis were associated with new
vertebral compression fractures.
Chen C, Fan P, Xie X, Wang Y. Risk Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Factors for Cement Leakage and Therapeutic ☒ Nonconsecutive patients
Adjacent Vertebral Fractures in Study Design: Comparative ☒ Nonrandomized
Kyphoplasty for Osteoporotic Vertebral Level III
☐ Nonmasked reviewers
Fractures. Clin Spine Surg. Stated objective of study: To analyze
☐ Nonmasked patients
2020;33(6):E251-E255. patient and procedural features for
doi:10.1097/BSD.0000000000000928 Explanation of failure to ☒ No validated outcome
correlative relationships with cement
meet guideline inclusion leak and adjacent vertebral fracture measures used
criteria in/after kyphoplasty for osteoporotic ☐ Small sample size
(when applicable) vertebral fractures ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Type of treatment(s): Bilateral ☐ Diagnostic method not
consensus) percutaneous kyphoplasty stated
(PKP) ☐ Other: Click or tap here to
☐ Level IV in presence of enter text.
higher quality studies Total number of patients: 102
Number of patients in relevant
Level of Evidence
☐ Subgroup analysis data subgroup(s):
Determination
not available 1. Group A—nonfracture (n=86) vs
Potential Level: III
group B—postoperative fracture
Downgraded Level: Not
(n=16)
☐ Not relevant to question Downgraded
2. Group C—nonleakage (n=87) vs
group D—postoperative leakage
Conclusions
(n=15).
This paper provides evidence
that: the incidence of
Consecutively assigned? No
postoperative adjacent
vertebral fractures is higher
Duration of follow-up: minimum 1-year
in diabetics and altered
follow-up
Cobb angle (post-surgery).
Validated outcome measures used
(list): NONE.
The study used validated metrics such
as VAS, Cobb angle; however these
925
were exposure variables and not used
as Outcome variables (see below---
non-validated outcomes)
Nonvalidated outcome measures used
(list):
1. Incidence (and risk factors) of
cement leak and adjacent vertebral
fracture
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X-rays
Results/subgroup analysis:
Cement Leakage:
- Rate of cement leakage =14.7%
(n=15 out of 102)
New adjacent vertebral fractures:
-The rate of adjacent vertebral
fractures is about 15.69% after the
kyphoplasty
- Factors positively associating with
postoperative secondary vertebral
fractures included diabetes and the
extent of Cobb angle adjustment after
the operation.
Author conclusions: Diabetes and the
alteration of the Cobb angle following
PKP are factors positively related to
the occurrence of
postoperative adjacent vertebral
fractures.
926
Chen Z, Chen Z, Wu Y, et al. Risk Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Factors of Secondary Vertebral Therapeutic ☒ Nonconsecutive patients
Compression Fracture After Study Design: Comparative ☒ Nonrandomized
Percutaneous Vertebroplasty or Level III
☐ Nonmasked reviewers
Kyphoplasty: A Retrospective Study of Stated objective of study: To
☐ Nonmasked patients
650 Patients. Med Sci Monit. investigate the risk factors contributing
2019;25:9255-9261. Published 2019 Explanation of failure to ☒ No validated outcome
to secondary vertebral compression
Nov 19. doi:10.12659/MSM.915312. meet guideline inclusion fractures measures used
criteria (SVCF) in patients undergoing ☐ Small sample size
(when applicable) percutaneous vertebroplasty (PVP) or ☐ <80% follow-up
kyphoplasty (PKP) due to osteoporotic ☐ Lacked subgroup analysis
☐ Level V (expert vertebral compression fracture ☒ Diagnostic method not
consensus) (OVCF). stated
☐ Other: Click or tap here to
☐ Level IV in presence of Type of treatment(s): PVP and PKP
enter text.
higher quality studies
Total number of patients: 650 (410
Level of Evidence
☐ Subgroup analysis data PVP; 240 PKP)
Determination
not available Number of patients in relevant
Potential Level: III
subgroup(s):
Downgraded Level: Not
SVCF= 102
☐ Not relevant to question Downgraded
Non-SVCF =548
Conclusions
Consecutively assigned? No
This paper provides evidence
that: increasing age is
Duration of follow-up: Average: 24
associated with higher
months; range: 6 mo to 36 month
likelihood of developing
SVCF after PKP/PVP
Validated outcome measures used
whereas higher BMD and
(list): n/a
higher outdoor activity is
associated with decreased
Nonvalidated outcome measures used
risk of developing
(list): Risk factor of SVCF after
fractures.
PVP/PKP
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
927
☒ CT
☐ CT/Myelogram
☒ Other: QCT, DEXA/BMD
Results/subgroup analysis: 650
patients, 701 fractured vertebra
122 new fractures in 102 patients
(15.7%) after PVP/PKP.
Patients in SVCG medium age was 75
and in non SVCF medium age was 69
BMD was lower in the SVCF than non
SVCF group.
outdoor activity showed significant
difference between SVCF and non
SVCF group.
Author conclusions: Older age and
lower BMD were identified as risk
factors of SVCF for OVCF patients
following PVP/PKP surgery, whereas
more ODA played a protective role in
SVCF development
Chou KN, Lin BJ, Wu YC, Liu MY, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Hueng DY. Progressive kyphosis after Therapeutic ☒ Nonconsecutive patients
vertebroplasty in osteoporotic vertebral Study Design: Comparative ☒ Nonrandomized
compression fracture. Spine (Phila Pa Level III
☐ Nonmasked reviewers
1976). 2014;39(1):68-73. Stated objective of study: identify the
☐ Nonmasked patients
doi:10.1097/BRS.0000000000000042. relevant incidence and risk factors of
☒ Include Explanation of failure to ☒ No validated outcome
delayed vertebral collapse and
measures used
☐ Exclude meet guideline inclusion progressive kyphosis with spinal canal
criteria encroachment after percutaneous ☐ Small sample size
(when applicable) vertebroplasty (PVP) for ☐ <80% follow-up
vertebral compression fracture (VCF ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Type of treatment(s): PVP stated
☐ Other: Click or tap here to
Total number of patients: 843
enter text.
928
☐ Level IV in presence of Number of patients in relevant
higher quality studies subgroup(s): Click or tap here to enter Level of Evidence
text. Determination
☐ Subgroup analysis data Potential Level: III
not available Consecutively assigned? No Downgraded Level: Not
Downgraded
Duration of follow-up: 2-years
☐ Not relevant to question
minimum Conclusions
This paper provides evidence
Validated outcome measures used that: fracture location (TL
(list): Click or tap here to enter text. junction) and type (IVC or
wedge) and material
Nonvalidated outcome measures used injected (non-integration
(list): Progressive kyphosis with properties) are risk factors
stenosis of spinal cord for development of
progressive kyphosis and
Diagnosis made by: neurological complications
☒ Clinical exam/history post VP.
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X rays
Results/subgroup analysis:
The incidence of progressive kyphosis
after vertebroplasty = 1.5% (13/843)
-3 risk factors associated with the
occurrence of progressive kyphosis
and neurological complications after
vertebroplasty--> (1) location of
fracture at the thoracolumbar junction,
(2) fracture type of intraver- tebral cleft,
or wedge-type fracture, and (3)
material of non- integration properties
injected into the fractured vertebra.
929
Author conclusions: The occurrence
rate of revision surgery for delayed
complications of PVP is 1.5%.
Conservative treatment and minimal
invasive vertebral augmentation
surgery can be selected from patients
with stable VCFs. Close follow-up is
warrant to monitor the occurrence of
late collapse with neurological
complications.
Civelek E, Cansever T, Yilmaz C, et al. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
The retrospective analysis of the effect Therapeutic ☐ Nonconsecutive patients
of balloon kyphoplasty to the adjacent- Study Design: Comparative ☒ Nonrandomized
segment fracture in 171 patients. J Level III
☐ Nonmasked reviewers
Spinal Disord Tech. 2014;27(2):98-104. Stated objective of study: To
☐ Nonmasked patients
doi:10.1097/bsd.0b013e31824e9b98 Explanation of failure to investigate the risk factors for new
meet guideline inclusion ☐ No validated outcome
symptomatic vertebral compression
criteria fractures (VCF) after BK. measures used
(when applicable) ☐ Small sample size
Type of treatment(s): BK ☐ <80% follow-up
☐ Level V (expert ☐ Lacked subgroup analysis
consensus) Total number of patients: 171 ☐ Diagnostic method not
Number of patients in relevant stated
☐ Level IV in presence of subgroup(s): Click or tap here to enter ☐ Other: Click or tap here to
higher quality studies text.
enter text.
☐ Subgroup analysis data Consecutively assigned? Yes
Level of Evidence
not available Determination
Duration of follow-up: 41.04±21.78
Potential Level: III
months
☐ Not relevant to question Downgraded Level: Not
Downgraded
Validated outcome measures used
(list): VAS was included but not used
Conclusions
as a primary outcome of interest.
This paper provides evidence
that: female sex and higher
Nonvalidated outcome measures used
preop KA have higher new
(list): Risk factors associated with
symptomatic VCF after BK.
adjacent-segment fractures after BK.
Diagnosis made by:
☒ Clinical exam/history
930
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xrays, DEXA
Results/subgroup analysis: Factors
associated with adjacent level
fractures were sex of the patient (F>M)
and kyphotic angle before the
procedure.
Severity of osteoporosis of low bone
mineral density was not a factor for
new VCF.
Author conclusions: If the patients
experience severe or mild back pain
with higher preoperative KA, especially
in the first 2 months,
then they deserve detailed radiologic
examination. To avoid
subsequent fracture in the same or
adjacent level, vertebral body
should be filled adequately and sagittal
balance should be obtained with KA
correction. BK alone did not influence
the incidence of subsequent VCF
De Kong L, Meng LC, Shen Y, Wang Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
LF, Wang P, Shang ZK. Effect of shape Therapeutic ☒ Nonconsecutive patients
and severity of vertebral fractures on the Study Design: Comparative ☒ Nonrandomized
outcomes of kyphoplasty. Acta Orthop Level III
☐ Nonmasked reviewers
Belg. 2013;79(5):565-571. Stated objective of study: To evaluate
☐ Nonmasked patients
the effect of shape and severity of
Explanation of failure to ☐ No validated outcome
osteoporotic vertebral fractures on the
meet guideline inclusion clinical and surgical outcomes of measures used
criteria kyphoplasty. ☐ Small sample size
(when applicable) ☐ <80% follow-up
Type of treatment(s): KP ☐ Lacked subgroup analysis
931
☐ Level V (expert Total number of patients: 94 ☐ Diagnostic method not
consensus) Number of patients in relevant stated
subgroup(s): ☐ Other: Click or tap here to
☐ Level IV in presence of Based on fracture shape: wedge type enter text.
higher quality studies (n = 54) or biconcave type (n = 40).
Level of Evidence
Consecutively assigned? No
☐ Subgroup analysis data Determination
not available Potential Level: III
Duration of follow-up: 12 months Downgraded Level: Not
☐ Not relevant to question Downgraded
Validated outcome measures used
(list): VAS, kyphotic angle correction Conclusions
This paper provides evidence
Nonvalidated outcome measures used that: postop VAS and
(list): Cement leakage, new fractures proportion of new fractures
does not significantly differ
Diagnosis made by: based upon fracture shape
☐ Clinical exam/history (wedge or biconcave), i.e.
☐ Electromyography equivocal rates of fracture
☐ Myelogram and similar VAS scores
☒ MRI based on shape. However,
greater correction is noted
☐ CT
in the KA in wedge
☐ CT/Myelogram
fractures compared to
☒ Other: X rays, BMD?DEXA biconcave type.
Results/subgroup analysis:
VAS (before/one day post/ 12 month)
Wedge type: 7.9/3.2/2.5
Biconcave : 8.0/3.2/2.7
Grade 1: 8.0/3.4/2.5
Grade 2: 7.9/3.1/2.9
Grade 3: 7.8/3.1/2.5
Wedge type had greater anterior
vertebral height and kyphotic angle
correction than biconcave type.
Biconcave had greater correction of
the middle vertebral height.
932
Cement leakage
Grade 1 12.8%
Grade 2 25.8%
Grade 3 50%
New fractures at 12 month follow up
Wedge group: 20.4%
Biconcave: 12.5%
Author conclusions: Assessing the
shape and severity of fractured
osteoporotic vertebrae gives an idea of
the potential correction of body height
and kyphosis, and of the risk of
cement leakage.
Deen HG, Aranda-Michel J, Reimer R, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Miller DA, Putzke JD. Balloon Therapeutic ☐ Nonconsecutive patients
kyphoplasty for vertebral compression Study Design: Comparative ☒ Nonrandomized
fractures in solid organ transplant Level II
☐ Nonmasked reviewers
recipients: results of treatment and Stated objective of study: To report on
☐ Nonmasked patients
comparison with primary osteoporotic the results of
vertebral compression fractures. Spine Explanation of failure to ☐ No validated outcome
kyphoplasty treatment in a group of
J. 2006;6(5):494-499. meet guideline inclusion organ transplantation measures used
doi:10.1016/j.spinee.2006.01.011 criteria recipients, and to compare the clinical ☒ Small sample size
. (when applicable) characteristics and ☐ <80% follow-up
treatment outcomes of ☐ Lacked subgroup analysis
☐ Level V (expert posttransplantation VCF with those ☐ Diagnostic method not
consensus) seen in primary osteoporosis. stated
☐ Other: Click or tap here to
☐ Level IV in presence of Type of treatment(s): BK
enter text.
higher quality studies
Total number of patients: 20
Level of Evidence
☐ Subgroup analysis data Number of patients in relevant
Determination
not available subgroup(s): Transplant group (solid
Potential Level: II
organ) = 10 patients with 29
Downgraded Level: Not
symptomatic VCFs
☐ Not relevant to question Downgraded
Comparison group = 10 (with primary
osteoporosis but no transplant history)
Conclusions
with 15 syptomatic VCFs
This paper provides evidence
that: transplant patients
Consecutively assigned? Yes
have more severe bony
933
disease, more severe
Duration of follow-up: 12 months baseline pain with higher
incidence of multiple
Validated outcome measures used fractures at diagnosis.
(list): VAS-Back pain, cobb angle Although postop VAS,
sagittal alignment
Nonvalidated outcome measures used improvement and narcotic
(list): Cement leakage, Narcotic analgesic usage may not
analgesic requirements, new fractures differ across transplant and
(at f/u) non-transplant patients, the
former has higher risk of
Diagnosis made by: new fracture development
☐ Clinical exam/history post BK.
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Plain films, bone scans
Results/subgroup analysis:
VAS
Transplant group had higher pain
levels at baseline (9.3 s 7.7)
Post treatment, both decreased to 3.2
and 1.5 (transplant/non)
There was improvement in sagittal
alignment 30% in each group.
Narcotic use was decreased or
eliminated in both groups.
New fractures (40% in transpant and
20% in non). Small sample size.
(30%) in each group.
934
Clinically insignificant cement
extravasation was noted
in 3 of 29 treated levels (10%) in the
transplant group vs 13% (2 of the 15
treated levels) in the comparison
group.
-Narcotic analgesic intake was
decreased or eliminated in all patients
New fractures:
-During f/u period, 40% (4 patients with
7 new VCFs) in transplant group vs
20% (2 patients with 3 new VCFs) in
comparioson group developed new
VCFs
Author conclusions: Transplant
patients developed earlier and more
severe bony disease, with more
severe baseline pain, a higher
incidence of multiple fractures at the
time of diagnosis, and a greater risk of
new fracture development
posttreatment, as
compared with the primary
osteoporosis group
Denoix E, Viry F, Ostertag A, et al. What Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
are the predictors of clinical success Therapeutic ☐ Nonconsecutive patients
after percutaneous vertebroplasty for Study Design: Comparative ☒ Nonrandomized
osteoporotic vertebral fractures?. Eur Level III
☐ Nonmasked reviewers
Radiol. 2018;28(7):2735-2742. Stated objective of study: To identify
☐ Nonmasked patients
doi:10.1007/s00330-017-5274-1 predictive factors for mid-term
Duplicate: Also in OVCF Int Q6 and Explanation of failure to ☐ No validated outcome
outcome after vertebroplasty in
OVCF Int Q7 meet guideline inclusion osteoporotic fractures with persistent measures used
criteria and intense pain ☐ Small sample size
(when applicable) ☐ <80% follow-up
Type of treatment(s): VP ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Total number of patients: 78 stated
935
☐ Level IV in presence of Number of patients in relevant ☐ Other: Click or tap here to
higher quality studies subgroup(s): Click or tap here to enter enter text.
text.
☐ Subgroup analysis data Level of Evidence
not available Consecutively assigned? Yes Determination
Potential Level: III
Duration of follow-up: 6-weeks (since
☐ Not relevant to question Downgraded Level: Not
phone call interview was atleast after Downgraded
6-wee postop)
Conclusions
Validated outcome measures used This paper provides evidence
(list): NRS, Global satisfaction that early intervention
- Semi-quantitative approach using (within 2-months after
standardized questionnaire if their pain fracture) and absent IVC on
decreased after 1-month postop via preop imaging increases
phone interview the likelihood of a favorable
outcome as assessed
Nonvalidated outcome measures used within 1-month postop.
(list): The dependent variable was the
outcome at 1 month, coded as
favourable or poor
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Results/subgroup analysis:
61.5% had favorable outcome after 1-
mo postop
-Absence of IV cleft on pre-
interventional imaging (OR = 3.7, 95%
CI 1.2–11.8, p = 0.024) AND EARLY
intervention--->VP within 2 months
after fracture (OR = 4.1, 95% CI 1.2–
936
13.8, p = 0.021).--- was associated
with favorable outcome (assessed at
1-month after sx).
- At the time of evaluation, the pain
NRS significantly differed by outcome
(favourable: 3.0 ± 2.3; poor: 6.6 ± 2.0,
p< 0.001) along with the satisfaction
numerical rating scale (favourable: 7.7
± 2.1;
poor: 2.0 ± 2.8, p< 0.001), supporting
the validity of the outcome
classification.
Author conclusions: In patients with
persistent and intense pain after an
osteoporotic vertebral fracture, early
intervention and absence of
intravertebral cleft were predictors of
favourable outcome at 1 month after
vertebroplasty
Gao C, Zong M, Wang WT, Xu L, Cao Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
D, Zou YF. Analysis of risk factors Therapeutic ☒ Nonconsecutive patients
causing short-term cement leakages Study Design: Comparative ☒ Nonrandomized
and long-term complications after Level III
☐ Nonmasked reviewers
percutaneous kyphoplasty for Stated objective of study: To evaluate
☐ Nonmasked patients
osteoporotic vertebral compression pre- and postoperative risk factors for
fractures. Acta Radiol. 2018;59(5):577- Explanation of failure to ☒ No validated outcome
the occurrence of short-term cement
585. doi:10.1177/0284185117725368 meet guideline inclusion leakages and measures used
criteria long-term complications after PKP for ☐ Small sample size
(when applicable) OVCFs ☒ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Type of treatment(s): PKP ☐ Diagnostic method not
consensus) stated
Total number of patients: 289 ☐ Other: Click or tap here to
☐ Level IV in presence of vertebrae in 239 pts.
enter text.
higher quality studies Number of patients in relevant
subgroup(s): Click or tap here to enter
Level of Evidence
☐ Subgroup analysis data text.
Determination
not available Potential Level: III
937
Consecutively assigned? No Downgraded Level: Not
☐ Not relevant to question Downgraded
Duration of follow-up: 13.6+/-6.9
months==>100 patients (123 Conclusions relative to
vertebrae) of the 239 had f/u question
This paper provides evidence
Validated outcome measures used that: low BMD and cortical
(list): Click or tap here to enter text. disruption are factors of
cement leakage. Low BMD
Nonvalidated outcome measures used also associated with new
(list): Cement leakage; VCF. IVC and Schmorl
Long-term complications (new VCFs nodes are respective risk
and recompression) factors for paravertebral
type and c-type CL.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☐ Other: BMD/DEXA, X-rays
Results/subgroup analysis: Low BMD
as a factor for cement leakage.
Cement Leakage: 79.9% (226 of 283
vertebre)
-The presence of cortical disruption
(P=0.001), large volume of cement
(P=0.012), and low bone mineral
density (BMD) (P=0.002) were three
strong predictors for cement leakage
-presence of intravertebral cleft
(p=0.045) and Schmorl nodes
(p=0.025) were respectively identified
as additional risk factors
for paravertebral and intradiscal
subtype of cortical (C-type) leakages
Outcomes (new VCFs and
938
recompression):
-Of the 100 patients with f/u, 41
(33.3%) and 31 (25.2%) developed
new VCFs and recompression
respectively
-Occurrence of cortical leakage was a
strong risk factor both for new VCFs
(P=0.043) and for recompression
(P=0.004
-Specifically, C-type CL (p=0.017)
AND low BMD (p=0.043) increased
risk of new VCF
-C-type leakage, large volume of
cement, and deformed fracture type
(P=0.004, 0.032, and 0.035,
respectively) were three risk factors
(Suppl. Table 3) of the recompression
with aggravated
kyphosis.
Author conclusions: The presence of
cortical disruption, large volume of
cement, and low BMD of treated level
are general but strong predictors for
cement leakage. The presence of
intravertebral cleft and Schmorl nodes
are additional risk factors for cortical
leakage. During follow-up, the
occurrence of C-type leakage is a
strong risk factor, for both new VCFs
and
recompression.
Grafe IA, Nöldge G, Weiss C, et al. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Prediction of immediate and long-term Therapeutic ☒ Nonconsecutive patients
benefit after kyphoplasty of painful Study Design: Comparative ☒ Nonrandomized
osteoporotic vertebral fractures by Level III
☐ Nonmasked reviewers
preoperative MRI. Eur J Trauma Emerg Stated objective of study: To evaluate
☐ Nonmasked patients
Surg. 2011;37(4):379-386. clinical and radiomorphological
doi:10.1007/s00068-010-0050-9. Explanation of failure to ☐ No validated outcome
outcomes after kyphoplasty of painful
meet guideline inclusion osteoporotic vertebral fractures with measures used
criteria and without preoperative MR- ☒ Small sample size
939
(when applicable) detectable bone marrow edema for 1 ☐ <80% follow-up
year of follow-up. ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Type of treatment(s): KP
stated
☐ Other: Click or tap here to
☐ Level IV in presence of Total number of patients: 45
enter text.
higher quality studies Number of patients in relevant
subgroup(s):
Bone edema group = 27 Level of Evidence
☐ Subgroup analysis data Determination
No edema = 18
not available Potential Level: III
Consecutively assigned? No Downgraded Level: Not
☐ Not relevant to question Downgraded
Duration of follow-up: 1-year
Conclusions
Validated outcome measures used This paper provides evidence
(list): Pain scores (VAS 0-100), that: patients with preop
radiomorphological measures (midline vertebral body edema had
VH, KA)—at baseline, postop and at relatively better pain
12-mo f/u control in the immediate
postop (along with greater
Nonvalidated outcome measures used VH restoration and KA
(list): Click or tap here to enter text. correction) compared to
those without edema.
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Plain x-rays
Results/subgroup
analysis: Postoperatively (after KP)—
immediate short-term-----in the bone
edema group (when compared to the
non-edema group):
1. Greater improvement in the mean
VAS scores (p=0.026). Also, the
940
proportion of patients with
improvement were higher in the bone
edema group (p=0.031). However, no
differences in pain scores were noted
at 12-months.
2. Greater height restoration 10.2 vs
8.7%--althought not significant
(p=0.450)
3. Greater correction in KA at 12
months from baseline (p=0.014)
compared to non-edema group.
Author conclusions: A preoperative
MR-detectable vertebral bone
marrow edema predicts a better short-
term outcome after
kyphoplasty, but is not a prerequisite
for long-term pain
reduction in patients with old,
chronically painful osteoporotic
vertebral fractures.
Ha KY, Lee JS, Kim KW, Chon JS. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Percutaneous vertebroplasty for Therapeutic ☐ Nonconsecutive patients
vertebral compression fractures with Study Design: Comparative ☒ Nonrandomized
and without intravertebral clefts. J Bone Level III
☒ Nonmasked reviewers
Joint Surg Br. 2006;88:629-633. Stated objective of study: To compare
☒ Nonmasked patients
Explanation of failure to the clinical and radiological
meet guideline inclusion ☐ No validated outcome
results of percutaneous vertebroplasty
criteria (PV) in patients with osteoporotic measures used
(when applicable) vertebral compression fractures with or ☒ Small sample size
without an intravertebral cleft ☐ <80% follow-up
☐ Level V (expert ☐ Lacked subgroup analysis
consensus) Type of treatment(s): PV ☐ Diagnostic method not
stated
☐ Level IV in presence of Total number of patients: N=51 pts ☐ Other: Click or tap here to
higher quality studies with 58 fractures (out of the 54
enter text.
patients with OVCFs treated with PV; 2
☐ Subgroup analysis data lost to f/u and 1 dead)
Level of Evidence
not available Determination
Potential Level: III
941
☐ Not relevant to question Number of patients in Downgraded Level: Not
relevant subgroup(s): Downgraded
~~~~~~~~~~ Group 1: 39 pts (46 vertebrae) without
NOTES: Click or tap here to IV cleft Conclusions
enter text. Group 2: 12 pts (12 vertebrae) with IV This paper provides evidence
cleft that: The presence of
intravertebral cleft is
Consecutively assigned? Yes associated with higher ODI,
VAS scores, and higher
Duration of follow-up: mean 26.3 rates of complications
months (range: 24- 36 months) compared to those without
clefts.
Validated outcome measures used
(list):
1. PRO: ODI, VAS
2. Radiological metrics: Kyphosis
correction
Nonvalidated outcome measures used
(list): cement leakage; bone resorption;
adjacent vertebral fractures
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒Other: Click or tap here to enter
text.
Results/subgroup analysis:
The ODI and VAS scores in both
groups improved after treatment,
Group 1 = 75.1 (preop) vs 38.7 (3 mo
postop) vs 37.3 (final f/u)
Group 2 = 79.9 (preop) vs 48.5 (3 mo
942
postop) vs 55.4 (final f/u)
-VAS
Group 1 = 8.3 (preop) vs 4.2 (postop)
vs 3.5 (final f/u)
Group 2 = 9.4 (preop) vs 4.5 (postop)
vs 5.9 (final f/u)
-There was a greater initial correction
of the kyphosis in group 2 than in
group 1,
Author conclusions: Percutaneous
vertebroplasty is an effective treatment
for osteoporotic compression
fractures with or without an
intravertebral cleft. Nonetheless,
higher rates of complications related to
the cement must be recognised in
patients in the presence of an
intravertebral cleft
Heo DH, Chin DK, Yoon YS, Kuh SU Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
(2009) Recollapse of previous vertebral Therapeutic ☒ Nonconsecutive patients
compression fracture after percutaneous Study Design: Comparative ☒ Nonrandomized
vertebroplasty. Osteoporos Int 20:473– Level III
☒ Nonmasked reviewers
480 Stated objective of study: To
☒ Nonmasked patients
Explanation of failure to investigate the
meet guideline inclusion ☒ No validated outcome
incidence rate, characteristics, and
criteria predisposing factors measures used
(when applicable) associated with recollapse of the same ☐ Small sample size
vertebrae after ☐ <80% follow-up
☐ Level V (expert percutaneous vertebroplasty (PVP). ☐ Lacked subgroup analysis
consensus) Stated objective of study: to assess ☐ Diagnostic method not
the characteristics and risk factors of stated
☐ Level IV in presence of patients who experience recollapse of ☐ Other: Click or tap here to
higher quality studies the same vertebra after PVP.
enter text.
☐ Subgroup analysis data Type of treatment(s): PVPVP
Level of Evidence
not available Determination
Total number of patients: N=343343
Potential Level: III
patients
☐ Not relevant to question
943
Number of patients in Downgraded Level: Not
relevant subgroup(s): “well maintained Downgraded
group” 332 pts vs “recollapse group”
11 patients11 recollapse Conclusions
This paper provides evidence
Consecutively assigned? No that: the presence of
osteonecrosis and the
Duration of follow-up: 4 MONTHS after degree of free expansion of
PVP4 months vertebral compression
fracture are predisposing
Validated outcome measures used factors for recollapse in
(list): Click or tap here to enter text. patients undergoing
vertebroplasty for OVCF.
Nonvalidated outcome measures used
(list): Risk-factor assessmentClick or ~~~~~~~~~~
tap here to enter text. NOTES: Statistical results
lack multivariate adjustments;
Diagnosis made by: the conclusions based on
☒☐ Clinical exam/history observation of quantitative
☐ Electromyography values and assessment of
differences across the values
☐ Myelogram
rather than an adjusted
☒ MRI
regression analysis.
☐ CT Recollapse was not clearly
☐ CT/Myelogram defined
☒ Other: BMDpalin radiographs and
bone scan
Results/subgroup analysis:
MRI showed higher incidence of
osteonecrosis (6/21)n the recollapse
group than the well maintained group
(5/402).
Degree of re expansion of the
compressed vertebra was significantly
higher in the recollapse group than
well maintained group.
944
Author conclusions: The most
important predisposing factor for
recollapse was pre-operative
osteonecrosis. Recollapse was not
related to trauma. Osteoporotic
vertebral compression fracture with
osteonecrosis or pseudoarthrosis has
been regarded as a relative indication
for PVP; however, the findings of this
study suggest that this disease
category may be a relative
contraindication for PVPAuthor
conclusions: The most important
predisposing factor for recollapse was
pre-operative osteonecrosis.
Recollapse wasnot related to trauma.
Osteoporotic vertebral compression
fracture with osteonecrosis or
pseudoarthrosis has been regarded as
a relative indication for PVP; however,
the findings of this study suggest that
this disease category may be a relative
contraindication for PVP.
Hey HW, Tan JH, Tan CS, Tan HM, Lau Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
PH, Hee HT. Subsequent Vertebral Therapeutic ☒ Nonconsecutive patients
Fractures Post Cement Augmentation of Study Design: Comparative ☒ Nonrandomized
the Thoracolumbar Spine: Does it Level III
☐ Nonmasked reviewers
Correlate With Level-specific Bone Stated objective of study: To
☐ Nonmasked patients
Mineral Density Scores? [published investigate the correlation
correction appears in Spine (Phila Pa Explanation of failure to ☐ No validated outcome
between level-specific preoperative
1976). 2016 Feb;41(4):368. Hwee meet guideline inclusion bone mineral density and measures used
Weng, Dennis Hey [corrected to Hey, criteria subsequent vertebral fractures. We ☐ Small sample size
Hwee Weng Dennis]; Jun, Hao Tan (when applicable) also identified factors associated with ☐ <80% follow-up
[corrected to Tan, Jun Hao]; Chuen, subsequent vertebral fractures. ☐ Lacked subgroup analysis
Seng Tan [corrected to Tan, Chuen ☐ Level V (expert ☐ Diagnostic method not
Seng]; Ming, Bryan Tan Hsi [corrected consensus) Type of treatment(s): VP or KP stated
to Tan, Hsi Ming Bryan]; Huh, Bernard
☐ Other: Click or tap here to
Lau Puang [corrected to Lau, Puang ☐ Level IV in presence of Total number of patients: 93
enter text.
Hu]. Spine (Phila Pa 1976). higher quality studies
945
2015;40(24):1903-1909. Number of patients in relevant Level of Evidence
doi:10.1097/BRS.0000000000001066 ☐ Subgroup analysis data subgroup(s): Click or tap here to enter Determination
not available text. Potential Level: III
Downgraded Level: Not
☐ Not relevant to question Consecutively assigned? No Downgraded
Duration of follow-up: 25.1 months Conclusions
(12–96 mo) This paper provides evidence
that specific cutoffs of T-
Validated outcome measures used scores and age correlate
(list): Click or tap here to enter text. with new fractures after
vertebral augmentation
Nonvalidated outcome measures used procedures.
(list):
To investigate factors associated with
subsequent vertebral fractures
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X rays, DEXA
Results/subgroup analysis: 17.2%
(n=16) pts had vertebral fractures; 7 of
these located in adjacent vertebrae.
Fractured vertebra had a mean T-
score of -2.860 (95% CI: 3.268 to -
2.452) vs nonfractured vertebra had a
mean T-score of -2.180 (95% CI -
2.373 to -1.986). Further analysis
showed that
beyond a cut-off of T-score -2.2 or
lower, there is a significant association
with the subsequent fracture of the
involved vertebra (P=0.047).
946
- As the level-specific T-scores
continue to drop -2.2 or less, the odds
ratio for subsequent fracture of that
vertebra increases as noted below:
<=2.3: OR: 1.104 (p= 0.015)
<=2.4 OR: 1.157 (p=0.010)
<=2.5 OR: 1.291 (p=0.004)
<=2.6 OR 1.463 (p=0.001)
Age (OR: 1.05; 95% CI: 1.00-1.12;
p=0.049) was one of the factor
associated with vertebral fractures
post cement augmentation
Author conclusions: Level-specific T-
scores are predictive of subsequent
fractures and the odds ratio increases
with lower Tscores from -2.2 or less to
-2.6 or less. They have a low
positive predictive value, but a high
negative predictive value
for subsequent fractures. Other
significant associations with
subsequent refractures include age
and anterior vertebral height.
Hiwatashi A, Westesson PL. Patients Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
with osteoporosis on steroid medication Therapeutic ☐ Nonconsecutive patients
tend to sustain subsequent fractures. Study Design: Comparative ☒ Nonrandomized
Am J Neuroradiol. 2007;28:1055–1057. Level III
☒ Nonmasked reviewers
Stated objective of study: To identify
☒ Nonmasked patients
characteristics of patients with new
Explanation of failure to ☒ No validated outcome
fractures after vertebroplastto identify
meet guideline inclusion characteristics of patients with new measures used
criteria fractures after vertebroplasty. ☒ Small sample size
(when applicable) ☐ <80% follow-up
Type of treatment(s): PVVP ☒ Lacked subgroup analysis
☐ Level V (expert ☒ Diagnostic method not
consensus) Total number of patients: 5555 stated
patients ☐ Other: Click or tap here to
enter text.
947
☐ Level IV in presence of Number of patients in
higher quality studies relevant subgroup(s): 35 without new Level of Evidence
fractures vs 20 with new fracturesnew Determination
☐ Subgroup analysis data fractures in 28 bodies in 20 patients Potential Level: III
not available Downgraded Level: Not
Consecutively assigned? Yes Downgraded
☐ Not relevant to question
Duration of follow-up: 535 daysMean Conclusions
follow-up was 535 days This paper provides evidence
that: in patients with
Validated outcome measures used osteoporotic compression
(list): Click or tap here to enter text. fractures, a higher
proportion of patients
Nonvalidated outcome measures used developing new fractures
(list): Risk factor assessment after PVP are those on
especially effect of long-term steroid long-term steroid
medicationClick or tap here to enter medications.
text.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Results/subgroup analysis: 16 of 55
patients had been on steroid
medication.
Subsequent vertebral fractures
Long term steroid: 69% (11/16)
Osteoporosis, non steroid: 23% (9/39)
948
Author conclusions: Patients who are
on long-term steroid medication have
an elevated risk of developing
new fractures after vertebroplasty
Author conclusions: Patients with
steroid-induced osteoporosis have a
higher incidence of new fractures after
vertebroplasty than patients with
primary osteoporosis.
Hiwatashi A, Yoshiura T, Yamashita K, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Kamano H, Dashjamts T, Honda H. Therapeutic ☐ Nonconsecutive patients
Subsequent fracture after percutaneous Study Design: Comparative ☒ Nonrandomized
vertebroplasty can be predicted on Level III
☐ Nonmasked reviewers
preoperative multidetector row Stated objective of study: To evaluate
☐ Nonmasked patients
CT. AJNR Am J Neuroradiol. Explanation of failure to preoperative multidetector row CT
2009;30(10):1830-1834. meet guideline inclusion ☒ No validated outcome
(MDCT) for the prediction of
doi:10.3174/ajnr.A1722 criteria subsequent fractures after measures used
(when applicable) vertebroplasty ☒ Small sample size
☐ <80% follow-up
☐ Level V (expert Type of treatment(s): Vertebroplasty ☐ Lacked subgroup analysis
consensus) ☐ Diagnostic method not
Total number of patients: 26 stated
☐ Level IV in presence of Number of patients in relevant ☐ Other: Click or tap here to
higher quality studies subgroup(s): Click or tap here to enter
enter text.
text.
☐ Subgroup analysis data Level of Evidence
not available Consecutively assigned? Yes
Determination
Potential Level: II
Duration of follow-up: mean: 200 days,
☐ Not relevant to question Downgraded Level: III
range: 26-730 days
Downgraded due to: small
sample size.
Validated outcome measures used
(list): Click or tap here to enter text.
Conclusions
This paper provides evidence
Nonvalidated outcome measures used
that: steroid use and low CT
(list): Risk factor of new fractures in
value are risk factors for
adjacent and remote vertebrae (atleast
new fractures in remote
3 months after Sx)
vertebrae while small
vertebral size may be a risk
Diagnosis made by:
949
☒ Clinical exam/history for adjacent vertebral
☐ Electromyography fractures.
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Click or tap here to enter
text.
Results/subgroup analysis:
The mean CT value of treated,
adjacent, and remote vertebrae
was 228.7, 154.6, and 147.5,
respectively
Subsequent fractures were noted at 14
adjacent vertebrae (12.1%==14 out of
116) in 13 patients and at 14
remote vertebrae in 6 patients
(23.1%). Subsequent fractures in
adjacent vertebrae tended to occur in
small vertebrae before treatment (P
<05).
Multivariate analysis assessing the
association of new fractures in
adjacent vertebrae showed no
signficiant patient specific or fracture
specific characteristics (except for
Vertebral height; OR: 0.807; 95% CI:
0.6663- 0.982; P=0.032)
However, multivariatre analysis
assessing the association of new
fractures in remote vertebrae noted
steroid medication (OR: 13.5; 95% CI:
1.476 to 123.4; P=0.021) and low CT
value (OR: 0.970; 95% CI: 0.942-
0.999; P=0.040) as potential risk
factors.
950
Author conclusions: The small size of
the treated vertebrae may relate to
subsequent fractures in adjacent
vertebrae. Steroid use and low CT
value of nonfractured vertebrae on
preoperative MDCT can be associated
with subsequent fractures in remote
vertebrae
Hong SJ, Lee S, Yoon JS, Kim JH, Park Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
YK. Analysis of intradiscal cement Therapeutic ☐ Nonconsecutive patients
leakage during percutaneous Study Design: Comparative ☒ Nonrandomized
vertebroplasty: multivariate study of risk Level III
☐ Nonmasked reviewers
factors emphasizing preoperative MR Stated objective of study: To evaluate
☐ Nonmasked patients
findings. J Neuroradiol. 2014;41(3):195- several clinical and preoperative MRI
201. doi:10.1016/j.neurad.2013.07.004 Explanation of failure to ☒ No validated outcome
risk factors for intradiscal cement
meet guideline inclusion leakage. measures used
criteria ☐ Small sample size
(when applicable) Type of treatment(s): PV ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Total number of patients: 136 (234 ☐ Diagnostic method not
consensus) vertebral bodies) stated
Number of patients in relevant ☒ Other: No mention of f/u
☐ Level IV in presence of subgroup(s):
time
higher quality studies 42 patients with no endplate cortical
disruption (55 bodies) vs 95 patients
Level of Evidence
☐ Subgroup analysis data (179 vertebral bodies) with cortical
Determination
not available disruption
Potential Level: III
Downgraded Level: Not
Consecutively assigned? Yes
☐ Not relevant to question Downgraded
Duration of follow-up: NOT
Conclusions
AVAILABLE
This paper provides evidence
that: intradiscal cement
Validated outcome measures used
leakage occurs in the
(list): Click or tap here to enter text.
presence of high signal T2
intensity in the adjacent
Nonvalidated outcome measures used
disc.
(list): Cement leakage (and risk factors
associated with it)
951
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X rays, DEXA
Results/subgroup analysis:
55/234 vertebbra with no endplate
cortical disruption showed no adjacent
intradiscal cement leakage.
54/179 vertebra with endplate cortical
disruption showed adjacent intradiscal
cement leakage.
Univariate analysis
Adjacent disc high signal intensity on
T2 weighted scan and cement injected
volume were significantly related to
risk of intradiscal cement leakage.
Multivaiate analysis
Only high T2 signal in the adjacent
disc was related to intrasdiscal cement
leakage.
Author conclusions: There was no
adjacent intradiscal cement leakage
without endplate cortical dis-ruption.
-Abnormal T2 hyperintensity in
adjacent discs may be related to
intradiscal cementleakage, but only in
the presence of endplate cortical
disruption. Also, not having
Kümmell’sdisease did not prevent
intradiscal cement leakage. Thus,
given these circumstances,
952
carefulcement injection is needed to
reduce intradiscal cement leakage.
Hu L, Sun H, Wang H, et al. Cement Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
injection and postoperative vertebral Therapeutic ☒ Nonconsecutive patients
fractures during vertebroplasty. J Orthop Study Design: Comparative ☒ Nonrandomized
Surg Res. 2019;14(1):228. Published Level III
☐ Nonmasked reviewers
2019 Jul 19. doi:10.1186/s13018-019- Stated objective of study: To study
☐ Nonmasked patients
1273-z factors causing such vertebral
Explanation of failure to ☒ No validated outcome
fractures after vertebroplasty and
meet guideline inclusion calculated the appropriate amount of measures used
criteria bone cement to inject ☐ Small sample size
(when applicable) ☐ <80% follow-up
Type of treatment(s): VP ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Total number of patients: 112 stated
Number of patients in relevant ☐ Other: Click or tap here to
☐ Level IV in presence of subgroup(s):
enter text.
higher quality studies Refracture = 28 vs no-refracture
(controls) = 84
Level of Evidence
☐ Subgroup analysis data Determination
not available Consecutively assigned? No
Potential Level: III
Downgraded Level: Not
Duration of follow-up: mean 9.1 mo (6
☐ Not relevant to question Downgraded
to 12 months)
Conclusions
Validated outcome measures used
This paper provides evidence
(list): Click or tap here to enter text.
that: refractures after VP
tend to occur more in
Nonvalidated outcome measures used
females and those with
(list): Refractures (and factors
lower BMD.
associated with it)
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X ray
953
Results/subgroup analysis: Patients
incurring refractures post VP tend to
have significantly lower BMD (-2.8 vs -
2.63; p=0.008) and occur in female
sex (23/28 vs 49/84; p=0.023).
Author conclusions: Bone cement
injection volume, BMD values, and sex
were statistically significantly related to
adjacent
vertebral fractures after vertebroplasty,
and cement injection volumes
exceeding 40.5% caused adjacent
vertebral
fractures.
Huang ZF, Xia P, Liu K, Xiong W. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Analysis of risk factors of new fracture of Therapeutic ☒ Nonconsecutive patients
vertebral body after percutaneous Study Design: Comparative ☒ Nonrandomized
kyphoplasty in patients with primary Level III
☐ Nonmasked reviewers
osteoporotic fracture of thoracic and Stated objective of study: To
☐ Nonmasked patients
lumbar spine. Journal of Biomaterials investigate the risk factors of vertebral
and Tissue Engineering. 2018;8(5):756- Explanation of failure to ☒ No validated outcome
new fractures after percutaneous
759. meet guideline inclusion kyphoplasty (PKP) in patients with measures used
= criteria primary osteoporotic thoracolumbar ☐ Small sample size
(when applicable) fractures ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Type of treatment(s): PKP ☐ Diagnostic method not
consensus) stated
Total number of patients: 161 with f/u ☐ Other: Click or tap here to
☐ Level IV in presence of (out of 182)
enter text.
higher quality studies Number of patients in relevant
subgroup(s): 148 without fractures vs
Level of Evidence
☐ Subgroup analysis data 13 with new fractures
Determination
not available Potential Level: III
Consecutively assigned? No
Downgraded Level: Not
☐ Not relevant to question Downgraded
Duration of follow-up: 11.93± 6.97
months
Conclusions
This paper provides evidence
that: osteoporosis and bone
954
Validated outcome measures used cement leakage are risk
(list): Click or tap here to enter text. factors associated with
new vertebra fractures post
Nonvalidated outcome measures used PKP.
(list): New fractures after PKP (and
associated risk factors)
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Results/subgroup analysis:
Of the 161 cases, 13 secondary
fractures (8.07%). Of these, 50% were
adjacent fractures.
Univariate analysis showed significant
differences in the two groups for
smoking, vertebral height recovery
rate, bone mineral density and bone
cement leakage.
Multivariate analysis showed
osteoporosis and bone cement
leakage as risk factors for vertebral
new fractures after PKP.
Author conclusions: Severe
osteoporosis and bone cement
leakage are risk factors of vertebral
new fractures
after PKP in patients with primary
osteoporotic thoracolumbar fractures.
955
Findings suggest a requirement for
anti-osteoporosis treatment after PKP
operation for patients with primary
osteoporotic thoracolumbar fractures
Kang S, Lee CW, Park NK, Kang T, Lim Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
J, Cha KY, Kim JH (2011) Predictive risk Therapeutic ☒ Nonconsecutive patients
factors for refracture after percutaneous Study Design: Comparative ☒ Nonrandomized
vertebroplasty. Ann Rehabil Med Level III
☒ Nonmasked reviewers
35:844–851 Stated objective of study: To identify
☒ Nonmasked patients
risk factors for developing a vertebral
Explanation of failure to ☐ No validated outcome
refracture after percutaneous
meet guideline inclusion vertebroplastyTo identify risk factors measures used
criteria for developing a vertebral refracture ☐ Small sample size
(when applicable) after percutaneous vertebroplasty. ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Type of treatment(s): PVPVP ☐ Diagnostic method not
consensus) stated
Total number of patients: 6060 ☐ Other: Click or tap here to
☐ Level IV in presence of patients
enter text.
higher quality studies Number of patients in
relevant subgroup(s): Click or tap here
Level of Evidence
☐ Subgroup analysis data to enter text.27 refractured vertebra,
Determination
not available 33 no refractures
Potential Level: III
Downgraded Level: Not
Consecutively assigned? No
☐ Not relevant to question Downgraded
Duration of follow-up: 1 year
. Conclusions
This paper provides evidence
Validated outcome measures used
that: in patients with
(list): VAS; radiological metricsre-
osteoporotic compression
fracture
fractures, differences in
local KA and sagittal index
Nonvalidated outcome measures used
are statistically significant
(list): Risk-factor assessment
factors for the risk of
refracture in patients
Diagnosis made by:
undergoing percutaneous
☒☐ Clinical exam/history vertebroplasty.
☐ Electromyography
☐ Myelogram
☒ MRI
956
☐ CT
☐ CT/Myelogram
☒ Other: x-rays; BMD
nuclear isotopes (99mTC MDP)
Results/subgroup analysis:
Risk faxtors for vertebral refractures
were kyphotic angle and sagittal index.
Kyphotic angle for refracture was 15.6
and without refracture was 9.4
Sagittal index was 12.7 and 6.7
Author conclusions: Patients who had
a high preoperative local kyphotic
angle and a high sagittal index
required a close follow-up and
attentionAuthor conclusions:
the local kyphotic angle and the sa
gittal index were significant predictiv
e factors among diverse risk factors
for vertebral refracture after percut
aneous vertebroplasty. Therefore, m
edical staff should warn patients
with a compression fracture and a
local kyphotic angle >15o and a
sagittal index >12o before
percutaneous
vertebroplasty for a high risk of vert
ebral refracture after percutaneous v
ertebroplasty. Close follow-
up observation is necessary.
Khurjekar K, Shyam AK, Sancheti PK, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Sonawane D. Correlation of kyphosis Therapeutic ☒ Nonconsecutive patients
and wedge angles with outcome after Study Design: Comparative ☒ Nonrandomized
percutaneous vertebroplasty: a Level III
☐ Nonmasked reviewers
prospective cohort study. J Orthop Surg Stated objective of study: To evaluate
☐ Nonmasked patients
(Hong Kong). 2011;19(1):35-40. the correlation of kyphosis and wedge
doi:10.1177/230949901101900108 Explanation of failure to ☐ No validated outcome
angles with pain relief and functional
meet guideline inclusion outcome after percutaneous measures used
criteria vertebroplasty (PV). ☒ Small sample size
957
(when applicable) ☐ <80% follow-up
Type of treatment(s): PV ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Total number of patients: 34
stated
Number of patients in relevant
☐ Other: Click or tap here to
☐ Level IV in presence of subgroup(s): Click or tap here to enter
enter text.
higher quality studies text.
Consecutively assigned? No Level of Evidence
☐ Subgroup analysis data Determination
not available Potential Level: II
Duration of follow-up: 1-year f/u
Downgraded Level: III
☐ Not relevant to question Downgraded due to:
Validated outcome measures used
(list): VAS, RMDQ Nonconsecutive patients,
-Outcomes were classified as nonrandomized, small
excellent, fair, and poor in terms of sample size
VAS scores (<3, 3–6, >6) and RMDQ
scores (<8, 8–16, >16). Conclusions
This paper provides evidence
Nonvalidated outcome measures used that: preop kyphosis and
(list): Click or tap here to enter text. wedge angles correlate
with postop outcomes
Diagnosis made by: (better VAS and RMDQ
scores).
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Results/subgroup analysis:
Mean VAS improved from 8 to 2.
RMDQ improved from 19 to 5
mean kyphosis angle improved from 9
to 8 degreees
mean wedge angle improved from 6 to
5 degrees
958
VAS and RMDQ correlated positively
with kyphosis and wedge angle.
Author conclusions: PV is a viable
treatment for vertebral
compression fractures with regard to
pain relief and
improvement of function. Preoperative
kyphosis and
wedge angles were predictive of post-
PV outcomes in
terms of VAS and RMDQ scores.
Kim YY, Rhyu KW. Recompression of Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
vertebral body after balloon kyphoplasty Therapeutic ☒ Nonconsecutive patients
for osteoporotic vertebral compression Study Design: Comparative ☒ Nonrandomized
fracture. Eur Spine J. 2010;19(11):1907- Level III
☐ Nonmasked reviewers
1912. doi:10.1007/s00586-010-1479-6 Stated objective of study: To evaluate
☐ Nonmasked patients
Explanation of failure to the factors that affect recompression of
meet guideline inclusion ☐ No validated outcome
operated vertebrae after percutaneous
criteria balloon kyphoplasty (PKP) for measures used
(when applicable) osteoporotic vertebral compression ☐ Small sample size
fractures ☐ <80% follow-up
☐ Level V (expert (VCFs) and assess their clinical ☐ Lacked subgroup analysis
consensus) importance ☐ Diagnostic method not
stated
☐ Level IV in presence of Type of treatment(s): PKP ☐ Other: Click or tap here to
higher quality studies enter text.
Total number of patients: 80
☐ Subgroup analysis data Number of patients in relevant
Level of Evidence
not available subgroup(s): 10 recompression group
Determination
vs 70 no-recompression (maintained
Potential Level: III
group)
☐ Not relevant to question Downgraded Level: Not
Downgraded
Consecutively assigned? No
Conclusions
Duration of follow-up: minimum 1-year
This paper provides evidence
that: patients incurring
Validated outcome measures used
recompression after PKP
(list): VAS
have high proportion of IVC
(100% VS 10%; P<0.05) and
959
Nonvalidated outcome measures used non-PMMA-endplate-
(list): Recompression rates contact (NPEC).
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X rays, DEXA
Results/subgroup analysis:
80 patients with 10 recompression
after PKP. 12.5% recompression rate.
The Pre and post operative KA, last
KA, IVC, NPEC differed significantly
between the two groups. And non
cement endplate contact showed
highly significant difference.
Author conclusions: The presence of
IVC and NPEC may play an important
role in inducing recompression of
treated vertebrae after PKP. Careful
observation of patients with these
conditions is necessary to prevent
deterioration of their clinical course.
Koch CA, Layton KF, Kallmes DF. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Outcomes of patients receiving long- Therapeutic ☒ Nonconsecutive patients
term corticosteroid therapy who undergo Study Design: Case Control ☒ Nonrandomized
percutaneous vertebroplasty. AJNR Am Level III
☐ Nonmasked reviewers
J Neuroradiol. 2007;28(3):563-566. Stated objective of study: To
☐ Nonmasked patients
determine the efficacy and rate of
Explanation of failure to ☐ No validated outcome
complications in patients undergoing
meet guideline inclusion percutaneous vertebroplasty (PVP) for measures used
criteria vertebral compression fractures as a ☐ Small sample size
(when applicable) result of secondary osteoporosis ☐ <80% follow-up
960
caused by long-term corticosteroid use ☐ Lacked subgroup analysis
☐ Level V (expert compared with patients with primary ☒ Diagnostic method not
consensus) osteoporosis treated with PVP. stated
☐ Other: Click or tap here to
☐ Level IV in presence of Type of treatment(s): PVP
enter text.
higher quality studies
Total number of patients: 447 (68
Level of Evidence
steroid users)
☐ Subgroup analysis data Determination
Number of patients in relevant
not available Potential Level: III
subgroup(s):
Downgraded Level: Not
68 steroid users vs 379 controls [475
☐ Not relevant to question Downgraded
PVP procedures]
Conclusions
Consecutively assigned? No
This paper provides evidence
that: steroid use is not a
Duration of follow-up: follow-up for
significant predictor of
patients on corticosteroids was 12.1
poor outcomes, specific to
+/- 10.3 mo vs 13.1 +/-9.3 mo for
complication rates and
control patients
development of new
fractures.
Validated outcome measures used
(list): pain (verbal analog pain scale=
Likert scale)
Nonvalidated outcome measures used
(list):
Periprocedural complications, and
frequency of new fractures in patients
(in corticosteroids group vs control)
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☐ Other:
Results/subgroup analysis:
961
Complication rate for patients with
corticosteroids was 4.4%, and for
control 3.4%
Long term corticosteroid use did not
result in increased new fractures after
PVP compared to control subjects.
Patients on corticosteroids had new
fractures after PVP o 29.4% compared
to control group of 29%
Author conclusions: Percutaneous
vertebroplasty performed for vertebral
compression fractures as a result of
long-term corticosteroid therapy is as
safe and effective in relieving pain as
PVP performed in patients with
vertebral compression fractures as a
result of primary osteoporosis.
Komemushi A, Tanigawa N, Kariya S, et Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
al. Biochemical markers of bone Therapeutic ☐ Nonconsecutive patients
turnover in percutaneous vertebroplasty Study Design: Comparative ☒ Nonrandomized
for osteoporotic compression Level III
☐ Nonmasked reviewers
fracture. Cardiovasc Intervent Radiol. Stated objective of study: To evaluate
☐ Nonmasked patients
2008;31(2):332-335. relationships between biochemical
doi:10.1007/s00270-007-9246-8. Explanation of failure to ☒ No validated outcome
markers of bone turnover, bone
meet guideline inclusion mineral density, and new compression measures used
criteria fractures following vertebroplasty ☒ Small sample size
(when applicable) ☒ <80% follow-up
Type of treatment(s): PV ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Total number of patients: 23 (out of 30) stated
with complete followup ☐ Other: Click or tap here to
☐ Level IV in presence of Number of patients in relevant
enter text.
higher quality studies subgroup(s):
Fractures (n=7; group F) vs no
Level of Evidence
☐ Subgroup analysis data fractures (n=16; group N) with respect
Determination
not available to the guidelines for the use of
Work group conclusions
biochemical markers of bone turnover
Potential Level: II
in osteoporosis: Group H (high fracture
☐ Not relevant to question Downgraded Level: III
962
risk) = 4 vs Group L (low fracture risk) Downgrade due to: Small
= 19 sample size, 80% follow-up,
no validated outcome
Consecutively assigned? Yes measures used,
nonrandomized
Duration of follow-up: mean follow-up
term, 255.0 ± 173.1 days; median Conclusions
follow-up term, 275.5 days; range, 31– This paper provides evidence
591 days that: high fracture risk
patients (based on
Validated outcome measures used biochemical markers) have
(list): Click or tap here to enter text. higher proportional of new
fractures.
Nonvalidated outcome measures used
(list): New compression fractures
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: DEXA
Results/subgroup analysis:
9 new fractures in 7 patients. There
were no significant differences
between groups F and N in terms of
seum (ALP) or urinary (crosslinked N-
telopeptide Type I collagfen;
deoxypyridinoline) markers or BMD.
We identified 5 new fractures in 3 of
the 4 patients in group
H, and 4 new fractures in 4 of the 19
patients in group L.
There was a significant difference in
the rate of
new fractures between group H and
963
group L (chi-square test: p = 0.03). No
significant difference in age, gender,
locations, and activity after initial
vertebroplasty between group H and
group L
Author conclusions: A combination of
high levels of bone
resorption markers and normal levels
of bone formation markers may be
associated with increased risk of new
recurrent fractures after percutaneous
vertebroplasty
Lee BG, Choi JH, Kim DY, Choi WR, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Lee SG, Kang CN. Risk factors for Therapeutic ☒ Nonconsecutive patients
newly developed osteoporotic vertebral Study Design: Comparative ☒ Nonrandomized
compression fractures following Level III ☐ Nonmasked reviewers
treatment for osteoporotic vertebral Stated objective of study: To ☐ Nonmasked patients
compression fractures. Spine Journal: investigate the risk factors for newly
Official Journal of the North American Explanation of failure to ☒ No validated outcome
developed OVCFs after treatment by
Spine Society.19(2):301-305. meet guideline inclusion measures used
vertebroplasty (VP), kyphoplasty (KP),
criteria or conservative treatment. ☐ Small sample size
(when applicable) ☒ <80% follow-up
Type of treatment(s): VP, KP or ☐ Lacked subgroup analysis
☐ Level V (expert conservative ☐ Diagnostic method not
consensus) stated
Total number of patients: 132 (out of ☐ Other: Click or tap here to
☐ Level IV in presence of 356) –had complete f/u enter text.
higher quality studies Number of patients in relevant
subgroup(s): Level of Evidence
☐ Subgroup analysis data 46 in Group A (new OVCF) vs 86 in Determination
not available Group B (no fracture group) Potential Level: II
Downgraded Level: III
Consecutively assigned? No
☐ Not relevant to question
Downgraded due to less than
Duration of follow-up: 28.9 (12-98) 80% follow-up,
months nonconsecutive patients, and
nonrandomization
Validated outcome measures used
(list): N/A Conclusions
964
Nonvalidated outcome measures used This paper provides evidence
(list): New OVCFs (and risk factors) that: low BMD and VK/KP
(with reference to
Diagnosis made by: conservative treatment) is
☒ Clinical exam/history associated with increased
☐ Electromyography odds of development of
new fractures.
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: DEXA, X-rays
Results/subgroup analysis:
New fractures occurred in 34.8%.
Factors for fractures include age, low
BMD, low compliance with
osteoporosis medication.
Multivariate analysis showed BMD T
score of the lumbar spine and
treatment by cement augmentation
showing correlation with new OVCF,
predictability of 71.4%
Author conclusions: Osteoporotic
vertebral compression fracture patients
with low BMD T-score of the lumbar
spine and those who have been
treated by cement augmentation have
an increased risk of new OVCFs after
treatment and, therefore, require
especially careful observation and
attention
Lee DG, Park CK, Park CJ, Lee DC, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Hwang JH. Analysis of Risk Factors Therapeutic ☐ Nonconsecutive patients
Causing New Symptomatic Vertebral Study Design: Comparative ☒ Nonrandomized
Compression Fractures After Level III
☐ Nonmasked reviewers
Percutaneous Vertebroplasty for Painful
☐ Nonmasked patients
965
Osteoporotic Vertebral Compression Stated objective of study: To analyze ☒ No validated outcome
Fractures: A 4-year Follow-up. Journal Explanation of failure to the incidence and risk factors of new measures used
of Spinal Disorders & meet guideline inclusion VCF (NVCF) after PVP and preventing ☐ Small sample size
Techniques.28(10):E578-583. criteria its development
☐ <80% follow-up
☐ Include (when applicable)
☐ Lacked subgroup analysis
☐ Exclude Type of treatment(s): PVP
☐ Level V (expert ☐ Diagnostic method not
consensus) Total number of patients: 198 (of 288) stated
Number of patients in relevant ☐ Other: Click or tap here to
☐ Level IV in presence of subgroup(s): 55 with NVCF vs rest that enter text.
higher quality studies did not develop NVCFClick or tap here
to enter text. Level of Evidence
Determination
☐ Subgroup analysis data
Consecutively assigned? Yes Potential Level: III
not available
Downgraded Level: Not
Duration of follow-up: mean 48.2±3.5 Downgraded
☐ Not relevant to question
mo (42 to 54 months)Click or tap here
to enter text. Conclusions
This paper provides evidence
Validated outcome measures used that: lower BMI and higher
(list): Click or tap here to enter text. number of compression
fractures are associated
Nonvalidated outcome measures used with a high risk of new VCF
(list): new VCF (incidence and risk after vertebroplasty.
factors)—adjacent and remote
fractures
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☒ CT
☐ CT/Myelogram
☒ Other: X rays
Results/subgroup analysis:
198 patients with PVP at 270 levels
treated. 34 patients (17.2%) had
966
symptomatic NVCF during 4 year
follow up.
All 34 patient had low BMD than
beforeinitial PVP.
For adjacent VDG, multivariable
analysis showed higher risk of
fractures in patients with larger number
of initial VCF and lower BMI.
Author conclusions: The most
important elements related to reducing
NVCF were treating osteoporosis and
improving BMD and BMI. More
aggressive BMD and BMI correction is
more important than the vertebroplasty
technique
Lee HJ, Park J, Lee IW, Yi JS, Kim T. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Clinical, Radiographic, and Therapeutic ☐ Nonconsecutive patients
Morphometric Risk Factors for Adjacent Study Design: Comparative ☒ Nonrandomized
and Remote Vertebral Compression Level III
☐ Nonmasked reviewers
Fractures Over a Minimum Follow-up of Stated objective of study: To analyze
☐ Nonmasked patients
4 Years After Percutaneous Explanation of failure to the risk factors for secondary new
Vertebroplasty for Osteoporotic meet guideline inclusion ☒ No validated outcome
vertebral compression fractures
Vertebral Compression Fractures: Novel criteria (SNVCFs) after percutaneous measures used
Three-dimensional Voxel-Based (when applicable) vertebroplasty (PVP) for osteoporotic ☐ Small sample size
Morphometric Analysis. World vertebral compression fractures ☐ <80% follow-up
Neurosurg. 2019;125:e146-e157. ☐ Level V (expert ☐ Lacked subgroup analysis
doi:10.1016/j.wneu.2019.01.020 consensus) Type of treatment(s): PVP ☐ Diagnostic method not
stated
☐ Level IV in presence of Total number of patients: 402 included ☐ Other: Click or tap here to
higher quality studies from 661
enter text.
Number of patients in relevant
☐ Subgroup analysis data subgroup(s):
Level of Evidence
not available Regression analysis conducted on
Determination
those with single-level OVCF: 91
Potential Level: III
SNVCF (46 AVCF and 45 RVCF) vs
☐ Not relevant to question Downgraded Level: Not
232 non-SNVCF.
Downgraded
Consecutively assigned? Yes
Conclusions
This paper provides evidence
that: In patients with single-
967
Duration of follow-up: 4.4 +/- 0.8 years level OVCF, a low BMD and
(range, 4 to 7.1 yearsClick or tap here high preop SI are
to enter text. associated with the risk of
developing secondary
Validated outcome measures used NVCFs following PVP.
(list): Click or tap here to enter text.
Nonvalidated outcome measures used
(list): Risk factors of new VCFs after
PVP---adjacent, remote.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: X-rays, DEXA
Results/subgroup analysis:
SNVCF occurred in 120 patients
(29.8% of the study sample),
of whom 72 (17.9%) and 48 (11.9%)
had AVCF and RVCF, respectively.
On univariate analysis in patients with
single-level OVCF, bone mineral
density (BMD), preoperative
compression ratio, preoperative
sagittal index (SI), and intradiscal bone
cement leakage were significantly
associated with SNVCF and AVCF (P
< 0.05), whereas only BMD and
preoperative SI were significantly
associated with remote vertebral
compression fracture (P < 0.05).
On multivariate analysis, BMDwas
significantly associated with SNVCF (P
968
=0.041), whereas upper adjacent
intradiscal bone cement leakage was
significantly associated with AVCF (P
=0.003).
Author conclusions: Low BMD, high
preoperative compression
ratio, and high preoperative SI may be
predictive factors for
SNVCFs. In particular, to prevent
AVCF, the injected bone
cement should be distributed both
evenly and symmetrically
along the inferior-to-superior axis and
the relative bone cement
volume should not be excessive. Bone
cement should be
injected carefully to avoid upper
adjacent intradiscal leakage.
Prompt BMD correction is important to
prevent SNVCF
Lee KA, Hong SJ, Lee S, Cha IH, Kim Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
BH, Kang EY. Analysis of adjacent Therapeutic ☒ Nonconsecutive patients
fracture after percutaneous Study Design: Comparative ☒ Nonrandomized
vertebroplasty: does intradiscal cement Level III
☐ Nonmasked reviewers
leakage really increase the risk of Stated objective of study: To evaluate
☐ Nonmasked patients
adjacent vertebral fracture?. Skeletal the
Radiol. 2011;40(12):1537-1542. Explanation of failure to ☐ No validated outcome
incidence and risk factors associated
doi:10.1007/s00256-011-1139-x meet guideline inclusion with adjacent vertebral measures used
criteria fracture after percutaneous ☐ Small sample size
(when applicable) vertebroplasty (PVP) to treat ☐ <80% follow-up
osteoporotic vertebral compression ☐ Lacked subgroup analysis
☐ Level V (expert fractures ☐ Diagnostic method not
consensus) stated
Type of treatment(s): PVP ☐ Other: Click or tap here to
☐ Level IV in presence of enter text.
higher quality studies Total number of patients: 188
Number of patients in relevant
Level of Evidence
☐ Subgroup analysis data subgroup(s): 28 with new adjacent
Determination
not available vertebral fracture (AVF) vs 160 with no
Potential Level: III
new AVF
969
☐ Not relevant to question Downgraded Level: Not
Consecutively assigned? No Downgraded
Duration of follow-up: mean: 38.5 Conclusions
months (range 1–74 months). This paper provides evidence
that: initial fracture location
Validated outcome measures used in the thoracolumbar
(list): Click or tap here to enter text. region is associated with
the development of
Nonvalidated outcome measures used adjacent vertebral fracture
(list): New AVFs after PVP.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X-rays
Results/subgroup analysis:
New adjacent fractures occurred in
36/351 (10.3%).
Intradiscal cement was present in 92
(25%) of levels treated.
There was no statistically significant
association between intradiscal
cement leakage and adjacent
vertebral fractures.
Only the vertebral levels treated in the
thoracolumbar junction showed
relationship to new adjacent vertebral
fractures.
970
Author conclusions: The
thoracolumbar location of the
initial compression fracture is the only
factor correlated with
an adjacent vertebral fracture after
PVP.
Lee WS, Sung KH, Jeong HT, et al. Risk Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
factors of developing new symptomatic Therapeutic ☐ Nonconsecutive patients
vertebral compression fractures after Study Design: Comparative ☒ Nonrandomized
percutaneous vertebroplasty in Level of Evidence:
☐ Nonmasked reviewers
osteoporotic patients. European Spine ☐I Stated objective of study: To
☐ Nonmasked patients
Journal.15(12):1777-1783. ☐ II investigate the factors affecting new
☐ No validated outcome
☐ III compression fractures in vertebral
measures used
bodies adjacent to or remote from
☒ IV ☐ Small sample size
those previously treated with PVP.
☒ <80% follow-up
Type of treatment(s): PVP ☐ Lacked subgroup analysis
Explanation of failure to
meet guideline inclusion ☐ Diagnostic method not
Total number of patients: 244 (of the stated
criteria
311 consecutive patients during the ☐ Other: Click or tap here to
(when applicable)
study period)
enter text.
Number of patients in relevant
☐ Level V (expert
subgroup(s): 38 patients in the New
consensus) Level of Evidence
fracture group vs remainder in the
Determination
control group (no new fracture)
☐ Level IV in presence of Work group conclusions
higher quality studies Potential Level: III
Consecutively assigned? Yes
Downgraded Level: IV
☐ Subgroup analysis data Duration of follow-up: 52.5 months
Downgraded due to:
not available (range 38–
nonrandomization, and less
67 months).
than 80% follow-up
☐ Not relevant to question
Validated outcome measures used
Conclusions relative to
(list): Click or tap here to enter text.
question
This paper provides evidence
Nonvalidated outcome measures used
that: When PVP is done on
(list): new VCFs after PVP
multiple levels on older pts
the risk of new
Diagnosis made by:
symptomatic VCF is
☒ Clinical exam/history increased
971
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: x RAYS
Results/subgroup analysis: 38
(15.6%) of the 244 patients returned
for subsequent intervention due to the
development of newly developed
symptomatic OVCFs.
Patients in the fracture group were
relative older compared to the controls
(69.2 vs 65.9 yrs; p<0.05) and had
more number of treated levels (2.08 vs
1.48; p<0.01), with higher mean AP
ratio (0.79 VS 0.69; p<0.01)
Author conclusions: PVP done on
multiple levels and older
age patients increases the risk of
developing new symptomatic vertebral
compression fracture after PVP.
-The initial wedge deformity of the
fractured vertebral body was less
severe in the ‘‘new symptomatic
fracture’’ group. So even though the
fractured vertebra(e) seems to
maintain normal appearance at the
initial PVP, it may not mean that
developing new
symptomatic OVCF later at the other
level is unlikely.
Li H, Yang DL, Ma L, Wang H, Ding WY, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Yang SD. Risk Factors Associated with Therapeutic ☒ Nonconsecutive patients
Adjacent Vertebral Compression Study Design: Comparative ☒ Nonrandomized
972
Fracture Following Percutaneous Level of Evidence: ☐ Nonmasked reviewers
Vertebroplasty After Menopause: A ☐I Stated objective of study: To ☐ Nonmasked patients
Retrospective Study. Med Sci Monit. ☐ II investigate risk factors
☒ No validated outcome
2017;23:5271-5276. Published 2017 for adjacent vertebral compression
☐ III measures used
Nov 5. doi:10.12659/msm.907364 fractures (AVCF) after PVP in patients
☒ IV ☐ Small sample size
with OVCF after menopause
☐ <80% follow-up
Type of treatment(s): PVP ☐ Lacked subgroup analysis
Explanation of failure to
☒ Diagnostic method not
meet guideline inclusion Total number of patients: 390 (out of stated
criteria 412 had complete f/u) ☐ Other: Click or tap here to
(when applicable) Number of patients in relevant enter text.
subgroup(s): AVCF =68 vs Non-
☐ Level V (expert AVCF=322 Level of Evidence
consensus)
Determination
Consecutively assigned? No Work group conclusions
☐ Level IV in presence of Potential Level: III
higher quality studies Duration of follow-up: 6 months Downgraded Level: IV
minimum; mean: 18 months Downgraded due to
☐ Subgroup analysis data information that was lacking
not available Validated outcome measures used on experimental study
(list): Click or tap here to enter text.
☐ Not relevant to question Conclusions relative to
Nonvalidated outcome measures used question
(list): This paper provides evidence
1. SNVCF (adjacent and remote) that: Duration of menopause
and number of preop
Diagnosis made by: vertebral fractures are
☒ Clinical exam/history associated with an increased
☐ Electromyography risk of AVCF after PVP. On
☐ Myelogram the contrary, BMD was
☐ MRI associated with lower risk of
AVCF after PVP.
☐ CT
☐ CT/Myelogram
☒ Other: QCT for osteoporosis
Results/subgroup analysis:
390 patients with follow up for average
18 months.
973
Mean age of AVCF group was 71.8
and non AVCF was 69.5
BMD less than 60mg/cm3 was
observed in more than half of AVCF
group and two third in the non AVCF
group.
Proportion of patients with DoM>10
years in the AVCF was higher than in
the non AVCF group.
Author conclusions: A long duration of
menopause and preoperative multi-
level vertebral fractures were the risk
factors for AVCF in patients following
PVP after menopause, while a high-
level BMD acted in a protective role for
AVCF development.
Li Y, Yue J, Huang M, et al. Risk factors Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
for postoperative residual back pain Therapeutic ☐ Nonconsecutive patients
after percutaneous kyphoplasty for Study Design: Comparative ☒ Nonrandomized
osteoporotic vertebral compression Level of Evidence:
☐ Nonmasked reviewers
fractures. Eur Spine J. ☐I Stated objective of study: To
☐ Nonmasked patients
2020;29(10):2568-2575. ☐ II determine the incidence of and risk
doi:10.1007/s00586-020-06493-6 ☐ No validated outcome
☐ III factors for residual back pain in
measures used
osteoporotic vertebral compression
☒ IV ☐ Small sample size
fracture (OVCF) patients after
percutaneous kyphoplasty (PKP) ☐ <80% follow-up
treatment ☐ Lacked subgroup analysis
Explanation of failure to
meet guideline inclusion ☐ Diagnostic method not
Type of treatment(s): PKP stated
criteria
(when applicable) ☐ Other: Click or tap here to
Total number of patients: 809 with
enter text.
complete f/u out of which the authors
☐ Level V (expert
included 52 with backpain and 163
consensus) Level of Evidence
controls (patients with no back pain) –
Determination
all of whom underwent PKP. So
☐ Level IV in presence of Work group conclusions
basically, the study sample size for
higher quality studies Potential Level: III
Downgraded Level: IV
974
regression/reporting of results should
☐ Subgroup analysis data be 215. Downgraded due to:
not available Number of patients in relevant nonrandomization
subgroup(s):
☐ Not relevant to question CASES: 52 with backpain vs Controls: Conclusions relative to
163 with no backpain question
This paper provides evidence
Consecutively assigned? Yes that: IVC and posterior fascia
edema are fracture-specific
Duration of follow-up: min of 30-days risk factors associated with
increased likelihood of
Validated outcome measures used residual back pain after PKP.
(list): VAS-back pain
Nonvalidated outcome measures used
(list): Click or tap here to enter text.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: Xrays, BMD/DEXA
Results/subgroup analysis:
In the multivariate analysis, risk
fractors for residual back pain after
PVK included vertebral vacume cleft,
posterior fascia edema, and jacet joint
violation and separated cement
distribution.
Author conclusions: The incidence of
postoperative residual back pain was
7.8% among 809 OVCF patients
following PKP. The
975
presence of an intravertebral vacuum
cleft, posterior fascia oedema, facet
joint violations and a separated
cement distribution
were identified as independent risk
factors for residual back pain.
Li YX, Guo DQ, Zhang SC, et al. Risk Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
factor analysis for re-collapse of Therapeutic ☒ Nonconsecutive patients
cemented vertebrae after percutaneous Study Design: Comparative ☒ Nonrandomized
vertebroplasty (PVP) or percutaneous Level III
☐ Nonmasked reviewers
kyphoplasty (PKP). Int Orthop. Stated objective of study: To review
☐ Nonmasked patients
2018;42(9):2131-2139. the incidence
doi:10.1007/s00264-018-3838-6 Explanation of failure to ☐ No validated outcome
and possible causative factors of
meet guideline inclusion refracture in patients with OVCF measures used
criteria treated with PVP/PKP ☐ Small sample size
(when applicable) ☐ <80% follow-up
Type of treatment(s): PKP/PVP ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Total number of patients: 230 stated
Number of patients in relevant ☐ Other: Click or tap here to
☐ Level IV in presence of subgroup(s):
enter text.
higher quality studies 200 in non-refracture group vs 30 in
refracture group
Level of Evidence
☐ Subgroup analysis data Determination
not available Consecutively assigned? No
Potential Level: III
Downgraded Level: Not
Duration of follow-up: One year
☐ Not relevant to question Downgraded
Validated outcome measures used
Conclusions r
(list):
This paper provides evidence
that: Low BMD is a risk
factor of vertebral re-
Nonvalidated outcome measures used
collapse after PKP/PVP
(list): Vertebral recollapse after
PKP/PVP
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
976
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X-rays, BMD/DEXA
Results/subgroup analysis:
Weight and BMI was significantly
higher in the refracture group and
BMD was much lower in the non
refracture group.
Binary logistic regression analysis
show that BMD, does of cement, and
operation were associated with
vertebra refracture. Low BMD had
higher risk of refracture compared to
patients with higher BMD.
Author conclusions: Patients with low
BMD, or undergoing PKP, or receiving
a low volume of injected cement might
have a high risk of re-collapse in
surgical vertebrae
Lin H, Bao LH, Zhu XF, Qian C, Chen X, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Han ZB. Analysis of recurrent fracture of Therapeutic ☒ Nonconsecutive patients
a new vertebral body after percutaneous Study Design: Comparative ☒ Nonrandomized
vertebroplasty in patients with Level of Evidence: ☐ Nonmasked reviewers
osteoporosis. Orthop Surg. ☐I Stated objective of study: To ☐ Nonmasked patients
2010;2(2):119-123. doi:10.1111/j.1757- ☐ II investigate the characteristics of
☒ No validated outcome
7861.2010.00074.x ☐ III recurrent fracture of a new vertebral
measures used
☒ IV body after percutaneous
☒ Small sample size
vertebroplasty in patients with
osteoporosis. ☐ <80% follow-up
☐ Lacked subgroup analysis
Explanation of failure to
meet guideline inclusion Type of treatment(s): PV ☒ Diagnostic method not
criteria stated
(when applicable) Total number of patients: 29 ☐ Other: No follow up
Number of patients in relevant duration (except xray of one
subgroup(s): 14 with recurrent fracture case on the 14th day)
☐ Level V (expert
of a new vertebral body after
consensus)
977
vertebroplasty; 15 without recurrent Level of Evidence
☐ Level IV in presence of fracture Determination
higher quality studies Work group conclusions
Consecutively assigned? No Potential Level: III
☐ Subgroup analysis data Downgraded Level: IV
not available Duration of follow-up: Not available
Conclusions relative to
Validated outcome measures used question
☐ Not relevant to question
(list): This paper provides evidence
that patients developing
Nonvalidated outcome measures used new fractures after PV for
(list): New fracture development OVCF differ significantly
from those not developing
Diagnosis made by: new fractures in terms of
☐ Clinical exam/history BMI (low BMI vs controls),
☐ Electromyography lower BMD and lower
serum PTH levels.
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X-rays, DEXA
Results/subgroup analysis: In 12
(86%) of the 14 patients’ new vertebral
fractures occurred within six months
after treatment of the initial fracture; 10
of the 14 cases (71.4%), the new
fracture occurred adjacent to the
previously treated vertebra, whereas
the rate of non-adjacent fracture was
28.6% (4 cases).
Author conclusions: A substantial
number of patients with osteoporosis
develop new fractures after
vertebroplasty; twothirds
of these new fractures occur in
vertebrae adjacent to those previously
treated.
978
Lin WC, Cheng TT, Lee YC, et al. New Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
vertebral osteoporotic compression Therapeutic ☒ Nonconsecutive patients
fractures after percutaneous Study Design: Comparative ☒ Nonrandomized
vertebroplasty: retrospective analysis of Level III
☐ Nonmasked reviewers
risk factors. J Vasc Interv Radiol. Stated objective of study: To
☐ Nonmasked patients
2008;19(2 Pt 1):225-231. investigate risk factors for new
doi:10.1016/j.jvir.2007.09.008. Explanation of failure to ☒ No validated outcome
vertebral compression fractures
meet guideline inclusion (VCFs) after vertebroplasty measures used
criteria ☐ Small sample size
(when applicable) Type of treatment(s): PV ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Total number of patients: 70 ☐ Diagnostic method not
consensus) Number of patients in relevant stated
subgroup(s): 19 new fracture group vs ☐ Other: Click or tap here to
☐ Level IV in presence of 51 with no new VCF after PV.
enter text.
higher quality studies
Consecutively assigned? No
Level of Evidence
☐ Subgroup analysis data Determination
not available Duration of follow-up: Mean 20.0
Potential Level: III
months +/-10.2 (range, 6–48 months)
Downgraded Level: Not
☐ Not relevant to question Downgraded
Validated outcome measures used
(list): Click or tap here to enter text.
Conclusions
This paper provides evidence
Nonvalidated outcome measures used
that: lower BMI (less than
(list): New fractures
22kg/m2) and greater
kyphosis correction are
Diagnosis made by:
associated with increased
☒ Clinical exam/history hazards of developing a
☐ Electromyography new VCF in patients
☐ Myelogram undergoing PV for single-
☒ MRI level OVCF.
☐ CT
☐ CT/Myelogram
☒ Other: X-rays
Results/subgroup analysis:
70 patient (61 female) followed for
mean of 20 months. 22 new fractures
in 19 of 70 patients.
979
Multi variable analysis showed greater
VCF risk after verbebroplsty with low
BMK and greater degree of kyphosis
correction.
Author conclusions: New VCFs are
common in patients with a low BMI,
which suggests osteoporosis as a
mechanism
of fracture.
Lin WC, Lu CH, Chen HL, Wang HC, Yu Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
CY, Wu RW, et al. The impact of Therapeutic ☐ Nonconsecutive patients
preoperative magnetic resonance Study Design: Observational ☐ Nonrandomized
images on outcome of cemented Level III
☐ Nonmasked reviewers
vertebrae. Eur Spine J. 2010;19:1899- Stated objective of study: to evaluate
☐ Nonmasked patients
1906. pre-procedural magneticresonance
Explanation of failure to ☐ No validated outcome
images (MRI) for the prediction of
meet guideline inclusion further col- measures used
criteria lapse and vertebral height loss after ☐ Small sample size
(when applicable) vertebroplasty. ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Type of treatment(s): VP ☐ Diagnostic method not
consensus) stated
Total number of patients: 81 ☐ Other: Click or tap here to
☐ Level IV in presence of Number of patients in
enter text.
higher quality studies relevant subgroup(s): Click or tap here
to enter text.
Level of Evidence
☐ Subgroup analysis data Determination
not available Consecutively assigned? Yes
Potential Level: III
Downgraded Level: Not
Duration of follow-up: minimum 6
☐ Not relevant to question Downgraded
months, mean follow-up of 23.0±8.2
months
Conclusions
This paper provides evidence
Validated outcome measures used
that: patients with
(list): Click or tap here to enter text.
osteoporotic vertebral
refracture.
compression fractures
undergoing vertebral
Nonvalidated outcome measures used
augmentation, higher
(list): Click or tap here to enter text.
signal intensity on T2 MRI-
980
weighted images are
Diagnosis made by: associated with less
☐ Clinical exam/history refractures.
☐ Electromyography
☐ Myelogram
☐☒ MRI
☐ CT
☐ CT/Myelogram
☐☒ Other: Click or tap here to enter
text.plain radiographs, BMD
Results/subgroup analysis: Click or
tap here to enter text.
Results/subgroup analysis:
The mean refracture ratewas estima
ted with the Kaplan–
Meier method. After amean follow-
up of 23.0±8.2
months, 46 cemented vertebrae
(57%) experienced refracture, and the
mean loss of anterior vertebral height
was 11.3%. The 1-year
refracturerate after vertebroplasty wa
s 7%, and rapid increased to76% i
n the third year. Cox proportional a
nalysis showed
that any 1% decrease in signal inte
nsity on T2-weighted images of the
injured vertebra will increase the
refracture rate by 0.74% (OR=0.26,
95% CI 0.08–0.81,p=0.02),and a 1%
increase in the poorly enhanced
volume ratio will increase the
refracture rate by 4.3% (OR=5.32,
95% CI1.22–23.14,p=0.03).
Author conclusions:
Although vertebroplasty can
initially stabilize injured
vertebrae, further collapse of the
981
cemented vertebrae occurred rapidly
during follow-up. In this study,
significant pre-procedure MRI-
based predictors of increased risk fo
r cemented vertebral refracture have
been identified.
Liu WG, He SC, Deng G, et al. Risk Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
factors for new vertebral fractures after Therapeutic ☐ Nonconsecutive patients
percutaneous vertebroplasty in patients Study Design: Comparative ☒ Nonrandomized
with osteoporosis: a prospective study. J Level II
☐ Nonmasked reviewers
Vasc Interv Radiol. 2012;23(9):1143- Stated objective of study: To
☐ Nonmasked patients
1149. doi:10.1016/j.jvir.2012.06.019 determine the risk factors for new
Explanation of failure to ☒ No validated outcome
vertebral compression fractures
meet guideline inclusion (VCFs) following percutaneous measures used
criteria vertebroplasty (PV) in patients with ☐ Small sample size
(when applicable) osteoporosis ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Type of treatment(s): PV ☐ Diagnostic method not
consensus) stated
Total number of patients: 132 (of 144; ☐ Other:
☐ Level IV in presence of 12 were excluded--->3 lost to f/u and 9
higher quality studies died)
Level of Evidence
Number of patients in relevant
Determination
☐ Subgroup analysis data subgroup(s):
Potential Level: II
not available 36 pts with 80 new VCFs [45 adjacent;
Downgraded Level: Not
35 non-adjacent] vs remainder without
Downgraded
new VCFs
☐ Not relevant to question
Conclusions
Consecutively assigned? Yes
This paper provides evidence
that: the number of VCFs
Duration of follow-up: (22.4 months +/-
initially, CT value of non-
12.1
fractured vertebrae, and
activity level following
Validated outcome measures used
discharge is strongly
(list):
associated with the risk of
new VCFs after PV.
Nonvalidated outcome measures used
(list): New VCFs after PV
Diagnosis made by:
☒ Clinical exam/history
982
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Xrays
Results/subgroup analysis: 36/132
patients developed 80 new
symptomatic VCF.
Multivariable analysis showed greater
new VCF risks after vertebroplsty on
larger number of VCF per time, lower
CT value of non fractured vertebra,
lower activity after discharge, longer
duration of follow up and cement
distribution less in the inferior area of
the vertebrdal body or close to the
endplate.
Author conclusions: The incidence of
new VCFs after PV is relatively high
and affected by several risk factors
that are related to both the PV
procedure and the natural course of
osteoporosis
Lu K, Liang CL, Hsieh CH, Tsai YD, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Chen HJ, Liliang PC. Risk factors of Therapeutic ☐ Nonconsecutive patients
subsequent vertebral compression Study Design: Comparative ☒ Nonrandomized
fractures after vertebroplasty. Pain Med. Level III
☐ Nonmasked reviewers
2012;13(3):376-382. doi:10.1111/j.1526- Stated objective of study: To elucidate
☐ Nonmasked patients
4637.2011.01297.x the risk factors for a subsequent
Explanation of failure to ☒ No validated outcome
vertebral compression fracture
meet guideline inclusion following percutaneous measures used
criteria vertebroplasty. ☐ Small sample size
(when applicable) ☐ <80% follow-up
Type of treatment(s): PV ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Total number of patients: 155 (out of stated
204) included in the study
983
☐ Level IV in presence of Number of patients in relevant ☐ Other: Click or tap here to
higher quality studies subgroup(s): 43 with new VCFs vs enter text.
remainder without VCFs
☐ Subgroup analysis data Level of Evidence
not available Consecutively assigned? Yes Determination
Potential Level: III
Duration of follow-up: 2-year minimum
☐ Not relevant to question Downgraded Level: Not
Downgraded
Validated outcome measures used
(list): Click or tap here to enter text. Conclusions
This paper provides evidence
Nonvalidated outcome measures used that low T-scores (low BMD)
(list): New VCF after PV are associated with the
development of new VCFs
Diagnosis made by: after PV in patients with
☒ Clinical exam/history OVCF.
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☐ Other: X-rays, BMD/DEXA
Results/subgroup analysis: 131
patients, 43 patients had 47 new VCF
within 2 years of treatment.
Univariate analysis showed only BMD
as significantly associated with new
VCF. Multivariable analysis showed
BMD as the only independent
prognostic factor for new VCF.
Forty-three (27.7%) of the 155 patients
had subsequent vertebral compression
fractures within 2 years of
percutaneous vertebroplasty, with 21
(48.8%) of these patients having
fractures detected within 3 months.
984
On multivariate analyses, only the T-
score of bone mineral density
was significantly associated with
subsequent vertebral compression
fractures (odds ratio = 0.27; 95%
confidence interval: 0.15–0.49;
p<0.001).
Author conclusions: The only risk
factor significantly
associated with subsequent vertebral
compression fractures following
percutaneous vertebroplasty was a low
bone mineral density T-score. Patients
with lower bone mineral density have a
higher incidence of vertebral
compression fractures and thus need
more intensive clinical and radiological
follow-up.
Martinez-Ferrer A, Blasco J, Carrasco Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
JL, et al. Risk factors for the Therapeutic ☒ Nonconsecutive patients
development of vertebral fractures after Study Design: RCT ☐ Nonrandomized
percutaneous vertebroplasty. J Bone Level II
☒ Nonmasked reviewers
Miner Res. 2013;28(8):1821-1829. Stated objective of study: To evaluate
☐ Nonmasked patients
doi:10.1002/jbmr.1899 the risk factors related
Explanation of failure to ☐ No validated outcome
to the development of VF after VP in
meet guideline inclusion these patients including not only measures used
criteria clinical and radiological factors but ☐ Small sample size
(when applicable) also densitometric and biochemical ☒ <80% follow-up
parameters. ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Type of treatment(s): VP stated
☐ Other: Click or tap here to
☐ Level IV in presence of Total number of patients: 57 patients
enter text.
higher quality studies that received allocated intervention of
VP; some part of the analysis includes
Level of Evidence
☐ Subgroup analysis data another 61 pts that were allocated to
Determination
not available the conservative management.
Potential Level: I
Of these, 111 were included for overall
Downgraded Level: II
analysis. [Table 1, Figure 1]
☐ Not relevant to question
985
Number of patients in relevant Downgraded due to:
subgroup(s): Click or tap here to enter Nonconsecutive patients,
text. nonmasked reviewers, <80%
Consecutively assigned? No Conclusions
This paper provides evidence
Duration of follow-up: minimum 12 that: lower (deficient) 25
months. (OH)D levels is associated
with increased risk of VCF
Validated outcome measures used after VP.
(list): Click or tap here to enter text.
Nonvalidated outcome measures used
(list): New VCF
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: X rays
Results/subgroup analysis: in the
vertebroplasty arm, 29 new fractures
were observed in 17/54 patients
treated. Of the conservative group 11
new VF were found.
VF after VP showed lower mean
vitamen D serum levels and higher
P1NP serum values that were not
seen in the conservative group.
On multivariate analysis, factor related
to VF after VP was 25(OH)D levels
<20ng/ml.
986
Increased risk of VF after VP also was
seen with cement leakage into the
inferior disc space and more than on
vertebral level treated during VP.
Author conclusions: Nearly 30% of
patients with osteoporotic VF treated
with VP had a new VF after the
procedure. Age, especially >80 years,
the presence of inferior disk cement
leakage after the procedure, the
number of cemented vertebrae, and
low 25(OH)D serum levels were
related to the development of new VF
in these patients, with the latter
indicating the need to correct vitamin D
deficiency prior to performing VP.
Moon ES, Kim HS, Park JO, et al. The Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
incidence of new vertebral compression Therapeutic ☐ Nonconsecutive patients
fractures in women after kyphoplasty Study Design: Comparative ☒ Nonrandomized
and factors involved. Yonsei Med J. Level II
☐ Nonmasked reviewers
2007;48(4):645-652. Stated objective of study: To identify
☐ Nonmasked patients
doi:10.3349/ymj.2007.48.4.645 the incidence of new VCF in women
Explanation of failure to ☒ No validated outcome
after kyphoplasty and to analyze
meet guideline inclusion influenctial factors in these patients measures used
criteria ☐ Small sample size
(when applicable) Type of treatment(s): Kyphoplasty ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Total number of patients: 111 female ☐ Diagnostic method not
consensus) patients (137 Vertebrae) stated
Number of patients in relevant ☐ Other: Click or tap here to
☐ Level IV in presence of subgroup(s): 20 in new fracture group
enter text.
higher quality studies [13 adjacent; 7 remote[ vs 90 with no
new fracture.
Level of Evidence
☐ Subgroup analysis data Determination
not available Consecutively assigned? Yes
Potential Level: III
Downgraded Level: Not
Duration of follow-up: mean 15.2
☐ Not relevant to question Downgraded
months (min 6 months)
Conclusions
987
Validated outcome measures used This paper provides evidence
(list): Click or tap here to enter text. that: female patients
incurring new VCF after
Nonvalidated outcome measures used index kyphoplasty for
(list): Disease -free survival without OVCF have lower BMI and
fracture. longer duration of
2. New VCF symptoms compared to
those not incurring new
Diagnosis made by: VCFs.
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X rays, surveys/telephonic
interviews.
Results/subgroup analysis: Patients
with new VCFs after kyphoplasty have
lower BMI (21.1 vs 23; p=0.0372), and
higher duration of symptoms (57.4
days vs 24.5 days; p=0.0403) and no
of kyphoplasties (1.6 vs 1.2;
p=0.0387). No differences were noted
in the BMD scores across the 2
groups.
Author conclusions: When
kyphoplasty is planned for the
management of patients with OVCFs,
the application of a small amount of
PMMA can be considered in order to
lower the risk of new fractures in
adjacent vertebrae. The post-op use of
anti-osteoporotic medication is
recommended for the prevention of
new VCFs
Movrin I, Vengust R, Komadina R. Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Adjacent vertebral fractures after Therapeutic ☐ Nonconsecutive patients
988
percutaneous vertebral augmentation of Study Design: Comparative ☒ Nonrandomized
osteoporotic vertebral compression Level II ☐ Nonmasked reviewers
fracture: a comparison of balloon Stated objective of study: To evaluate
☐ Nonmasked patients
kyphoplasty and vertebroplasty. Arch the adjacent level fracture
☐ No validated outcome
Orthop Trauma Surg. 2010;130(9):1157- Explanation of failure to risk after BK as compared with VP and
1166. doi:10.1007/s00402-010-1106-3 meet guideline inclusion to determine measures used
criteria the possible dominant risk factor ☐ Small sample size
(when applicable) associated with new compression ☐ <80% follow-up
fractures. ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Type of treatment(s): BK vs VP stated
☐ Other: Click or tap here to
☐ Level IV in presence of Total number of patients: 73
enter text.
higher quality studies Number of patients in relevant
subgroup(s): 46 in BK (51 levels) and
Level of Evidence
27 in VP (32 levels)
☐ Subgroup analysis data Determination
not available Potential Level: II
Consecutively assigned? Yes
Downgraded Level: Not
☐ Not relevant to question Downgraded
Duration of follow-up: 1-year min
Conclusions
Validated outcome measures used
This paper provides evidence
(list): VAS
that: the degree of
osteoporosis is a risk
Nonvalidated outcome measures used
factor for new VCFs after
(list): New VCFs
percutaneous vertebral
augmentation.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: X-rays
Results/subgroup analysis: 107
patients BK in 46 patients (51 levels)
and 61 (64 levels) conservative group.
989
Mean vAS after BK baseline 9,
immediate post surgery 2, and after 1
year 2.0
Conservative group VAS was 3.8 at 1
year.
In BK and control group local cyphotic
angle and BMD seemed to be related
to adjacent level fracture.
Author conclusions: Our results
indicate that BK and VP are
methods with a low risk of adjacent
level fractures. The most important
factors for new VCFs after a
percutaneous
augmentation procedure are the
degree of osteoporosis and
altered biomechanics in the treated
area of the spine due to
resistant kyphosis. These results
suggest that the adjacent
vertebrae would fracture eventually,
even without the procedure. BK and
VP offer a comparable rate of pain
relief
Nakamae T, Yamada K, Tsuchida Y, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Osti OL, Adachi N, Fujimoto Y. Risk Therapeutic ☒ Nonconsecutive patients
Factors for Cement Loosening after Study Design: Comparative ☒ Nonrandomized
Vertebroplasty for Osteoporotic Level III
☐ Nonmasked reviewers
Vertebral Fracture with Intravertebral Stated objective of study: To evaluate
☐ Nonmasked patients
Cleft: A Retrospective Analysis. Asian the primary outcomes and
Spine J. 2018;12(5):935-942. Explanation of failure to ☐ No validated outcome
radiographic results of percutaneous
doi:10.31616/asj.2018.12.5.935 meet guideline inclusion vertebroplasty (PVP) in patients with measures used
criteria singlelevel osteoporotic vertebral ☐ Small sample size
(when applicable) fracture (OVF) with intravertebral cleft ☐ <80% follow-up
(IVC) to identify the risk factors for ☐ Lacked subgroup analysis
☐ Level V (expert cement loosening after PVP. ☐ Diagnostic method not
consensus) stated
990
Type of treatment(s): PVP ☐ Other: Click or tap here to
☐ Level IV in presence of enter text.
higher quality studies Total number of patients: 195
Number of patients in relevant Level of Evidence
☐ Subgroup analysis data subgroup(s): Click or tap here to enter Determination
not available text. Potential Level: III
Downgraded Level: Not
Consecutively assigned? No
☐ Not relevant to question Downgraded
Duration of follow-up: 6 months Conclusions
minimum (for assessment of cement This paper provides evidence
leakage) that: patients with single-
level OVCF with IVC
Validated outcome measures used incurring cement loosening
(list): VAS Back pain, ODI after PVP have significantly
higher mean VAS scores
Nonvalidated outcome measures used compared to those without
(list): Cement loosening cement loosening.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Results/subgroup analysis: 195
patients with single OVD with IVC.
Before procedure and 6 month follow
up: VAS 87/31, ODI 59/37
49 (25%) had cement loosening 6
month after PVP.
Intravertebral instability was higher
with cement loosening, and
parkinsons, spinous process fracture,
991
split vertebra, adjacent intervetebra
vacuum were higher in non loosening
group.
6 month post PVP, mean vas was
50mm in patients with cement
loosening and 26mm without cement
loosening.
Author conclusions: Patients with
cement loosening experienced worse
back pain than those without cement
loosening. The important risk factors
that influenced cement loosening after
PVP were high intravertebral
instability, Parkinson’s disease,
spinous process fracture, and split
vertebrae
Nieuwenhuijse MJ, Putter H, van Erkel Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
AR, Dijkstra PD. New vertebral fractures Therapeutic ☒ Nonconsecutive patients
after percutaneous vertebroplasty for Study Design: Comparative ☒ Nonrandomized
painful osteoporotic vertebral Level II
☐ Nonmasked reviewers
compression fractures: a clustered Stated objective of study: To perform
☐ Nonmasked patients
analysis and the relevance of intradiskal clustered analysis of fracture-free
cement leakage. Radiology. Explanation of failure to ☒ No validated outcome
probabilities of intact nontreated
2013;266(3):862-870. meet guideline inclusion vertebrae after percutaneous measures used
criteria vertebroplasty (PVP) in painful long- ☐ Small sample size
(when applicable) standing osteoporotic vertebral ☐ <80% follow-up
compression fractures (OVCFs) to ☐ Lacked subgroup analysis
☐ Level V (expert determine risk factors for new ☐ Diagnostic method not
consensus) vertebral fractures and estimate stated
fracture-free probabilities of ☐ Other: Click or tap here to
☐ Level IV in presence of multiple intact nontreated vertebrae
enter text.
higher quality studies given their patient- and vertebra-
specific covariate status.
Level of Evidence
☐ Subgroup analysis data Determination
not available Type of treatment(s): PVP
Potential Level: II
Downgraded Level: Not
Total number of patients: 115 (216
☐ Not relevant to question Downgraded
painful OVCF)
Conclusions
992
Number of patients in relevant This paper provides evidence
subgroup(s): Click or tap here to enter that: patient level (low BMD,
text. high spine deformity index,
short-time since fracture
Consecutively assigned? No onset) and vertebral-
specific (thoracolumbar
Duration of follow-up: 1-year junction, close vicinity to
the treated level) factors
Validated outcome measures used are associated with the
(list): Click or tap here to enter text. development of new VCFs
within 1-year after PVP.
Nonvalidated outcome measures used
(list): New VCF
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: X rays, BMD/DEXA.
Results/subgroup analysis: Vertebral
fracture free probability was 97% at 3
month and 94.5% at 12 months.
New fracture risk factors were TL
junction, proximity to treated level, and
presence of intradisc cement leakage,
low BMD, high spinal deformity index,
low fracture age.
Author conclusions: New vertebral
fractures after PVP were clustered
within patients and depended heavily
on the presence or absence of both
patient- and vertebra-specific risk
factors. Intradiskal cement leakage
was a pronounced augmentation-
993
related risk factor, for which a
volumetric association was found.
Ren HL, Jiang JM, Chen JT, Wang JX. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Risk factors of new symptomatic Therapeutic ☒ Nonconsecutive patients
vertebral compression fractures in Study Design: Comparative ☒ Nonrandomized
osteoporotic patients undergone Level III
☒ Nonmasked reviewers
percutaneous vertebroplasty. European Stated objective of study: To evaluate
☒ Nonmasked patients
Spine Journal.24(4):750-758. the risk factors of new
Explanation of failure to ☐ No validated outcome
vertebral compression fractures
meet guideline inclusion (VCFs) following percutaneous measures used
criteria vertebroplasty (PVP) ☐ Small sample size
(when applicable) ☐ <80% follow-up
Type of treatment(s): PVP ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Total number of patients: 182 stated
Number of patients in relevant ☐ Other: Click or tap here to
☐ Level IV in presence of subgroup(s): 21 with new VCFs vs 161
enter text.
higher quality studies without new VCF
Level of Evidence
☐ Subgroup analysis data Consecutively assigned? No
Determination
not available Potential Level: III
Duration of follow-up: Mean: 26.4
Downgraded Level: Not
months; Range: 24-50 months
☐ Not relevant to question Downgraded
Validated outcome measures used
Conclusions
(list): preoperative kyphosis,
This paper provides evidence
preoperative degree of anterior
that a higher BMI and
vertebral compression (DAVC),
increase in number of
preoperative degree of middle
initial VCFs are associated
vertebral compression (DMVC),
with increased risk of new
kyphosis correc- tion, anterior vertebral
VCFs after PVP.
height restoration, middle vertebral
height restoration, and number of initial
symptomatic fractures (levels treated).
Nonvalidated outcome measures used
(list): New VCFs after maiden PVP.
Diagnosis made by:
☒ Clinical exam/history
994
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: x-rays; DEXAClick or tap
here to enter text.
Results/subgroup analysis: 182
patients. 155 females.
28 new fractures in 21 patients
occurred.
Average BMD was -4.7 in patients with
new VCF and -4.5 in patients without
new VCF.
Average BMI was 23.7 in patients with
nef VCF and 21.6 in patients without
new VCF.
Number of initial symptomatic
fractures were associated with new
VCF after PVP.
Risk of new fracture increased 1.268
fold with BMI increased by 1 kg/m2
Risk o fnew fracture increased by
2.518 fold when number of initial VCF
incrased by one level.
Author conclusions: The incidence of
new symptomatic VCFs after PVP was
higher in osteoporotic patients with
initial multiple-level fractures. The
number of initial symptomatic fractures
was an important risk factor for new
VCFs. Age, sex, BMD T-score, amount
995
of bone cement, cement leakage into
the disk, preoperative kyphosis,
preoperative DAVC, preoperative
DMVC, kyphosis correction, anterior
vertebral height restoration, and
middle vertebral height restoration did
not increase the risk of new fractures
after PVP.
Rho YJ, Choe WJ, Chun YI. Risk factors Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
predicting the new symptomatic Therapeutic ☒ Nonconsecutive patients
vertebral compression fractures after Study Design: Comparative ☒ Nonrandomized
percutaneous vertebroplasty or Level of Evidence: ☐ Nonmasked reviewers
kyphoplasty. Eur Spine J. ☐I Stated objective of study: To quantify
☐ Nonmasked patients
2012;21(5):905-911. ☐ II symptomatic NVCFs in patients who
doi:10.1007/s00586-011-2099-5 ☐ No validated outcome
☐ III underwent PVP or PKP and to
measures used
investigate factors that could
☒ IV ☐ Small sample size
contribute to de novo fractures.
☐ <80% follow-up
Explanation of failure to
Type of treatment(s): PVP or PKP ☐ Lacked subgroup analysis
meet guideline inclusion ☐ Diagnostic method not
Total number of patients: 147 included stated
criteria
(out of 162 reviewed) ☐ Other: Click or tap here to
(when applicable)
enter text.
Number of patients in relevant
☐ Level V (expert subgroup(s): 27 new fracture group
consensus) Level of Evidence
[NVCF group) vs 120 in the control Determination
group (without new VCF) Work group conclusions
☐ Level IV in presence of
higher quality studies Potential Level: III
Consecutively assigned? No Downgraded Level: IV
☐ Subgroup analysis data Duration of follow-up: Minimum 1-year; Downgraded due to:
not available mean: 35.5 months (range 12–73
month) Conclusions relative to
☐ Not relevant to question question
Validated outcome measures used This paper provides evidence
(list): VAS, new vertebral fractures that: osteoporosis (low
BMD T-scores) is
Nonvalidated outcome measures used associated with new VCFs
(list): New VCF. after vertebral
augmentation.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
996
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☐ Other: Tc-99 m methylene
diphosphonate whole-body bone scan;
DEXA/BMD; X-rays
Results/subgroup
analysis: Multivariate analysis
demonstrates that lower BMD T-score
(p=0.01) is associated with increased
risk of new VCF after vertebral
augmentation.
When comparing the control group and
the adjacent NVCF group, discal
cement leakage was the only
significant factor that affected the
adjacent NVCF in univariate analysis
(P = 0.01). BMD was significantly
lower in the adjacent NVCF group,
compared with the control group, from
the results of multivariate analysis (P =
0.02; Table 4).
Author conclusions: Symptomatic
NVCFs occurred in 15% of the patients
during the year following PVP or PKP.
The factors affecting NVCFs are old
age, PVP procedure, low BMD, and
discal cement leakage. The most
predictive factors were cement
leakage into the intervertebral disc
space and osteoporosis. A prospective
study involving a large number of
patients with long-term follow-up is
necessary to con- firm the results of
our study.
Spross C, Aghayev E, Kocher R, Röder Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
C, Forster T, Kuelling FA. Incidence and Therapeutic ☒ Nonconsecutive patients
risk factors for early adjacent vertebral Study Design: Comparative ☒ Nonrandomized
fractures after balloon kyphoplasty for Level III
☒ Nonmasked reviewers
997
osteoporotic fractures: analysis of the Stated objective of study: To report the ☒ Nonmasked patients
SWISSspine registry. Eur Spine J. Explanation of failure to incidence and ☐ No validated outcome
2014;23(6):1332-1338. meet guideline inclusion potential risk factors of ASF within the measures used
doi:10.1007/s00586-013-3052-6. criteria SWISSspine registry (SSR) dataset
☐ Small sample size
(when applicable)
☐ <80% follow-up
Type of treatment(s): BKP
☐ Level V (expert Total number of patients: 375 ☐ Lacked subgroup analysis
consensus) ☒ Diagnostic method not
Number of patients in relevant stated
☐ Level IV in presence of subgroup(s): Adjacent segment ☐ Other: Click or tap here to
higher quality studies fracture (ASF) group = 37 vs No-ASF enter text.
group = 338
☐ Subgroup analysis data Level of Evidence
Consecutively assigned? No Determination
not available
Potential Level: III
Duration of follow-up: mean 3.6 Downgraded Level: Not
☐ Not relevant to question
months (range Downgraded
0.8–6.6 months).
Conclusions
Validated outcome measures used This paper provides evidence
(list): Adjacent segment fractures, EQ- that a preop kyphotic angle
5D, VAS, Kyphosis angle of over 30 degrees, and
patient-specific
Nonvalidated outcome measures used comorbidities (such as RA,
(list): Development of adjacent cardiovascular disease) are
segment fracture (ASF) after BKP significantly associated
with the risk of new
Diagnosis made by: adjacent segment fracture
☐ Clinical exam/history (ASF) after BKP.
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: This is a secondary dataset.
Analyses based upon already
available data in the secondary
dataset.
998
Results/subgroup analysis: 37
patients had ASF.
Cardiovascular disease, rheumatoid
arthritis were more frequent in patient
with ASF.
Multivariate regression showed
segmental kyphosis as significant
association with ASF.
Author conclusions: Patients with a
preoperative segmental kyphosis >30
DEGREEs or patients with
comorbidities like rheumatoid arthritis
and a cardiovascular disease are at
high risk of ASF within 6 months after
the index surgery. In case of an ASF
event, back pain levels are
significantly increased.
Sun G, Tang H, Li M, Liu X, Jin P, Li L. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Analysis of risk factors of subsequent Therapeutic ☒ Nonconsecutive patients
fractures after vertebroplasty. Eur Spine Study Design: Comparative ☒ Nonrandomized
J. 2014;23(6):1339-1345. Level III
☒ Nonmasked reviewers
doi:10.1007/s00586-013-3110-0 Stated objective of study: To identify
☒ Nonmasked patients
risk factors related to the development
Explanation of failure to ☐ No validated outcome
of subsequent fractures after
meet guideline inclusion vertebroplasty. measures used
criteria ☐ Small sample size
(when applicable) Type of treatment(s): VP ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Total number of patients: 175 patients ☐ Diagnostic method not
consensus) single level fracture stated
Number of patients in relevant ☐ Other: Click or tap here to
☐ Level IV in presence of subgroup(s): Click or tap here to enter
enter text.
higher quality studies text.
Level of Evidence
☐ Subgroup analysis data Consecutively assigned? No
Determination
not available Potential Level: III
Duration of follow-up: Min 1-year
Downgraded Level: Not
☐ Not relevant to question Downgraded
999
Validated outcome measures used Conclusions
(list): VAS, subsequent fractures This paper provides evidence
that: low BMD and
Nonvalidated outcome measures used thoracolumbar location is
(list): new fractures after VP associated with the
development of
Diagnosis made by: subsequent new fractures
☒ Clinical exam/history in OVCF patients after VP.
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: BMD/DEXA
Results/subgroup analysis: 175
patients 147 women. 37 subsequent
fractures (21.1%)
Univariate abnd multivariate analysis
showed BMD with statistically
significant relationship to subsequent
fractures. Average BMD was -3.4 in
fracture group and -2.9 in no
subsequent fracture group.
Subsequent fracture was 13.9% in non
thoracolumbar junction and 26.2% in
thoracolumbar junction.
Author conclusions: symptomatic
subsequent fractures occurred
in 21.1 % of the patients with first-time
and single-level
fractures during the year following
vertebroplasty. The
factors affecting subsequent fractures
are low BMD T-scores and treated
vertebral levels at the thoracolumbar
junction. We believe the subsequent
1000
fractures reflect a natural evolution of
osteoporosis in the spine, regardless
of the presence of vertebroplasty. A
prospective study involving a larger
number of patients with long-term
follow-up is necessary to confirm the
results of our study.
Takahara K, Kamimura M, Moriya H, et Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
al. Risk factors of adjacent vertebral Therapeutic ☒ Nonconsecutive patients
collapse after percutaneous Study Design: Comparative ☒ Nonrandomized
vertebroplasty for osteoporotic vertebral Level III
☒ Nonmasked reviewers
fracture in postmenopausal Stated objective of study: To
☒ Nonmasked patients
women. BMC Musculoskelet Disord. determine the risk factors among
2016;17:12. Published 2016 Jan 12. Explanation of failure to ☐ No validated outcome
several potential predictors for de novo
doi:10.1186/s12891-016-0887-0 meet guideline inclusion VFs following PVP in patients with measures used
criteria osteoporosis. ☐ Small sample size
(when applicable) ☐ <80% follow-up
Type of treatment(s): PVP ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Total number of patients: 88 patients stated
Number of patients in relevant ☐ Other: Click or tap here to
☐ Level IV in presence of subgroup(s): 14 in the collapse group
enter text.
higher quality studies vs 47 in the non-collapse group
Level of Evidence
☐ Subgroup analysis data Consecutively assigned? YesNo
Determination
not available Potential Level: III
Duration of follow-up: Not specifically
Downgraded Level: Not
quantified but the text mentions that
☐ Not relevant to question Downgraded
patients were monitored with plain
radiographs/MRI at 12 months.
Conclusions
This paper provides evidence
Validated outcome measures used
that: lower BMD and
(list): VAS
advancing age are
significant risk factors
Nonvalidated outcome measures used
associated with vertebral
(list): New fractures after PVP
collapse after PVP in post-
menopausal women.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
1001
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: radiographs
Results/subgroup analysis: Denovo
fractures occurred in 14 of 61 patients.
BMD was significantly lower in the
collapsed group at lumbar, hip, femoral
neck compared to the non collapse
group.
Positive odds ration show that age
>85 suggests higher risk of fracture.
Author conclusions: Our study
revealed that advanced age and
decreased lumbar and hip BMD scores
most strongly indicated a risk of
adjacent VF following PVP
-Not only lumbar, but also hip, BMD
scores strongly reflect
a risk of adjacent VF following PVP. As
patients over 85 years of age with low
BMD scores showed the highest risk of
the fracture, PVP may be
contraindicated in such individuals. In
contrast, we uncovered a good
surgical indication in patients less than
75 years old and having high BMD
scores.
Trout AT, Kallmes DF, Lane JI, Layton Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
KF, Marx WF. Subsequent vertebral Therapeutic ☒ Nonconsecutive patients
fractures after vertebroplasty: Study Design: Comparative ☒ Nonrandomized
association with intraosseous Level III
☒ Nonmasked reviewers
clefts. AJNR Am J Neuroradiol. Stated objective of study: In this study,
☒ Nonmasked patients
2006;27(7):1586-1591. we evaluated the potential adverse
☐ No validated outcome
consequences of vertebroplasty in the
measures used
1002
Explanation of failure to setting of intraosseous clefts, ☐ Small sample size
meet guideline inclusion specifically regarding the incidence ☐ <80% follow-up
criteria and pattern of subsequent vertebral
☐ Lacked subgroup analysis
(when applicable) fractures.
☐ Diagnostic method not
stated
☐ Level V (expert Type of treatment(s): VP
☐ Other: Click or tap here to
consensus)
Total number of patients: 362 patients enter text.
☐ Level IV in presence of Number of patients in relevant
subgroup(s): Level of Evidence
higher quality studies
Group 1: 63 patients treated at Determination
fractures containing clefts (65 Potential Level: III
☐ Subgroup analysis data Downgraded Level: Not
vertebrae)
not available Downgraded
Group 2: 250 treated patients without
clefts (399 vertebrae)
☐ Not relevant to question Conclusions
Consecutively assigned? No This paper provides evidence
that: the presence of IVC is
Duration of follow-up: N/A? associated with the
increased risk of
Validated outcome measures used subsequent fractures in
(list): subsequent vertebral fractures OVCF patients after VP.
after VP
Nonvalidated outcome measures used
(list): Click or tap here to enter text.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: radiographs, bone scan
Results/subgroup analysis: 463 levels
in 313 patients were in the study
group.
1003
Patients with intraosseous clefts had
significant mor subsequent fractures,
almost two fold increase compared to
patients without clefts.
The timing of the subsequent fracture
was not statistically significant
between the two groups.
Author conclusions: Patients with
osteoporotic vertebral fractures
containing clefts are at increased risk
for subsequent fractures and treatment
of these clefts is associated with
increased rates of adjacent fracture.
There is no significant difference in the
timing of subsequent fractures based
on the presence of a cleft.
Tseng YY, Yang TC, Tu PH, Lo YL, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Yang ST. Repeated and multiple new Therapeutic ☒ Nonconsecutive patients
vertebral compression fractures after Study Design: Comparative ☒ Nonrandomized
percutaneous transpedicular Level III
☒ Nonmasked reviewers
vertebroplasty. Spine (Phila Pa 1976). Stated objective of study: To
☒ Nonmasked patients
2009;34(18):1917-1922. investigate the characteristics and
doi:10.1097/BRS.0b013e3181ac8f07. Explanation of failure to ☐ No validated outcome
associated risk factors of new-onset
meet guideline inclusion vertebral compression measures used
criteria fractures after vertebroplasty ☐ Small sample size
(when applicable) ☐ <80% follow-up
Type of treatment(s): VP ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Total number of patients: 852 stated
Number of patients in relevant ☐ Other: Click or tap here to
☐ Level IV in presence of subgroup(s):
enter text.
higher quality studies Group A: 1 PVP (711 patients)
Group B: >=2 PVPs (141 patients)
Level of Evidence
☐ Subgroup analysis data Determination
not available Consecutively assigned? No
Potential Level: III
Downgraded Level: Not
Duration of follow-up: minimum 24
☐ Not relevant to question Downgraded
months (range: 24–78 months)
Conclusions
1004
Validated outcome measures used This paper provides evidence
(list): Click or tap here to enter text. that: patients experiencing
2 or more VCFs after initial
Nonvalidated outcome measures used PVP for OVCF tend to be
(list): Click or tap here to enter text. relatively older, with lower
baseline BMD, and have
Diagnosis made by: more pre-existing VCFs.
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X-rays
Results/subgroup analysis: 141/852
(16.6%) patients had new VCF.
Mean age in group A was significantly
younger than group B (73.7 vs 76.4)
The BMD was significantly higher in
group A (-2.3) compared to group B (-
3.7)
Author conclusions: PVP is a
minimally invasive procedure resulting
in prompt pain relief and has a low
complication rate. Vertebral fracture
significantly increases the lifetime risk
of further fracture and new
compression fractures occur
repeatedly after vertebroplasty.
Specifically, following
vertebroplasty, patients are at
increased risk of new onset
adjacent-level fractures, and these
fractures occur
much sooner than nonadjacent level
fractures. Older patient
age, lower baseline BMD, and more
1005
pre-existing vertebral fractures were
found to be risk factors for multiple
vertebral compression fractures. Post-
vertebroplasty disc space bone
cement leakage also plays an
important role in the onset of new
adjacent fractures. More precise
data should be collected in further
biomechanical and clinical studies.
Effective and sustained treatment for
osteoporosis should be introduced as
early as possible.
Voormolen MH, Lohle PN, Juttmann JR, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
van der Graaf Y, Fransen H, Lampmann Therapeutic ☐ Nonconsecutive patients
LE. The risk of new osteoporotic Study Design: Comparative ☒ Nonrandomized
vertebral compression fractures in the Level II
☒ Nonmasked reviewers
year after percutaneous vertebroplasty. Stated objective of study: To
☒ Nonmasked patients
Journal of Vascular & Interventional prospectively assess the incidence,
Radiology.17(1):71-76. Explanation of failure to ☐ No validated outcome
location, and possible causative
☒ Include meet guideline inclusion mechanisms of new vertebral measures used
☐ Exclude criteria compression fractures (VCFs) in 66 ☐ Small sample size
(when applicable) symptomatic patients with osteoporotic ☒ <80% follow-up
VCFs treated with percutaneous ☐ Lacked subgroup analysis
☐ Level V (expert vertebroplasty ☐ Diagnostic method not
consensus) (PV) and to study the relation between stated
new VCFs and back pain ☐ Other: Click or tap here to
☐ Level IV in presence of symptomsStated objective of study: To
enter text.
higher quality studies prospectively assess the incidence,
location, and possible causative
Level of Evidence
☐ Subgroup analysis data mechanisms of new vertebral
Determination
not available compression fractures (VCFs) in 66
Work group conclusions
symptomatic patients with osteoporotic
Potential Level: II
VCFs treated with percutaneous
☐ Not relevant to question Downgraded Level: Not
vertebroplasty
Downgraded
(PV) and to study the relation between
new VCFs and back pain symptoms.
Conclusions
This paper provides evidence
Type of treatment(s): PVVP
that: the presence of
multiple pre-existing VCFs
Total number of patients: 6666
(3 or more) is a risk-factor
patients, 102 fractures
for new VCF after PV.
1006
Number of patients in relevant
subgroup(s): 16 with new VCFs vs 50
with no new VCFs
Consecutively assigned? Yes
Duration of follow-up: 12 months
Validated outcome measures used
(list): VAS, new vertebral fractures
Nonvalidated outcome measures used
(list): New VCFs after PV
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: x-rays
Results/subgroup analysis: 66
patients with 228 preexisting VCF. 46
[atoemts jad 12 month MR followup.
16/66 new VCF occurred at 1 year
follow up after PV.
The presence of 2 preexisting VCS
was a risk factor for development of
new VCF. With 3 or more preexisting
VCF there was a significantly higher
risk of new VCF.
Author conclusions: New VCFs
occurred after PV in 24% of patients.
Half of new VCFs occurred in levels
adjacent to
1007
treated levels and half were
symptomatic. The presence of more
than two preexisting VCFs was the
only independent risk factor for the
development of a new VCF.
Wang YT, Wu XT, Chen H, Wang C, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Mao ZB. Adjacent-level symptomatic Therapeutic ☒ Nonconsecutive patients
fracture after percutaneous vertebral Study Design: Comparative ☒ Nonrandomized
augmentation of osteoporotic vertebral Level III
☒ Nonmasked reviewers
compression fracture: a retrospective Stated objective of study: To analyze
☒ Nonmasked patients
analysis. J Orthop Sci. 2014;19(6):868- Explanation of failure to the associated incidence, risk factors,
876. doi:10.1007/s00776-014-0610-7. meet guideline inclusion ☐ No validated outcome
and possible causative mechanism of
criteria symptomatic AVF, and to evaluate the measures used
(when applicable) intrinsic relationship between cement ☐ Small sample size
leakage ☐ <80% follow-up
☐ Level V (expert into the disk and AVF. ☐ Lacked subgroup analysis
consensus) ☐ Diagnostic method not
Type of treatment(s): VP, KP stated
☐ Level IV in presence of ☐ Other: Click or tap here to
higher quality studies Total number of patients: 358
enter text.
Number of patients in relevant
☐ Subgroup analysis data subgroup(s): AVF (n = 26) and AVF-
Level of Evidence
not available free (n = 332)
Determination
Potential Level: III
Consecutively assigned? NoYes
☐ Not relevant to question Downgraded Level: Not
Downgraded
Duration of follow-up: 31.2 ± 10.7
months (range: 18–84 months)
Conclusions
This paper provides evidence
Validated outcome measures used
that: advancing age, lower
(list): new symptomatic fractures
BMD, and the presence of
IVC is associated with the
Nonvalidated outcome measures used
risk of AVF after PV in
(list): New AVF
patients with OVCF.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
1008
☒ CT
☐ CT/Myelogram
☒ Other: X-rays, DEXADEXA
Results/subgroup
analysis: Symptomatic AVF was
7.3%. Regression showed age, BMD,
intravertebral clefts with association to
symptomatic AVF.
Author conclusions: Older age, lower
BMD, and intravertebral
clefts are the main risk factors for
symptomatic AVF after
vertebral augmentation, but intradiscal
cement leakage
does not increase the risk of AVF. AVF
occurs because of
the natural progression of
osteoporosis. Even distribution
of bone cement in the vertebral body is
important in OVCF
patients with intravertebral clefts.
Wu J, Guan Y, Fan S. Analysis of risk Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
factors of secondary adjacent vertebral Therapeutic ☒ Nonconsecutive patients
fracture after percutaneous kyphoplasty. Study Design: Comparative ☒ Nonrandomized
Biomedical Research (India). Level III
☒ Nonmasked reviewers
2017;28(5):1956-1961. Stated objective of study: To explore
☒ Nonmasked patients
the potential risk factors of secondary
Explanation of failure to ☐ No validated outcome
adjacent vertebral fracture after
meet guideline inclusion percutaneous kyphoplasty (PKP) for measures used
criteria Osteoporotic Vertebral Compression ☐ Small sample size
(when applicable) Fractures (OVCFs) ☐ <80% follow-up
☐ Lacked subgroup analysis
☐ Level V (expert Type of treatment(s): PKP ☐ Diagnostic method not
consensus) stated
Total number of patients: 189 ☐ Other: Click or tap here to
☐ Level IV in presence of Number of patients in relevant
enter text.
higher quality studies subgroup(s): Fracture group 22 vs
non-fracture group 167
1009
Level of Evidence
☐ Subgroup analysis data Consecutively assigned? No Determination
not available Potential Level: III
Duration of follow-up: mean 36 ± 8 Downgraded Level: Not
☐ Not relevant to question months; range: 12 to 69 months Downgraded
Validated outcome measures used Conclusions
(list): new fractures This paper provides evidence
that: fracture type, use of
Nonvalidated outcome measures used anti-osteoporotic
(list): secondary adjacent vertebral treatment, and bone
fractures (AVF) density are factors
associated with the
Diagnosis made by: development of secondary
☒ Clinical exam/history AVF after PKP in OVCF
☐ Electromyography patients.
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: X-rays
Results/subgroup analysis: Univariate
analysis shows type of fracture, type of
bone cement, leakage of cement,
anesthetic approach, systemic anti
osteoporosis medication, bone density,
quantity of surgical cement all had
significant correlation with post surgery
vertebral fractures.
Multivariate analysis showed type of
bone fracture, systemic anti
osteoporosis medication, leakage of
bone cement into adjacent disc,
anesthesia approach, bone density as
risk fractures for secondary fractures
after PKP.
1010
Author conclusions: Taken together,
fissure fracture, no use of systemic
antiosteoporosis therapy, leakage of
bone cement into
intervertebral disc, topical anaesthesia
and reduction in bone
density are high-risk factors of
secondary adjacent vertebral
fracture after PKP. Much attention
should be diverted to the
understanding of osteoporosis
disease, early diagnosis and
treatment of spinal fracture and
enhancing surgical skills. PKP
under general anaesthesia is an
effective approach to reduce the
risk of secondary adjacent vertebral
fracture after PKP.
Xu W, Wang S, Chen C, et al. Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Correlation analysis between the Therapeutic ☐ Nonconsecutive patients
magnetic resonance imaging Study Design: Observational ☒ Nonrandomized
characteristics of osteoporotic vertebral Level III
☒ Nonmasked reviewers
compression fractures and the efficacy .Stated objective of study: To explore
☒ Nonmasked patients
of percutaneous vertebroplasty: a the relationship between the magnetic
prospective cohort study. BMC Explanation of failure to ☐ No validated outcome
resonance imaging (MRI)
Musculoskeletal Disorders.19(1):114. meet guideline inclusion characteristics of osteoporotic measures used
criteria vertebral compression fractures ☐ Small sample size
(when applicable) (OVCFs) and the efficacy of ☐ <80% follow-up
percutaneous vertebroplasty (PVP). ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Type of treatment(s): .VP stated
☐ Other: Click or tap here to
☐ Level IV in presence of Total number of patients: 93 patients
enter text.
higher quality studies Number of patients in
relevant subgroup(s): N/A
Level of Evidence
☐ Subgroup analysis data Determination
not available Consecutively assigned? .Yes
Potential Level: III
Downgraded Level: Not
Duration of follow-up: 12 months
☐ Not relevant to question Downgraded
1011
Validated outcome measures used Conclusions
(list): VAS, ODI, MOS, SF-36 This paper provides evidence
that: in patients with OVCF,
Nonvalidated outcome measures used patients with moderate or
(list): Click or tap here to enter text. severe edema in the MRI
pre op have better
Diagnosis made by: outcomes compares to
☐ Clinical exam/history patients with mild edema
☐ Electromyography undergoing percutaneous
vertebroplasty.
☐ Myelogram
☐☒ MRI
☒ CT
☐ CT/Myelogram
☐☒ Other: radiographs and DXA
Results/subgroup analysis: The VAS,
ODI, and SF-36 scores showed
significant differences (P< 0.05) before
and after surgeryamong the three
groups. The ODI and SF-36 scores
were significantly different (P < 0.05)
at 1 day and1 month after surgery
among the three groups. GroupsA and
B showed significantly better pain relief
thangroup C. Group B experienced
better pain relief than group A. These
results indicate that PVP was
associated with better pain relief
effects among patients with a greater
extent of bone marrow edema. The
edema ranges of thevertebral fractures
were negatively correlated with the
postoperative VAS and ODI scores 1
month aftersurgery, whereas the
ranges were positively correlated with
postoperative SF-36 scores 1 month
after surgery.
1012
Author conclusions: PVP is an
effective treatment for OVCFs. The
MRI characteristics of OVCFs
are helpful in predicting their
treatment outcomes. Better outcomes
were observed among patients with
severe or moderate bone marrow
edema than among those with mild
bonemarrow edema. The greater
degree of pain relief afterPVP was
correlated with the faster recovery of
post-operative function. However, this
correlation graduallybecame weak
over time and disappeared 6
monthsafter surgery. Therefore, PVP
should be an option forearly stage
OVCFs, especially for patients with
bonemarrow edema signs on MRI.
Yang S, Liu Y, Yang H, Zou J. Risk Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
factors and correlation of secondary Therapeutic ☒ Nonconsecutive patients
adjacent vertebral compression fracture Study Design: Comparative ☒ Nonrandomized
in percutaneous kyphoplasty. Level III
☒ Nonmasked reviewers
International Journal Of Surgery.36:138- Stated objective of study: To analyze
☒ Nonmasked patients
142. risk factors and correlation of
Explanation of failure to ☐ No validated outcome
secondary adjacent vertebral
meet guideline inclusion compression fracture (AVCF) in measures used
criteria percutaneous kyphoplasty ☐ Small sample size
(when applicable) ☐ <80% follow-up
Type of treatment(s): PKP ☐ Lacked subgroup analysis
☐ Level V (expert ☐ Diagnostic method not
consensus) Total number of patients: 139 stated
Number of patients in relevant ☐ Other: Click or tap here to
☐ Level IV in presence of subgroup(s): Group A: 21 pts (27
enter text.
higher quality studies vertebrae) with AVCF vs Group B (no
AVCF)
Level of Evidence
☐ Subgroup analysis data Determination
not available Consecutively assigned? No
Potential Level: III
Downgraded Level: Not
Duration of follow-up: 19.56 ± 3.92
☐ Not relevant to question Downgraded
months
Conclusions
1013
Validated outcome measures used This paper provides evidence
(list): VAS, ODI that: patients incurring
ACVF after PKP for OVCF
Nonvalidated outcome measures used have lower BMD.
(list): New AVCF
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: X rays
Results/subgroup analysis: Patients
incurring ACVF post PKP had lower
BMD (-2.85 vs -2.38; p=0.01) and
greater recovery rate of vertebral
height (47.67 vs 38.04; p<0.00001)
Author conclusions: Patients with a
lower bone mineral density value
preoperative, larger balloon volume,
cement volume, recovery rate of
vertebral height and bone cement
leakage intraoperative have an
increased risk of adjacent vertebral
compression fracture after
percutaneous kyphoplasty
Zafeiris CP, Lyritis GP, Papaioannou Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
NA, et al. Hypovitaminosis D as a risk Therapeutic ☒ Nonconsecutive patients
factor of subsequent vertebral fractures Study Design: Comparative ☒ Nonrandomized
after kyphoplasty. Spine J. Level III
☒ Nonmasked reviewers
2012;12(4):304-312. Stated objective of study: To
☒ Nonmasked patients
doi:10.1016/j.spinee.2012.02.016 Explanation of failure to determine the incidence of recurrent
meet guideline inclusion ☐ No validated outcome
fractures after kyphoplasty and explore
criteria whether the status of bone metabolism measures used
(when applicable) and 25-hydroxyvitamin D (25(OH)D) ☒ Small sample size
☐ <80% follow-up
1014
☐ Level V (expert levels affect the occurrence of these ☐ Lacked subgroup analysis
consensus) fractures ☐ Diagnostic method not
stated
☐ Level IV in presence of Type of treatment(s): KP
☐ Other: Click or tap here to
higher quality studies enter text.
Total number of patients: 40 females
with acute fractures, 98 kyphoplasties
☐ Subgroup analysis data Level of Evidence
Number of patients in relevant
not available Determination
subgroup(s): 9 in the fracture group vs
Potential Level: II
31 in the non-fracture group
☐ Not relevant to question Downgraded Level: III
Downgraded due to:
Consecutively assigned? No
Nonconsecutive patients,
nonrandomized, nonmasked
Duration of follow-up: 18 months
reviewers, nonmasked
patients, small sample size
Validated outcome measures used
(list): Identification of new vertebral
Conclusions
fractures and documentation of
This paper provides evidence
indicators
that: patients incurring new
of bone metabolism.
VCFs after maiden KP tend
to have a lower vit D level
Nonvalidated outcome measures used
compared to those not
(list): New fractures after initial KP
incurring fractures.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☒ Other: bone scintigraphy, X-rays,
DEXA
Results/subgroup analysis: 40 patients
at 98 vertebral levels. 9 patients
(22.5%) had new VCF and total of 11
levels (11.2%).
1015
Stastically significant differenc was
present between the two group for
25(OH)D. The no fracture group had
higher levels compared to fracture
group (22.6 vs 14.39).
Multivariate analysis showed statistical
significance for recurrent fracture with
cement leakage and 25(OH)D levels.
Author conclusions: Bone metabolism
and 25(OH)D levels seem to play a
role in the occurrence of recurrent
vertebral compression fractures after
kyphoplasty. Further larger studies are
required
to systematically analyze the influence
of bone metabolism
on augmentation techniques and draw
strong conclusions.
Zhang SB, Chen H, Xu HW, Yi YY, Type of evidence: ☒ Prospective ☐ Retrospective Critique of methodology:
Wang SJ, Wu DS. Association between Therapeutic ☒ Nonconsecutive patients
handgrip strength and subsequent Study Design: Comparative ☒ Nonrandomized
vertebral-fracture risk following Level II
☒ Nonmasked reviewers
percutaneous vertebral augmentation. J Stated objective of study: To
☒ Nonmasked patients
Bone Miner Metab. 2021;39(2):186-192. Explanation of failure to investigate the association between
doi:10.1007/s00774-020-01131-z meet guideline inclusion ☐ No validated outcome
handgrip strength (HGS) and the risk
criteria of subsequent vertebral fracture (SVF) measures used
(when applicable) after percutaneous vertebral ☐ Small sample size
augmentation (PVA). ☐ <80% follow-up
☐ Level V (expert ☐ Lacked subgroup analysis
consensus) Type of treatment(s): PKP/PVP ☐ Diagnostic method not
stated
☐ Level IV in presence of Total number of patients: 340 ☐ Other: Click or tap here to
higher quality studies Number of patients in relevant
enter text.
subgroup(s): Click or tap here to enter
☐ Subgroup analysis data text.
Level of Evidence
not available Determination
Consecutively assigned? No
Potential Level: II
☐ Not relevant to question Downgraded Level: Not
Downgraded
1016
Duration of follow-up: Minimum f/u of 3
years Conclusions
This paper provides evidence
Validated outcome measures used that: in both men and
(list): subsequent vertebral fracture, women, hand grip strength,
VAS older age, and lower BMI
associated with higher risk
Nonvalidated outcome measures used of subsequent VF.
(list): HGS
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
☒ Other: Click or tap here to enter
text.
Results/subgroup analysis: total of
340 patients (234 women), there were
SVF in93 patients (27.4%). Patients
with SVF had significant older age.
Use of anti osteoporosis drug use was
lower for those with SVF.
Among women, higher SVF risk was
related to older age, lower BMI,
diabetes, history of falls. Among
males, older age, lower BMI, history of
falls, smoking.
Kaplan meier analysis showed that
HGS of women <18kg and men <28kg
was significantly associated with lower
SVF free survival.
1017
Author conclusions: In conclusion, the
present data suggest that SVF is
highly prevalent among OVF patients
who undergo single-level PVA. Lower
HGS was significantly associated with
a reduction in SVF-free survival among
elderly OVF patients. The
occurrence of SVF in male patients
may be more affected
by the natural course of osteoporosis.
HGS is a simple and
inexpensive test that can be
considered in clinical settings to
evaluate muscle strength and identify
patients at increased
risk of SVF after PVA.
1018
Surgical Treatment Section
Surgical Treatment Question 1: Does instrumented fusion improve outcomes in patients with acute osteoporotic vertebral compression fractures compared
to nonoperative care or interventional procedures?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
An KC, Kang S, Choi JS, Seo JH. The Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
clinical and radiological availability of Therapeutic ☒ Nonconsecutive patients
percutaneous balloon kyphoplasty as Study Design: Comparative ☒ Nonrandomized
a treatment for osteoporotic burst Level IV
☒ Nonmasked reviewers
fractures. Asian Spine J. 2008;2(1):9- Stated objective of study: Examined
14. doi:10.4184/asj.2008.2.1.9 Explanation of failure to ☒ Nonmasked patients
the clinical and radiological
meet guideline inclusion outcomes in patients undergoing ☐ No validated outcome
criteria percutaneous measures used
(when applicable) KP as a treatment for osteoporotic ☒ Small sample size
burst fractures refractory to 4 weeks ☐ <80% follow-up
☐ Level V (expert of conservative treatment. ☐ Lacked subgroup analysis
consensus) ☐ Diagnostic method not stated
Type of treatment(s): ☒ Other: Method of assignment
☐ Level IV in presence of Conservative treatment, posterior of patients to treatment groups
higher quality studies instrumentation and fusion, was not described; selection
Percutaneous kyphoplasty (PK) bias
☐ Subgroup analysis data
not available Total number of patients: 12 pts/ 13 Level of Evidence
fx treated; Determination
control group = 33 cases of
☐ Not relevant to question Potential Level: III
conservative rx and 13 cases of Downgraded Level: IV
posterior instrumentation Downgraded due to: Method of
assignment of patients to
Consecutively assigned? No treatment groups was not
described, selection bias,
Duration of follow-up: > 1 year Small sample size,
nonconsecutive and
Validated outcome measures used nonrandomized patients,
(list): VAS, nonmasked reviewers, and
Non validated outcome measures nonmasked patients
use: semiquantitative scale
assessing mobility—Chen and Lee’s, Conclusions
Kyphotic deformity angle (KDA) This paper provides evidence
that: in female patients with
Diagnosis made by: osteoporotic vertebral
☒ Clinical exam/history compression fractures with
1019
☐ Electromyography burst morphology,
☐ Myelogram kyphoplasty and
instrumented fusion are
☒ MRI
equally effective in improving
☒ CT kyphosis, VAS and mobility
☐ CT/Myelogram and both management
☒ Other: Dexa scan approaches provide more
improvement than medical
Results/subgroup analysis: treatment.
KDA: KP better than KDA p= 0.016,
no stat diff KP vs. PS
KP preo-op 15.9 +/- 2.4 post op 6.2
+/- 1.6, final 5.9 +/-1.4
PS: pre op 19.1 +/- 2.4 post op 9.1
+/- 1.8, final 8.9 +/- 1.7
Cons: pre op 5.2 +/- 1.4. post op
14.8 +/- 2.1
VAS: KP better than KDA p=0.012,
no stat diff KP vs. PS
KP pre-op 8.3; 3 days post-op 3.9; 3
mos. post-op 3.2; 1 yr 3.1
PS: pre-op 8.5; 3 days post-op 3.5; 3
mos post-op 3.4; 1 yr. 3.2
Cons: pre-op
7.9; 3 mos post op
4.8; 1 yr. 4.5
Chen and Lee
KP improved to 0 in KP and PS
Author conclusions: KP is safe and
useful for treating osteoporotic burst
fractures.
Kim HS, Heo DH. Percutaneous Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Pedicle Screw Fixation with Therapeutic ☒ Nonconsecutive patients
Polymethylmethacrylate Study Design: Comparative ☒ Nonrandomized
Augmentation for the Treatment of Level IV
☒ Nonmasked reviewers
Thoracolumbar Intravertebral Stated objective of study: The
Pseudoarthrosis Associated with ☒ Nonmasked patients
purpose of this study was to assess,
Kummell's Osteonecrosis. BioMed Explanation of failure to for at least 2 years, the radiologic ☐ No validated outcome
Research International. meet guideline inclusion and clinical outcomes of patients measures used
2016;2016:3878063. criteria who underwent short segment ☒ Small sample size
1020
(when applicable) pedicle screw fixation with PMMA ☐ <80% follow-up
augmentation to treat osteoporotic ☐ Lacked subgroup analysis
☐ Level V (expert vertebral compression fractures with
☐ Diagnostic method not stated
consensus) intravertebral pseudoarthrosis
comparing to patients who were ☒ Other: Method of treatment
allocation not described
☐ Level IV in presence of treated by percutaneous
higher quality studies vertebroplasty.
Level of Evidence
Type of treatment(s): short segment Determination
☐ Subgroup analysis data Potential Level: III
percutaneous pedicle screw fixation
not available Downgraded Level: IV
(PPF) with PMMA augmentation;
percutaneous vertebroplasty (PVP) Downgraded due to:
☐ Not relevant to question Nonconsecutive and
Total number of patients: 56 pts; 49 nonrandomized patients,
pts with single-level OVF with AVN nonmasked reviewers,
followed for more than 24 months nonmasked patients, small
Number of patients in relevant sample size, and method of
subgroup(s): treatment allocation not
18 pts PFF described
31 pts PVP
PFF – 18. PVP - 31 Conclusions relative to question
This paper provides evidence
Consecutively assigned? No that: in patients with
osteoporotic vertebral
Duration of follow-up: 24 months or compression fractures and
more nonhealing intravertebral
cleft, percutaneous pedicle
screw fixation (PPF) with
Validated outcome measures used
PMMA versus percutaneous
(list): VAS, ODI
vertebroplasty (PVP) provides
similar clinical outcomes but
Nonvalidated outcome measures
PPF with PMMA provides
used (list): operation time, bleeding
better radiological outcomes
amount, complications, compression
at two years post treatment
ratio (Anterior/posterior height; AP
compared to PVP.
ratio), kyphotic angle
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☐ CT/Myelogram
1021
☒ Other: Dexa, BMD, dynamic x-ray;
acute osteoporotic compression
fractures with avascular
osteonecrosis and intravertebral air
cleft in all the patients
Results/subgroup analysis:
Vertebral height and kyphotic
angle of the compressed vertebral
bodies were significantly corrected
after the operation (𝑃 < 0.05).
Further, restored vertebral
height was maintained during the 2
or more years of postoperative
follow-up. Compared to the PVP
group the postoperative
compression ratio and kyphotic
angle were significantly lower in the
PPF group (𝑃 < 0.05). The
postoperative ODI and VAS
of the PVP group were significantly
higher than the PPF (𝑃 < 0.05).
Author conclusions: According to
our results, short-segment PPF
with PMMA augmentation may be an
effective minimally invasive
treatment for osteoporosis in cases
of osteoporotic vertebral
compression fractures with
Kummell’s osteonecrosis.
Surgical Treatment Question 2: What are the clinical or radiological indications for recommending open surgical procedures in patients with acute
osteoporotic vertebral compression fractures?
A systematic review of the literature yielded no studies to adequately address this question.
1022
Surgical Treatment Question 3: Does the use of minimally invasive surgical approaches (e.g., percutaneous pedicle screws, muscle-sparing
decompression/arthrodesis techniques) improve outcomes compared to open surgical approaches in patients undergoing surgery for acute osteoporotic
vertebral compression fractures?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Liu G, Liu B, Yang Y, Tian L, Liu Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Y, Wang J. Minimally invasive Prognostic/Therapeutic ☐ <80% follow-up
percutaneous pedicle screw Combined Study Design: Comparative ☐ Small sample size
fixation versus open pedicle screw
fixation for senile osteoporotic Level IV Stated objective of study: to ☐ Lacked subgroup analysis
vertebral fracture. International compare efficacy of minimally ☐ Diagnostic methods not
Journal of Clinical and invasive percutaneous pedicle described.
Experimental Medicine. Explanation of failure to meet screw and open pedicle screw ☐ No validated outcome
2020;13(3):1816-1822. guideline inclusion criteria fixation for senile OVF
(when applicable) measures used
Applicable to prognostic
Type of treatment(s): minimally
studies (Q2):
☐ Level V (expert consensus) invasive percutaneous pedicle
screw fixation open pedicle ☐ Patients not enrolled at
☐ Level IV in presence of higher screw fixation same point in their
quality studies disease
Total number of patients: 59 ☐ Follow-up not
☐ Subgroup analysis data not standardized
available Number of patients in Applicable to therapeutic
relevant subgroup(s): open studies (Q3):
☐ Not relevant to question reduction and internal fixation ☒ Nonconsecutive patients
n=23; minimally invasive ☒ Nonrandomized
percutaneous pedicel screw
☒ Nonmasked reviewers
fixation n=36
☐ Nonmasked patients
Consecutively assigned? No ☒ Other: unknown whether acute
fx.; experience bias and failure to
Duration of follow-up: 6 months report actual numbers of VAS and
ODI making it impossible to
Validated outcome measures determine clinical significance
used (list): VAS, ODI
Level of Evidence Determination
Nonvalidated outcome Potential Level: III
measures used (list):.various Downgraded Level: IV
radiographic measures— Downgraded due to
percentage vert height, kyphotic :Nonconsecutive and
angle, disc height all before and nonrandomized patients,
after surgery nonmasked reviewers, uncertainty
1023
of whether acute fracture,
Diagnosis made by: experience bias, failure to report
☒ Clinical exam/history actual numbers of VAS and ODI
☐ Electromyography (making it impossible to determine
☐ Myelogram the clinical significance)
☐ MRI
Conclusions
☐ CT This paper provides evidence that:
☐ CT/Myelogram in patients with osteoporotic
☒ Other: X-Ray, DEXA vertebral compression fractures
undergoing surgical fixation,
Results/subgroup analysis: the use of minimally invasive
Vertebral height percutaneous pedicle screws
There were no significant (compared to open pedicle
differences between groups 1 screw placement) provides a
week and 6 months after greater magnitude of VAS
internal fixation (P>0.05) improvement and ODI scores at
6 months and reduces operative
Kyphotic Angle time, intraoperative blood loss,
There were no significant hospital length of stay, and
differences between groups 1 incision size.
week and 6 months after
internal fixation (P>0.05) .
Disc Height
There were no significant
differences between groups 1
week and 6 months after
internal fixation (P>0.05)
VAS
Both groups decreased 6
months after internal fixation
(both P<0.01) VAS score of the
experimental group decreased
more significantly than that of
the control group (P<0.01)
ODI
Both groups decreased
significantly 6 months after
internal fixation (both P<0.01),
and ODI of the experimental
group decreased more
1024
significantly than that of the
control group (P<0.001)
Operation time
experimental group was shorter
than that in the control group
(82.85± 21.51 minutes vs.
105.63±19.35 minutes,
P=0.012).
Intraoperative blood loss
experimental group was
significantly less than that in the
control group (p=0.001)
Incision length
experimental group was
significantly shorter than that in
the control group (P=0.001)
Hospitalization days
experimental group were less
than that of the control group
(P=0.001).
Complications:
Compared with the control
group, the incidence of postop
complications in the
experimental group was
decreased (P<0.05)
Author conclusions: Both
minimally invasive percutaneous
pedicle screw fixation and open
pedicle screw fixation can
achieve satisfactory internal
fixation, while the former has
less trauma, short operative
time, fast recovery, few
postoperative complications and
light postoperative pain
1025
Surgica Question 4: What are the risk factors for adjacent vertebral body fractures after surgical intervention in patients with osteoporotic vertebral
compression fractures?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Tamai K, Terai H, Suzuki A, et al. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Risk Factors for Proximal Prognostic ☐ Patients not enrolled at same
Junctional Fracture Following Study Design: Observational point in their disease
Fusion Surgery for Osteoporotic Level IV ☐ <80% follow-up
Vertebral Collapse with Delayed Stated objective of study: the aim ☐ Follow-up not standardized
Neurological Deficits: A of current study was to identify
Retrospective Cohort Study of 403 Explanation of failure to meet ☐ No validated outcome measures
the incidence and independent
Patients. Spine Surgery & Related guideline inclusion criteria used
risk factors of
Research.3(2):171-177.\ (when applicable) proximal junctional fx PJFr, ☐ Small sample size
following surgically treated OVC. ☐ Lacked subgroup analysis
☐ Level V (expert ☒ Diagnostic methods not
consensus) Total number of patients in the described.
study: 403, but not all had BMD ☒ Other: multiple centers, the
☐ Level IV in presence of done; decompression without surgical procedure, surgical
higher quality studies fusion indication, and postsurgical
therapy were inconsistent
☐ Subgroup analysis data not Number of patients in
available relevant subgroup(s): 63 w/ Level of Evidence Determination
PJFx Potential Level: III
38 pts fx UIV Downgraded Level: IV
☐ Not relevant to question
25 pts prox adjacent vert Downgraded due to inconsistent
indications and applications of
Duration of follow-up: mean surgical and medical treatments
duration 45.7 months across centers.
Validated outcome measures Conclusions
used (list): Frankel grade This paper provides evidence that:
in patients undergoing
Nonvalidated outcome measures instrumented fusion for
used (list): proximal junction osteoporotic fracture with a
fracture diagnosed by senior neurologic deficit, the following
surgeons on xray or CT scan at characteristics are associated
regular f/u or when pt complained with proximal junctional fracture
of back pain; imaging; (PJFr): severe baseline
1026
osteoporosis (based on a
Diagnosis made by: qualitative radiographic
☒ Clinical exam/history assessment) and when the lowest
☐ Electromyography instrumented vertebrae (LIV) of
the fusion construct is the
☐ Myelogram
sacrum. In addition, lumbar bone
☐ MRI mineral density (BMD) rather than
☒ CT hip BMD is predictive of PJFr.
☐ CT/Myelogram
☐ Other: Click or tap here to
enter text.
Results/subgroup analysis
(relevant to question):
Multivariate Analysis identified
the following independent risk
factors for PJFr…
Grade of osteoporosis (grade 0
or I: reference, grade II or III:
aOR 2.92, p=0.001),
LIV levels (thoracolumbar
junction: reference, sacrum: aOR
6.75, p=0.003).
While, Age, UIV level, surgical
approach, and the number of
fused segments were not
significant independent factors.
Lumbar BMD was a significant
factor with good predictive ability
(AUC=0.72, 95%CI: 0.57-0.88,
p=0.035), but that of the hip was
not a significant factor.
The optimal cut-off value for
predicting PJFr after primary
surgery
was 0.61 g/cm2 lumbar BMD
(sensitivity, 76.5%; specificity,
58.3%).
1027
Author conclusions (relevant to
question): PJFr following fusion
surgery for OVC was found in
15.6% cases with a mean follow-
up term of 45.7 months, while the
independent risk factors for PJFr
were severe osteoporosis and
extended fusion to the sacrum.
In addition, the lumbar DXA cut-
off value of 0.61 g/cm2 may
potentially predict the PJFr, but
the hip DXA was not predictive.
Our findings could help surgeons
to decide the perioperative
adjuvant therapy as well as the
surgical strategy to prevent
PJFr following surgery.
Surgical Treatment Question 5: Are there specific characteristics of the fracture or the patient that influence outcomes in patients with osteoporotic
vertebral compression fractures undergoing surgical treatment?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
Gupta A, Upadhyaya S, Cha T, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Schwab J, Bono C, Hershman S. Prognostic ☐ Patients not enrolled at
Serum albumin levels predict which Study Design: Comparative same point in their disease
patients are at increased risk for Level III ☐ <80% follow-up
complications following surgical Stated objective of study: We ☐ Follow-up not standardized
management of acute osteoporotic Explanation of failure to meet hypothesized that lower albumin levels
vertebral compression guideline inclusion criteria would be statistically correlated with a ☐ No validated outcome
fractures. Spine J. (when applicable) measures used
higher incidence of complications,
2019;19(11):1796-1802. mortality, and 30-day readmission ☐ Small sample size
doi:10.1016/j.spinee.2019.06.023 ☐ Level V (expert (following surgical treatment for ☐ Lacked subgroup analysis
consensus) OVCF.) ☐ Diagnostic methods not
described.
☐ Level IV in presence of Total number of patients in the study: ☐ Other:
higher quality studies 1,979
Number of patients in Level of Evidence
☐ Subgroup analysis data relevant subgroup(s): Albumin > 3.5 = Determination
not available 1,194; Albumin. 3.00-3.49 = 461; Potential Level: III
1028
Albumin < 3.00 =324 Downgraded Level: Not
☐ Not relevant to question Total 1,1914 (missing data for others) Downgraded
Duration of follow-up: 30 days Conclusions
This paper provides evidence
Validated outcome measures used that: preoperative
(list): N/A hypoalbuminemia is associated
with increased rates of post-
Nonvalidated outcome measures used operative complications in the
(list): postoperative surgical treatment of
complications, patient mortality, and osteoporotic vertebral
30-day readmission due to any cause, compression fractures.
30-day readmission due to OVCF and
total length of hospital stay
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: ICD-10
Results/subgroup analysis (relevant to
question): 1,194 normal nutritional
status, 461 mildly malnourished, 324
severely malnourished patients with
increasingly severe hypoalbuminemia
were statistically more likely to have a
history of congestive heart failure,
chronic obstructive pulmonary disease,
coagulopathy, diabetes, dialysis,
hypertension, steroid use, weight loss
of greater than 10% in the last 6
months, and a poorer ASA status
Preoperative albumin levels showed a
statistically significant
association with the development of
minor complications,
major complications, and mortality
1029
A patient with severe hypoalbuminemia
has an odds ratio of
2.18 for minor complications, 2.48 for
major complications,
and 2.96 for mortality relative to that of
healthy patients
Author conclusions (relevant to
question): Preoperative albumin has
the potential to serve as a prognostic
indicator of adverse outcomes for
patients undergoing surgery for OVCF.
Isogai N, Hosogane N, Funao H, et Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
al. The Surgical Outcomes of Spinal Prognostic ☐ Patients not enrolled at
Fusion for Osteoporotic Vertebral Study Design: Comparative same point in their disease
Fractures in the Lower Lumbar Level IV ☐ <80% follow-up
Spine with a Neurological Stated objective of study: We aimed to ☐ Follow-up not standardized
Deficit. Spine Surg Relat Res. Explanation of failure to meet investigate the postoperative functional
2020;4(3):199-207. Published 2020 guideline inclusion criteria and radiographic outcomes, as well as ☐ No validated outcome
Jan 29. doi:10.22603/ssrr.2019- (when applicable) measures used
the postoperative complications, in
0079 patients who had fusion surgery for ☐ Small sample size
☐ Level V (expert lower lumbar OVF with neurological ☐ Lacked subgroup analysis
consensus) deficits using a large sample size ☒ Diagnostic methods not
cohort. described.
☐ Level IV in presence of ☒ Other: indications for sx and
higher quality studies Total number of patients in the study: sx technique determined at
N=403 each inst.; treatment
☐ Subgroup analysis data paradigm employed may
not available Number of patients in not be generalizable to
relevant subgroup(s): lower lumbar other geographic regions
(L3-L5) n= 76 (after matching n=73)
☐ Not relevant to question
Thoracolumbar junction (T10-L2) Level of Evidence
n=327 (after matching n=146) Determination
Potential Level: III
Duration of follow-up: minimum of 2 Downgraded Level: IV
years; mean 3.9 +/- 1.7 years Downgraded due: to diagnostic
methods not described and
Validated outcome measures used treatment paradigm employed
(list): VAS, JOA may not be generalizable to
other geographic regions
Nonvalidated outcome measures used
(list): Conclusions
1030
Mechanical failure (implant) This paper provides evidence
New vertebral fracture that: in patients undergoing
Need for revision surgical treatment of OVCF,
Local kyphosis angle those with lower lumbar
complications (new vertebral fracture, fractures compared to
mechanical failure, revision surgery), thoracolumbar junction
periop complications within 6 weeks of fractures have higher rates
surgery, local kyphosis angle (LKA), of post-operative mechanical
ADL failure (instrumentation
failure, cage subsidence or
Diagnosis made by: fracture at upper
☒ Clinical exam/history instrumented vertebrae
☐ Electromyography (UIV)/lowest instrumented
vertebrae (LIV).
☐ Myelogram
☒ MRI
☐ CT
☐ CT/Myelogram
☐ Other:
Results/subgroup analysis (relevant to
question):
The number of fused segments was
larger in the T group than that in the L
group (L group: 3.4 ± 2.2, T group: 4.2
± 2.0; p < 0.01)
Preoperative LKA was lower in the L
group (L group: 5.4
± 15.7°, T group: 26.3 ± 15.9°; p <
0.001). LKA was significantly
corrected after surgery (L group: −5.9
± 14.0°, T group: 8.3 ± 11.3°). There
was no significant difference in the
mean correction loss of LKA.
Mechanical failure was more frequently
found in the L group (L group: 64%, T
group: 39%; p < 0.001). There was no
significant difference in the rate of
perioperative complication, newly
developed vertebral fracture, and
revision surgery.
1031
Both leg and low back pain improved
significantly at final
follow-up in both groups
No significant difference in the JOA
score preoperatively
and at final follow-up. The JOA score
improved significantly at final follow-up
in both the L group and the T group.
ADL score improved significantly at
final follow-up in both groups.
Author conclusions (relevant to
question): There was no difference in
clinical and radiographical outcomes
between OVF at the lumbar spine and
that at the thoracolumbar spine,
although the rate of complication and
revision surgery remains high in both
regions because of bone
fragility.Therefore, we concluded that
surgical intervention for OVF is
effective in patients with myelopathy or
radiculopathy regardless of the
fractured level.
Maruo K, Tachibana T, Arizumi F, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Kusuyama K, Kishima K, Yoshiya S. Prognostic ☐ Patients not enrolled at
Effect of Teriparatide on Study Design: Comparative same point in their disease
Subsequent Vertebral Fractures Level IV ☐ <80% follow-up
after Instrumented Fusion Surgery Stated objective of study: Our ☐ Follow-up not standardized
for Osteoporotic Vertebral Fractures Explanation of failure to meet hypothesis was as follows: (1)
with Neurological Deficits. Asian guideline inclusion criteria long-instrumented fusion surgery for ☐ No validated outcome
Spine J. 2019;13(2):283-289. (when applicable) measures used
OVFs with neurological
doi:10.31616/asj.2018.0098 deficits increases the risk of ☒ Small sample size
☐ Level V (expert subsequent VFs and (2) ☐ Lacked subgroup analysis
consensus) TP decreases the risk of subsequent ☒ Diagnostic methods not
VFs. This study aimed described.
☐ Level IV in presence of to assess the incidence and effect of ☒ Other: pre-op treatment
higher quality studies TP (teriparatide) on subsequent VFs was not standardized;
after long-instrumented fusion surgery patient selection
☐ Subgroup analysis data for OVFs.
not available
1032
Total number of patients in the study:Level of Evidence
☐ Not relevant to question N=47 Determination
Number of patients in Potential Level: III
relevant subgroup(s): 18 pts with Downgraded Level: IV
subsequent VF (38%) Downgraded due to small
sample size, diagnostic
methods not described;
Duration of follow-up: mean follow-up
pre-op treatment was not
was 23 months
standardized; patient selection
Validated outcome measures used
Conclusions
(list): VAS, JOA
This paper provides evidence
that: for patients undergoing
Nonvalidated outcome measures used
surgery for OVCF, the use of
(list): postop vertebral fractures,
teriparatide in the
complications, reoperation, , Barthel
perioperative setting
Index, , kyphotic angle (KA)
reduces the incidence of
subsequent OVCFs
Diagnosis made by:
compared to
☐ Clinical exam/history bisphosphonate treatment.
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Results/subgroup analysis (relevant to
question):
Fusion rate was similar between the
TP group and the non-
TP group.
There were no significant differences in
the age, sex, fused levels, presence of
prevalent fracture, postoperative KA
(immediately and at the final follow-up),
and LBP score between the TP group
and the non-TP group.
Occurrence of subsequent vertebral
fracture was lower in the TP group
1033
(16% versus 54%, p=0.014).
log-rank test revealed that the TP
treatment significantly reduced the risk
of subsequent VFs (p=0.048)
Preoperative TP treatment was only a
protective factor for subsequent VFs
after instrumented fusion surgery for
osteoporotic vertebral collapse (hazard
ratio, 0.281; 95% confidence interval,
0.08–0.985; p=0.047).
Author conclusions (relevant to
question): TP treatment significantly
reduced the incidence of subsequent
VFs
after instrumented fusion surgery for
OVFs. A prospective randomized study
is warranted to determine the efficacy
of TP treatments.
Murata K, Matsuoka Y, Nishimura Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
H, et al. The factors related to the Prognostic ☐ Patients not enrolled at
poor ADL in the patients with Study Design: Case Control same point in their disease
osteoporotic vertebral fracture after Level IV ☐ <80% follow-up
instrumentation surgery. Eur Spine Stated Objective: ☐ Follow-up not standardized
J. 2020;29(7):1597-1605. Explanation of failure to meet To determine prognostic factors for
doi:10.1007/s00586-019-06092-0. ☐ No validated outcome
guideline inclusion criteria postoperative function
measures used
(when applicable) in ADL in light of differences between
walkers and chairbound/ ☐ Small sample size
☐ Level V (expert bedridden patients ☐ Lacked subgroup analysis
consensus) ☒ Diagnostic methods not
Total number of patients in the study: described.
☐ Level IV in presence of N=309 (403 pts initially reviewed) ☐ Other: Click or tap here to
higher quality studies enter text.
Number of patients in
relevant subgroup(s): Level of Evidence
☐ Subgroup analysis data
126 pts with neuro deficit ASIA A-C Determination
not available
pre-op Work group conclusions
poor ADL pre-op 164 (53%) Potential Level: III
☐ Not relevant to question poor ADL post-op 28 (9%) Downgraded Level: IV
Downgraded due to unclear
Duration of follow-up: mean methodological concerns
observation 45.9 months
1034
regarding rPTH administration
Validated outcome measures used (selection bias)
(list): VAS, JOA, mJOA for LBP
Conclusions relative to
Nonvalidated outcome measures used question
(list): Recovery rate, (Hirabayashi’s This paper provides evidence
equation), ADL that: for patients undergoing
surgery for OVCF, the
Diagnosis made by: presence of a pre-operative
☒ Clinical exam/history neurological deficit (Level III)
☐ Electromyography or perioperative
complication (Level III) or the
☐ Myelogram
absence of post-operative
☐ MRI rPTH administration (Level
☐ CT IV) is associated with chair
☐ CT/Myelogram bound or bedridden
☐ Other: functional status post-
operatively.
Results/subgroup analysis (relevant to
question):
In multivariate analysis…
preoperative neurological deficit (OR,
4.6; 95% CI, 1.9–12.4; P < 0.001),
presence of perioperative complication
(OR, 3.4; 95% CI, 1.4–8.3; P = 0.01),
and
absence of postoperative rPTH
administration (OR, 3.9; 95% CI, 1.3–
15.0; P = 0.02)
Author conclusions (relevant to
question): Preoperative neurological
deficit, perioperative complication, and
absence of postoperative rPTH
administration were considered as
predictors for postoperative poor ADL
in patients with OVF. Neurological
deficits and complications are often
inevitable factors; therefore, rPTH is an
important option for postoperative
treatment for OVF.
Ohba T, Yokomichi H, Koyama K, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Tanaka N, Oda K, Haro H. Factors Prognostic
1035
affecting postoperative mortality of Study Design: Case Control ☐ Patients not enrolled at
patients with insufficient union Level IV same point in their disease
following osteoporotic vertebral Stated objective of study: evaluate the ☐ <80% follow-up
fractures and impact of preoperative preoperative factors affecting the
☐ Follow-up not standardized
serum albumin on mortality. BMC Explanation of failure to meet postoperative mortality of patients who
Musculoskelet Disord. guideline inclusion criteria underwent spinal surgery for an ☐ No validated outcome
2020;21(1):528. Published 2020 (when applicable) insufficient bone union following OVF measures used
Aug 10. doi:10.1186/s12891-020- and determine postoperative mortality. ☐ Small sample size
03564-z ☐ Level V (expert ☐ Lacked subgroup analysis
consensus) Total number of patients in the study: ☒ Diagnostic methods not
105, but not all considered in analysis described.
☐ Level IV in presence of Number of patients in ☒ Other: timing of outcome
higher quality studies relevant subgroup(s): measure was not clearly
75 survived more than two years after described
☐ Subgroup analysis data surgery, of those
19 died Level of Evidence
not available
56 survived Determination
☐ Not relevant to question Potential Level: III
Duration of follow-up: mean follow- Downgraded Level: IV
up 4.1 ± 0.8 years. Downgraded due to diagnostic
methods and timing of
Validated outcome measures used outcome measure not clearly
(list): VAS described
Nonvalidated outcome measures used Conclusions
(list): mortality This paper provides evidence
that: in patients undergoing
Diagnosis made by: surgery for OVCF,
☒ Clinical exam/history preoperative
☐ Electromyography hypoalbuminemia is
☐ Myelogram associated with increased
☐ MRI mortality at 2 years
postoperatively.
☐ CT
☐ CT/Myelogram
☐ Other:
Results/subgroup analysis (relevant to
question):
multivariate analysis…
hypoalbuminemia was the only
significant risk factor for long-term
postoperative mortality of OVF
(adjusted HR was 3.37; p = 0.014)
1036
estimated risk of mortality at the final
followup, using the Kaplan-Meier
method, was significantly greater in
patients with preoperative serum
albumin ≤3.5 g/dL than in those with a
serum albumin > 3.5 g/dL (p < 0.0001
for log-rank test
Author conclusions (relevant to
question): Preoperative
hypoalbuminemia was associated with
postoperative mortality following
surgery for OVF.
Tamai K, Terai H, Suzuki A, et al. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Risk Factors for Proximal Junctional Prognostic ☐ Patients not enrolled at
Fracture Following Fusion Surgery Study Design: Observational same point in their disease
for Osteoporotic Vertebral Collapse Level IV ☐ <80% follow-up
with Delayed Neurological Deficits: Stated objective of study: the aim of ☐ Follow-up not standardized
A Retrospective Cohort Study of current study was to identify the
403 Patients. Spine Surg Relat Res. Explanation of failure to meet incidence and independent risk factors ☐ No validated outcome
2018;3(2):171-177. Published 2018 guideline inclusion criteria of measures used
Oct 19. doi:10.22603/ssrr.2018- (when applicable) proximal junctional fx PJFr, following ☐ Small sample size
0068 surgically treated OVC. ☐ Lacked subgroup analysis
☐ Level V (expert ☒ Diagnostic methods not
consensus) Total number of patients in the study: described.
403, but not all had BMD done ☐ Other: Click or tap here to
☐ Level IV in presence of enter text.
higher quality studies Number of patients in
relevant subgroup(s): 63 w/ PJFx Level of Evidence
☐ Subgroup analysis data 38 pts fx UIV Determination
not available 25 pts prox adjacent vert Potential Level: III
Downgraded Level: IV
Duration of follow-up: mean duration Downgraded due to diagnostic
☐ Not relevant to question
45.7 months methods not described
Validated outcome measures used Conclusions relative to
(list): Frankel grade question
This paper provides evidence
Nonvalidated outcome measures used that: for patients undergoing
(list): proximal junction fracture instrumented fusion for
diagnosed by senior surgeons on xray osteoporotic fracture with a
neurologic deficit, the
1037
or CT scan at regular f/u or when pt following characteristic is
complained of back pain, imaging associated with proximal
junctional fracture (PJFr):
Diagnosis made by: severe baseline
☒ Clinical exam/history osteoporosis (based on a
☐ Electromyography qualitative radiographic
☐ Myelogram assessment). In addition,
lumbar bone mineral density
☐ MRI (BMD) rather than hip BMD is
☒ CT predictive of PJFr.
☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Results/subgroup analysis (relevant to
question):
Multivariate Analysis identified the
following independent risk factors for
PJFr…
Grade of osteoporosis (grade 0 or I:
reference, grade II or III: aOR 2.92,
p=0.001),
LIV levels (thoracolumbar junction:
reference, sacrum: aOR 6.75,
p=0.003).
While, Age, UIV level, surgical
approach, and the number of fused
segments were not significant
independent factors.
Lumbar BMD was a significant factor
with good predictive ability (AUC=0.72,
95%CI: 0.57-0.88, p=0.035), but that of
the hip was not a significant factor.
The optimal cut-off value for predicting
PJFr after primary surgery
was 0.61 g/cm2 lumbar BMD
(sensitivity, 76.5%; specificity,
58.3%).
1038
Author conclusions (relevant to
question): PJFr following fusion
surgery for OVC was found in 15.6%
cases with a mean follow-up term of
45.7 months, while the independent
risk factors for PJFr were severe
osteoporosis and extended fusion to
the sacrum.
In addition, the lumbar DXA cut-off
value of 0.61 g/cm2 may potentially
predict the PJFr, but the hip DXA was
not predictive.
Our findings could help surgeons to
decide the perioperative adjuvant
therapy as well as the surgical strategy
to prevent
PJFr following surgery.
Surgical Treatment Question 6: In patients undergoing surgery for symptomatic osteoporotic vertebral compression fractures, are clinical and radiological
outcomes affected by the types of implants used?
Article Level Description of study Conclusion
(Alpha by Author) of evidence
El Saman A, Meier S, Sander A, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Kelm A, Marzi I, Laurer H. Reduced Therapeutic ☒ Nonconsecutive patients
loosening rate and loss of correction Study Design: Comparative ☒ Nonrandomized
following posterior stabilization with Level IV ☐ Nonmasked reviewers
or without PMMA augmentation of Stated objective of study: aim of the
pedicle screws in vertebral fractures ☒ Nonmasked patients
present study was to
in the elderly. Eur J Trauma Emerg Explanation of failure to meet evaluate postoperative loss of ☒ No validated outcome
Surg. 2013;39(5):455-460. guideline inclusion criteria correction and loosening of measures used
doi:10.1007/s00068-013-0310-6 (when applicable) the pedicle screws at osteoporotic ☒ Small sample size
vertebral fractures in ☐ <80% follow-up
☐ Level V (expert consensus) elderly ☐ Lacked subgroup analysis
☒ Diagnostic method not
☐ Level IV in presence of Type of treatment(s): Screw stated
higher quality studies augmentation with PMMA vs. No ☐ Other: Click or tap here to
PMMA Specifically: Either 6.35 enter text.
☐ Subgroup analysis data not fenestrated/cement screws or 6mm
available
1039
non-cemented screws, max 3 cc Level of Evidence
☐ Not relevant to question cement per screw Determination
Potential Level: III
Total number of patients: n=24 Downgraded Level: IV
Number of patients in relevant Downgraded due to no
subgroup(s): 15 pts (117 screws) w/ validated outcome measures
PMMA; 9 pts. (86 screws) without used, small sample size,
diagnostic method not stated,
Consecutively assigned? No nonconsecutive and
nonrandomized patients, and
Duration of follow-up: 430 days nonmasked patients.
(ranging from 44 to 1,467 days)
Conclusions
Validated outcome measures used This paper provides evidence
(list): N/A that: in patients undergoing
surgery for osteoporotic
Nonvalidated outcome measures used vertebral fractures, the use
(list): of PMMA screw
Xrays, CT scan of fractured vertebra augmentation reduces rates
in intrumented spine or adjacent levels; of screw loosening and
loss of correction sagittal plane, provides a 3.8° reduction in
kyphosis of fractured vertebra, loss of sagittal correction
loosening of pedicle screws compared to pedicle screw
fixation without PMMA.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☒ CT
☐ CT/Myelogram
☒ Other: vertebral fractures of
traumatic origin in the thoracolumbar
junction or lumbar spine
Results/subgroup analysis:
group 1, clear zones detected in 54
screws (62.8 %) compared with group
2, clear zones found in only 4.3 % of
screws (5/117) The difference in the
loosening rates between groups 1 and
2 was significant (chi2 test), p<0.001
1040
group 1 displayed a loss of correction
of 4.9° ± 3.8°. In group 2, we saw a
significantly lower loss of correction
concerning the bisegmental Cobb
angle of 1.1° ± 0.78° (p < 0.01)
kyphosis angle of the fractured
vertebra, cement augmentation (group
2) was significantly reduced (3.3° ±
3.1° in group 1 vs. 0.9° ± 0.5° in group
2, (p < 0.01,
Author conclusions: The reinforcement
of pedicle screws using PMMA
augmentation may be a viable option in
the surgical treatment of spinal
fractures in the elderly.
Girardo M, Rava A, Fusini F, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Gargiulo G, Coniglio A, Cinnella P. Therapeutic ☒ Nonconsecutive patients
Different pedicle osteosynthesis for Study Design: Comparative ☒ Nonrandomized
thoracolumbar vertebral fractures in Level III
☒ Nonmasked reviewers
elderly patients. Eur Spine J. Stated objective of study: Aim of our ☒ Nonmasked patients
2018;27(Suppl 2):198-205. Explanation of failure to meet
study is to report the outcomes and
doi:10.1007/s00586-018-5624-y guideline inclusion criteria ☐ No validated outcome
complications of thoracolumbar
(when applicable) vertebral fractures in aged population measures used
treated with three different types of ☐ Small sample size
☐ Level V (expert consensus) screws: solid screws, cannulated ☐ <80% follow-up
screws and cannulated ☐ Lacked subgroup analysis
☐ Level IV in presence of screws with PMMA augmentation. ☐ Diagnostic method not
higher quality studies stated
Type of treatment(s): Pedicle screws, ☒ Other: statistical power; 5
☐ Subgroup analysis data not cannulated screws, cannulated screws cases of loosening?
available with PMMA
Level of Evidence
☐ Not relevant to question Total number of patients: 91 pts total Determination
(33 group one, 26 group 2, 32 group Potential Level: III
3) Downgraded Level: Not
Downgraded
Consecutively assigned? No
Conclusions
Duration of follow-up: 18-70 months This paper provides evidence
(mean 26 months) that: in patients undergoing
surgery for osteoporotic
1041
Validated outcome measures used vertebral compression
(list): VAS, ODI fractures, the use of screw
augmentation with PMMA
Nonvalidated outcome measures used results in lower rates of
(list): Radiologic measurements—loss screw loosening with similar
of sagittal plane correction, kyphosis clinical outcomes compared
angle of the fracture, loosening of to pedicle screw fixation
pedicle screws (screw’s apex vertebral without PMMA. The use of
body’s anterior cortex mean gap screw augmentation with
(SAAC gap) and screw’s apex superior PMMA is associated with the
endplate mean gap (SASE) gap, attendant risks of possible
cement leakage classified with Yeom embolization and adjacent
classification level fracture.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☐ MRI
☐ CT
☐ CT/Myelogram
☒ Other: DEXA
Results/subgroup analysis:
bisegmental Cobb angle and kyphosis
angle of the fractured vertebra.
Significant differences found between
all groups, and Group 3 resulted to
have the best performances.
fractured vertebra angle
no significative difference between
Group 1 and Group 2 (p > 0.05).
Group 3 resulted in significant
difference compared to Group 1 and
Group 2 (p < 0.05).
VAS
2.3 (range 0–5); no significative
differences found between groups (p >
0.05).
Oswestry questionnaire results
1042
9% (range 3–12%)’ no significative
differences between groups (p >
0.05).
Author conclusions: All stabilization
methods showed good clinical results,
but cannulated screws augmented with
PMMA seem to provide better implant
stability with the lowest rate of
loosening. However, it must be
considered that PMMA
augmentation may cause severe
complications such as death
by embolism and adjacent level
fractures. An accurate preoperative
planning is essential to achieve best
results.
Kashii M, Yamazaki R, Yamashita T, Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
et al. Surgical treatment for Therapeutic ☐ Nonconsecutive patients
osteoporotic vertebral collapse with Study Design: Comparative ☐ Nonrandomized
neurological deficits: retrospective Level IV
☐ Nonmasked reviewers
comparative study of three Stated objective of study: to compare
procedures—anterior surgery versus Explanation of failure to meet neurological recovery among three ☐ Nonmasked patients
posterior spinal shorting osteotomy guideline inclusion criteria typical procedures ☐ No validated outcome
versus posterior spinal fusion using (when applicable) for OVC with neurological deficits. measures used
vertebroplasty. Eur Spine J. ☐ Small sample size
2013;22:1633-1642. ☐ Level V (expert consensus) Type of treatment(s): ☐ <80% follow-up
SOURCE: (1)anterior neural decompression and ☐ Lacked subgroup analysis
☐ Level IV in presence of reconstruction (AR ☐ Diagnostic method not
higher quality studies group: 27 patients), stated
(2) posterior spinal shortening ☒ Other: inconsistent
☐ Subgroup analysis data not osteotomy with direct neural application of treatments and
available decompression (PS group: 36 heterogeneous population;
patients), and groups did not match up,
(3) posterior indirect neural
☐ Not relevant to question comparison between groups
decompression and short-segment limited
spinal fusion combined with
vertebroplasty (VP group: 25 patients) Level of Evidence
Determination
Total number of patients: 8888 (29 Potential Level: III
male, 59 female) Downgraded Level: IV
Downgraded due to
Number of patients in inconsistent application of
relevant subgroup(s): treatments and significant
1043
three surgical procedures in 88 differences in baseline
patients: characteristics between the
(1)anterior neural decompression and treatment groups
reconstruction (AR
group: 27 patients), Conclusions
(2) posterior spinal shortening This paper provides evidence
osteotomy with direct neural that: in patients with OVCF
decompression (PS group: 36 with neurological deficits
patients), and undergoing surgical
(3) posterior indirect neural decompression and fixation,
decompression and short-segment the use of anterior vs.
spinal fusion combined with posterior surgical
vertebroplasty approaches selected based
(VP group: 25 patients) on presenting
characteristics results in
Consecutively assigned? No similar clinical outcomes.
Due to selection bias, the
Duration of follow-up: 24-123 radiological differences
months.882 years between groups should be
interpreted with caution.
Validated outcome measures used
(list): Neurological deficits(modified .
Frankel grading) and ADLs Scoring
Systemt estab by Ministry of Health,
Welfare and Labor of Japan
Preoperative and postoperative
pain, Franklel
grade, function level in ADL,
and postoperative complications,
Local kyphotic angle (LKA)
Nonvalidated outcome measures used
(list): radiographic results, post-op cx
Click or tap here to enter text.
Diagnosis made by:
☒ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒ MRI
☒ CT
☒ CT/Myelogram
1044
☒ Other: radiographic results - type
not specifiedClick or tap here to enter
text.
Results/subgroup analysis: Among the
3 groups, there were no Pre and post-
op pain score - no sig differences
Neurological score - no sign
differences
ADL function- no sig difference
Improvement in LBP or BP, leg pain -
no sig differences
VP group had a higher correction loss
rate (AR group, 54 %; Ps group, 43 %;
VP group, 88 %).
Post-op VFs- The PS group had the
highest incidence
of subsequent VFs within the fused
level, at the adjacent
level, and at the nonadjacent level
Results/subgroup analysis:
Among the 3 groups,
Preop-Postop pain score
There were no significant
differences
Neurological score:
there were no significant differences
ADL function score
there were no significant differences
Blood Loss
VP group lost significantly less blood
and needed
significantly less time in surgery than
did patients in the AR group and those
in the PS group
Short-segment PSF with indirect
decompression using vertebroplasty
was less-invasive surgical procedure
1045
than the other 2 procedures.
LKA
The PS group had the highest
incidence of subsequent VFs
within the fused level, at the adjacent
level, and at the nonadjacent
level (incidence of total
subsequent VFs: AR group, 26
%; PS group, 71 %; VP group, 38
%).
PS group had a higher incidence of
subsequent osteoporotic VFs at the
non adjacent level than both the AR
and the VP groups.
Complications
Nine of 88 patients (10.2 %) had a
deep surgical site infection (SSI) after
spinal instrumentation surgery(AR
group, 2 cases; PS group, 4 cases; VP
group, 3 cases), and 2 of those 9
patients had septic shock.
Results/subgroup analysis: Click or
tap here to enter text.
Author conclusions: Click or tap here
to enter text.Author conclusions: It is
not always necessary to perform
direct neural decompression in
comparing clinical results
among 3 typical procedures for OV
C with neurological deficits.
The majority of these patients can be
treated by less-invasive procedures
such as short-segment PSF within
direct decompression combined with
vertebroplasty.Author conclusions:
Click or tap here to enter text. .
Nakashima H, Imagama S, Yukawa Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Y, et al. Comparative study of 2 Therapeutic ☒ Nonconsecutive patients
surgical procedures for osteoporotic Study Design: Comparative ☒ Nonrandomized
delayed vertebral collapse: anterior Level IV
☒ Nonmasked reviewers
and posterior combined surgery
1046
versus posterior spinal fusion with Stated objective of study: to compare ☒ Nonmasked patients
vertebroplasty. Spine (Phila Pa Explanation of failure to meet the surgical results of anterior and ☐ No validated outcome
1976). 2015;40(2):E120-E126. guideline inclusion criteria posterior combined surgery (AP) and measures used
doi:10.1097/BRS.000000000000066 (when applicable) posterior fixation with vertebroplasty
☐ Small sample size
1 (VP) for treating osteoporotic delayed
☐ <80% follow-up
☐ Level V (expert consensus) vertebral collapse, and provide a
detailed analysis of the associated ☐ Lacked subgroup analysis
☐ Level IV in presence of problems ☐ Diagnostic method not
higher quality studies stated
Type of treatment(s): ☐ Other: Click or tap here to
☐ Subgroup analysis data not Anterior and Posterior Combined enter text.
Surgery
available
Posterior Spinal Fusion (short-seg) Level of Evidence
with Vertebroplasty Determination
☐ Not relevant to question
Potential Level: III
Total number of patients: 93 patients Downgraded Level: IV
65 pts AP surgery Downgraded due to selection
28 VP surgery bias and treatment allocation
decisions not specified.
Consecutively assigned? No
Conclusions relative to
Duration of follow-up: at least 2 years question
This paper provides evidence
Validated outcome measures used that: in patients undergoing
(list): Frankel classification surgery for progressive
osteoporotic vertebral
Nonvalidated outcome measures used fractures, the use of anterior
(list): Kyphotic angle, spinal canal column reconstruction plus
encroachment, OR time, intraoperative posterior fixation results in
blood loss, complications, similar neurological
Radiographic—xrays & CT scan, MRI, outcomes with increased
pedicle screw loosening/cutout, fusion, operative times and
operation time, adjacent segment estimated blood loss (EBL)
fracture but reduced rates of pedicle
screw loosening,
Diagnosis made by: pseudarthrosis and loss of
☒ Clinical exam/history correction compared to
☐ Electromyography posterior fixation with
☐ Myelogram vertebroplasty.
☐ MRI
☒ CT
☐ CT/Myelogram
☒ Other: x-ray
1047
Results/subgroup analysis:
Frankel Grade
No significant differences between the
2 groups either pre- or postoperatively.
Neurological recovery was also similar
in both groups.
Kyphootic angle
mean loss of correction was
significantly greater in the VP group
than in the AP group. (p= 0.003)
spinal canal encroachment
spinal canal encroachment at the final
follow-up was significantly less in the
AP group (P < 0.0001).
operation time
mean operation time was significantly
longer in the AP group.
intraoperative blood loss
mean blood loss significantly greater in
the AP group.
pedicle screw loosening
VP had significantly greater screw
loosening (p=<0.001)
adjacent segment fracture
no significant difference between
groups
Author conclusions: Although VP
surgery is a minimally invasive surgery
in terms of surgical duration and blood
loss, postoperative complications such
as nonunion and severe local kyphosis
progression were more often observed
in patients with VP than in patients with
AP in our study. For this reason, AP
surgery is more preferable for
osteoporotic delayed vertebral fracture
with low bone quality.
1048
Sudo H, Ito M, Kaneda K, et al. Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
Anterior decompression and strut Therapeutic ☐ Nonconsecutive patients
graft versus posterior Study Design: Comparative ☒ Nonrandomized
decompression and pedicle screw Level IV
☒ Nonmasked reviewers
fixation with vertebroplasty for Stated objective of study: This study
osteoporotic thoracolumbar vertebral Explanation of failure to meet ☒ Nonmasked patients
aimed to compare
collapse with neurologic guideline inclusion criteria surgical results of anterior and ☐ No validated outcome
deficits. Spine J. 2013;13(12):1726- (when applicable) posterior procedures for measures used
1732. treating osteoporotic thoracolumbar ☒ Small sample size
doi:10.1016/j.spinee.2013.05.041 ☐ Level V (expert consensus) vertebral collapse with ☐ <80% follow-up
sustained neurologic deficits and ☐ Lacked subgroup analysis
☐ Level IV in presence of provide a detailed explanation of the ☐ Diagnostic method not
higher quality studies associated problems stated
☐ Other: Click or tap here to
☐ Subgroup analysis data not Type of treatment(s): Anterior enter text.
available decompression and strut graft vs.
posterior decompression and pedicle Level of Evidence
screw fixation with vertebroplasty
☐ Not relevant to question Determination
Work group conclusions
Total number of patients: 50 (43 F, 7M) Potential Level: III
Downgraded Level: IV
Number of patients in Downgraded due to small
relevant subgroup(s): sample size and experience
32 pts (1996-2003) Anterior group bias.
18 pts Posterior group
Conclusions relative to
Consecutively assigned? No question
This paper provides evidence
Duration of follow-up: minimum 2 years that: in patients undergoing
(60 month mean, range 30-185 mo) surgery for progressive
osteoporotic vertebral
Validated outcome measures used fractures, the use of anterior
(list): Japanese Orthopedic Association column reconstruction plus
(JOA) score posterior fixation results in
similar neurological
Nonvalidated outcome measures used outcomes with increased
(list): spinal canal encroachment, OR operative times and EBL but
time, EBL complications, sagittal Cobb reduced rates of pedicle
angle screw loosening,
pseudarthrosis and loss of
Diagnosis made by: correction compared to
☒ Clinical exam/history
1049
☐ Electromyography posterior fixation with
☐ Myelogram vertebroplasty.
☐ MRI
☒ CT
☐ CT/Myelogram
☒ Other: DEXA, x-rayDEXA
Results/subgroup analysis:
Japanese Orthopedic Association
(JOA) score
Neurologic improvement was similar
between the groups at both
postoperative and final follow-up
assessments
sagittal Cobb angle
mean loss of correction was similar
between the two groups.
Spinal canal encroachment
Spinal canal encroachment at final
follow-up was significantly less in the
anterior group (p<.0001)
complications
No vascular or neurologic
complications occurred in either group
except for one patient in the anterior
group who developed postoperative
neurologic deterioration.
Additional posterior instrumentation
surgery was required in nine patients
(28%) in the anterior group because of
progression of a kyphotic deformity or
screw loosening within 3 months
postoperatively.
No significant differences in age at
surgery, sex, preoperative JOA score,
kyphosis, spinal canal encroachment,
operation time, or intraoperative blood
loss were observed when the anterior
group was divided into an additional
1050
surgery group and an anterior-only
surgery group.
mean BMD was significantly less in the
additional surgery group (0.60 g/cm2)
than that in the anterior-only group
(0.71 g/cm2).
Author conclusions: Anterior
reconstruction for osteoporotic
vertebral collapse is significant
because anterior elements, particularly
those at the thoracolumbar junction,
play a major role in load bearing.
However, difficulties arise when
anterior reconstruction is performed in
cases with very low bone density and
in those with multiple vertebral
collapse.
1051
Uchida K, Nakajima H, Yayama T, et Type of evidence: ☐ Prospective ☒ Retrospective Critique of methodology:
al. Vertebroplastyaugmented short- Therapeutic Study Design: Comparative ☒ Nonconsecutive patients
segment posterior fixation of ☒ Nonrandomized
osteoporotic vertebral collapse with Level IV .Stated objective of study: clarify the ☐ Nonmasked reviewers
neurological deficit in the
thoracolumbar spine: comparisons
clinical outcome of posterior ☐ Nonmasked patients
surgery with vertebroplasty, and to ☐ No validated outcome
with posterior surgery without Explanation of failure to meet
vertebroplasty and anterior surgery. compare the 3 surgical procedures
guideline inclusion criteria measures used
J Neurosurg Spine. 2010;13: 612-6 (when applicable) for osteoporotic vertebral collapse ☐ Small sample size
associated with neurological ☐ <80% follow-up
☐ Level V (expert consensus) deficits in the thoracolumbar spine. ☐ Lacked subgroup analysis
☐ Diagnostic method not
☐ Level IV in presence of .Type of treatment(s): posterior stated
higher quality studies surgery combined with ☒ Other: inconsistent
vertebroplasty (Group A), posterior application of treatments
☐ Subgroup analysis data not surgery without vertebroplasty across groups
available (Group B), and anterior surgery
(Group C) Level of Evidence
☐ Not relevant to question Determination
Total number of patients: 83 patients; Potential Level: III
13 men and 70 women Downgraded Level: IV
Downgraded due to
Number of patients in inconsistent application of
relevant subgroup(s): Group A n=28 treatments across groups
Group B n=25
Group C n=30 Conclusions
This paper provides evidence
Consecutively assigned? No that: in patients with
neurological deficits
Duration of follow-up: 4.4 years undergoing posterior short
segment fixation for OVCF,
Validated outcome measures used the addition of vertebral
(list): kyphotic angle, JOA neurological augmentation to the
status, VAS fractured level reduces rates
of postoperative loss of
Nonvalidated outcome measures used correction as well as
(list): complications instrumentation failure.
Diagnosis made by:
☐ Clinical exam/history
☐ Electromyography
☐ Myelogram
☒☐ MRI
1052
☒☐ CT
☒☐ CT/Myelogram
☐ Other: Click or tap here to enter
text.
Results/subgroup analysis:
Kyphotic Angle:
Postoperative (4–6 weeks) kyphotic
angle in Group B was significantly
reduced in a comparison between
Group B and Group C (p = 0.007;
8.9° ± 6.0°and 13.9° ± 6.8°,
respectively). Final follow-up kyphotic
angle was not significantly different
among the 3 groups.
The mean losses of correction at
follow-up were 4.6° ± 4.5° (Group A),
8.6° ± 6.2° (Group B), and 4.5° ± 5.9°
(Group C). The correction loss at
follow-up in Group B was significantly
higher compared with Groups A and C
(p = 0.0171 and p = 0.0180,
respectively).
JOA/Neurological Status:
Post-operative (4–6 weeks) and final
follow-up neurological
score and neurological improvement
rate at follow-up were not significantly
different among the 3 groups (p =
0.163).
VAS:
Postoperative (4–6 weeks) and final
follow-up VAS scores were also not
significantly different among the 3
groups (p = 0.0758; 2.1 ± 1.0, 2.4 ±
1.0, 2.7 ± 1.1 for Groups A, B, and C,
re-spectively), although patients in
Group A tended to have
less pain postoperatively than did th
ose in the anterior group (Group C).
Complications:
1053
Group A: 4 (14%) of the 28 patients
developed
instrumentation failures, including 3
with screw pullout and 1 with screw
disconnection during the postoperative
course.
No vertebroplasty-related
complications.
No adjacent vertebral fracture related
to the posterior fusion
Group B: 7 (28%) of 25 cases,
including 4 patients with screw pullout,
2 with screw fracture, and 1 with screw
disconnection. Pseudarthrosis of PLF
developed in 2 cases in Group B.
No adjacent vertebral fracture related
to the posterior fusion
Group C: 4 cases of 30 patients,
despite a lack
of correlation with neurological statu
s. These included loose vertebral
screw (4 cases), dislodgment of the
anterior plate (3), and subsidence of
the titanium cage within the distal level
of the vertebra > 5 mm (3). A low-
grade
asymptomatic compression fracture
occurred in vertebrae 1–3 levels
above or below the reconstruction level
in 2 patients at the final follow-up.
Author conclusions: Vertebroplasty
using CPC or HA materials
supports and maintains kyphosis cor
rection, and also
increases and maintains anterior ver
tebral height in short-
segment PS fixation performed in p
atients with
thoracolumbar osteoporotic vertebral
collapse.
1054
1055
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