CLINICAL ARTICLE

J Neurosurg Spine 37:607–616, 2022

Outcomes of operative treatment for adult spinal

deformity: a prospective multicenter assessment with
mean 4-year follow-up
Elias Elias, MD, MPH, MSc,1 Shay Bess, MD,2 Breton Line, BSME,2 Virginie Lafage, PhD,3
Renaud Lafage, MS,4 Eric Klineberg, MD,5 Han Jo Kim, MD,4 Peter G. Passias, MD,6
Zeina Nasser, MSc, PhD,7 Jeffrey L. Gum, MD,8 Khal Kebaish, MD,9 Robert Eastlack, MD,10
Alan H. Daniels, MD,11 Gregory Mundis Jr., MD,10 Richard Hostin, MD,12
Themistocles S. Protopsaltis, MD,6 Alex Soroceanu, MD,13 D. Kojo Hamilton, MD,14
Michael P. Kelly, MD,15 Munish Gupta, MD,16 Robert Hart, MD,17 Frank J. Schwab, MD,3
Douglas Burton, MD,18 Christopher P. Ames, MD,19 Christopher I. Shaffrey, MD,20
Justin S. Smith, MD, PhD,1 and the International Spine Study Group
1
Department of Neurosurgery, University of Virginia, Charlottesville, Virginia; 2Presbyterian St. Luke’s Medical Center,
Denver, Colorado; 3Department of Orthopedic Surgery, Lenox Hill Hospital, New York, New York; 4Department of Orthopaedic
Surgery, Hospital for Special Surgery, New York, New York; 5Department of Orthopaedic Surgery, University of California,
Davis, Sacramento, California; 6Department of Orthopaedic Surgery, NYU Hospital for Joint Diseases, New York, New York;
7
Neuroscience Research Center, Faculty of Medical Sciences, Lebanese University, Hadath, Lebanon; 8Leatherman Spine
Center, Louisville, Kentucky; 9Department of Orthopedic Surgery, Johns Hopkins Hospital, Baltimore, Maryland; 10Scripps
Clinic, San Diego, California; 11Department of Orthopedic Surgery, Brown University, Providence, Rhode Island; 12Department of
Orthopaedic Surgery, Baylor Scoliosis Center, Plano, Texas; 13Department of Orthopedic Surgery, University of Calgary, Alberta,
Canada; 14Department of Neurosurgery, University of Pittsburgh, Pittsburgh, Pennsylvania; 15Department of Orthopedic Surgery,
Rady Children’s Hospital, San Diego, California; 16Department of Orthopedic Surgery, Washington University, St. Louis, Missouri;
17
Department of Orthopaedic Surgery, Swedish Medical Center, Seattle, Washington; 18Department of Orthopaedic Surgery,
University of Kansas Medical Center, Kansas City, Kansas; 19Department of Neurological Surgery, University of California, San
Francisco, California; and 20Departments of Neurosurgery and Orthopedic Surgery, Duke University, Durham, North Carolina

OBJECTIVE  The current literature has primarily focused on the 2-year outcomes of operative adult spinal deformity
(ASD) treatment. Longer term durability is important given the invasiveness, complications, and costs of these proce-
dures. The aim of this study was to assess minimum 3-year outcomes and complications of ASD surgery.
METHODS  Operatively treated ASD patients were assessed at baseline, follow-up, and through mailings. Patient-report-
ed outcome measures (PROMs) included scores on the Oswestry Disability Index (ODI), Scoliosis Research Society–22r
(SRS-22r) questionnaire, mental component summary (MCS) and physical component summary (PCS) of the SF-36, and
numeric rating scale (NRS) for back and leg pain. Complications were classified as perioperative (≤ 90 days), delayed
(90 days to 2 years), and long term (≥ 2 years). Analyses focused on patients with minimum 3-year follow-up.
RESULTS  Of 569 patients, 427 (75%) with minimum 3-year follow-up (mean ± SD [range] 4.1 ± 1.1 [3.0–9.6] years) had
a mean age of 60.8 years and 75% were women. Operative treatment included a posterior approach for 426 patients
(99%), with a mean ± SD 12 ± 4 fusion levels. Anterior lumbar interbody fusion was performed in 35 (8%) patients, and
89 (21%) underwent 3-column osteotomy. All PROMs improved significantly from baseline to last follow-up, including

ABBREVIATIONS  ASD = adult spinal deformity; BMI = body mass index; CCI = Charlson Comorbidity Index; GCA = global coronal alignment; HRQOL = health-related
quality of life; MCID = minimal clinically important difference; MCS = mental component summary; NRS = numeric rating scale; ODI = Oswestry Disability Index; PCS =
physical component summary; PI-LL = pelvic incidence to lumbar lordosis mismatch; PROM = patient-reported outcome measure; PT = pelvic tilt; SRS-22r = Scoliosis
Research Society–22r; SVA = sagittal vertical axis; TK = thoracic kyphosis.
SUBMITTED  January 22, 2022.  ACCEPTED  March 16, 2022.
INCLUDE WHEN CITING  Published online April 29, 2022; DOI: 10.3171/2022.3.SPINE2295.

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Elias et al.

scores on ODI (45.4 to 30.5), PCS (31.0 to 38.5), MCS (45.3 to 50.6), SRS-22r total (2.7 to 3.6), SRS-22r activity (2.8 to
3.5), SRS-22r pain (2.3 to 3.4), SRS-22r appearance (2.4 to 3.5), SRS-22r mental (3.4 to 3.7), SRS-22r satisfaction (2.7
to 4.1), NRS for back pain (7.1 to 3.8), and NRS for leg pain (4.8 to 3.0) (all p < 0.001). Degradations in some outcome
measures were observed between the 2-year and last follow-up evaluations, but the magnitudes of these degradations
were modest and arguably not clinically significant. Overall, 277 (65%) patients had at least 1 complication, including 185
(43%) perioperative, 118 (27%) delayed, and 56 (13%) long term. Notably, the 142 patients who did not achieve 3-year
follow-up were similar to the study patients in terms of demographic characteristics, deformities, and baseline PROMs
and had similar rates and types of complications.
CONCLUSIONS  This prospective multicenter analysis demonstrated that operative ASD treatment provided significant
improvement of health-related quality of life at minimum 3-year follow-up (mean 4.1 years), suggesting that the benefits
of surgery for ASD remain durable at longer follow-up. These findings should prove useful for counseling, cost-effective-
ness assessments, and efforts to improve the safety of care.
https://thejns.org/doi/abs/10.3171/2022.3.SPINE2295
KEYWORDS  adult spinal deformity; prospective multicenter; outcomes; complications; surgery

A
spinal deformity (ASD) is a heterogeneous
dult
entity that can cause significant pain and disabil-
ity.1,2 Degenerative conditions are the most com-
mon etiologies of ASD, resulting in combinations of sco-
liosis and sagittal-plane malalignment that can produce
back and leg pain, marked functional impact, and neuro-
logical deficits.3–5 Among the aging population, the preva-
lence of ASD has been estimated to be as high as 68%.6
Although symptoms may be mild and readily manage-
able for some individuals with ASD, for others the impact
may drive them to seek medical care. In the absence of
rapidly progressive deformity or significant neurological
compromise, nonoperative measures are typically favored
as first-line treatments. These may include combinations
of physical therapy, targeted steroid injections, and phar-
macological treatments (e.g., muscle relaxers, gabapentin,
nonsteroidal anti-inflammatory drugs).7 These nonopera-
tive measures may provide at least temporary benefit in
a subset of patients, but over longer follow-up these mea-
sures appear to at best maintain the presenting level of
symptoms.4,5,8–12
Several studies have shown that surgical treatment can
provide significant improvement in health-related qual-
ity of life (HRQOL), including pain and disability, for
symptomatic ASD patients who do not receive sufficient
benefit from nonoperative measures.4,5,8–11,13–17 However,
most previous studies have focused on 1- or 2-year out-
comes,4,5,8,9,11,13,15 with only a few including longer term
outcomes.10,14,17 Given the invasiveness,15 high associated
complication rates,15,16,18–20 and costs21–23 of these proce-
dures, assessment of the longer term durability of these
procedures is important. It is particularly important to as-
sess whether patients continue to demonstrate significant
improvements in HRQOL measures with longer follow-up
or whether the benefits seen with shorter term follow-up
are lost over time. It is also important to assess the occur-
rence of delayed complications because one of the most
common complications associated with ASD surgery is
implant failure, and the majority of these failures occur
between 2 and 5 years after surgery.18
Our objectives in the present study were to assess the
outcomes and the rates and types of complications associ-
ated with ASD surgery with minimum 3-year follow-up in
a prospective multicenter patient cohort. In addition, we
sought to assess for evidence of degradation in outcomes
between 2-year and minimum 3-year follow-up evalua-
tions.
Methods
Study Population
This prospective multicenter observational cohort
study was conducted to assess the outcomes of ASD
among those who underwent operative management at
one of 11 centers across the United States. Contributing
surgeons included orthopedic and neurological surgeons
with a practice focused on complex spinal reconstruction
and deformity treatment. IRB approval was obtained at
each participating site prior to enrollment, and all enrolled
patients provided informed consent. Study enrollment be-
gan in August 2008 and ended in December 2017. Eligible
patients were older than 18 years of age and had at least
one of the following radiographic measures at presenta-
tion: scoliosis ≥ 20°, sagittal vertical axis (SVA) ≥ 5 cm,
pelvic tilt (PT) ≥ 25°, and thoracic kyphosis ≥ 60°. Avail-
able data were collected from all patients who provided
consent for long-term follow-up.
A minimum follow-up of 3 years was selected for anal-
ysis in the present study on the basis of the standardized
follow-up windows applied across enrolling centers. After
the 2-year postoperative follow-up, the next standardized
window of follow-up was between 3 and 5 years. Although
the primary analyses focused on patients with minimum
3-year follow-up, we have also provided a summary of the
available complications and outcomes of the patients who
were eligible for, but did not receive, the minimum 3-year
follow-up as a means to assess potential confounding ef-
fects on outcomes that may have been introduced by the
patients who were lost to follow-up.
This study and the database from which the patients
were extracted were observational in design. Decisions
regarding surgical indications, clinical and radiographic
evaluations, surgical procedure and approach, and instru-
mentation were at the discretion of the operating surgeon.
Data Collection
At preoperative baseline and the postoperative fol-
low-up intervals, demographic, radiographic, and opera-

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tive data were collected, as well as scores for measures
of HRQOL. Standardized data collection forms were
used across all enrolling sites. Demographic and clini-
cal data included patient age and sex, body mass index
(BMI), Charlson Comorbidity Index (CCI), and history of
smoking, depression, osteoporosis, diabetes, and previous
spine surgery. HRQOL was assessed with patient-report-
ed outcomes measures (PROMs) that included the modi-
fied Oswestry Disability Index (ODI), Scoliosis Research
Society–22r (SRS-22r) questionnaire, the mental compo-
nent summary (MCS) and physical component summary
(PCS) of SF-36, and the numeric rating scale (NRS) for
back and leg pain.
Full-length standing anteroposterior and lateral radio-
graphs were obtained for all patients at the time of enroll-
ment and follow-up visits. Radiographs were analyzed at a
central site using validated software (Spineview, ENSAM
Laboratory of Biomechanics).24 Maximum coronal Cobb
angle, PT, pelvic incidence to lumbar lordosis mismatch
(PI-LL), global positive sagittal malalignment (SVA),
global coronal alignment (GCA), and thoracic kyphosis
(TK) were assessed with standard techniques. Patients
were classified on the basis of the Scoliosis Research So-
ciety–Schwab adult thoracolumbar spinal deformity clas-
sification.25–27
A standardized complications-reporting form was
completed for the perioperative time interval, for each
clinical follow-up, and at any time when the site became
aware of a new complication. De-identified data from each
center were sent to a central site where the collective data
sets were summarized and analyzed, and the complica-
tions were reviewed. The reported complications were
classified as minor or major, with major complications
classified as those that involved invasive intervention, pro-
longed or permanent morbidity, or death. Complications
were grouped on the basis of time of occurrence as peri-
operative (within 90 days of surgery), delayed (within 90
days to 2 years after surgery), or long term (greater than 2
years after surgery).
To maximize follow-up, patients who were eligible for
but had not completed the minimum 3-year follow-up
were contacted by telephone and/or direct mailings in or-
der to collect PROMs and complication/reoperation data.
Statistical Analysis
Statistical analysis was carried out using SPSS version
27.0 (IBM Corp.). Descriptive statistics were reported us-
ing mean ± SD for continuous variables and number (per-
cent) for categorical variables. The Pearson chi-square test
was used to compare categorical variables and the Student
t-test was used for continuous variables, as appropriate.
Repeated measures within-subjects analysis of variance
was performed to compare continuous radiographic mea-
sures and PROMs across clinical time points (baseline,
2-year follow-up, and last follow-up) in order to assess for
improvement after surgery and to assess for maintenance
of any improvement between the 2-year follow-up time
point and the last follow-up. C7–S1 SVA was considered
as a categorical variable (≤ 5 cm or > 5 cm) and was re-
ported as number (percent). Cochran’s Q test was used to
assess for differences in percentages across time points.
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Elias et al.
The post hoc McNemar test, with Bonferroni correction
for multiple comparisons, was performed to assess for dif-
ferences in percentages of patients with C7–S1 SVA > 5
cm between time points. The paired t-test was performed
to compare mean PROMs at baseline versus those at last
follow-up for the patients who did not achieve minimum
3-year follow-up. Continuous data were assessed using the
Kolmogorov-Smirnov test for normality. All tests were
2-tailed, with a significance level of p < 0.05.
The minimal clinically important difference (MCID)
values for the included PROMs were 12.8 for ODI, 4.9
PCS score of SF-36, 0.587 SRS-22r pain, 0.8 SRS-22r ap-
pearance, 0.375 SRS-22r activity, 0.42 SRS-22r mental, 1.2
NRS score for back pain, and 1.6 NRS score for leg pain,
which were based on the findings of previous reports.28–30
Results
Patient Population
Of 569 patients who met the inclusion criteria, 427
(75.0%) achieved the minimum 3-year follow-up (mean ±
SD 4.1 ± 1.2 years). Baseline demographic, clinical, and
radiographic parameters are summarized in Table 1. The
mean patient age was 60.8 years, and the majority of pa-
tients (74.6%) were women. The mean BMI was 27.8 ± 6.1,
and the mean Charlson Comorbidity Index was 1.9 ± 1.8.
More than one-half (53.5%) of patients had a history of
previous spine surgery. At baseline, patients demonstrated
moderate to severe disease impact, with mean ODI of 45.4,
PCS score 30.9, MCS score 45.5, SRS-22r total score 2.7,
NRS score for back pain 7.1, and NRS score for leg pain
4.9 (Table 1). Figure 1 provides a summary of deformities
based on the SRS-Schwab ASD classification.
Operative treatment included a posterior procedure for
426 (99.8%) patients. The mean number of posterior fu-
sion levels was 11.6 ± 3.9, and 35 (8.2%) patients under-
went anterior lumbar interbody fusion, 19 (4.4%) lateral
lumbar interbody fusion, 68 (15.9%) pedicle subtraction
osteotomy, and 21 (4.9%) vertebral column resection. The
mean estimated blood loss was 1.8 ± 1.5 L, and the mean
operative time was 7.1 ± 2.7 hours.
For the 142 patients who did not achieve the minimum
3-year follow-up, the mean follow-up duration was 1.2
± 0.8 years. In terms of baseline demographic, clinical,
PROM, and radiographic parameters, the subset of pa-
tients without 3-year follow-up was similar to those who
achieved minimum 3-year follow-up (Table 1). Notably,
the only observed statistically significant difference be-
tween these groups was modestly greater GCA in those
with minimum 3-year follow-up (38.0 mm vs 31.1 mm,
p = 0.02). Of the 142 patients without minimum 3-year
follow-up, 19 had died and thus assessment of longer term
outcomes was impossible. These deaths occurred at mean
± SD (range) 3.3 ± 1.6 (0.1–6.8) years after surgery. These
deaths appeared to have been unrelated to deformity sur-
gery, except for possibly the only 2 deaths that occurred
within 1 year of surgery. These included 1 patient who
died of cardiac arrest approximately 6 weeks after surgery
and the other patient who died of complications related to
a previous solid organ transplant approximately 3 months
after deformity surgery.
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TABLE 1. Baseline demographic, clinical, and radiographic

parameters of 569 patients with ASD
Achieved Minimum 3-Yr FU p
Parameter Yes (n = 427) No (n = 142) Value*
Demographic
  Female sex 74.6 70.2 0.32
  Age, yrs 60.8 ± 14.3 59.8 ± 13.9 0.45
Clinical
 BMI 27.8 ± 6.1 28.6 ± 6.8 0.22
 CCI 1.9 ± 1.8 1.8 ± 1.7 0.63
 Depression 24.4 27.5 0.50
 Smoker 3.9 5.8 0.34
 Osteoporosis 16.2 18.3 0.60
 Diabetes 8.7 11.3 0.41
  Previous spine surgery 53.5 50.4 0.56 FIG. 1. Distribution of Scoliosis Research Society–Schwab thoracolum-
bar classification scores for 427 adults with ASD. D = double coronal
PROMs curve; N = no coronal curve; T = thoracic coronal curve; TL = thoraco-
 ODI 45.4 ± 16.8 45.9 ± 18.3 0.77 lumbar coronal curve; 0 = normal; + = moderate deformity; ++ = severe
  SF-36 deformity.
  PCS 30.9 ± 9.5 29.6 ± 9.8 0.16
  MCS 45.5 ± 13.8 43.8 ± 14.2 0.24
  SRS-22r total 2.7 ± 0.6 2.6 ± 0.6 0.15 up evaluations was not statistically significant (p = 0.036)
  NRS score according to Bonferroni correction for multiple compari-
  Back pain 7.1 ± 2.2 7.4 ± 2.3 0.21 sons (3 post hoc McNemar tests [0.05/3 = 0.016], thus the
  Leg pain 4.9 ± 3.3 4.9 ± 3.3 0.97 p value threshold of < 0.016). Although the increase in
Radiographic TK between the 2-year and last follow-up evaluations was
  Global positive sagittal 58.7 65.0 0.12
statistically significant, the mean difference of 1.3° was
malalignment, %†
likely not clinically significant.
 PT, ° 25.1 ± 11.0 25.3 ± 11.0 0.90
Complications
 PI-LL, ° 18.6 ± 21.3 20.5 ± 21.3 0.38
Table 3 summarizes the perioperative (≤ 90 days),
  Max coronal Cobb angle, ° 38.3 ± 21.4 36.9 ± 20.9 0.52 delayed (90 days to 2 years), and long-term (> 2 years)
  Coronal alignment, mm 38.0 ± 34.4 31.1 ± 27.3 0.02 complications of the ASD patients who had at least 3-year
  T4–12 kyphosis, ° 34.9 ± 20.2 33.7 ± 21.4 0.56 follow-up. Overall, 507 complications were reported (237
FU = follow-up.
minor and 270 major), and 64.9% of patients were affected
Values are shown as percent or mean ± SD unless indicated otherwise. by 1 or more complications. A total of 114 patients (26.7%)
Boldface type indicates statistical significance (p < 0.05). underwent reoperations at any time from surgical inter-
* Exact 2-sided values are shown. vention to the last follow-up. A total of 282 perioperative
† Defined as C7–S1 SVA > 5 cm. complications (156 minor and 126 major) were reported,
with a mean number of complications per patient of 0.66.
A total of 151 delayed complications were reported (53
minor and 98 major). The mean number of delayed com-
Radiographic Assessment plications per patient was 0.35. Seventy-four long-term
Radiographic parameters at baseline and follow-up complications (28 minor and 46 major) were reported,
are summarized in Table 2. At 2-year follow-up, all as- with a mean number of complications per patient in this
sessed radiographic parameters demonstrated significant subcategory of 0.17.
improvement, including SVA (i.e., percentage of patients Table 4 provides a summary of the perioperative, de-
with SVA > 5 cm), PT, PI-LL, maximum coronal Cobb layed, and long-term complications reported for the 142
angle, GCA, and TK (all p < 0.001). Radiographic imaging ASD patients who were treated surgically but did not
was available beyond 2-year follow-up (mean ± SD 3.7 ± achieve minimum 3-year follow-up. Overall, 163 com-
0.9 years) for 318 patients; for these patients, the assessed plications were reported (71 minor and 92 major), with a
radiographic parameters remained significantly improved mean number of complications per patient of 1.15. A total
compared with baseline. Improvements in radiographic of 35 patients (24.7%) underwent reoperations at any time
measures at 2 years did not demonstrate clinically signifi- from surgical intervention to the last follow-up evaluation.
cant degradation between the 2-year follow-up and the last Collectively, the rates and types of perioperative and de-
follow-up evaluations for the 318 patients with available layed complications did not substantially differ from those
imaging beyond 2 years (Table 2). The 5% increase in pa- observed in patients with minimum 3-year follow-up. As
tients with SVA > 5 cm between the 2-year and last follow- expected, the rates of long-term complications were mark-

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TABLE 2. Radiographic parameters at baseline, 2-year follow-up, and last available imaging follow-up for 427 ASD patients who were
treated surgically with minimum 3-year follow-up (mean 4.1 years)
p Value
Preop Last Mean (95% CI) Difference Baseline vs Baseline vs 2-Yr vs
Radiographic Parameter Baseline 2-Yr FU Imaging FU* Btwn 2-Yr & Last FU 2-Yr FU Last FU Last FU
C7–S1 SVA >5 cm 58† 32† 37† <0.001† <0.001† 0.036†
PT, ° 25.0 ± 0.6 21.9 ± 0.6 21.9 ± 0.6 0.0 (−0.5 to 0.5) <0.001‡ <0.001‡ 1.00‡
PI-LL, ° 18.5 ± 1.2 2.5 ± 0.8 2.6 ± 0.8 0.1 (−0.6 to 0.8) <0.001‡ <0.001‡ >0.99‡
Max coronal Cobb angle, ° 37.9 ± 1.2 19.2 ± 0.9 18.8 ± 0.9 −0.4 (−1.0 to 0.3) <0.001‡ <0.001‡ 0.51‡
GCA, mm 38.5 ± 2.0 28.1 ± 1.3 28.0 ± 1.3 −0.1 (−2.1 to 2.0) <0.001‡ <0.001‡ >0.99‡
T4–12 TK, ° 35.2 ± 1.1 47.5 ± 0.9 48.8 ± 1.0 1.3 (0.6 to 2.1) <0.001‡ <0.001‡ <0.001‡
Values are shown as percent or mean ± SE unless indicated otherwise. Boldface type indicates statistical significance (p < 0.05).
* Data were obtained from 318 patients with postoperative follow-up imaging performed more than 2 years (mean ± SD 3.7 ± 0.9 years) after surgery.
† p < 0.001 according to Cochran’s Q test, reflecting significant differences in the proportions of patients with C7–S1 SVA > 5 cm across the 3 time points. The p values
shown were subsequently determined with McNemar test and used to assess differences between time points, with p < 0.016 (0.05/3) considered statistically significant
on the basis of Bonferroni correction for multiple comparisons.
‡ Calculated with repeated measures within-subjects analysis of variance.

edly lower for patients who were lost to follow-up before
3 years.
Clinical Outcomes
The baseline, 2-year, and last follow-up PROM scores
for the patients with minimum 3-year follow-up (mean 4.1
years) are summarized in Table 5. All assessed outcomes
measures demonstrated significant improvement—includ-
ing scores on ODI, PCS and MCS of SF-36, SRS-22r (total
and all subscores), and NRS for back and leg pain—from
baseline to 2-year follow-up and from baseline to mini-
mum 3-year follow-up (all p < 0.001). The percentages
of patients who improved at least 1 MCID from baseline
to last follow-up are summarized in Fig. 2, ranging from
41.7% for SRS-22r mental to 79.6% for NRS score for back
pain. Between the 2-year and last follow-up evaluations,
only modest and likely clinically insignificant changes
were noted (Table 5). Notably, SRS-22r satisfaction re-
mained unchanged from the 2-year to the last follow-up
evaluation (p > 0.99).
The baseline and last follow-up outcomes scores of the
patients who did not achieve minimum 3-year follow-up
are summarized in Table 6. The mean ± SD (range) overall
follow-up for these patients was 1.2 ± 0.8 (0–2.5) years.

TABLE 3. Summary of complications for 427 ASD patients who were treated surgically and received minimum 3-year
follow-up (mean 4.1 year)
Complication Category Periop* Delayed† Long Term‡ Total
Radiographic 11 (2.6)/7 (1.6) [6] 29 (6.8)/33 (7.7) [29] 14 (3.3)/14 (3.3) [5] 54 (12.6)/54 (12.6) [40]
Op 53 (12.4)/41 (9.6) [5] 0 (0)/1 (0.2) [1] 0 (0)/1 (0.2) [1] 53 (12.4)/43 (10.1) [7]
Implant 2 (0.5)/5 (1.2) [4] 6 (1.4)/52 (12.2) [34] 5 (1.2)/22 (5.2) [6] 13 (3.0)/79 (18.5) [44]
Neurological 27 (6.3)/21 (4.9) [3] 15 (3.5)/8 (1.9) [6] 9 (2.1)/5 (1.2) [1] 51 (11.9)/34 (8.0) [10]
Infection 16 (3.7)/18 (4.2) [10] 2 (0.5)/1 (0.2) 0 (0)/2 (0.5) [1] 18 (4.2)/21 (4.9) [11]
Gastrointestinal 26 (6.1)/4 (0.9) 0 (0)/1 (0.2) 0 (0)/0 (0) 26 (6.1)/5 (1.2)
Cardiopulmonary 15 (3.5)/13 (3.0) 1 (0.2)/1 (0.2) 0 (0)/0 (0) 16 (3.7)/14 (3.3)
Vascular/hematological 0 (0)/15 (3.5) 0 (0)/0 (0) 0 (0)/2 (0.5) 0 (0)/17 (4.0)
Wound (excluding infection) 5 (1.2)/1 (0.2) [1] 0 (0)/1 (0.2) [1] 0 (0)/0 (0) 5 (1.2)/2 (0.5) [2]
Renal 1 (0.2)/1 (0.2) 0 (0)/0 (0) 0 (0)/0 (0) 1 (0.2)/1 (0.2)
Total no. (minor/major) 282 (156/126) 151 (53/98) 74 (28/46) 507 (237/270)
Mean complications/patient 0.66 (0.37/0.30) 0.35 (0.12/0.23) 0.17 (0.07/0.11) 1.19 (0.56/0.63)
(minor/major)
Patients affected 185 (43.3) 118 (27.6) 56 (13.1) 277 (64.9)
Values are shown as no. (%) minor complications/no. (%) major complications [no. of major complications associated with reoperation] unless
stated otherwise.
* ≤ 90 days.
† 90 days to 2 years.
‡ > 2 years.

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TABLE 4. Summary of complications for 142 ASD patients who were treated surgically and did not
receive minimum 3-year follow-up
Complication Category Periop* (n = 142†) Delayed‡ (n = 119§) Long Term¶ (n = 44**)
Radiographic 5 (3.5)/5 (3.5) [4] 7 (5.9)/6 (5.0) [4] 0 (0)/1 (2.3)
Op 18 (12.7)/14 (9.9) [2] 0 (0)/0 (0) 0 (0)/0 (0)
Implant 0 (0)/3 (2.1) [2] 0 (0)/12 (10.1) [7] 0 (0)/1 (2.3)
Neurological 14 (9.9)/10 (7.0) [2] 3 (2.5)/5 (4.2) [3] 1 (2.3)/1 (2.3)
Infection 8 (5.6)/12 (8.5) [7] 0 (0)/3 (2.5) [1] 0 (0)/2 (4.5) [1]
Gastrointestinal 7 (4.9)/1 (0.7) 0 (0)/0 (0) 1 (2.3)/0 (0)
Cardiopulmonary 7 (4.9)/4 (2.8) 0 (0)/0 (0) 0 (0)/0 (0)
Vascular/hematological 0 (0)/8 (5.6) 0 (0)/1 (0.8) 0 (0)/0 (0)
Wound (excluding infection) 0 (0)/3 (2.1) [2] 0 (0)/0 (0) 0 (0)/0 (0)
Renal 0 (0)/0 (0) 0 (0)/0 (0) 0 (0)/0 (0)
Total no. (minor/major) 119 (59/60) 37 (10/27) 7 (2/5)
Mean complications/patient 0.84 (0.42/0.42) 0.31 (0.08/0.23) 0.16 (0.05/0.11)
(minor/major)
Patients affected 70 (49.3) 28 (23.5) 4 (9.1)
Values are shown as no. (%) minor complications/no. (%) major complications [no. of major complications associated
with reoperation] unless stated otherwise.
* ≤ 90 days.
† The mean ± SD (range) overall follow-up for these 142 patients was 1.2 ± 0.8 (0–2.5) years.
‡ 90 days to 2 years.
§ These 119 patients had at least 90 days of follow-up.
¶ > 2 years.
** These 44 patients had at least 2 years but less than 3 years of follow-up.

As of the last follow-up, this group of patients had demon-
strated significant improvement in all assessed outcomes
measures (p ≤ 0.001).
Discussion
The present study provided a prospective multicenter
assessment of the outcomes of operative treatment for
ASD at minimum 3-year follow-up. At mean 4.1 years of
follow-up, there was significant improvement in each of
the assessed standardized outcome measures. These data
suggest that the clinical benefits of operative treatment for
ASD remain durable beyond the 1- and 2-year follow-up
time points that have been the primary end points of most
previous studies.4,5,​8,​9,​11,​13,15 In addition, the findings of the
present study are consistent with those of the few currently
available studies that provide longer than 2-year follow-
up.10,14,17 The expanding literature that supports the longer
term durability of ASD surgery is critical because these
procedures are highly invasive, have high rates of associat-

FIG. 2. Percentages of patients with ASD who improved by at least 1 MCID from baseline to the minimum 3-year follow-up (mean
4.1 years) after surgical treatment.

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 Elias et al.

TABLE 5. Comparison of clinical outcome parameters at baseline, 2-year follow-up, and last follow-up (minimum 3 years; mean 4.1 years)
for 427 ASD patients who were treated surgically
p Value*
Outcome Mean (95% CI) Difference Baseline vs Baseline vs 2-Yr vs
Parameter Baseline 2-Yr FU Last FU Btwn 2-Yr & Last FU 2-Yr FU Last FU Last FU
ODI 45.3 ± 0.8 28.1 ± 1.0 30.5 ± 1.1 2.3 (0.3 to 4.3) <0.001 <0.001 0.02
SF-36
 PCS 30.9 ± 0.5 39.3 ± 0.6 38.4 ± 0.6 −0.9 (−1.9 to 0.02) <0.001 <0.001 0.06
 MCS 45.6 ± 0.7 51.5 ± 0.6 50.5 ± 0.6 −1.0 (−2.1 to 0.2) <0.001 <0.001 0.13
SRS-22r
 Total 2.74 ± 0.03 3.66 ± 0.04 3.58 ± 0.04 −0.09 (−0.15 to −0.02) <0.001 <0.001 0.006
 Activity 2.83 ± 0.05 3.56 ± 0.05 3.46 ± 0.05 −0.10 (−0.18 to −0.01) <0.001 <0.001 0.02
 Pain 2.33 ± 0.04 3.44 ± 0.06 3.36 ± 0.06 −0.08 (−0.19 to 0.02) <0.001 <0.001 0.19
 Appearance 2.38 ± 0.04 3.59 ± 0.05 3.53 ± 0.05 −0.06 (−0.15 to 0.02) <0.001 <0.001 0.20
 Mental 3.41 ± 0.05 3.87 ± 0.04 3.75 ± 0.04 −0.12 (−0.21 to −0.03) <0.001 <0.001 0.003
 Satisfaction 2.73 ± 0.06 4.12 ± 0.05 4.09 ± 0.05 −0.03 (−0.12 to 0.06) <0.001 <0.001 >0.99
NRS scores
  Back pain 7.13 ± 0.11 3.63 ± 0.16 3.84 ± 0.16 0.21 (−0.08 to 0.50) <0.001 <0.001 0.24
  Leg pain 4.91 ± 0.17 2.65 ± 0.15 2.97 ± 0.16 0.32 (0.003 to 0.65) <0.001 <0.001 0.047
Values are shown as mean ± SE unless indicated otherwise. Boldface type indicates statistical significance (p < 0.05).
* Calculated with repeated measures within-subjects analysis of variance.

ed complications, and are costly.31 These data should prove comes helps to reduce the overall cost per quality-adjusted
valuable for preoperative patient counseling with regard to life-year gained.21,22,32
expectations and longer term outcomes. In addition, these There were significant degradations in the amounts of
data are generally supportive of the cost-effectiveness of improvement between the 2-year and last follow-up evalu-
ASD surgery because longer durability of favorable out- ations for some of the assessed outcome measures. How-
ever, the magnitudes of these degradations, despite reach-
ing statistical significance, were relatively modest and
arguably not clinically significant. Similar to the outcome
TABLE 6. Comparison of clinical outcomes parameters at measures at 2 years, all outcome scores at last follow-up
baseline and last follow-up for 142 ASD patients treated remained significantly improved compared with the base-
surgically and without minimum 3-year follow-up line values. Notably, there was no degradation in patient
Outcome Parameter Baseline Last FU* p Value† satisfaction between the 2-year and last follow-up evalua-
tions based on the scores on the SRS-22r satisfaction do-
ODI 45.1 ± 17.6 30.7 ± 22.9 <0.001 main, further suggesting the limited overall impact of the
SF-36 degradations observed for the other outcome measures. In
 PCS 30.1 ± 10.4 38.6 ± 12.5 <0.001 addition, it is important to recognize that the mean age of
 MCS 44.3 ± 14.4 49.4 ± 12.7 0.001 the study population was approximately 60 years at enroll-
SRS-22r
ment and that some degradation in HRQOL measures may
be expected with longer term follow-up owing to the aging
  Total score 2.7 ± 0.6 3.6 ± 0.8 <0.001 process.
  Activity domain 2.8 ± 0.8 3.3 ± 1.0 <0.001 The number of complications identified at the mini-
  Pain domain 2.2 ± 0.8 3.3 ± 1.1 <0.001 mum 3-year follow-up was relatively high but is consistent
  Appearance domain 2.3 ± 0.8 3.6 ± 1.0 <0.001 with those of previous reports.15,20,33 Overall, a total of 507
  Mental domain 3.4 ± 0.9 3.8 ± 0.8 <0.001 complications (237 minor and 270 major) were reported,
  Satisfaction domain 2.8 ± 1.1 4.0 ± 1.0 <0.001
and 64.9% of patients were affected by 1 or more compli-
cation. However, it is important to note that not all compli-
NRS scores cations had the same impact on outcomes.10,16,34 Although
  Back pain 7.4 ± 2.3 3.7 ± 2.9 <0.001 many complications have limited or no significant impact
  Leg pain 4.9 ± 3.4 2.4 ± 2.8 <0.001 on long-term outcomes, they can affect length of hospital
Values are shown as mean ± SD unless indicated otherwise. Boldface type
stay, necessitate invasive procedures, produce pain, nega-
indicates statistical significance (p < 0.05). tively impact patient recovery, and increase cost of care.23,35
* Mean ± SD (range) overall follow-up for the 142 included patients was 1.2 ± In the present study, the most common complications
0.8 (0–2.5) years. were radiographic (25.3%), operative (22.5%), implant re-
† Determined with the paired t-test. lated (21.5%), neurological (19.9%), and infection related
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Elias et al.
(9.1%). Since study enrollment began, a number of tech-
niques have been introduced to help reduce the occurrence
of many of the more common complications. For example,
concerning radiographic complications, proximal junc-
tional kyphosis/failure is one of the more common early-
and delayed-onset complications.36 It can lead to a progres-
sion of worsening sagittal alignment, vertebral collapse,
and neurological injury.37 Inferior clinical outcomes due
to proximal junctional kyphosis/failure have encouraged
surgeons to develop techniques and strategies that prevent
its occurrence and to understand the risk factors associat-
ed with this complication.19,38–40 Intraoperative tranexamic
acid has been introduced and is now used by many sur-
geons for complex spinal surgery, including those for adult
deformity, to help reduced excessive blood loss and the
resulting associated complications.41 Implant-related com-
plications, most notably rod fractures, are often the most
common delayed complications of ASD surgery. Use of
multirod constructs appears to reduce the rate of rod frac-
ture in at least the short term, but longer term follow-up
is necessary to assess the true effectiveness of these con-
tructs.42–44 Finally, intrawound vancomycin powder is used
by many surgeons to help prevent surgical site infection.45
Although the present study focused on the patients who
achieved 3-year follow-up, in an effort to account for all
patients and to assess for apparent bias in follow-up, details
have been provided for those who did not achieve minimum
3-year follow-up, too. Based on the demographic, clinical,
and radiographic data and PROMs, the patients with and
without minimum 3-year follow-up appeared to be similar
at baseline. In addition, the lack of clear differences in the
rates and types of complications at last follow-up evalua-
tion between the patients with and without 3-year follow-
up suggests that the occurrence of complications was not
likely a primary reason for patients not receiving follow-
up. Lastly, patients lost to follow-up before 3 years demon-
strated significant improvements in all outcome measures,
as assessed at last follow-up, which suggests that poor clin-
ical outcome was also not a primary reason for not receiv-
ing follow-up. Collectively, these findings suggest that the
75% of patients who achieved minimum 3-year follow-up
are likely reflective of the overall study cohort.
The strengths of the present study included the pro-
spective multicenter study design, the length of and pro-
portion of patients with clinical follow-up, the relatively
large number of study patients, and the demonstrated lack
of apparent differences between the patients who did and
did not achieve the minimum follow-up for analysis. The
limitations included the potential for indication and exper-
tise bias to have influenced the results, which may have
negatively impacted the ability to generalize the findings
beyond the included study centers. In addition, we cannot
rule out selection bias. Although we endeavored to account
for all patients in the study cohort, patients were lost to
follow-up before the minimum 3-year threshold for analy-
sis, and these patients could have impacted the outcome
assessment.
Conclusions
This prospective multicenter analysis demonstrated that
614 J Neurosurg Spine  Volume 37 • October 2022
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operative ASD treatment provided significant improve-
ment of HRQOL at minimum 3-year follow-up (mean 4.1-
year), suggesting that the benefits of surgery for ASD re-
main durable at longer follow-up than reported by previous
studies. Although relatively modest degradations in some
outcome measures were observed between the 2-year and
last follow-up evaluations, the magnitudes of these degra-
dations were likely clinically insignificant. These findings
should prove useful for counseling, cost-effectiveness as-
sessments, and efforts to improve the safety of care.
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Disclosures
The ISSG is funded through research grants from DePuy Synthes.
Dr. Bess is a consultant for Alphatec, Stryker, and MiRus; holds
patents with Stryker and NuVasive; receives study-related clinical
or research support from DePuy Synthes, Orthofix, and ISSGF;
receives non–study-related clinical or research support from
J Neurosurg Spine  Volume 37 • October 2022 615
Elias et al.
DePuy Synthes, NuVasive, Stryker, Medtronic, Globus, SeaSpine,
Carlsmed, and ISSGF; and receives royalties from Stryker and
NuVasive. Dr. Lafage is a consultant for Globus Medical; receives
royalties from NuVasive; receives honoraria from DePuy Synthes
and Stryker; and owns stock in VFT Solutions. Dr. Klineberg is a
consultant for DePuy Synthes, Stryker, and Medicrea/Medtronic;
and receives honoraria and a fellowship grant paid to an institu-
tion from AO Spine. Dr. Passias is a consultant for Medtronic,
Globus, and Royal Biologics. Dr. Gum is an employee of Norton
Healthcare, Inc.; is a consultant for Acuity, DePuy, Medtronic,
NuVasive, and Stryker; owns stock in Cingulate; holds patents
with Medtronic; receives honoraria from Baxter, Broadwater,
NASS, and Pacira Pharmaceuticals; is on the speakers bureau of
Medtronic and Stryker; receives royalties from Acuity, Medtronic,
and NuVasive; serves on the medical scientific board of the
National Spine Health Foundation; receives research support from
the Alan L. & Jacqueline B. Stuart Spine Center, Cerapedics,
Biom’Up, Medtronic, Pfizer, Scoliosis Research Society, TSRH,
Empirical Spine, Inc., National Health Foundation, and Stryker;
and serves as a journal reviewer for Global Spine Journal, Spine
Deformity, and The Spine Journal. Dr. Eastlack owns stock in
NuVasive, Alphatec, SI Bone, SeaSpine, and Spine Innovation; is
a consultant for NuVasive, SeaSpine, SI Bone, Stryker, Medtronic,
Spinal Elements, Biedermann-Motech, and Carevature; holds
patents with SI Bone, Spine Innovation, and Globus Medical;
receives royalties from NuVasive, SeaSpine, SI Bone, and Globus;
and receives non–study-related clinical or research support from
NuVasive, Medtronic, SeaSpine, and AONA. Dr. Mundis is a con-
sultant for NuVasive, Stryker, Viseon, Carlsmed, and SeaSpine;
holds patents with Stryker; and receives royalties from NuVasive
and K2M/Stryker. Dr. Protopsaltis is a consultant for Globus,
NuVasive, Stryker K2M, and Medtronic; receives royalties from
Altus; receives stock options from Torus Medical; and is a stock
option unit holder for Spine Align. Dr. Kelly receives honoraria
from Spine and non–study-related clinical or research support
from the Setting Scoliosis Straight Foundation. Dr. Gupta owns
stock in J&J; is a consultant for DePuy, Medtronic, Globus, and
Alphatec (began and ended in 2019); receives royalties from
Innomed, DePuy, and Globus; receives honoraria from AO Spine,
Wright State, LSU, and the Malaysia Spine Society; serves on
the board of directors of the Scoliosis Research Society; receives
travel reimbursements from DePuy, Globus, Medtronic, Scoliosis
Research Society, Zimmer, and AO Spine; and has a voluntary
relationship with the National Spine Health Foundation. Dr. Hart
is a consultant for Allosource, Globus, Orthofix, MiRus, DePuy,
Medtronic, PropioVision, and SeaSpine; and has a personal rela-
tionship with ISSG and Amplify. Dr. Schwab is a consultant for
616 J Neurosurg Spine  Volume 37 • October 2022
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MSD, Zimmer Biomet, and Mainstay Medical; receives royalties
from Zimmer Biomet, Medtronic, and Medicrea; owns stock in
VFT Solutions and SeaSpine; is an executive committee mem-
ber of ISSG; and receives non–study-related clinical or research
support from DePuy, K2M, NuVasive, Medtronic, Globus,
Allosource, Orthofix, and SI Bone (via grants paid through
ISSG). Dr. Burton is a consultant for Blue Ocean Spine, Globus,
and DePuy; and owns stock in Progenerative Medical. Dr. Ames
receives royalties from Stryker, Biomet Zimmer Spine, DePuy
Synthes, NuVasive, Next Orthosurgical, K2M, and Medicrea; is a
consultant for DePuy Synthes, Medtronic, Medicrea, K2M, Agada
Medical, and Carlsmed; receives research support from Titan
Spine, DePuy Synthes, and ISSG; serves on the editorial board of
Operative Neurosurgery; receives grant funding from SRS; serves
on the executive committee of ISSG; is the director of Global
Spinal Analytics; and is the safety and value committee chair
of SRS. Dr. Shaffrey is a consultant for NuVasive, Medtronic, SI
Bone, and Proprio; owns stock in NuVasive; holds patents with
NuVasive, Medtronic, and Zimmer Biomet; and receives royalties
from NuVasive, Medtronic, and Zimmer Biomet. Dr. Smith is a
consultant for Zimmer Biomet, NuVasive, Cerapedics, Carlsmed,
Stryker, SeaSpine, and DePuy Synthes; owns stock in Alphatec
and NuVasive; receives study-related clinical or research sup-
port from DePuy Synthes and ISSGF; receives non–study-related
clinical or research support from DePuy Synthes, ISSGF, and AO
Spine; receives royalties from Zimmer Biomet, NuVasive, and
Thieme; and receives fellowship support from AO Spine.
Author Contributions
Conception and design: Smith, Bess, Line, Shaffrey. Acquisition
of data: Smith, Bess, Line, V Lafage, Klineberg, Kim, Passias,
Gum, Kebaish, Eastlack, Daniels, Mundis, Hostin, Protopsaltis,
Soroceanu, Hamilton, Kelly, Gupta, Hart, Schwab, Burton, Ames,
Shaffrey. Analysis and interpretation of data: Smith, Elias, Bess,
Line, V Lafage, R Lafage, Klineberg, Passias, Nasser. Drafting
the article: Smith, Elias, R Lafage. Critically revising the article:
all authors. Reviewed submitted version of manuscript: all
authors. Approved the final version of the manuscript on behalf of
all authors: Smith. Statistical analysis: Smith, Elias, Nasser, Kelly.
Administrative/technical/material support: Bess. Study supervi-
sion: Smith.
Correspondence
Justin S. Smith: University of Virginia Health Sciences Center,
Charlottesville, VA. jss7f@virginia.edu.