Calcium Phosphate Cements for Vertebroplasty

Presented by: Mahak Ajmera

Contents

Clinical Problem
Introduction
Calcium Phosphate Cements
Products
Clinical cases

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Calcium Phosphate Cements for

Vertebroplasty

Clinical Problem

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Causes of Vertebral Compression Fracture

Osteoporosis
Low bone mineral density
Advanced age
Cancer, Tumors
Trauma i.e car accident, fall, gunshot
Degenerative spine conditions

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Introduction : What is a healthy bone?

45 60 % mineral: Calcium Phosphate
20-30 % matrix: collagen
10-20% water

Source: Flahiff CM, Blackwell AS, Hollis JM, Feldman DS. Analysis of a
biodegradable composite for bone healing. J Biomed Mater Res 1996;32:419-424.

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Comparison of Healthy and Osteoporotic bone

Healthy Bone

Osteoporotic Bone

Source: http://www.tarjetaweb.org/clientes/lopezolivares/images/huesos.jpg
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Calcium Phosphate Cements for

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Effect of Osteoporosis
The decrease in bone mass.
Imbalance in the production
and usage of calcium, therefore
the bone voids are not filled in
completely.
This leads to instability in fixing
metal hardware such as bone
screws and plates resulting in poor
performance of the implants.
Source: http://www.inpensacola.com/fe/cityguide/seniors/articles/images/osteoporosis.jpg
Source: Bone and Joint Decade http://www.boneandjointdecade.org/eLecture/1609/GMaalouf.html
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Calcium Phosphate Cements for

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Method in use : Inject Bone Cement

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Calcium Phosphate Cements for

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Properties of Injectable cements

Injectability
Easy and safe injection
Sufficient radio opacity
Adjusted setting time
Adaptable mechanical properties

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Calcium Phosphate Cements for

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Comparison of bone cements

Basis

PMMA

Composite Cement

Calcium
Phosphate
Cement

1 Biocompatibility

Non
biocompatible

Biocompatible

Highly
biocompatible

2 Radio Opacity

Good radio
opacity

Low radio opacity

Good radio
opacity

3 Curing temperature

High

Low

Low

4 Toxicity

Yes

No

No

5 Cost

Low

High

High

6 Bioresorption

No

No

Yes

Therefore use injectable CPCs for Vertebroplasty

Source: http://www.openradiology.org/zosirws/survey/vertebroplasty/cementsreview/discussion
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Vertebroplasty

Calcium Phosphate Cements (CPCs)

A synthetic bone graft material
It has similarity to bone mineral composition,
bioactivity, osteoconductivity and ability to
form a strong interface with bone
Blocks granules, coatings on dental and
medical implants and cements are eg. of
different CaP biomaterials
Being injectable and easy to shape help them
in using to fill geometrically complicated bone
defects
Source: Advanced Chemical Engineering Research (ACER) Volume 1 Issue 1, December 2012

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Combinations of calcium phosphate powders

Tetracalcium phosphate (TTCP)

Hydorxylapatite (HA)
Dicalcium phosphate anhydrous (DCPA)
Dicalcium phosphate dihydrous (DCPD or brushite)
-tricalcium phosphate (-TCP)
-tricalcium phosphate (-TCP)

Source: Advanced Chemical Engineering Research (ACER) Volume 1 Issue 1, December 2012

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Calcium Phosphate Cements

Source: http://www.ossano.se/bibliotek/vertekyphoplastik/vertebroplasty%20and%20kyphoplasty%20-%20filler%20materials.pdf
http://www.openradiology.org/zosirws/survey/vertebroplasty/cementsreview/calciumphosphate
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Vertebroplasty

Bonesource (Stryker orthopaedics, Mahwah,

NJ)
Chemical Composition:
Powder:
Dicalcium phosphate
dihydrate
Tetracalcium phosphate

Liquid:
Phosphate Solution
Distilled Water

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Source: http://www.stryker.com/stellent/groups/public/documents/web_prod/023526.pdf
Calcium Phosphate Cements for
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Vertebroplasty

HydroSet (Stryker orthopaedics, Mahwah, NJ)

Chemical Composition:

Powder:
Dicalcium phosphate
dihydrate
Tetracalcium phosphate
Tri-sodium citrate
Liquid:
Sodium phosphate
Polyvinylpyrrolidone
Distilled Water
Source: http://www.stryker.com/en-us/products/Orthopaedics/BoneSubstitutes/Hydroset/index.htm
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Beta-BSM (ETEX Corporation, Cambridge, MA)

Chemical Composition:

Powder:
Amorphous calcium
phosphate
Calcium phosphate Acid
Dicalcium phosphate
dihydrate
Liquid:
Sodium phosphate
Water
Source: http://www.orthopediatrics.com/binary/org/ORTHOPEDIATRICS/doc/ETEX%20Beta%20Sales%20Sheet%20edit.pdf
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Cementek (Teknimed)
Chemical Composition:

Powder:
tricalcium phosphate
dihydrate
Tetracalcium phosphate
Calcium hydroxide
Phosphoric acid
Liquid:
Distilled Water

Soutrce: http://www.teknimed.com/files/2012/03/Cementek-LV-Ind-3.pdf
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Calcibon (Biomet)
Chemical Composition:

Powder:
tricalcium phosphate
dihydrate
Calcium hydrogen phosphate
Calcium carbonate
Hydroxylapatite
Liquid:
Distilled Water
Sodium hydrogen phosphate
solution
Source: http://www.biomet.com.tr/tr-medical/tr-biomaterials/tr-calcibon
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Biopex (Mitsubishi material, Tokyo, Japan)

Chemical Composition:

Powder:
tricalcium phosphate dihydrate
Tetracalcium phosphate
Dicalcium Phosphate
Hydroxylapatite
Liquid:
Distilled Water
Chondroitin sodium sulphate
Sodium succinate
Source: http://www.taisho.co.jp/en/company/release/2000/060600-e.htm
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Clinical Case

Vertebroplasty using CPCs

for Osteoporotic
Fractures:
Study of outcomes at a
minimum follow up of two
years
Source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3302913/
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Biopex (Tokyo, Japan)

Purpose : To asses the long term clinical and radiographic outcomes
after Vertebroplasty using CPC (Biopex) for treatment of
osteoporotic vertebral fractures (OVF).
Method : Reviewed 86 patients (total 106 patients : 8 died in two
years and 12 lost follow up )
Procedure A : Vertebroplasty using CPC in patients with
osteoporotic burst fracture. (41 patients)
Procedure B : Vertebroplasty using CPC in patients with
osteoporotic compression fracture. ( 65 Patients)

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Biopex (Tokyo, Japan)

Results:
The mean age was 77 years old and the mean duration of follow up
was 44 months.
all patients reported decreased pain according to VAS (Visual
analogue scale) immediately after Vertebroplasty and pain relief
was maintained till the last follow up without new osteoporotic
vertebral fractures.

Conclusion: Vertebroplasty using CPC gave a satisfactory outcome and

no delayed complications in elderly patients with osteoporotic
vertebral fractures in follow up time of 2 years.
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Clinical Case : Norian XR, Cupertino, CA

Source: http://features.blogs.fortune.cnn.com/2012/09/18/synthes-norian-criminal/
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Norian XR, Cupertino, CA

Medical device maker Synthes Inc. And Norian subsidiary was
charged for illegally testing Norian XR bone cement on humans,
which lead to death of five patients on the operating room table
due to rapid drop in blood pressure after the surgeon injected the
cement.
It was approved by FDA, in 2002 for use in arm but not in spine with
a prior notice, as it contains multiple blood vessels and any leakage
could sent cement to lungs and heart leading to death.
A clinical trial for using Norian in Vertebroplasty would take 3 years
and $ 1 million. They decided not to pursue an IDE (Investigational
Device Exemption) study but to perform 60-80 procedures and
publish their clincal results.
Norian had to pay fine of $ 22 million.
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Norian XR, Cupertino, CA

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Norian XR, Cupertino, CA

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Thank You

Any Questions?
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