Calcium Phosphate Cements for Vertebroplasty

Presented by: Mahak Ajmera

Contents

• Clinical Problem

• Introduction

• Calcium Phosphate Cements

• Products

• Clinical cases

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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

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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.

Comparison of Healthy and Osteoporotic bone

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Healthy Bone

Osteoporotic Bone

Source: http://www.tarjetaweb.org/clientes/lopezolivares/images/huesos.jpg

Effect of Osteoporosis

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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

• The decrease in bone mass.

• Imbalance in the productionand usage of calcium, thereforethe bone voids are not filled incompletely.

• This leads to instability in fixingmetal hardware such as bonescrews and plates resulting in poorperformance of the implants.

Method in use : Inject Bone Cement

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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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Comparison of bone cements

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Therefore use injectable CPCs for Vertebroplasty

Basis PMMA Composite Cement Calcium Phosphate

Cement

1 Biocompatibility Non biocompatible

Biocompatible Highlybiocompatible

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

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

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

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

Combinations of calcium phosphate powders

• Tetracalcium phosphate (TTCP)

• Hydorxylapatite (HA)

• Dicalcium phosphate anhydrous (DCPA)

• Dicalcium phosphate dihydrous (DCPD or brushite)

• α-tricalcium phosphate (α-TCP)

• β-tricalcium phosphate (β-TCP)

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

Calcium Phosphate Cements

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

Bonesource (Stryker orthopaedics, Mahwah, NJ)

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Source: http://www.stryker.com/stellent/groups/public/documents/web_prod/023526.pdf

Chemical Composition:

Powder:• Dicalcium phosphate dihydrate• Tetracalcium phosphate

Liquid:• Phosphate Solution• Distilled Water

HydroSet (Stryker orthopaedics, Mahwah, NJ)

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Source: http://www.stryker.com/en-us/products/Orthopaedics/BoneSubstitutes/Hydroset/index.htm

Chemical Composition:

Powder:• Dicalcium phosphate dihydrate• Tetracalcium phosphate• Tri-sodium citrate

Liquid:• Sodium phosphate• Polyvinylpyrrolidone• Distilled Water

Beta-BSM (ETEX Corporation, Cambridge, MA)

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Source: http://www.orthopediatrics.com/binary/org/ORTHOPEDIATRICS/doc/ETEX%20Beta%20Sales%20Sheet%20edit.pdf

Chemical Composition:

Powder:• Amorphous calcium phosphate• Calcium phosphate Acid• Dicalcium phosphate dihydrate

Liquid:• Sodium phosphate•Water

Cementek (Teknimed)

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Soutrce: http://www.teknimed.com/files/2012/03/Cementek-LV-Ind-3.pdf

Chemical Composition:

Powder:• α tricalcium phosphate dihydrate• Tetracalcium phosphate• Calcium hydroxide• Phosphoric acid

Liquid:•Distilled Water

Calcibon (Biomet)

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Source: http://www.biomet.com.tr/tr-medical/tr-biomaterials/tr-calcibon

Chemical Composition:

Powder:• α tricalcium phosphate dihydrate• Calcium hydrogen phosphate• Calcium carbonate• Hydroxylapatite

Liquid:•Distilled Water• Sodium hydrogen phosphate solution

Biopex (Mitsubishi material, Tokyo, Japan)

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Source: http://www.taisho.co.jp/en/company/release/2000/060600-e.htm

Chemical Composition:

Powder:• α tricalcium phosphate dihydrate• Tetracalcium phosphate• Dicalcium Phosphate• Hydroxylapatite

Liquid:•Distilled Water• Chondroitin sodium sulphate• Sodium succinate

Clinical Case

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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/

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

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Source: http://features.blogs.fortune.cnn.com/2012/09/18/synthes-norian-criminal/

Norian XR, Cupertino, CA

• Medical device maker Synthes Inc. And Norian subsidiary wascharged for illegally testing Norian XR bone cement on humans,which lead to death of five patients on the operating room tabledue to rapid drop in blood pressure after the surgeon injected thecement.

• It was approved by FDA, in 2002 for use in arm but not in spine witha prior notice, as it contains multiple blood vessels and any leakagecould sent cement to lungs and heart leading to death.

• A clinical trial for using Norian in Vertebroplasty would take 3 yearsand $ 1 million. They decided not to pursue an IDE (InvestigationalDevice Exemption) study but to perform 60-80 procedures andpublish 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

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Any Questions?