Cpc for vertebroplasty
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One of the popular bone graft substitute, especially in spine surgery is calcium phosphate cements (CPCs). This article presents a comparative analysis of the characteristics of different bone grafts substitute and talks about the widespread products used in spine surgery concerning experience of their use.
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Cpc for vertebroplasty
- 1. Calcium Phosphate Cements for Vertebroplasty Presented by: Mahak Ajmera
- 2. Contents • Clinical Problem • Introduction • Calcium Phosphate Cements • Products • Clinical cases 12/3/2014 Calcium Phosphate Cements for 2 Vertebroplasty
- 3. Clinical Problem 12/3/2014 Calcium Phosphate Cements for 3 Vertebroplasty
- 4. Causes of Vertebral Compression Fracture • Osteoporosis • Low bone mineral density • Advanced age • Cancer, Tumors • Trauma i.e car accident, fall, gunshot • Degenerative spine conditions 12/3/2014 Calcium Phosphate Cements for 4 Vertebroplasty
- 5. 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. 12/3/2014 Calcium Phosphate Cements for 5 Vertebroplasty
- 6. Comparison of Healthy and Osteoporotic bone 12/3/2014 Calcium Phosphate Cements for 6 Vertebroplasty Healthy Bone Osteoporotic Bone Source: http://www.tarjetaweb.org/clientes/lopezolivares/images/huesos.jpg
- 7. Effect of Osteoporosis 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 12/3/2014 Calcium Phosphate Cements for 7 Vertebroplasty • 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.
- 8. Method in use : Inject Bone Cement 12/3/2014 Calcium Phosphate Cements for 8 Vertebroplasty
- 9. Properties of Injectable cements • Injectability • Easy and safe injection • Sufficient radio opacity • Adjusted setting time • Adaptable mechanical properties 12/3/2014 Calcium Phosphate Cements for 9 Vertebroplasty
- 10. Comparison of bone cements Basis PMMA Composite Cement Calcium Therefore use injectable CPCs for Vertebroplasty 12/3/2014 Calcium Phosphate Cements for 10 Vertebroplasty 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 Source: http://www.openradiology.org/zosirws/survey/vertebroplasty/cementsreview/discussion
- 11. 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 12/3/2014 Calcium Phosphate Cements for 11 Vertebroplasty
- 12. 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) Source: Advanced Chemical Engineering Research (ACER) Volume 1 Issue 1, December 2012 12/3/2014 Calcium Phosphate Cements for 12 Vertebroplasty
- 13. 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 12/3/2014 Calcium Phosphate Cements for 13 Vertebroplasty
- 14. Bonesource (Stryker orthopaedics, Mahwah, NJ) Source: http://www.stryker.com/stellent/groups/public/documents/web_prod/023526.pdf 12/3/2014 Calcium Phosphate Cements for 14 Vertebroplasty Chemical Composition: Powder: • Dicalcium phosphate dihydrate • Tetracalcium phosphate Liquid: • Phosphate Solution • Distilled Water
- 15. HydroSet (Stryker orthopaedics, Mahwah, NJ) Source: http://www.stryker.com/en-us/products/Orthopaedics/BoneSubstitutes/Hydroset/index.htm 12/3/2014 Calcium Phosphate Cements for 15 Vertebroplasty Chemical Composition: Powder: • Dicalcium phosphate dihydrate • Tetracalcium phosphate • Tri-sodium citrate Liquid: • Sodium phosphate • Polyvinylpyrrolidone • Distilled Water
- 16. Beta-BSM (ETEX Corporation, Cambridge, MA) Source: http://www.orthopediatrics.com/binary/org/ORTHOPEDIATRICS/doc/ETEX%20Beta%20Sales%20Sheet%20edit.pdf 12/3/2014 Calcium Phosphate Cements for 16 Vertebroplasty Chemical Composition: Powder: • Amorphous calcium phosphate • Calcium phosphate Acid • Dicalcium phosphate dihydrate Liquid: • Sodium phosphate •Water
- 17. Cementek (Teknimed) Soutrce: http://www.teknimed.com/files/2012/03/Cementek-LV-Ind-3.pdf 12/3/2014 Calcium Phosphate Cements for 17 Vertebroplasty Chemical Composition: Powder: • α tricalcium phosphate dihydrate • Tetracalcium phosphate • Calcium hydroxide • Phosphoric acid Liquid: •Distilled Water
- 18. Calcibon (Biomet) Source: http://www.biomet.com.tr/tr-medical/tr-biomaterials/tr-calcibon 12/3/2014 Calcium Phosphate Cements for 18 Vertebroplasty Chemical Composition: Powder: • α tricalcium phosphate dihydrate • Calcium hydrogen phosphate • Calcium carbonate • Hydroxylapatite Liquid: •Distilled Water • Sodium hydrogen phosphate solution
- 19. Biopex (Mitsubishi material, Tokyo, Japan) Chemical Composition: Powder: • α 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 12/3/2014 Calcium Phosphate Cements for 19 Vertebroplasty
- 20. Clinical Case Vertebroplasty using CPCs for Osteoporotic 12/3/2014 Calcium Phosphate Cements for 20 Vertebroplasty Fractures: Study of outcomes at a minimum follow up of two years Source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3302913/
- 21. 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) 12/3/2014 Calcium Phosphate Cements for 21 Vertebroplasty
- 22. 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. 12/3/2014 Calcium Phosphate Cements for 22 Vertebroplasty
- 23. Clinical Case : Norian XR, Cupertino, CA Source: http://features.blogs.fortune.cnn.com/2012/09/18/synthes-norian-criminal/ 12/3/2014 Calcium Phosphate Cements for 23 Vertebroplasty
- 24. 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. 12/3/2014 Calcium Phosphate Cements for 24 Vertebroplasty
- 25. Norian XR, Cupertino, CA 12/3/2014 Calcium Phosphate Cements for 25 Vertebroplasty
- 26. Norian XR, Cupertino, CA 12/3/2014 Calcium Phosphate Cements for 26 Vertebroplasty
- 27. Thank You Any Questions? 12/3/2014 Calcium Phosphate Cements for 27 Vertebroplasty
Editor's Notes
- This leads to instability in fixing metal hardware such as bone screws and plates resulting in poor performance of the implants.
- ‐tricalcium phosphate (‐TCP).
- (Powder) 72.3% w/w tetracalcium phospate, 27.7% w/w dicalcium phosphate anhydrous, (Fluid) [31–34,44,45] 0.25 mol/L phosphate solution and distilled water -(Ca9.970 (HPO4)0.080(PO4) 5.892(CO3)0.080(OH)1.944)
- http://static.orthoconnect.com/files/file_29.pdf
- calcium-hydrogen-phosphate, calcium-carbonate, and precipitated hydroxyapatite. The Calcibon® liquid is an aqueous di-sodium-hydrogen-phosphate solution