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  1. 1. Multi Center Outcome Study<br />USE AND EFFICACY OF TCP<br />(TriCalcium Phosphate)<br />By Jeff Freshour, Staci Lorimer and Laurie Holmes<br />
  2. 2. WHY USE GRAFTING MATERIAL?<br /><ul><li>Many medical situations call for a bone graft. Among them are fusions of the spine, fusions of the joints in the arms and legs, fractures, gaps in bones caused by trauma or infection, revision joint surgery and oral/maxillofacial surgery.
  3. 3. Americans suffer 5.6 million fractures a year, and surgeons perform nearly half a million bone graft operations annually. Bone grafts are second only to blood transfusions on the list of transplanted materials.
  4. 4. In a typical bone graft involving a fracture, bone or synthetic material is shaped by the surgeon to fit the affected area. It is then held in place with pins or screws that hold the healthy bone to the implanted material.
  5. 5. Bone grafts provide a framework into which the host bone can regenerate and heal. Bone cells weave into and through the porous microstructure of the implant. The implant provides a framework to support the new tissue, blood cells and soft tissue as they grow to connect fractured bone segments. Bone cells and living cells inside the graft may also stimulate growth of bone and other tissue. </li></li></ul><li>Where Is Grafting Material Used?<br />Foot and Ankle <br />Triple Arthrodesis<br />Traumatic Fx<br />Sub-Talar Fx<br />Tibial Plafond Fx<br />Lis Franc Fx<br />Foot Deformities<br />(congenital & degenerative)<br />
  6. 6. Where Grafting Material Used?<br />Upper Extremity Surgeries<br />Colles Fracture<br />Distal Radius Fracture<br />Both Bone Forearm Fracture<br />Supracondylar Humeral Fracture<br />Proximal Fracture<br />Clavicle Fracture<br />
  7. 7. CLINICAL TRIAL TRICALCIUM PHOSPHATE IN ORTHOPEDIC SURGERY C.H. Siebert; D.C. Wirtz; D. Gottschalk; and C. Niedhart <br />TCP implanted in 21 patients used in a variety of settings<br />1. Pelvic osteotomies in children<br />2. Filling of bone cysts or osseous defects <br />3. Dorsal spondylodesis <br />4. Grafting of pseudarthroses<br />Follow-up period was 6 to 18 months<br />
  8. 8. CLINICAL TRIAL TRICALCIUM PHOSPHATE IN ORTHOPEDIC SURGERY C.H. Siebert; D.C. Wirtz; D. Gottschalk; and C. Niedhart <br /><ul><li>The ß-TCP granules, when used as part of a compositegraft in combination with autologous bone, were completely resorbedafter an average period of 14 weeks, while the cubes required12 to 15 months. The more massive wedges have shown only a decreasein size and radio density. Due to the ability of the cubes andwedges to bear loads of up to 30 MPa, they were successfullyimplanted during pelvic osteotomies to augment or completelyreplace the bicortical grafts. Complications or foreign bodyreactions were not noted. The osseointegration was found tobe favorable for all forms.</li></li></ul><li>CLINICAL TRIAL - Conclusion<br /><ul><li>The use of synthetic bone substitutes will continueto increase. The combination of complete resorption, lack ofrisk of infection, and load sharing ability make the ß-tricalciumphosphate implants a valuable addition to the spectrum of bonereplacement products presently available. Their use in pediatricorthopedics could help avoid donor site morbidity includingcontour changes or growth disturbances, while providing a morestable graft. During the first phase of a prospective clinicaltrial, we have come to the conclusion, that the ß-tricalciumphosphate ceramics represent a real alternative to other bonesubstitutes.</li></li></ul><li>Surgical Treatment of Calcaneal Fractures with Use of β-Tricalcium Phosphate Ceramic GraftingSheng-Dan Jiang, MD, PhD; Lei-Sheng Jiang, MD, PhD; Li-Yang Dai, MD, PhDShanghai, China<br />Background - Internal fixation and grafting with sintered β-tricalcium phosphate (β-TCP) ceramic is alternative to bone grafting in the treatment of calcaneal fractures.<br />Methods - Seventy-four patients with intraarticular calcaneal fractures were treated with open reduction internal fixation and grafting with sintered β-TCP ceramic.<br />Results - All patients were followed for 15 months. Clinical results as assessed by the Maryland foot score were excellent 54.1%, good 37.8%, and fair in 8.1%. There was no statistical correlation between the severity of fracture and functional outcome in this series. All fractures healed.<br />Conclusion: These findings suggest that use of β-TCP combined with open reduction and internal fixation is an effective and safe method for the surgical treatment of intra-articular calcaneal fractures.<br />
  9. 9. BioabsorbableTricalcium Phosphate Bone Cement Strengthens Fixation of Suture Anchors.Oshtory R, Lindsey DP, Giori NJ, Mirza FM.Department of Orthopedic Surgery,, San Francisco, CA, 94115, USA,<br /><ul><li>Background – Failure of suture anchor fixation in rotator cuff repair can occur at different interfaces. Prior studies show fixation at the bone-anchor interface can be augmented using polymethylmethacrylate (PMMA) cement, and screw fixation into bone can be strengthened using bioabsorbabletricalcium phosphate cement.
  10. 10. Methods – They used 10 matched pairs of cadaveric proximal humeri and implanted a metal screw-type suture anchor in one side and on the other side injected tricalcium phosphate cement into the anchor holes before anchor placement. They tested all specimens to failure using a ramped cyclic loading protocol.
  11. 11. Results - Tricalcium phosphate cement augmentation increased the final load to failure by 29% and the number of cycles to failure by 20%. Visual inspection confirmed that failure occurred at the cement-bone interface
  12. 12. Conclusion: Tricalcium phosphate cement appears to augment suture anchor fixation into bone, reducing the risk of anchor pullout and failure</li></li></ul><li>CONCLUSION<br />In conclusion the examination of a variety of multi-center studies involving the use of TRICALCIUM PHOSPHATE leads us to determine that bone growth and fusion rates increase in patients with healthy and osteoporotic bone.<br />
  13. 13. THANK YOU!<br />Questions or Comments?<br />