Ceramic Tibia for Mobile Bearing Knee

移动轴承膝关节用陶瓷胫骨

• 批准号: 7157037
• 负责人: ASHOK C KHANDKAR
• 金额: $ 34.11万
• 依托单位: SINTX TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-29 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7157037
• 关键词: ceramics; implant; knee; performance; success; tibia

DESCRIPTION (provided by applicant): Mobile bearing TKA implants are preferred owing to their potential to better restore natural knee kinematics, and could find increased acceptance if the important clinical concern related to increased wear is addressed. Equally, overcoming the materials fatigue related failures of polyethlylene (PE) tibial inserts over the long term would be a significant step forward in extending the life, range of motion and function of the more popular fixed bearing TKA implants. In Phase I, we successfully demonstrated the feasibility of a novel, ultra-low wear bearing for TKA implants by developing and wear testing of a new ceramic optimized for low friction articulation against established CoCr alloys. The novel ceramic material was shown in standard tests to possess the highest combination of strength, toughness and Weibull modulus, with a significant enhancement over current state of the art Biolox Delta. We have also demonstrated in pin on disc tests a 10 fold reduction in multidirectional wear compared to CoCr-PE bearings, under a 3X higher contact stress. This success points to the clinical potential of a novel alternate TKA implant bearing with ultra-low wear and high safety characteristics: a CoCr femoral condyle/ with a ceramic tibia insert. If successful, this novel TKA bearing offers the potential to eliminate PE material failure and promises to increase the life of TKA implants by a factor of 2 - 3X. Indeed, this bearing has the potential to introduce a unique, safe and effective alternative bearing for the first time, for TKA implants. In Phase II, we aim to extend these results by developing and demonstrating the wear performance, mechanical and biological safety of actual TKA implant components in a physiologically / clinically more relevant geometry. In Phase II, we propose to extend these promising results by developing, optimizing and demonstrating in vitro, the wear performance, mechanical safety and function in a set of comprehensive, statistically rigorous experimental designs. We also propose to conduct wear tests to 10 million cycles in a knee simulator on actual TKA bearing components of both mobile and fixed bearing designs, using physiologically relevant test parameters, to confirm the superiority of the novel proposed bearings. Major orthopedic implant manufacturers have expressed interest in our technology and collaborating on the evaluation of the novel TKA bearings.

描述（由申请人提供）：移动轴承 TKA 植入物是首选，因为它们有可能更好地恢复自然膝关节运动学，并且如果解决与增加磨损相关的重要临床问题，可能会得到更高的接受度。同样，从长远来看，克服聚乙烯 (PE) 胫骨插入物与材料疲劳相关的故障将是延长更流行的固定轴承 TKA 植入物的寿命、运动范围和功能的重要一步。在第一阶段，我们通过针对现有 CoCr 合金针对低摩擦关节进行优化的新型陶瓷的开发和磨损测试，成功证明了用于 TKA 植入物的新型超低磨损轴承的可行性。标准测试表明，这种新型陶瓷材料具有最高的强度、韧性和威布尔模量组合，比当前最先进的 Biolox Delta 有了显着增强。我们还在销盘测试中证明，在接触应力高出 3 倍的情况下，与 CoCr-PE 轴承相比，多向磨损减少了 10 倍。这一成功表明了具有超低磨损和高安全特性的新型替代 TKA 植入轴承的临床潜力：CoCr 股骨髁/带有陶瓷胫骨插入物。如果成功，这种新型 TKA 轴承将有可能消除 PE 材料失效，并有望将 TKA 植入物的寿命延长 2 - 3 倍。事实上，该轴承有可能首次为 TKA 植入物引入独特、安全且有效的替代轴承。在第二阶段，我们的目标是通过在生理/临床更相关的几何形状中开发和展示实际 TKA 植入部件的磨损性能、机械和生物安全性来扩展这些结果。在第二阶段，我们建议通过在一组全面的、统计上严格的实验设计中开发、优化和演示体外磨损性能、机械安全性和功能来扩展这些有希望的结果。我们还建议使用生理相关的测试参数，在膝关节模拟器中对移动和固定轴承设计的实际 TKA 轴承部件进行 1000 万次磨损测试，以确认所提出的新颖轴承的优越性。主要骨科植入物制造商对我们的技术表示兴趣，并合作评估新型 TKA 轴承。