Composite Metal/Ceramic Bearings for THA Implants

用于 THA 植入物的复合金属/陶瓷轴承

• 批准号: 6534455
• 负责人: ASHOK C KHANDKAR
• 金额: $ 36.54万
• 依托单位: SINTX TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 2005-09-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6534455
• 关键词: biomaterial compatibility; biomaterial development /preparation; biomaterial evaluation; biomechanics; biotechnology; ceramics; chromium; cobalt; hip prosthesis; mechanical stress; medical implant science; silicon compounds

DESCRIPTION (Provided by Applicant): The implications of developing materials with enhanced fracture toughness, damage resistance, reliability and ultra low wear is of significant interest to the orthopedic community, since it directly addresses a vital clinical concern- eliminating wear debris mediated THA implant failures. In Phase I we made a significant step towards addressing this central issue by successfully demonstrating a novel ceramic material with superior mechanical properties. An enhancement of 50 percent in fracture toughness, 50 percent in weibull modulus and significant damage resistance over conventional ceramics was demonstrated. Thus, we have been able to establish materials which, from a safety and design aspect, will have significantly lower risk of brittle failure in vivo. Furthermore, we have been able to adpat the ceramics for articulation with CoCr. From a bio-compatibility aspect, no adverse effects are expected in-vivo. Early wear performance results of head/cup components made from these ceramics also clearly show the ultra low wear characteristics, with wear volumes 2-3 orders of magnitude lower than present CoCr-PE. In Phase II, we propose to extend these promising results by optimizing the component design tolerances using a rigorous statistically valid approach, characterizing the static and fatigue strength of THA implant components, and performing a comprehensive in-vitro and invivo bio-compatibility evaluation. We also propose to extend the wear tests (n=6) to 10 million cycles in a hip simulator to confirm the functionality of the optimized components. Major orthopedic implant manufacturers have expressed interest in collaborating on the evaluation and optimization of the novel ceramic designs. PROPOSED COMMERCIAL APPLICATION: The combination of safety (mechanical and biological) and function (ultra-low wear) and compatibility with CoCr offers a new bearing materail set that promises to eliminate the central issue plaguing THA - wear debris mediated osteolysis and implant failures. A comprehanesive program to establish the safety and function of the materials will help speed the commercialization of these implants in Phase III.

描述（由申请人提供）：开发材料的含义 具有增强的断裂韧性，抵抗力，可靠性和超低 磨损引起了骨科社区的重大兴趣，因为它直接 解决了至关重要的临床问题 - 消除磨损碎屑介导的tha 植入物失败。在第一阶段，我们朝着解决这个问题迈出了重要一步 通过成功证明一种新颖的陶瓷材料，与中心问题 优质的机械性能。骨折增强50％ 韧性，威布尔模量为50％ 证明了传统的陶瓷。因此，我们能够建立 从安全性和设计方面，将显着降低的材料 体内易碎失败的风险。此外，我们已经能够 与COCR发音的陶瓷。从生物兼容的方面，没有 预期在体内不利影响。早期磨损性能结果 这些陶瓷制成的头部/杯子组件也清楚地显示了超低 磨损特性，磨损量比低2-3个数量级低于 现在的cocr-pe。在第二阶段，我们建议通过 使用严格的统计有效 方法，表征植入物的静态和疲劳强度 组件，并执行全面的体外和Invivo 生物兼容评估。我们还建议将磨损测试（n = 6）扩展到 臀部模拟器中的1000万个循环以确认 优化的组件。主要的骨科植入物制造商已表示 对合作评估和优化小说的兴趣 陶瓷设计。 拟议的商业应用： 安全性（机械和生物学）和功能（超低磨损）和与COCR的兼容性的组合提供了一个新的轴承式产科套件，有望消除困扰THA的核心问题 - 磨损碎屑介导的骨溶解和植入物故障。一项了解材料安全性和功能的理解力，将有助于加快这些植入物在第三阶段的商业化。