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）：开发材料的影响 具有增强的断裂韧性、抗损伤性、可靠性和超低 磨损引起了骨科界的极大兴趣，因为它直接 解决了一个重要的临床问题——消除磨损碎片介导的全髋关节置换术 植入失败。在第一阶段，我们朝着解决这个问题迈出了重要一步 中心问题是成功展示了一种新型陶瓷材料 优越的机械性能。骨折强度提高 50% 韧性、威布尔模量 50% 和显着的抗损伤能力 展示了传统陶瓷。因此，我们已经能够建立 从安全和设计方面来看，这些材料的性能将显着降低 体内脆性破坏的风险。此外，我们已经能够适应 用于与 CoCr 接合的陶瓷。从生物相容性角度来说，不 预期会在体内产生不良影响。早期磨损性能结果 由这些陶瓷制成的头/杯组件也清楚地显示出超低 磨损特性，磨损量比 目前CoCr-PE。在第二阶段，我们建议通过以下方式扩展这些有希望的结果： 使用严格的统计有效优化组件设计公差 方法，表征 THA 植入物的静态强度和疲劳强度 组件，并进行全面的体外和体内 生物相容性评价。我们还建议将磨损测试 (n=6) 扩展到 在髋关节模拟器中进行 1000 万次循环，以确认髋关节的功能 优化的组件。各大骨科植入物制造商纷纷表示 有兴趣合作评估和优化小说 陶瓷设计。 拟议的商业应用： 安全性（机械和生物）和功能（超低磨损）以及与 CoCr 的兼容性的结合提供了一种新的轴承材料组，有望消除困扰 THA 的核心问题 - 磨损碎片介导的骨质溶解和植入物失效。确定材料安全性和功能的综合计划将有助于加快这些植入物第三阶段的商业化。

项目成果

Fabrication and testing of silicon nitride bearings in total hip arthroplasty: winner of the 2007 "HAP" PAUL Award.

全髋关节置换术中氮化硅轴承的制造和测试：荣获 2007 年“HAP”PAUL 奖。

• 发表时间: 2009-01
• 作者: Bal, B Sonny;Khandkar, Ashok;Lakshminarayanan, R;Clarke, Ian;Hoffman, Aaron A;Rahaman, Mohamed N
• 通讯作者: Rahaman, Mohamed N

Testing of silicon nitride ceramic bearings for total hip arthroplasty.

用于全髋关节置换术的氮化硅陶瓷轴承的测试。

• 发表时间: 2008-11
• 作者: Bal, B Sonny;Khandkar, Ashok;Lakshminarayanan, R;Clarke, Ian;Hoffman, Aaron A;Rahaman, Mohamed N
• 通讯作者: Rahaman, Mohamed N