Development and wear testing of bi-material bearing surfaces for hip arthroplasty

用于髋关节置换术的双材料支撑表面的开发和磨损测试

• 批准号: 8713021
• 负责人: Douglas W Van Citters
• 金额: $ 14.99万
• 依托单位: CORNERSTONE PARTNERS, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8713021
• 关键词: Accounting; Address; Adhesives; Arthroplasty; Clinical; Cobalt; Complication; Couples; Degenerative polyarthritis; Development; Devices; Elements; Environment; Equipment Malfunction; Failure; Fatigue; Generations; Geometry; Goals; Head; Health; Health system; Hip region structure; Implant; Industry; Joints; Laboratory Research; Longevity; Marketing; Mechanics; Medical; Metals; Modeling; Morbidity - disease rate; Motion; Neck; Operative Surgical Procedures; Orthopedics; Outcome; Patients; Pattern; Penetration; Performance; Plastics; Polymers; Procedures; Protocols documentation; Research; Resistance; Retrieval; Risk; Running; Simulate; Stress; Surface; System; Testing; United States; Validation; Work; clinically relevant; commercial application; cost; design; high risk; hip replacement arthroplasty; improved; in vivo; innovation; mechanical behavior; novel; novel strategies; research study; resilience; simulation; survivorship; technological innovation; ultra-high molecular weight polyethylene

DESCRIPTION (provided by applicant): Hip replacement surgery is a tremendously effective and successful treatment for patients suffering from degenerative joint disease. However, revision surgery accounts for about 13% of hip implant surgeries in the U.S., costing $3 billion annually and presenting significantly increased morbidity and risk of complication for patients. Wear and/or failure of total hip arthroplasty (THA) bearing surfaces is one of the leading causes of device failure, either directly because of poor bearing articulation or through the detrimental effects of wear debris. The proposed work will develop and test a new bearing to be employed in a THA device. This novel approach will reduce bearing surface damage and wear when compared to state of the art approaches in bearing design. If this project is successful, the fundamental design of the bearing surface in THA could change for hundreds of thousands of patients every year. It is expected that this product design will reduce the United States arthroplasty revision burden. Laboratory research in failed orthopedic devices has informed the development team's understanding of the shortcomings of current industry designs. Independent studies of clinical retrievals provide compelling evidence that hard-on-hard hip bearing failure is driven by unanticipated dynamic head-to-rim contact. Wear, fatigue failure, and surface damage occur clinically. Thus, the goal of the proposed project is to develop new bearing surfaces for artificial hips that offer patients the very high wear resistance of hard-on-hard bearing couples and also offer the toughness and impact resistance of polymers such as ultra-high molecular weight polyethylene where most needed. The proposed work will establish feasibility through further development, manufacture, testing and modeling of the new bearing. The research plan will establish measureable and repeatable protocols for testing resilience and wear resistance of proposed surfaces, will proceed to validation in high contact stress loading that reflects true in vivo conditions, will establish proof of concept of new wear interfaces, and will develop a numerical model of the mechanical behavior of the bearing interface. Questions to be answered include validity of the simulation environment, resilience of the proposed material interface, and the ability to predict damage in the proposed bearing designs.

描述（由申请人提供）：髋关节置换手术对于患有退行性关节疾病的患者来说是一种非常有效且成功的治疗方法。然而，翻修手术约占美国髋关节植入手术的 13%，每年花费 30 亿美元，并且患者的发病率和并发症风险显着增加。全髋关节置换术 (THA) 轴承表面的磨损和/或失效是装置失效的主要原因之一，这可能是直接由于轴承关节不良造成的，也可能是由于磨损碎片的有害影响造成的。拟议的工作将开发和测试用于 THA 装置的新轴承。与轴承设计中最先进的方法相比，这种新颖的方法将减少轴承表面的损坏和磨损。如果该项目成功，每年可能会为数十万患者改变全髋关节置换术中支撑表面的基本设计。预计这一产品设计将减轻美国关节置换翻修手术的负担。对失效矫形器械的实验室研究使开发团队了解了当前工业设计的缺点。临床检索的独立研究提供了令人信服的证据，表明硬对硬的髋关节轴承故障是由意外的动态头与轮缘接触引起的。临床上会发生磨损、疲劳失效和表面损伤。因此，该项目的目标是开发用于人工髋关节的新型轴承表面，为患者提供硬对硬轴承对的极高耐磨性，并在最需要的地方提供超高分子量聚乙烯等聚合物的韧性和抗冲击性。拟议的工作将通过新轴承的进一步开发、制造、测试和建模来确定可行性。该研究计划将建立可测量和可重复的协议来测试拟议表面的弹性和耐磨性，将继续在反映真实体内条件的高接触应力载荷下进行验证，将建立新磨损界面的概念验证，并将开发轴承界面机械行为的数值模型。要回答的问题包括模拟环境的有效性、所提出的材料界面的弹性以及预测所提出的轴承设计中的损坏的能力。