Clinically Relevant Artificial Lubricants for Implant Wear Testing

全关节置换术（TJA）是一种成熟的手术干预，用于缓解关节炎患者的疼痛并改善其生活质量。随着预期寿命的增加以及接受TJA的患者越来越年轻和活跃的趋势，更有必要最大限度地延长这些医疗器械的寿命。由于磨损颗粒引起的骨吸收，TJA可能会失效，这可能导致昂贵且耗时的翻修手术;该手术也与患者发病风险较高相关。在大规模植入前对全关节置换进行磨损评价已成为识别关节面材料磨损特性并估计其可能的体内磨损性能的标准化程序;然而，目前的标准化测试条件表明，润滑剂的生化和微生物特性与体内条件不匹配。本提案的主要目的是开发和验证一种临床相关性更高的润滑剂，用于植入物（髋关节和膝关节）磨损试验，该试验得到临床结果和体外磨损试验的支持。为了实现这一目标，需要采取多学科办法。该方法涉及机械工程、骨科、生物化学和微生物学研究的组合，以开发一种更具临床相关性的润滑剂，从而可以在体外对植入物进行无菌评价。拟议的研究包括分析患者的滑液，然后进行体外模拟器磨损试验、磨损颗粒评估、磨损表面分析和磨损过程的计算建模，所有这些都是跨学科研究和医疗器械产品开发的组成部分。使用已开发的植入物润滑知识，拟议的研究将长期扩展到关节模拟器测试和体内发生的润滑现象的建模。这些努力将产生科学证据，鼓励国家和国际监管机构逐步将新的科学知识纳入标准化测试程序，这可能有助于开发更耐用的植入物。

Total joint arthroplasty (TJA) is a well established surgical intervention used to provide pain relief and improve the quality of life for patients suffering from arthritis. With increasing life expectancy and a growing trend that points to younger and more active patients undergoing TJA, it is even more imperative to maximize the longevity of these medical devices. TJAs can fail due to wear-particle induced bone resorption that can cause expensive and time-intensive revision surgery; a surgery that is also associated with a higher risk of patient morbidity. Wear evaluation of total joint replacements prior to large scale implantation has become a standardized procedure to identify bearing material wear characteristics, and to estimate their possible in vivo wear performance; however, current standardized test conditions have shown that the lubricants` biochemical and microbiological characteristics do not match the in vivo conditions. The main objective of this present proposal is to develop and validate a more clinically relevant lubricant for implant (hip and knee) wear testing that is supported by both clinical findings and by in vitro wear tests. In order to achieve this objective, a multi-disciplinary approach is required. This approach involves a combination of mechanical engineering, orthopaedic, biochemical, and microbiological research to develop a more clinically relevant lubricant that permits the sterile evaluation of implants in vitro. The proposed studies include the analysis of synovial fluid from patients, followed by in vitro simulator wear testing, wear particle assessment, wear surface analysis, and computational modeling of the wear process, all of which are an integral part of interdisciplinary research and medical device product development. Using the developed knowledge of implant lubrication, the proposed research will extend in the long term to the modeling of the lubrication phenomena that occur in both joint simulator testing and in vivo. These endeavors will generate scientific evidence to encourage national and international regulatory bodies to gradually integrate the new scientific knowledge into standardized test procedures, which may facilitate the development of more durable implants.