Wear Testing for Enhanced Prediction of TKR Clinical Performance

磨损测试可增强 TKR 临床表现的预测

• 批准号: 8457144
• 负责人: Markus Anton Wimmer
• 金额: $ 32.7万
• 依托单位: RUSH UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2015-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8457144
• 关键词: Activities of Daily Living; Address; Affect; Area; Autopsy; Back; Behavior; Beryllium; Body Weight; Cicatrix; Clinical; Data; Development; Device Approval; Devices; Future; Gait; Goals; Implant; In Situ; International; Investigation; Kinetics; Knee; Knee Prosthesis; Knee joint; Lanthanoid Series Elements; Lateral; Lead; Life; Life Expectancy; Location; Longevity; Marketing; Mass Spectrum Analysis; Measures; Mechanics; Medial; Methodology; Methods; Morphology; Motion; Movement; Operative Surgical Procedures; Osteolysis; Osteolytic; Pain; Particulate; Patients; Pattern; Performance; Personal Satisfaction; Physical activity; Physiological; Polyethylenes; Preclinical Testing; Principal Investigator; Procedures; Process; Prosthesis; Protocols documentation; Relative (related person); Reporting; Rest; Retrieval; Serum; Services; Shapes; Site; Specimen; Speed; Stearates; Surface; Testing; Time; Tissues; United States National Institutes of Health; Walking; base; design; experience; improved; in vitro testing; in vivo; kinematics; knee replacement arthroplasty; meetings; new technology; novel; particle; pre-clinical; programs; simulation; success; trend

DESCRIPTION (provided by applicant): With over 450,000 surgeries performed annually in the US alone, total knee replacement (TKR) has become a common surgical procedure to alleviate pain and increase functional mobility in diseased or traumatized knee joints. A major limiting factor to the service life of TKRs remains the wear of the polyethylene tibial liner. Increases in life expectancy and body weight, as well as the trend for TKR surgery in younger patients will put even higher demands on future devices. Preclinical endurance testing has become a standard procedure to predict the mechanical performance of new devices during implant development. These testing procedures follow a test-to-success strategy, which require input data derived from the load and motion spectrum of daily use. However, recent studies show that current international testing standards do not mimic the kinematic and kinetic conditions during gait for patients implanted with a cruciate retaining knee prosthesis. In addition, current protocols focus only on walking, completely omitting other activities of daily living. Although walking is the most frequent activity throughout the day, other daily physicals activities often generate higher tibial loads, larger prosthetic movements, and more detrimental cross-shear than walking. Indeed, wear features of tested components do not match those worn in vivo, neither regarding wear scar size and shape, nor wear morphology. The frontside medial and lateral bearing surfaces of TKRs are not the only surfaces which contribute to wear and osteolysis. Micromotion between the back of the polyethylene liner and the metallic base plate/tray leads to "backside wear". Backside wear has been claimed to be of greater osteolytic significance than the wear experienced on the front articulating surfaces because of the larger backside contact area and the potentially smaller particles generated, although accurate quantification of backside wear has proven difficult. The relationship between daily physical activity and location specific TKR wear is also not known. We hypothesize that the motion and force profiles inputted to wear simulators must be from multiple daily activities measured from TKR patients in order to accurately reproduce clinically observed wear rates and patterns on both the front and backside of TKRs. We propose three aims to investigate our overall hypothesis. In the first two aims we will demonstrate that more realistic wear is generated using input profiles from TKR patients and from multiple daily activities. In the third aim we will design and validate a new multi-activity wear protocol reflecting true in vivo use. We will use novel technology that uses lanthanide stearates to track polyethylene wear in serum with mass spectrometry. Different elements are used for different TKR interfaces to allow in situ tracking of frontside versus backside wear. Findings will be validated using retrievals with unique gait and activity information. The studies are purposefully limited to cruciate-retaining TKR design with a high market share.

描述（由申请人提供）：仅在美国每年进行的手术就超过 450,000 例，全膝关节置换术 (TKR) 已成为减轻患病或受伤膝关节疼痛并增加功能活动能力的常见外科手术。 TKR 使用寿命的主要限制因素仍然是聚乙烯胫骨衬垫的磨损。预期寿命和体重的增加，以及年轻患者进行 TKR 手术的趋势将对未来的设备提出更高的要求。临床前耐久性测试已成为预测植入物开发过程中新设备机械性能的标准程序。这些测试程序遵循从测试到成功的策略，该策略需要从日常使用的负载和运动频谱中得出的输入数据。然而，最近的研究表明，当前的国际测试标准并不能模拟植入十字形保留膝关节假体的患者步态期间的运动学和动力学条件。此外，目前的方案仅关注步行，完全忽略了其他日常生活活动。尽管步行是一天中最频繁的活动，但其他日常体力活动通常会比步行产生更高的胫骨负荷、更大的假肢运动和更有害的横向剪切力。事实上，测试部件的磨损特征与体内磨损的特征不匹配，无论是磨损疤痕的大小和形状，还是磨损形态。 TKR 的前侧内侧和外侧支撑表面并不是唯一导致磨损和骨溶解的表面。聚乙烯衬里背面和金属底板/托盘之间的微动会导致“背面磨损”。据称，背面磨损比前关节表面的磨损具有更大的溶骨意义，因为背面接触面积更大并且可能产生更小的颗粒，尽管事实证明背面磨损的准确量化很困难。日常体力活动与特定地点 TKR 佩戴之间的关系尚不清楚。我们假设输入磨损模拟器的运动和力曲线必须来自 TKR 患者测量的多种日常活动，以便准确再现临床观察到的 TKR 正面和背面的磨损率和模式。我们提出三个目标来研究我们的总体假设。在前两个目标中，我们将证明使用 TKR 患者和多种日常活动的输入配置文件可以生成更真实的磨损。在第三个目标中，我们将设计并验证反映真实体内使用的新的多活动佩戴协议。我们将使用新技术，利用镧系硬脂酸盐通过质谱法追踪血清中聚乙烯的磨损情况。不同的 TKR 界面使用不同的元件，以实现正面与背面磨损的原位跟踪。将使用具有独特步态和活动信息的检索来验证研究结果。这些研究有目的地仅限于具有高市场份额的十字形固位 TKR 设计。