Pre-Clinical Development of an Instrumented Trapezium Carpal Bone

仪器化梯形腕骨的临床前开发

• 批准号: 10132242
• 负责人: Joseph J Crisco
• 金额: $ 13.74万
• 依托单位: RHODE ISLAND HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10132242
• 关键词: Activities of Daily Living; Adult; Affect; Age; Aged, 80 and over; Arthritis; Arthrodesis; Biofeedback; Cadaver; Calibration; Clinical Research; Clinical Treatment; Clinical Trials; Cobalt; Communities; Complication; Custom; Data; Data Analyses; Data Collection; Databases; Degenerative Disorder; Degenerative polyarthritis; Development; Device or Instrument Development; Disease; Electronics; Engineering; Etiology; Excision; Failure; Foundations; Functional disorder; Future; Goals; Hand; Health Care Costs; Hip region structure; Impairment; Implant; Injury; Joints; Knee; Knowledge; Longitudinal Studies; Manufacturer Name; Measurement; Measures; Mechanics; Mediating; Metacarpal bone; Modeling; Morphology; Movement; Musculoskeletal; Operative Surgical Procedures; Outcome Measure; Pain; Pain management; Patients; Pattern; Performance; Physical therapy; Positioning Attribute; Preclinical Testing; Prevalence; Protocols documentation; Records; Rehabilitation therapy; Replacement Arthroplasty; Research; Research Personnel; Robotics; Role; Science; Shapes; Shoulder; Standardization; Surface; Surgical sutures; Suspensions; Technology; Testing; Thumb structure; Titanium; United States National Institutes of Health; Validation; Vertebral column; Work; base; bone; carpus bone; clinical implementation; cost effective; design; early detection biomarkers; improved; in vivo; innovation; insight; instrument; joint function; joint loading; kinematics; loss of function; mathematical model; miniaturize; novel; pre-clinical; preclinical development; preclinical evaluation; primary outcome; prototype; repair model; seal; sensor; skills; soft tissue; success; trapezium

The goal of this R21 proposal is to complete the preclinical development and evaluation of an instrumented replacement trapezium (iTrapz) capable of measuring joint contact loads at the base of the thumb, establishing the rigor for a future clinical trial in trapezial arthroplasty. The numerous surgical treatments for late-stage osteoarthritis (OA) of the thumb carpometacarpal (CMC) – or trapeziometacarpal (TMC) – joint, are highly varied and suboptimal. TMC OA is a degenerative disease that results in significant impairment due to pain and loss of function. The prevalence of TMC OA is at least 20-25% in those over 50, and it increases into the eighth decade when as many as 80% have evidence of disease. High forces in the trapeziometacarpal joint are believed to influence OA development and treatment success. However, our understanding of joint loads developed in the hand is limited to predictions from mathematical models that have yet to be validated by in vivo measurements. Custom implants instrumented to measure joint contact loads have been developed for the hip, knee, and spine. Data from these implants has provided critical insight into joint function, with the tangible direct benefits of validating and improving musculoskeletal models and providing important information for implant designers and manufacturers. Instrumented implants also have the potential to provide highly novel biofeedback to patients to guide rehabilitation. Building on our extensive and rigorous in vivo studies of TMC morphology and kinematics, and the records of success in other instrumented joints, we propose to develop and validate a preclinical instrumented trapezium implant, which we refer to as the iTrapz. In our first aim we will design, fabricate and validate a proof-of-concept wired iTrapz. In Aim 2 we will validate the wired iTrapz in a cadaver model using a robotic musculoskeletal simulator. Once we complete these aims we will have a highly innovative load sensor suitable for cadaver studies. Given the need for more rigorous studies of thumb arthroplasties, this accomplishment alone will have a significant impact. In Aim 3 we will develop a first-prototype inductively powered and telemeterized iTrapz implant. In Aim 3 we will also begin planning for in vivo implementation in a clinical study. Upon completion of Aim 3 we will have demonstrated that measuring in vivo thumb loads during the activities of daily living is feasible, and we will have developed the necessary knowledge, skills and technologies to support the fabrication of a hermetically sealed implant suitable for clinical implementation. This project is significant in that it will benefit several constituencies: clinicians will benefit from the knowledge of the loads associated with disease, injury, surgery and repair; the modeling and research communities will benefit directly from measurements of joint loads during activities of daily living, which are unknown in the hand; and engineers and manufacturers will benefit from critically-needed performance data.

该R21提案的目的是完成仪表的临床前开发和评估 替换梯形（ITRAPZ）能够测量拇指底部的关节接触载荷，建立 未来在梯性关节置换术中进行临床试验的严格性。晚期的众多手术治疗 拇指腕骨（CMC）的骨关节炎（OA） - 或梯二氨基甲烷（TMC） - 关节高度多样化 和次优。 TMC OA是一种退化性疾病，由于疼痛和丧失而导致重大损害 功能。 TMC OA的患病率在50岁以上的患病率至少为20-25％，并且增加到第八个十年 当多达80％的疾病证据时。据认为，梯二氨基甲丙泊接头中的高力量 影响OA的发展和治疗成功。但是，我们对关节负荷的理解在 手仅限于尚未通过体内测量验证的数学模型的预测。 为臀部，膝盖和脊柱开发了用于测量关节接触负荷的定制插入器。 这些关闭的数据为联合功能提供了关键的洞察力，并具有明显的直接好处 验证和改善肌肉骨骼模型，并为植入物设计师和 制造商。仪器的inctress也有可能为患者提供高度新颖的生物反馈 指南康复。以我们广泛而严格的TMC形态和运动学研究为基础 以及其他乐器关节成功的记录，我们建议开发和验证临床前 仪器梯形植入物，我们称为iTrapz。在我们的第一个目标中，我们将设计，制造和 验证概念验证有线ITRAPZ。在AIM 2中，我们将使用A中的尸体模型验证有线的Itrapz 机器人肌肉骨骼模拟器。完成这些目标后，我们将拥有一个高度创新的负载传感器 适用于尸体研究。考虑到需要对拇指关节塑料进行更严格的研究，这 仅成就将产生重大影响。在AIM 3中，我们将归纳开发一种原型 动力和遥测的Itrapz植入物。在AIM 3中，我们还将开始计划在体内实施 临床研究。 AIM 3完成后，我们将证明测量在体内拇指载荷 日常生活的活动是可行的，我们将发展必要的知识，技能和 支持适合临床实施的密封植入物制造的技术。这 项目很重要，因为它将受益几个选区：临床医生将从知识中受益 与疾病，受伤，手术和修复有关的负荷；建模和研究社区将受益 直接来自日常生活活动期间关节负荷的测量，手中未知；和 工程师和制造商将受益于急需的性能数据。