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.

本R21提案的目标是完成仪器化的临床前开发和评价。 能够测量拇指根部关节接触载荷的替代骨水泥（iTrapz）， 未来临床试验的严格性。晚期癌症的众多手术治疗 拇指腕掌（CMC）或拇指腕掌（TMC）关节的骨关节炎（OA）变化很大 和次优。TMC OA是一种退行性疾病，由于疼痛和神经功能丧失而导致严重损伤。 功能TMC OA的患病率在50岁以上的人群中至少为20-25%，并且在80岁时会增加 当多达80%的人有疾病的证据时。据信，掌指关节中的高力量 影响OA发展和治疗成功。然而，我们对关节载荷的理解是在 Hand仅限于来自数学模型的预测，这些模型尚未通过体内测量来验证。 已经开发了用于测量髋关节、膝关节和脊柱关节接触载荷的定制植入物。 这些植入物的数据为关节功能提供了重要的见解， 验证和改进肌肉骨骼模型，为植入物设计者提供重要信息， 厂商器械植入物也有可能为患者提供高度新颖的生物反馈， 引导康复。基于我们对TMC形态学和运动学的广泛和严格的体内研究， 以及其他内固定关节的成功记录，我们建议开发和验证临床前 我们称之为iTrapz。在我们的第一个目标，我们将设计，制造和 验证一个概念验证的有线iTrapz。在目标2中，我们将使用 机器人肌肉骨骼模拟器一旦我们完成这些目标，我们将有一个高度创新的负载传感器 适合尸体研究。鉴于需要对拇指关节成形术进行更严格的研究， 单是成绩本身就将产生重大影响。在目标3中，我们将开发第一个原型感应 动力和遥测的iTrapz植入物在目标3中，我们还将开始计划在体内实施， 临床研究目标3完成后，我们将证明，在体内测量拇指负荷， 日常生活的活动是可行的，我们将发展必要的知识，技能和 支持制造适合临床实施的密封植入物的技术。这 该项目意义重大，因为它将使几个选区受益：临床医生将受益于 与疾病、损伤、手术和修复相关的负载;建模和研究社区将受益 直接来自日常生活活动期间关节载荷的测量，这在手部是未知的;以及 工程师和制造商将受益于急需的性能数据。