Pre-Clinical Development of an Instrumented Trapezium Carpal Bone

仪器化梯形腕骨的临床前开发

基本信息

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
项目类别：
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

项目摘要

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 提案的目标是完成仪器化的临床前开发和评估替换梯形 (iTrapz) 能够测量拇指根部的关节接触载荷，建立未来梯形关节置换术临床试验的严格性后期的众多手术治疗。拇指腕掌 (CMC) 或斜方掌 (TMC) 关节的骨关节炎 (OA) 差异很大 TMC OA 是一种退行性疾病，会因疼痛和丧失功能而导致严重损伤。在 50 岁以上人群中，TMC OA 的患病率至少为 20-25%，并且到 80 岁则有所增加。据信，多达 80% 的患者存在斜方掌骨关节受力过大的情况。影响 OA 的发展和治疗的成功然而，我们对关节负荷的理解是在手仅限于数学模型的预测，尚未通过体内测量验证。已经为髋部、膝部和脊柱开发了用于测量关节接触载荷的定制植入物。来自这些植入物的数据为关节功能提供了重要的见解，并带来了切实的直接好处验证和改进肌肉骨骼模型，并为植入物设计者和提供重要信息仪器化植入物还有可能为患者提供高度新颖的生物反馈。康复指南以我们对 TMC 形态和运动学的广泛而严格的体内研究为基础，以及其他仪表关节的成功记录，我们建议开发并验证临床前仪器化梯形植入物，我们称之为 iTrapz 在我们的第一个目标中，我们将设计、制造和制造。验证有线 iTrapz 的概念验证在目标 2 中，我们将使用尸体模型验证有线 iTrapz。一旦我们完成这些目标，我们将拥有一个高度创新的负载传感器。考虑到需要对拇指关节成形术进行更严格的研究，这适用于尸体研究。在目标 3 中，我们将通过归纳方式开发第一个原型。在 Aim 3 中，我们还将开始计划在体内实施动力和遥测 iTrapz 植入物。完成目标 3 后，我们将证明测量体内拇指负荷。日常生活活动是可行的，我们将掌握必要的知识、技能和支持制造适合临床实施的密封植入物的技术。该项目意义重大，因为它将惠及多个群体：新移民将受益于该领域的知识与疾病、损伤、手术和修复相关的负荷；建模和研究界将从中受益直接来自日常生活活动期间关节负荷的测量，而这些负荷在手上是未知的；工程师和制造商将受益于急需的性能数据。