Screening of Above Elbow Amputees for Advanced Prosthetic Devices

相关性：这项研究将创建一个数据库，上面的肘部截肢人群正在接受治疗 VA医院系统和患者分类系统在新的研究和开发中使用 假肢技术。这项工作旨在收集解剖学、生活质量和生物力学数据， 用于优化正在开发的肘上骨集成植入物的设计，以提高质量 退伍军人截肢者的生活。萨琳娜·辛克莱博士和她的合作者拥有临床和研究 这是成功完成这项工作的基础。 通过骨整合(OI)直接骨骼附着假肢，目前正在测试和 在弗吉尼亚州盐湖城乔治·E·沃伦医疗保健系统进行了优化。OI技术正在开发中 改善假体附着性，改善功能结果，减少并发症 与套接字接口系统相关联。我们的研究团队目前正在进行FDA批准的提前 老年股骨截肢者行OI假体的可行性研究。从我们的研究中获得的知识 成功的经股动脉OI计划现正应用于上肢截肢者。我们的目标是提供 经胸截肢者OI系统将使他们能够充分利用先进的上肢 近年来为最大限度地发挥功能而开发的假肢技术。这项研究是关于 截肢者将是第一个收集全面的解剖学、生活质量和功能数据的人 用于开发分类系统，以确定未来临床试验的候选者。 目标：目标1)创建美国退伍军人经胸截肢数据库，用于制定 通过图表审查、临床转介和个人访谈获得假肢技术；目标2)进行完整的 上肢骨与软组织解剖的体格检查、大体解剖及临床评价 测量、X光、DEXA和CT扫描；目的3)评估截肢者的功能能力 在VA系统内使用经过验证的工具进行治疗，以监测运动范围、生物力学、活动度、 损伤和患者满意度；目标4)建立截肢者的患者分类系统，该系统可以 用于确定假体技术临床试验的合适候选者。 方法：在全国范围内寻找肘部以上的退伍军人截肢者。医疗记录将会是 审查以收集人口统计学和流行病学数据，包括：原因、截肢时间、残肢 长度、假体使用和合并症。符合一组预先确定的纳入标准的患者将 给他们发了一封信，告知他们这项研究，如果他们对OI技术感兴趣，请他们做出回应。如果 同意参加筛查访问的参与者将接受以下评估：前部/后部 和侧位X光，计算机断层扫描(CT)，DEXA扫描，残肢体检，自身 报告疼痛、生活质量和功能的评估，功能评估执行日常活动 在动作捕捉实验室生活，专注于运动范围和运动学评估。这是我们的目标 在三年内完成对50名截肢者的现场筛查. 将对数据进行解释，以开发一个系统，根据骨骼质量、功能、疼痛和 假体的局限性。该系统将用于确定未来临床试验的合适候选者和OI 装置和其他先进的假体技术。 意义：这项工作有可能显著改善截肢者的VA临床护理，通过提供 这项研究收集了一组以前未收集到的经验丰富的经胸截肢患者的综合数据 社区和医疗保健提供者。将开发一种新的可应用的分类系统 为未来的假肢研究和临床实践选择合适的候选人以提高 退伍军人的机能和整体生活质量。

RELEVANCE: This study will create a database of the above elbow amputee population being treated within the VA hospital system and a patient classification system for use in the research and development of new prosthetic technologies. This work aims to collect anatomical, quality of life and biomechanical data that will be used to optimize the design of an above-elbow osseointegrated implant being developed to improve the quality of life for Veterans amputees. Dr. Sarina Sinclair and her collaborators have the clinical and research foundation on which to successfully complete this work. Direct skeletal attachment of prosthetic limbs through osseointegration (OI), is currently being tested and optimized at the George E. Wahlen VA Salt Lake City Health Care System. OI technology is being developed to improve prosthetic attachment, improve functional outcomes and reduce complications commonly associated with socket interface systems. Our research team is currently conducting an FDA approved Early Feasibility Study of an OI prosthesis in veteran transfemoral amputees. The knowledge gained from our successful transfemoral OI program is now being applied to upper extremity amputees. It is our goal to offer transhumeral (TH) amputees an OI system that will enable them to take full advantage of the advanced upper extremity prosthetic technologies that have been developed in recent years to maximize function. This study on TH amputees will be the first to gather comprehensive anatomical, quality of life and functional data that will be used to develop a classification system to identify candidates for future clinical trials. AIMS: Aim 1) Create a database of US Veterans with transhumeral amputations for use in the development of prosthetic technologies through a chart review, clinical referrals and personal interviews; Aim 2) Conduct a full clinical evaluation of upper extremity bone and soft tissue anatomy via physical exam, gross anatomical measurements, X-rays, DEXA and CT scans; Aim 3) Assess the functional capabilities of TH amputees being treated within the VA system utilizing validated tools for monitoring range of motion, biomechanics, activity, impairment and patient satisfaction; Aim 4) Develop a patient classification system of TH amputees that can be used to identify appropriate candidates for clinical trials of prosthetic technologies. METHODS: A national search will be conducted for veteran above elbow amputees. Medical records will be reviewed to gather demographic and epidemiologic data including: cause, time since amputation, residual limb length, prosthetic use and comorbidities. Patients that meet a predetermined set of inclusion criteria will be sent a letter informing them of the study and requesting a response if they have interest in OI technologies. If consented to attend a screening visit, participants will undergo the following assessments: Anterior/Posterior and Lateral X-rays, Computed Tomography (CT) scan, DEXA scan, Physical examination of residual limb, self report assessments of pain, quality of life and function, functional assessment performing activities of daily living with a focus on range of motion, and kinematic assessment in a Motion Capture Laboratory. It is our goal to complete onsite screening of 50 TH amputees within a three-year period. Data will be interpreted to develop a system to classify subjects based on bone quality, function, pain and prosthetic limitations. This system will be used to identify appropriate candidates for future clinical trials an OI device and other advance prosthetic technologies. SIGNIFICANCE: This work has the potential to significantly improve VA clinical care for amputees by providing a previously uncollected comprehensive data set from veteran transhumeral amputees to the research community and healthcare providers. A new classification system will be developed that can be applied towards selection of appropriate candidates for future prosthetics research and in clinical practice to improve the Veteran's function and overall quality of life.