Screening of Above Elbow Amputees for Advanced Prosthetic Devices

对肘部以上截肢者进行高级假肢装置筛查

• 批准号: 10731362
• 负责人: Sarina Kay Sinclair
• 金额: --
• 依托单位: VA SALT LAKE CITY HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10731362
• 关键词: 3-Dimensional; Activities of Daily Living; Amputation; Amputees; Anatomy; Anterior; Articular Range of Motion; Biomechanics; Bone Density; Bone Tissue; Bone structure; Caring; Categories; Cities; Classification; Client satisfaction; Clinical; Clinical Trials; Community Healthcare; Consent; Data; Data Set; Databases; Development; Device Designs; Devices; Dimensions; Dual-Energy X-Ray Absorptiometry; Elbow; Eligibility Determination; Emerging Technologies; Epidemiology; Evaluation; FDA approved; Feasibility Studies; Femur; Foundations; Funding; Future; Goals; Health Personnel; Healthcare Systems; Hospitals; Impairment; Interview; Investigation; Kinetics; Knowledge; Laboratories; Lateral; Length; Letters; Life; Limb Prosthesis; Measurement; Medical Records; Monitor; Morphology; Motion; Movement; Osseointegration; Pain; Pain Measurement; Pain interference; Participant; Patient Self-Report; Patients; Physical Examination; Population; Prosthesis; Protocols documentation; Psychometrics; Quality of life; Registries; Research; Research Personnel; Roentgen Rays; Scanning; Site; Sodium Chloride; Suspensions; System; Techniques; Technology; Telephone; Testing; Thick; Time; Upper Extremity; Veterans; Visit; Work; X-Ray Computed Tomography; anatomic imaging; bone; bone quality; candidate identification; clinical candidate; clinical care; clinical practice; comorbidity; cortical bone; density; design; disability; epidemiologic data; experience; functional improvement; improved; inclusion criteria; interest; kinematics; member; new technology; novel; osseointegrated implant; patient population; programs; prosthesis fitting; prosthetic socket; reconstruction; research and development; research clinical testing; residual limb; response; satisfaction; screening; skeletal; soft tissue; tool

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.

相关性：本研究将创建上述肘关节截肢患者人群的数据库， VA医院系统和患者分类系统，用于研究和开发新的 假肢技术这项工作的目的是收集解剖，生活质量和生物力学数据， 用于优化肘上骨整合种植体的设计，以提高质量 退伍军人截肢者的生活。萨里纳辛克莱博士和她的合作者有临床和研究 为顺利完成这项工作奠定了基础。 通过骨整合（OI）的假肢直接骨骼附着，目前正在测试中， 在乔治E.弗吉尼亚州瓦伦湖城卫生保健系统。OI技术正在开发中 为了改善假体附着，改善功能结果并减少并发症， 与套接字接口系统相关联。我们的研究团队目前正在进行一项FDA批准的早期 在经股截肢老兵中进行OI假体的可行性研究。从我们获得的知识 成功的经股动脉开放性关节置换术正被应用于上肢截肢者。我们的目标是提供 经股骨头（TH）截肢者的OI系统，使他们能够充分利用先进的上部 近年来开发的肢体假肢技术，以最大限度地发挥功能。这项研究对 TH截肢者将是第一个收集全面解剖，生活质量和功能数据的人， 用于开发一个分类系统，以确定未来临床试验的候选人。 目的：目的1）创建一个美国退伍军人经股动脉截肢数据库，用于开发 通过病历审查、临床转诊和个人访谈了解假肢技术;目标2）进行全面的 通过体格检查、大体解剖学和临床评估上肢骨和软组织解剖 测量，X射线，DEXA和CT扫描;目标3）评估TH截肢者的功能能力， 使用经确认的工具在VA系统内进行治疗，以监测活动范围、生物力学、活动， 损伤和患者满意度;目标4）开发TH截肢者的患者分类系统， 用于确定合适的候选人进行修复技术的临床试验。 方法：将在全国范围内搜索肘部以上截肢的退伍军人。医疗记录将 审查以收集人口统计学和流行病学数据，包括：原因、自截肢以来的时间、残肢 长度、假体使用和合并症。符合预定入选标准的患者将被纳入 向他们发送了一封信，通知他们这项研究，并要求他们对开放式创新技术感兴趣的人做出回应。如果 同意参加筛选访视，受试者将接受以下评估：前/后 X线和侧位片，计算机断层扫描（CT），DEXA扫描，残肢体格检查，自我检查 报告疼痛评估、生活质量和功能、执行日常活动的功能评估 在运动捕捉实验室中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50名TH截肢者的现场筛查。 将对数据进行解释，以开发一个系统，根据骨质、功能、疼痛和 假肢限制该系统将用于确定未来临床试验的适当候选药物 设备和其他先进的假肢技术。 意义：这项工作有可能通过提供 一个以前未收集的综合数据集，从经验丰富的经股动脉截肢者到研究 社区和医疗保健提供者。将开发一个新的分类系统， 为未来的假肢研究和临床实践选择合适的候选人，以提高 退伍军人的功能和整体生活质量。