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: 9980716
• 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 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9980716
• 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; Cities; Classification; Client satisfaction; Clinical; Clinical Research; 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; Foundations; Funding; Future; Goals; Health Personnel; Healthcare Systems; Hospitals; Image; Impairment; Implant; 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; Sodium Chloride; Suspensions; System; Techniques; Technology; Telephone; Testing; Thick; Time; Upper Extremity; Veterans; Visit; Work; X-Ray Computed Tomography; base; bone; bone quality; clinical candidate; clinical care; clinical practice; comorbidity; cortical bone; density; design; disability; epidemiologic data; experience; functional outcomes; improved; inclusion criteria; interest; kinematics; member; new technology; novel; patient population; programs; 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：这项研究将创建一个数据库 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。这项工作旨在收集解剖学，生活质量和生物力学数据 用于优化开发肘上骨整合植入物的设计以提高质量 退伍军人的生活。 Sarina Sinclair博士和她的合作者拥有临床和研究 可以成功完成这项工作的基础。 通过骨整合（OI）直接对假肢的直接骨骼依恋，目前正在测试和 在George E. Wahlen VA盐湖城卫生保健系统上进行了优化。 OI技术正在开发 为了改善假肢依恋，改善功能结果并通常减少并发症 与插座接口系统相关联。我们的研究团队目前正在提早进行FDA批准 在经验丰富的截肢者中的OI假体的可行性研究。从我们那里获得的知识 现在，成功的转换OI计划已应用于上肢截肢者。这是我们提供的目标 经式（TH）Amputees一个OI系统，该系统将使他们充分利用高级鞋面 近年来开发的肢体假肢技术以最大化功能。这项研究 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识别未来临床试验的候选人。 目的：目标1）创建一个具有经济截肢的美国退伍军人数据库，用于开发 假肢技术通过图表审查，临床推荐和个人访谈；目标2） 通过体格检查的上肢骨和软组织解剖结构的临床评估 测量，X射线，DEXA和CT扫描；目标3）评估截肢者的功能功能 使用经过验证的工具在VA系统中进行处理，以监视运动范围，生物力学，活动， 障碍和患者满意度；目的4）开发一种可以是截肢者的患者分类系统 用于确定适当的候选假体技术试验。 方法：将为肘部截肢者上方的退伍军人进行国家搜索。病历将是 审查以收集人口统计学和流行病学数据，包括：自截肢以来的时间，残留肢体 长度，假体使用和合并症。符合预定一套纳入标准的患者将是 发送一封信，通知他们研究并要求他们对OI技术感兴趣。如果 同意参加筛查访问，参与者将接受以下评估：前/后部 和侧面X射线，计算机断层扫描（CT）扫描，DEXA扫描，残留肢体的体格检查，自我检查 报告评估疼痛，​​生活质量和功能，功能评估表演日常活动 在运动捕获实验室中专注于运动范围和运动学评估。这是我们的目标 要在三年内完成现场筛查50截距。 数据将被解释为开发一个系统，以根据骨骼质量，功能，疼痛和 假体局限性。该系统将用于确定适当的候选人以将来的临床试验 设备和其他前进的假肢技术。 意义：这项工作有可能通过提供明显改善截肢者的VA临床护理 先前未收集的综合数据集，从经验丰富的经济截肢者到研究 社区和医疗保健提供者。将开发一个可以应用的新分类系统 为未来的假肢研究和临床实践选择合适的候选人以改进 退伍军人的功能和整体生活质量。