Safety Study of Percutaneous Osseointegrated Implants for Prosthetic Attachment

经皮骨整合植入物用于假体附着的安全性研究

• 批准号: 8990878
• 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: 2013
• 资助国家: 美国
• 起止时间: 2013-10-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8990878
• 关键词: Accelerometer; Address; Amputation; Amputees; Assessment tool; Caring; Cities; Client satisfaction; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Complications of Diabetes Mellitus; Conflict (Psychology); Data; Data Collection; Device Designs; Devices; Dual-Energy X-Ray Absorptiometry; Enrollment; European; Event; Exclusion Criteria; Face; Feasibility Studies; Foundations; Freedom; Friction; Goals; Hour; Human; Impairment; Implant; Individual; Infection; Infection prevention; Institution; Laboratories; Life; Limb Prosthesis; Limb structure; Measurement; Measures; Medical center; Medicine; Microbiology; Military Personnel; Modification; Monitor; Operative Surgical Procedures; Orthopedics; Outcome; Pain; Patients; Peripheral Vascular Diseases; Physical Medicine; Plastic Surgical Procedures; Population; Postoperative Period; Procedures; Prosthesis; Protocols documentation; Quality of life; Reconstructive Surgical Procedures; Rehabilitation therapy; Research; Residual state; Safety; Scanning; Scientist; Skin; Sodium Chloride; Staging; Swab; System; Techniques; Technology; Testing; Time; United States Food and Drug Administration; Utah; Vascular blood supply; Veterans; War; Work; bone; clinical care; design; experience; follow-up; human subject; implantation; improved; improved functioning; inclusion criteria; innovation; insight; internal control; novel; operation; post-operative rehabilitation; preclinical study; programs; prosthetic socket; residual limb; safety study; sample fixation; satisfaction; skeletal; soft tissue; success; tool

DESCRIPTION (provided by applicant): RELEVANCE: This study will test a novel percutaneous osseointegrated prosthetic implant for transfemoral amputees as an alternative to a socket prosthetic limb attachment system. This work aims to address the complications associated with socket technology with a device that is implanted directly into the residual bone and can be used to improve the quality of life for Veterans amputees. Dr. Erik Kubiak and his collaborators have the clinical and research foundation on which to successfully complete this work. The Department of Veterans Affairs currently provides care for over 340,000 individuals with limb loss. The rate of amputations within the U.S. military population has doubled over the past decade as a result of the Operation Enduring Freedom and Operation Iraqi Freedom conflicts compared to previous wars. The majority of these amputees are eager to regain function but face ongoing burdens as a result of their limb loss. The current prosthetic socket system is fraught with complications and is difficul to use in cases where the residual limb is short and with multiple-limb loss. Commonly, socket wearers experience recurring complications, which include skin breakdown due to friction, discomfort, limb pain, infection, insecure socket fixation, and frequent re-fitting due to body mass changes. These challenges prohibit most amputees from comfortably wearing their prosthesis more than a few hours a day. OBJECTIVE: The objective of this study is to test a novel percutaneous osseointegrated prosthetic implant in Veteran transfemoral amputees. The following specific aims will be tested: AIMS: 1) Evaluate a new percutaneous prosthetic attachment system for safety in a limited number of human subjects (N=10); 2) Optimize the surgical technique for implanting the percutaneous osseointegrated prosthetic attachment system in a limited number of human subjects; 3) Develop post-operative monitoring and rehabilitation techniques specific for subjects implanted with this percutaneous osseointegrated device to measure efficacy; 4) Build the clinical platform for transferring osseointegrated technology to other VA and military institutions. METHODS: Ten subjects that have undergone transfemoral amputation not due to peripheral vascular disease, complications from diabetes, or infection will be enrolled at the George E. Wahlen VA Medical Center, Salt Lake City, Utah. All subjects will receive the percutaneous osseointegrated device. The surgical protocol will consist of a two-stage procedure. The endo-prosthetic portion of the device will be implanted at Stage 1. The exo-prosthetic portion of the device will be implanted six weeks later to allow the soft tissue envelope to mature and regain a viable blood supply. Subjects will be systematically monitored for one year following the Stage 2 surgery for data collection. Subjects will be followed for life as part of routine clinical care. Each subject will undergo careful assessment prior to the implant surgery and during the one-year follow-up period. Radiographs, DEXA scanning, microbiology and validated tools for monitoring activity, impairment and patient satisfaction will be used to objectively quantify prosthetic utilization and patient quality of lif. SIGNIFICANCE: The success of this novel percutaneous osseointegrated prosthetic device has the potential to significantly improve VA clinical care for amputees by reducing complications associated with traditional socket attachment system. This research would also greatly improve the Veteran's function and overall quality of life.

描述（由申请人提供）： 相关性：这项研究将测试一种新型经皮骨整合的假体植入物，用于透明度截肢者，以替代插座假肢附着系统。这项工作旨在通过直接植入残留骨骼的设备来解决与插座技术相关的并发症，并可用于改善退伍军人amuputees的生活质量。 Erik Ku​​biak博士和他的合作者拥有临床和研究基金会，可以成功完成这项工作。 退伍军人事务部目前为肢体损失的340,000多人提供护理。与以前的战争相比，由于持久的自由和行动伊拉克自由冲突，在过去十年中，美国军事人口内的截肢率增加了一倍。这些截肢者中的大多数渴望恢复功能，但由于肢体损失而面临持续的负担。当前的假体插座系统充满并发症，在残留肢体短并且有多个LIMB损失的情况下，很难使用。通常，套筒佩戴者经历了重复的并发症，包括由于摩擦，不适，肢体疼痛，感染，不安全的插座固定以及由于体重变化而频繁重新安装。这些挑战禁止大多数截肢者每天超过几个小时舒适地穿着假体。 目的：这项研究的目的是测试一种新型经皮骨整合的假肢植入物中的植入物。将测试以下具体目的：目的：1）评估有限数量的人类受试者的新经皮假肢附着系统（n = 10）； 2）优化用于植入有限数量的人类受试者的经皮骨构成的假肢附着系统的手术技术； 3）开发术后监测和康复技术，专门针对使用这种经皮骨整合装置植入的受试者来测量功效； 4）建立临床平台，将骨整合技术转移到其他VA和军事机构。 方法：十个经历了经济截肢的受试者并不是由于周围血管疾病，糖尿病并发症或感染的并发症将在犹他州盐湖城的乔治·E·沃伦VA医疗中心招募。所有受试者都将接收经皮骨整合设备。手术方案将由两阶段的程序组成。设备的内部螺旋式部分将在第1阶段植入。六周后，将植入该设备的外螺旋部分，以允许软组织包膜成熟并恢复可行的血液供应。 2阶段手术后，将对受试者进行系统的监测，以进行数据收集。作为常规临床护理的一部分，将遵循生命的受试者。每个受试者将在植入手术前和一年的随访期间进行仔细评估。 X光片，DEXA扫描，微生物学和经过验证的监测活动，障碍和患者满意度的工具将用于客观地量化假体利用率和LIF的患者质量。 意义：这种新颖的经皮骨整合假体装置的成功有可能通过减少与传统插座附着系统相关的并发症来显着改善截肢者的VA临床护理。这项研究还将大大改善退伍军人的职能和整体生活质量。