Safety Study of Percutaneous Osseointegrated Implants for Prosthetic Attachment

描述(由申请人提供)： 相关性：这项研究将测试一种用于经股截肢者的新型经皮骨集成假体植入物，作为插入式假肢附着系统的替代方案。这项工作旨在解决与插座技术相关的并发症，该设备直接植入残骨中，可用于改善退伍军人截肢者的生活质量。Erik Kubiak博士和他的合作者拥有成功完成这项工作的临床和研究基础。退伍军人事务部目前为34万多名肢体丧失患者提供护理。由于持久自由行动和伊拉克自由行动的冲突，与以前的战争相比，美国军队人口中的截肢率在过去十年中翻了一番。这些截肢者中的大多数都渴望恢复功能，但由于失去肢体，他们面临着持续的负担。目前的假肢套筒系统充满了并发症，在残肢较短和多肢缺失的情况下很难使用。通常，插座佩戴者会经历反复出现的并发症，包括因摩擦导致的皮肤破裂、不适、四肢疼痛、感染、插座固定不牢固，以及由于身体质量变化而频繁重新装配。这些挑战禁止大多数截肢者每天舒适地佩戴假肢超过几个小时。目的：本研究的目的是测试一种新型的经皮骨整合假体在退伍军人股骨截肢者中的应用。将测试以下具体目标：1)评估一种新型经皮假体附着体系统在有限数量的人体受试者(N=10)中的安全性；2)优化在有限数量的受试者身上植入经皮骨整合假体附着体系统的手术技术；3)开发针对植入这种经皮骨整合装置的受试者的术后监测和康复技术，以衡量疗效；4)建立将骨整合技术转让给其他退伍军人和军事机构的临床平台。方法：10名非因外周血管疾病、糖尿病并发症或感染行股动脉截肢的受试者将在犹他州盐湖城的George E.Wahlen VA医学中心登记。所有受试者都将接受经皮骨整合装置。手术方案将包括两个阶段的程序。该装置的内部假体部分将在第一阶段植入。装置的外部假体部分将在六周后植入，以使软组织包膜成熟并重新获得可行的血液供应。在第二阶段手术后，受试者将接受为期一年的系统监测，以收集数据。受试者将被终身跟踪，作为常规临床护理的一部分。在植入手术前和一年的随访期内，每个受试者都将接受仔细的评估。将使用X光片、DEXA扫描、微生物学和用于监测活动、损伤和患者满意度的有效工具来客观地量化假体利用率和患者的生活质量。意义：这种新型经皮骨集成假体装置的成功有可能通过减少与传统插座附着体系统相关的并发症，显著改善截肢者的VA临床护理。这项研究也将极大地改善退伍军人的机能和整体生活质量。

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.