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: 9394729
• 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 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9394729
• 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; Investigation; 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; Roentgen Rays; Safety; Scanning; Scientist; Skin; Sodium Chloride; 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; implant design; 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：本研究将测试一种用于经股截肢者的新型经皮骨整合假体植入物，作为接受腔假肢附着系统的替代品。这项工作的目的是解决与插座技术相关的并发症，该设备直接植入残余骨中，可用于改善退伍军人截肢者的生活质量。Erik Kubiak博士及其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34万多名肢体丧失者提供护理。在过去的十年中，由于持久自由行动和伊拉克自由行动的冲突，美军人口中的截肢率比以前的战争增加了一倍。这些截肢者中的大多数都渴望恢复功能，但由于他们的肢体损失而面临持续的负担。目前的假肢接受腔系统充满了并发症，并且难以用于残肢短和多肢缺失的情况。通常，承窝佩戴者会经历反复出现的并发症，包括由于摩擦引起的皮肤破裂、不适、肢体疼痛、感染、承窝固定不牢固以及由于体重变化引起的频繁重新装配。这些挑战使大多数截肢者每天无法舒适地佩戴假肢超过几个小时。 目的：本研究的目的是在退伍军人经股截肢者中测试一种新型经皮骨整合假体植入物。将测试以下特定目标：目标：1）在有限数量的人类受试者（N=10）中评价新的经皮假体连接系统的安全性; 2）优化在有限数量的人类受试者中植入经皮骨整合假体连接系统的手术技术; 3）开发针对植入该经皮骨整合器械的受试者的术后监测和康复技术，以衡量疗效; 4）建立骨整合技术向其他VA和军队机构转移的临床平台。 方法：乔治E将入组10例非因外周血管疾病、糖尿病并发症或感染而接受经股截肢术的受试者。 犹他湖城退伍军人医疗中心。所有受试者将接受经皮骨整合器械。手术方案将包括两阶段手术。器械的内假体部分将在第1阶段植入。该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。第2阶段手术后将对受试者进行一年的系统监测以收集数据。作为常规临床护理的一部分，将对受试者进行终身随访。在植入手术前和1年随访期间，将对每例受试者进行仔细评估。X线片、DEXA扫描、微生物学和经验证的监测活动、损伤和患者满意度的工具将用于客观量化假体利用率和患者生活质量。 重要性：这种新型经皮骨整合假体器械的成功有可能通过减少与传统接受腔连接系统相关的并发症来显著改善截肢者的VA临床护理。这项研究也将大大改善退伍军人的功能和整体生活质量。