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: 8487301
• 负责人: Erik Kubiak
• 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 2016-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8487301
• 关键词: Address; Amputation; Amputees; 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; preclinical study; programs; prosthetic socket; public health relevance; 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. PUBLIC HEALTH RELEVANCE: PROJECT NARRATIVE - A direct skeletal attachment system for prosthetic limbs, known as osseointegrated (OI) prosthesis, is being developed for transfemoral amputees to improve prosthetic attachment, function and reduce complications commonly associated with current socket systems. European groups have had success with OI technology, but with concerning infection rates. An OI implant design has been developed for introduction into the U.S., which has shown to prevent infection in preclinical studies, but requires testing in a human trail. This will be accomplished through the collaboration from prolific clinicians and scientists in the field of orthopedic medicine, plastic and reconstructive surgery and rehabilitation medicine. The success of this program has the potential to greatly improve the quality of life of the Veteran amputee population.

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肢植入物，作为接受腔假肢附着系统的替代品。这项工作旨在解决与接受腔技术相关的并发症，该设备可直接植入残余骨中，并可用于改善退伍军人截肢者的生活质量。 Erik Ku​​biak 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超过 340,000 名肢体丧失者提供护理。与之前的战争相比，过去十年，由于“持久自由行动”和“伊拉克自由行动”的冲突，美国军人的截肢率增加了一倍。大多数截肢者渴望恢复功能，但由于肢体丧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，并且在残肢较短和多肢丧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，包括由于摩擦而导致的皮肤破损、不适、肢体疼痛、感染、插座固定不牢固以及由于体重变化而频繁重新安装。这些挑战使得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。将测试以下具体目标： 目标： 1) 在有限数量的人类受试者（N = 10）中评估新的经皮假肢附着系统的安全性； 2）优化在有限数量的人体受试者中植入经皮骨整合假体附着系统的手术技术； 3) 开发专门针对植入该经皮骨整合装置的受试者的术后监测和康复技术，以测量疗效； 4）建立骨整合技术向其他退伍军人事务部和军队机构转移的临床平台。 方法：犹他州盐湖城的 George E. Wahlen VA 医疗中心将招募 10 名非因周围血管疾病、糖尿病并发症或感染而接受经股截肢的受试者。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手术​​。该装置的内假体部分将在第一阶段植入。该装置的外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，将对受试者进行为期一年的系统监测以收集数据。作为常规临床护理的一部分，将对受试者进行终生跟踪。每个受试者都将在种植手术前和一年的随访期间接受仔细的评估。 X 线照片、DEXA 扫描、微生物学和用于监测活动、损伤和患者满意度的经过验证的工具将用于客观量化假肢利用率和患者生活质量。 意义：这种新型经皮骨整合假肢装置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，显着改善 VA 对截肢者的临床护理。这项研究还将极大地改善退伍军人的功能和整体生活质量。 公共卫生相关性： 项目叙述 - 一种用于假肢的直接骨骼附着系统，称为骨整合 (OI) 假肢，正在为经股截肢者开发，以改善假肢附着、功能并减少与当前接受腔系统相关的常见并发症。欧洲团体在成骨不全技术方面取得了成功，但感染率却令人担忧。一种 OI 植入物设计已经开发出来并引入美国，临床前研究表明该设计可以预防感染，但需要进行人体试验。这将通过骨科医学、整形外科和康复医学领域多产的临床医生和科学家的合作来实现。该计划的成功有可能大大改善退伍截肢者的生活质量。