Functional Expectations of Transhumeral Percutaneous Osseointegration Patients.

经肱骨经皮骨整合患者的功能预期。

• 批准号: 10261447
• 负责人: Kent N. Bachus
• 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: 2018-10-01 至 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10261447
• 关键词: Activities of Daily Living; Amputation; Anatomy; Attention; Back; Biomechanics; Cities; Clinical; Clinical Trials; Consultations; Data; Development; Developmental Process; Device Designs; Device Removal; Device or Instrument Development; Devices; Distal; Docking; Dual-Energy X-Ray Absorptiometry; Effectiveness; Elbow; Enrollment; Evaluation; FDA approved; Feasibility Studies; Female; Fracture; Goals; Home; Hospitals; Implant; Individual; Investigation; Joints; Length; Measurement; Measures; Methods; Military Personnel; Modification; Monitor; Operative Surgical Procedures; Osseointegration; Osteomyelitis; Outpatients; Patient Selection; Patients; Performance; Postoperative Period; Procedures; Prosthesis; Protocols documentation; Recovery of Function; Rehabilitation therapy; Research Design; Residual state; Safety; Scanning; Site; Skin; Sodium Chloride; Suspensions; System; Technology; Testing; Time; Training; Upper Extremity; Veterans; Visit; Weight-Bearing state; Woman; X-Ray Computed Tomography; base; bone; clinical investigation; design; evidence base; expectation; experience; follow-up; functional improvement; limb loss; longitudinal analysis; male; military patient; osseointegrated implant; patient oriented; patient population; programs; prosthetic socket; recruit; research clinical testing; residual limb; safety study; shared decision making; soft tissue; success; wound healing

An FDA Early Feasibility Study (EFS) allows “for early clinical evaluation of devices to provide proof of principle and initial clinical safety data.” Over the past four years, our team has performed the first EFS clinical trial of a percutaneous osseointegrated (OI) docking system for patients with transfemoral amputations. As of December 1, 2017, 10 transfemoral VA patients received the device and are ambulating successfully for up to 22-months with positive safety and functional results. Currently, the EFS safety and functionality data are being used to target a pivotal study of the transfemoral device to obtain Premarket Approval (PMA) that will result in the broad clinical introduction of the transfemoral OI device within the US. However, transhumeral patients are currently underserved by prosthetic technologies. Nearly 60% of transhumeral patients limit their use of suspension-based prostheses and upwards of 30% of upper-limb suspension-type prosthetic devices are completely abandoned by both the VA and the military patient populations—with abandonment of the prosthesis most common among women. The overarching goal of this proposal is to maximize the functional recovery of US veteran, military, and civilian patients with transhumeral limb loss. We believe that this can be done by bringing FDA approved percutaneous OI devices to this patient population. Over the past 3 years, we developed a unique percutaneous OI device, known here as PODS, specifically for transhumeral patients using an evidence based approach. The Primary Aim of this proposal is to perform an FDA guided EFS of the PODS device for transhumeral patients, establishing its initial clinical safety. An initial group (N=20) of transhumeral patients will be recruited to the Salt Lake City (SLC) VA for in-depth consultation and patient centered functional evaluation using a shared decision making approach. Recruited candidates will undergo a full clinical evaluation of the residual limb. Functional assessments, focusing on activities of daily living (ADL), and evaluation of joint and terminal device biomechanics will be collected with their socket-prosthetic device (time = 0). These data will be used for final patient selection (N=10) for inclusion in the FDA EFS clinical trial. The EFS patients will be brought back to the SLC VA, admitted to the hospital, and have the Stage 1 surgery to receive the PODS endoprosthetic device, and then discharged to home. Approximately 4 weeks later, patients will return to the SLC VA and have the Stage 2 procedure performed to place the percutaneous post and attach their prosthetic device. Post- operatively, wound healing will be monitored at the percutaneous site. Patients will be discharged from the hospital to continue outpatient rehabilitation. Periodically (time = 3, 6, and 12 months) following the Stage 2 procedure, patients will be brought back to the SLC VA for assessment of their residual bone, soft tissues and device. The patient centered functional assessments will be repeated with their PODS device at each follow-up visit. Success of the Primary Aim (Safety) will be determined for the 1-year follow-up period with patients successfully using their PODS devices with no device removal due to deep bone infections, aseptic loosening, or atraumatic fracture. The Secondary Aim of this proposal is to use a patient-centered approach to quantify the functional effectiveness of the PODS device, giving specific attention to protocol differences required for male and female patients. Success for the Secondary Aim (Functional Effectiveness) will be to quantify the degree to which patients achieve functional improvement with the PODS device compared to the pre-operative performance. These data will be the first longitudinal analyses to evaluate the impact of percutaneous OI prostheses on objective functionality measures of these transhumeral amputation individuals.

FDA的一项早期可行性研究(EFS)允许对设备进行早期临床评估，以提供原则证据 和初步的临床安全性数据。在过去的四年里，我们的团队进行了第一次EFS临床试验 经皮骨整合(OI)对接系统，用于经股动脉截肢患者。自.起 2017年12月1日，10名经股动脉VA患者接受了该装置，并成功行走了长达 22个月，安全性和功能性结果均为阳性。目前，EFS的安全和功能数据正在 用于针对经股动脉装置的关键研究，以获得上市前批准(PMA)，这将导致 经股动脉OI装置在美国的广泛临床推介。然而，经胸骨的患者 目前假体技术的服务不足。近60%的经腹患者限制使用 悬挂式假体和30%以上的上肢悬挂式假体是 完全被退伍军人和军队患者群体抛弃-放弃 在女性中最常见的假肢。该提案的总体目标是最大限度地提高 美国退伍军人和平民四肢缺失患者的康复。我们相信这是可以实现的 通过将FDA批准的经皮OI设备带到这一患者群体来完成。在过去的3年里，我们 开发了一种独特的经皮OI设备，这里称为Pod，专门用于经胸患者 使用基于证据的方法。 这项建议的主要目的是在FDA的指导下对经肩关节的PODS装置进行EFS 患者，建立其初步的临床安全性。最初的一组(N=20)经胸患者将被招募 到盐湖城(SLC)退伍军人管理局进行深入咨询和以患者为中心的功能评估 共享决策方法。招募的候选人将接受残留物的全面临床评估 四肢。功能评估，重点是日常生活能力(ADL)，以及关节和终末的评估 装置生物力学将与他们的承窝假体装置一起收集(时间=0)。这些数据将用于 最终患者选择(N=10)纳入FDA EFS临床试验。EFS患者将被带回 到SLCVA，住进医院，进行第一阶段手术接受吊舱内假体 装置，然后被释放回家。大约4周后，患者将返回SLC VA并拥有 第2阶段手术放置经皮桩并安装假体装置。邮寄- 在手术上，伤口愈合将在经皮部位进行监测。病人将从医院出院 医院继续门诊康复。在阶段2之后定期(时间=3、6和12个月) 手术后，患者将被带回SLC VA进行残留骨、软组织和 设备。以患者为中心的功能评估将在每次随访时使用患者的PODS设备重复进行 参观。主要目标(安全性)的成功将在患者1年的随访期内确定 成功地使用了他们的吊舱装置，没有由于深部骨骼感染、无菌性松动、 或非创伤性骨折。 该建议的次要目标是使用以患者为中心的方法来量化功能性 吊舱装置的有效性，特别注意男性和女性所需的协议差异 病人。次要目标(功能有效性)的成功将量化到以下程度 与手术前相比，患者使用PODS装置后功能得到了改善。 这些数据将是第一次纵向分析，以评估经皮OI假体对 目的测量这些经胸段截肢者的功能。