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: 9929447
• 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 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9929447
• 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 environment; Hospitals; Implant; Individual; Investigation; Joints; Length; Limb structure; 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; Wound Healing; X-Ray Computed Tomography; base; bone; clinical investigation; design; evidence base; expectation; experience; follow-up; functional improvement; longitudinal analysis; male; patient oriented; patient population; programs; prosthetic socket; recruit; research clinical testing; residual limb; safety study; shared decision making; soft tissue; success

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 早期可行性研究 (EFS) 允许“对设备进行早期临床评估，以提供原理证明” 和初步的临床安全数据。”在过去的四年里，我们的团队进行了第一个 EFS 临床试验。 用于经股骨截肢患者的经皮骨整合（OI）对接系统。 2017 年 12 月 1 日，10 名经股 VA 患者接受了该设备，并成功下床行走长达 22 个月取得了积极的安全性和功能性结果 目前，EFS 安全性和功能性数据正在进行中。 用于针对经股装置的关键研究以获得上市前批准 (PMA)，这将导致 然而，经股骨 OI 装置在美国的广泛临床应用。 目前，近 60% 的经肱骨患者限制了假肢技术的使用。 悬挂式假肢和 30% 以上的上肢悬挂式假肢装置 被退伍军人管理局和军队患者群体完全抛弃——放弃了 该提案的首要目标是最大限度地提高假肢的功能。 我们相信，美国退伍军人、军人和平民肢体丧失患者的康复是可能的。 在过去的 3 年里，我们将 FDA 批准的经皮 OI 设备引入到这一患者群体中。 开发了一种独特的经皮 OI 装置，此处称为 PODS，专门针对经肱骨患者 使用基于证据的方法。 该提案的主要目标是对用于经肱骨的 PODS 装置执行 FDA 指导的 EFS 患者，确定其初始临床安全性将招募初始组（N = 20）经肱骨患者。 前往盐湖城 (SLC) VA 进行深入咨询并使用以患者为中心的功能评估 共同决策方法。招募的候选人将对剩余人员进行全面的临床评估。 肢体功能评估，重点是日常生活活动 (ADL) 以及关节和末梢评估。 设备生物力学将通过其接受腔假肢设备进行收集（时间 = 0）。 最终选择患者 (N=10) 纳入 FDA EFS 临床试验 EFS 患者将被带回。 前往 SLC VA，入院并进行第一阶段手术以接收 PODS 内置假体 大约 4 周后，患者将返回 SLC VA 并接受治疗。 进行第二阶段手术以放置经皮桩并连接假肢装置。 手术后，将在经皮部位监测伤口愈合情况，患者将出院。 第 2 阶段后定期（时间 = 3、6 和 12 个月）到医院继续门诊康复。 手术后，患者将被带回 SLC VA 评估其残余骨、软组织和 每次随访时都会使用 PODS 设备重复以患者为中心的功能评估。 主要目标（安全性）的成功与否将取决于患者的 1 年随访期。 成功使用他们的 PODS 装置，没有因深部骨感染、无菌性松动而移除装置， 或非外伤性骨折。 该提案的次要目标是使用以患者为中心的方法来量化功能 PODS 设备的有效性，特别关注男性和女性所需的协议差异 次要目标（功能有效性）的成功将是量化其程度。 与术前相比，患者使用 PODS 装置实现了功能改善。 这些数据将是评估经皮 OI 假体对患者影响的第一个纵向分析。 对这些经肱骨截肢者的功能进行客观测量。