Functional Expectations of Transhumeral Percutaneous Osseointegration Patients.

FDA早期可行性研究（EFS）允许“对器械进行早期临床评价，以提供原理证明 和初始临床安全性数据。”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，用于经股截肢患者。截至 2017年12月1日，10名经股动脉VA患者接受了该器械，并成功行走长达 22-几个月的积极的安全和功能的结果。目前，EFS的安全性和功能性数据正在 用于针对经股动脉器械的关键性研究，以获得上市前批准（PMA），这将导致 经股动脉OI器械在美国的广泛临床应用。然而，经股动脉患者 目前还没有得到足够的修复技术。近60%的经股动脉患者限制使用 悬吊式假肢和30%以上的上肢悬吊式假肢装置 完全被退伍军人事务部和军队的病人抛弃了， 假肢在女性中最为常见。该提案的总体目标是最大限度地发挥 恢复美国退伍军人，军队和平民患者的经股动脉肢体丧失。我们相信这可以成为 通过将FDA批准的经皮OI器械用于该患者人群来完成。在过去的三年里，我们 开发了一种独特的经皮OI器械，在这里称为PODS，专门用于经股动脉患者 使用基于证据的方法。 本提案的主要目的是对经股动脉PODS器械进行FDA指导的EFS 患者，建立其初步临床安全性。将招募初始组（N=20）经股动脉患者 到湖城（SLC）VA进行深入咨询和以患者为中心的功能评估，使用 共享决策方法。被招募的候选人将接受全面的临床评估， 四肢功能评估，重点是日常生活活动（ADL），以及关节和终末关节功能评估。 将收集其接受腔-假体器械的器械生物力学（时间= 0）。这些数据将用于 最终入选FDA EFS临床试验的患者（N=10）。EFS的病人会被带回 SLC VA，入院，并进行第1阶段手术以接受PODS内假体 设备，然后出院回家。大约4周后，患者将返回SLC VA， 进行第2阶段手术，以放置经皮立柱并连接其假体装置。后 在手术中，将在经皮部位监测伤口愈合。患者将从 医院继续门诊康复。阶段2后定期（时间= 3、6和12个月） 手术后，患者将被带回SLC VA，以评估其残余骨、软组织和 设备.每次随访时，将使用PODS器械重复进行以患者为中心的功能评估 访问将在患者1年随访期内确定主要目的（安全性）的成功 成功使用PODS器械，未因深部骨感染、无菌性松动 或非创伤性骨折 该提案的次要目的是使用以患者为中心的方法来量化功能性 PODS器械的有效性，特别注意男性和女性所需的方案差异 患者次要目标（功能有效性）的成功将量化 与术前性能相比，患者使用PODS器械实现了功能改善。 这些数据将是第一个纵向分析，以评价经皮OI假体对 这些经肱骨截肢患者的客观功能测量。

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.