Percutaneous Osseointegrated Docking System for Above Elbow Amputees

描述（由申请人提供）： 这个为期三年的项目的总体目标是最大限度地恢复患者的功能， 通过开发一种髓内经皮骨整合对接系统（PODS），可用于人体临床试验，AEA PODS的设计将解决现代战士肘部以上残肢（即短残肢、异位骨化（HO）、弹片）的挑战。背景：外装假肢与残肢的套接式连接是目前的护理标准，但并不适用于所有患者。即使成功安装了套式附件的患者也可能不满意，因为他们经常因套式附件配合不良导致软组织持续恶化而感到疼痛。此外，爆炸相关的异位骨化（HO）的软组织内的残肢造成进一步减少 在生活质量上。PODS设备正是针对这些患者开发的。该提案有三个具体目标。首先，我们将使用来自目前为美国服役的各种人员的合并尸体人群的形态学数据，设计一系列AEA PODS内假体。我们在这类工作方面有着良好的记录，不仅在转化动物模型方面，而且在即将到来的FDA AKA患者小型可行性临床试验中也有人类股骨。在这个项目中，我们将提供一个 一系列AEA PODS足以达到95%置信度，以拟合合并尸体人群。第二，我们将使用去识别VA和创伤性截肢的军人患者样本人群验证AEA PODS的内假体适配性。到目前为止，PODS的设计还没有考虑到VA和军事医疗保健人群中发现的独特临床挑战。直接与VA、WRNMMC和BAMC医疗保健系统内的合作者合作，我们将从创伤相关AEA人群中获得去识别的CT图像集。通过使用样本患者人群评价设计的AEA PODS，我们将能够验证设计足以保持该独特人群的内假体适合性。我们将提供一系列足以达到95%置信度的AEA PODS，以拟合样本患者人群。第三，我们将建立AEA PODS的初始术后固定预期。我们认为，在可以安全地开始AEA PODS患者的康复之前，必须确定测量的AEA PODS内假体的内假体匹配与预期的术后固定之间的关系。我们将提供一个数学关系，在95%置信度内估计AEA PODS的初始术后固定，考虑到内假体的适配性。研究设计：使用我们用于开发先前绵羊动物模型内假体的既定方案和即将进行的AKA PODS器械的FDA可行性试验，我们将设计一系列AEA PODS，足以达到95%置信度的样本AEA患者人群拟合，并开发数学关系，以在95%置信度内估计AEA PODS的初始术后固定（给定内假体拟合）。相关性：在PODS器械的开发中，肘部以上创伤性截肢患者目前服务不足。截至2012年7月2日，来自OIF/OEF的重大截肢患者人数已达到1 506人，其中263人（17%）患上肢受累。据2005年估计，在全国范围内，2005年有150万人失去肢体，其中541 000人（36%）患有上肢疾病。不幸的是，在AEA患者中，插座型外假体的排斥尤其普遍。近60%的AEA患者拒绝使用基于关节窝的外假体，原因包括适配性差、训练困难、有用性有限和残肢长度短等问题。

DESCRIPTION (provided by applicant): The overall goal of this three-year project is to maximize the functional recovery of patients with above elbow amputations (AEA) by developing an intramedullary Percutaneous Osseointegrated Docking System (PODS) that is ready for translation to human clinical trials. The design of the AEA PODS will address the challenges found in above elbow residual limbs of modern day warfighters (i.e. short residual limbs, heterotopic ossification (HO), shrapnel). Background: Socket-type attachment of an exoprosthesis to the residual limb is currently the standard of care, but is not suitable for all patients. Even patients successfully fitted with sockt-type attachments can be dissatisfied since they frequently experience pain from persistent deterioration of the soft tissues resulting from poor socket fit. In addition, blast related heterotopic ossification (HO) within the soft tissues of the residual limb cause further reductions in quality of life. It is for these kinds of patients that PODS devices are developed. There are three Specific Aims to this proposal. First, using morphological data from a pooled cadaver population with the diversity of personnel currently serving active duty for the United States, we will engineer a series of AEA PODS endoprostheses. We have a proven track record with this type of work not only with translational animal models, but also with human femurs for an upcoming FDA small feasibility clinical trial with AKA patients. In this project, we will deliver a series of AEA PODS sufficient to achieve a 95% confidence of fitting the pooled cadaver population. Second, we will verify the endoprosthetic fit of the AEA PODS using a sample population of de-identified VA and military patients with traumatic amputations. To date, PODS have not been designed to account for the unique clinical challenges found in both the VA and the military healthcare populations. Working directly with collaborators within the VA, the WRNMMC, and the BAMC healthcare systems, we will obtain de-identified CT image sets from trauma related AEA populations. By evaluating the designed AEA PODS using a sample patient population, we will be able to verify that the designs are adequate to preserve endoprosthetic fit of this unique population. We will deliver a series of AEA PODS sufficient to achieve a 95% confidence of fitting a sample patient population. Third, we will establish the initial post-operatve fixation expectations for AEA PODS. We believe that before rehabilitation of AEA PODS patients can safely be initiated, it is imperative to determine the relationship between the measured endoprosthetic fit of the AEA PODS endoprostheses and the expected post-operative fixation. We will deliver a mathematical relationship to estimate, within 95% confidence, the initial post-operative fixation of AEA PODS given the endoprosthetic fit. Study Design: Using our established protocols used to develop endoprosthesis for previous sheep animal models and upcoming FDA Feasibility trials for AKA PODS devices, we will engineer a series of AEA PODS sufficient to achieve a 95% confidence of fitting a sample AEA patient population and develop a mathematical relationship to estimate, within 95% confidence, the initial post-operative fixation of AEA PODS given the endoprosthetic fit. Relevance: In the development of PODS devices, patients with traumatic amputations above the elbow are currently underserved. As of 02 July 2012, the number of patients from OIF/OEF with major limb amputations has reached 1,506, of which 263 (17%) suffer from upper extremity involvement. Nationally, it is estimated in 2005, of the 1.5 million persons living with limb loss in 2005, 541,000 (36%) have an upper extremity involvement. Unfortunately, rejection of socket-type exoprosthetics is especially prevalent in AEA patients. Nearly 60% of AEA patients reject the use of their socket-based exoprosthesis because of issues such as poor fit, difficulties with training, limited usefulness, and short residual limb-length.