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促进患者的功能恢复 通过开发一种可转化为人体临床试验的髓内经皮骨整合对接系统(PODS)，可实现肘部截肢(AEA)以上的功能。AEA吊舱的设计将解决现代作战人员肘部以上残肢(即残肢较短、异位骨化(HO)、弹片)的挑战。背景：插槽式外假体连接到残肢是目前的治疗标准，但并不适用于所有患者。即使成功安装了套筒型附着体的患者也会感到不满意，因为他们经常会因为插座适合性差而导致软组织持续恶化而感到疼痛。此外，残肢软组织内的爆炸性异位骨化(HO)会导致进一步的减少。 在生活质量方面。正是为这类患者开发了吊舱设备。这项提议有三个具体目标。首先，利用来自美国现役人员多样性的混合身体人口的形态数据，我们将设计一系列AEA吊舱内假体。我们不仅在翻译动物模型上，而且在即将到来的FDA针对AKA患者的小型可行性临床试验中，也有这类工作的可靠记录。在这个项目中，我们将提供一个 一系列AEA吊舱，足以达到95%的置信度，适合汇集的身体种群。其次，我们将使用未确认的退伍军人和军人创伤性截肢患者的样本人群来验证AEA吊舱的假体内适合性。到目前为止，Pod的设计还没有考虑到退伍军人和军队医疗保健人群中发现的独特的临床挑战。我们将直接与退伍军人管理局、WRNMMC和BAMC医疗保健系统的合作者合作，从创伤相关的AEA人群中获得未识别的CT图像集。通过使用样本患者群体评估设计的AEA吊舱，我们将能够验证设计足以保持这一独特人群的内假体适合性。我们将提供一系列AEA吊舱，足以达到95%的置信度来适应样本患者群体。第三，我们将建立手术后对AEA Pod的初始固定期望。我们认为，在安全地开始AEA吊舱患者的康复之前，有必要确定AEA吊舱假体所测量的假体适合性与预期的术后固定之间的关系。我们将提供一个数学关系来估计，在95%的置信度内，在假体匹配的情况下，AEA吊舱的初始固定。研究设计：使用我们为以前的绵羊动物模型开发人工关节的既定方案和即将进行的FDA对AKA Pods装置的可行性试验，我们将设计一系列AEA Pods，足以达到95%的置信度来适应样本AEA患者群体，并建立数学关系，在95%的置信度内估计AEA Pods的初始术后固定情况。相关性：在PODS设备的开发中，肘部以上创伤性截肢的患者目前没有得到足够的服务。截至2012年7月2日，OIF/OEF的大腿截肢患者已达1,506人，其中263人(17%)受累于上肢。在全国范围内，据估计，在2005年150万失去肢体的人中，有541,000人(36%)有上肢受累。不幸的是，插槽式外假体的排斥反应在AEA患者中尤其普遍。近60%的AEA患者拒绝使用基于插座的外假体，原因是配合性差、训练困难、实用性有限以及剩余肢体长度较短。

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.