Percutaneous Osseointegrated Docking System for Above Elbow Amputees

用于肘部以上截肢者的经皮骨整合对接系统

• 批准号: 9188778
• 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: 2014
• 资助国家: 美国
• 起止时间: 2014-11-01 至 2018-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9188778
• 关键词: Address; Age; Amputation; Amputees; Anatomy; Animal Model; Area; Blast Cell; Cadaver; Clinical; Clinical Trials; Computer-Aided Design; Data; Dermal; Deterioration; Development; Devices; Dimensions; Docking; Elbow; Engineering; Femur; Freezing; Gender; Goals; Healthcare; Healthcare Systems; Heterotopic Ossification; Human; Human Resources; Image; Implant; Length; Limb structure; Location; Mathematics; Measures; Military Personnel; Modernization; Morphology; Patients; Persistent pain; Persons; Population; Postoperative Period; Protocols documentation; Quality of life; Race; Recovery of Function; Rehabilitation therapy; Research Design; Residual state; Sampling; Series; Sheep; System; Techniques; Thick; Tissues; Torsion; Training; Trauma; Traumatic Amputation; United States; Upper Extremity; Veterans; Work; X-Ray Computed Tomography; base; bone; design; expectation; experience; implant design; improved; instrumentation; limb amputation; metallicity; patient population; prototype; public health relevance; reconstruction; residual limb; sample fixation; seal; soft tissue; standard of care; translation to humans; virtual

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.

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化患者的功能恢复 通过开发髓内经皮骨整合对接系统（PODS）来治疗肘部截肢（AEA），该系统已准备好转化为人体临床试验。 AEA PODS 的设计将解决现代战士肘部以上残肢所面临的挑战（即短残肢、异位骨化 (HO)、弹片）。背景：将外假体套接在残肢上是目前的标准治疗方法，但并不适合所有患者。即使成功安装了插座型附件的患者也可能会不满意，因为他们经常会因插座贴合不良而导致软组织持续恶化而感到疼痛。此外，残肢软组织内与爆炸相关的异位骨化（HO）会导致残肢进一步减少 在生活质量方面。 PODS 设备正是针对此类患者而开发的。该提案有三个具体目标。首先，我们将利用来自汇总尸体群体的形态学数据以及目前在美国服役的各种人员的形态学数据，设计一系列 AEA PODS 内置假体。我们在此类工作方面拥有良好的记录，不仅针对转化动物模型，而且针对即将开展的 FDA 小型可行性临床试验（针对 AKA 患者）的人类股骨。在这个项目中，我们将交付一个 系列 AEA PODS 足以达到 95% 的置信度来拟合合并的尸体群体。其次，我们将使用身份不明的退伍军人管理局和遭受创伤性截肢的军人样本群体来验证 AEA PODS 的内置假体贴合性。迄今为止，PODS 的设计尚未考虑到 VA 和军队医疗保健人群中发现的独特临床挑战。我们将直接与 VA、WRNMMC 和 BAMC 医疗保健系统内的合作者合作，从创伤相关的 AEA 人群中获取去识别化的 CT 图像集。通过使用样本患者群体评估设计的 AEA PODS，我们将能够验证该设计是否足以保持该独特人群的内置假体贴合性。我们将提供一系列 AEA PODS，足以达到 95% 的置信度来拟合样本患者群体。第三，我们将为 AEA PODS 建立初始术后固定期望。我们认为，在 AEA PODS 患者安全开始康复之前，必须确定测量的 AEA PODS 内置假体的内置假体贴合度与预期的术后固定之间的关系。我们将提供数学关系，以在 95% 的置信度内估计 AEA PODS 给定内置假体配合的术后初始固定。研究设计：利用我们为之前的绵羊动物模型开发内置假体的既定方案以及即将进行的 AKA PODS 装置 FDA 可行性试验，我们将设计一系列 AEA PODS，足以达到 95% 的置信度来拟合 AEA 患者群体样本，并开发数学关系，在 95% 的置信度内估计 AEA PODS 给定内置假体配合的术后初始固定。相关性：在 PODS 设备的开发过程中，目前肘部以上创伤性截肢患者的服务不足。截至2012年7月2日，OIF/OEF导致截肢的患者人数已达1,506人，其中263人（17%）上肢受累。据估计，2005 年全国有 150 万肢体丧失者，其中 541,000 人（36%）有上肢受累。不幸的是，接受窝型外假体的排斥在 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，因为存在诸如适配性差、训练困难、实用性有限和残肢长度短等问题。