Dynamic Bone-Implant Loading in Osseointegrated Prostheses

骨整合假体中的动态骨植入负载

• 批准号: 10597791
• 负责人: Brecca Gaffney
• 金额: $ 14.44万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-15 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10597791
• 关键词: Activities of Daily Living; Amputation; Awareness; Body mass index; Bone remodeling; Chronic; Clinical; Clinical Data; Data; Data Set; Distal; Elements; Exercise; Failure; Femur; Fracture; Goals; Growth; Image; Implant; Intervention; Joints; Knowledge; Limb Prosthesis; Lower Extremity; Measures; Mechanics; Modality; Modeling; Motion; Movement; Muscle; Musculoskeletal; Musculoskeletal System; Osseointegration; Outcome; Pathologic; Pathology; Patient-Focused Outcomes; Patients; Pattern; Physiologic calcification; Population; Procedures; Prosthesis; Protocols documentation; Quality of life; Rehabilitation therapy; Research Design; Residual state; Retrospective Studies; Risk; Stress; Training; Validation; Walking; Weight-Bearing state; Work; biomechanical model; bone; bone health; career; clinical care; design; efficacious intervention; follow-up; functional improvement; gait rehabilitation; habituation; healing; improved; in vivo; independent ambulation; kinematics; limb amputation; limb bone; mechanical load; novel; osseointegrated implant; patient subsets; prosthetic socket; residual limb; strength training; transmission process

PROJECT SUMMARY An osseointegrated prosthesis is a novel alternative to a prosthesis socket that directly mounts the prosthesis to the residual limb through a bone anchored implant, which improves the load transmission between the ground and residual limb. Proper loading at the bone-implant interface is critical to long-term outcome as underloading can lead to implant loosening and overloading can lead to periprosthetic fracture. Preliminary outcome evidence is highly promising regarding improvements in function and quality of life following prosthesis osseointegration compared to a traditional socket; however, mechanical failure due to implant loosening or fracture persists in a small subset of this population, which can have devastatingly negative impacts on the patient. Although bone-implant loading has a direct impact on outcome, it cannot be measured in-vivo. As a result, finite element models are the most widely used surrogate to estimate bone-implant loading. However, these prior models have three primarily limitations that impede their clinical utility: 1) they have not included activities of daily living, 2) they have not incorporated muscle forces, and 3) they have not been developed for transtibial osseointegrated prostheses. The first goal of this proposal is to leverage an existing dataset that will develop a state-of-the-art modeling platform that will quantify bone-implant interface loading in patients with transfemoral and transtibial osseointegrated prostheses during activities of daily living. Rehabilitation following prosthesis osseointegration involves progression of mechanical loading through gradual increase in weight bearing and strengthening exercises designed to promote bone remodeling to prepare the bone and implant to sustain loads required for daily living. Further on in the healing stage, gait retraining is prescribed to retrain the movement patterns of the patient as they habituate to the new ability to directly load the residual bone. Although rehabilitation is pivotal to optimize patient outcome, it remains hindered by a lack of empirical data that results in protocols being not well defined, lacking validation, and not specific to amputation level. The second goal of this proposal will be to establish the effects of simulated rehabilitation on bone- implant interface loading in patients with transtibial and transtibial osseointegrated prostheses. This proposal will be the first to quantify dynamic bone-implant interface loading in osseointegrated prostheses while incorporating subject-specific movement, muscle, and joint forces (Aim 1) and to assess the effects of rehabilitation on these loading patterns (Aim 2). Because mechanical failures are largely due to pathologic loading at the bone-implant interface, understanding how it is altered by amputation level, activity, and rehabilitation following prosthesis osseointegration is critical to optimizing outcomes in this population. As prosthesis osseointegration gains in awareness, evidence regarding its effect on the musculoskeletal system is critically needed to make this promising prosthesis more accessible to a broader population.

项目概要 骨整合假肢是直接安装假肢的假肢接受腔的新型替代品 通过骨锚固植入物传递到残肢，从而改善了地面之间的负载传递 和残肢。骨-种植体界面处的适当负载对于长期结果至关重要，因为负载不足 可导致种植体松动，超载可导致假体周围骨折。初步结果证据 对于假体骨整合后功能和生活质量的改善非常有希望 与传统插座相比；然而，由于种植体松动或断裂而导致的机械故障仍然存在 该人群的一小部分，可能会对患者产生毁灭性的负面影响。 尽管骨植入物负载对结果有直接影响，但无法在体内测量。因此， 有限元模型是估计骨植入物负载最广泛使用的替代方法。然而，这些之前 模型具有三个主要限制，阻碍了其临床实用性：1）它们没有包括日常活动 活着，2）它们没有结合肌肉力量，3）它们不是为跨胫骨而开发的 骨整合假体。该提案的第一个目标是利用现有数据集 开发最先进的建模平台，量化患者骨-植入物界面负载 在日常生活活动中使用经股骨和经胫骨骨整合假体。 假体骨整合后的康复涉及机械负荷的进展 逐渐增加负重和强化练习，旨在促进骨骼重塑，做好准备 骨骼和植入物可承受日常生活所需的负荷。在愈合阶段，步态再训练是 规定用于重新训练患者的运动模式，因为他们习惯了直接加载的新能力 残留骨。尽管康复对于优化患者治疗效果至关重要，但由于缺乏康复治疗，康复仍然受到阻碍。 导致方案定义不明确、缺乏验证且不特定于截肢的经验数据 等级。该提案的第二个目标是确定模拟康复对骨骼的影响。 经胫骨和经胫骨骨整合假体患者的种植体界面负载。 该提案将是第一个量化骨整合中动态骨-种植体界面负载的提案 假肢，同时结合受试者特定的运动、肌肉和关节力（目标 1）并评估 康复对这些负荷模式的影响（目标 2）。因为机械故障很大程度上是由于 骨-植入物界面的病理负荷，了解截肢水平、活动、 假体骨整合后的康复对于优化该人群的治疗结果至关重要。作为 假体骨整合的认识有所提高，有关其对肌肉骨骼系统影响的证据是 迫切需要让这种有前途的假肢更容易为更广泛的人群所使用。