Pilot Investigation of Ewing Amputation in Veterans with Peripheral Arterial Disease Undergoing Below Knee Amputation

患有周围动脉疾病并接受膝下截肢的退伍军人尤因截肢的试点研究

• 批准号: 10707110
• 负责人: LUKE Packard BREWSTER
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10707110
• 关键词: Accelerometer; Accounting; Affect; Agonist; Algorithms; Amputation; Amputees; Benchmarking; Benefits and Risks; Caring; Clinical; Clinical Research; Clinical Trials; Competence; Consent; Data; Diabetes Mellitus; Dissection; Enrollment; Equilibrium; Equipoise; Exclusion; Expert Opinion; Fall prevention; Femur; Funding; Gastrocnemius Muscle; Goals; Health; Individual; Informed Consent; Institution; Investigation; Knee; Lead; Limb structure; Literature; Love; Modification; Morbidity - disease rate; Muscle; Muscle Tension; Operative Surgical Procedures; Outcome; Pain; Pain management; Patients; Performance; Peripheral; Peripheral arterial disease; Phase; Phase 0 Study; Pilot Projects; Population; Postoperative Period; Proprioception; Prosthesis; Protocols documentation; Provider; Quality of life; Randomized; Research Personnel; Safety; Site; Surgeon; Surgical Wound Infection; Talents; Techniques; Testing; Time; Training; Veterans; Walking; antagonist; arm; care systems; chronic pain; design; feasibility testing; follow-up; improved; military veteran; mortality; muscle degeneration; neural; operation; pain outcome; pilot test; primary outcome; prosthesis fitting; randomized, clinical trials; recruit; regenerative; residual limb; safety outcomes; secondary outcome; wound healing

Diabetes and peripheral arterial disease (PAD) disproportionately affect our nation’s Veterans and are the major contributors to major amputation in our Veterans. These dysvascular Veterans undergo ~ 1000 below the knee or transtibial amputations annually. Our Veterans are more likely than younger/healthier patients to suffer from prolonged wound healing, pain, and not regaining ambulatory status after amputation. Amputation operations have not changed much in recent decades, but there are a number of exciting techniques that have been developed and hold potential for improving Veteran outcomes. Ewing amputation (EA) is a technical modification of transtibial amputation that may be able to provide a better limb for ambulation by recreating agonist antagonist myoneural interface (AMI) under the gastrocnemius flap and improve pain control through the creation of regenerative peripheral neural regenerative interfaces (RPNI). EA has been successfully pilot tested in healthy, high-functioning individuals, but it has not been tested in dysvascular patients. This proposal takes advantage of the phased clinical trial RFA to first test feasibility of EA in Veterans in a small group of patients at a single VA site. If feasible, a 3 VA study will randomly compare the results of EA versus standard transtibial amputation. The primary outcome is ambulation with a prosthesis. Safety parameters are 30-day mortality and rate of revision to transfemoral amputation. Secondary outcomes are pain, balance, and quality of life. Positive results will be disseminated across VAMCs broadly. In so doing, we will meet the tripartite goals of the VHA Amputation System of Care (ASoC) to: 1) provide state of the art care; 2) maximize health and independence; and 3) be the provider of choice for amputated Veterans [VHA Directive 1172.03(1)].

糖尿病和外周动脉疾病 (PAD) 对我国退伍军人的影响尤为严重，并且是 造成我们退伍军人严重截肢的主要因素 这些血管不良的退伍军人经历了约 1000 以下的情​​况。 每年我们的退伍军人比年轻/健康的患者更有可能进行膝盖或经胫骨截肢。 截肢后伤口愈合时间长、疼痛且无法恢复行走状态。 近几十年来，操作并没有太大变化，但有许多令人兴奋的技术已经出现 尤因截肢术（EA）是一种技术 经胫骨截肢术的改良可能能够通过重建提供更好的行走肢体 腓肠肌皮瓣下的激动剂拮抗剂肌神经界面（AMI）并通过以下方式改善疼痛控制 再生周围神经再生接口（RPNI）的创建已成功试点。 在健康、高功能个体中进行了测试，但尚未在血管疾病患者中进行测试。 利用阶段性临床试验 RFA，首先在一小群退伍军人中测试 EA 的可行性 如果可行，3 VA 研究将随机比较 EA 与标准的结果。 经胫骨截肢术的主要结果是使用假肢下床行走，安全参数为 30 天。 死亡率和经股截肢翻修率次要结果是疼痛、平衡和质量。 积极的成果将在 VAMC 中广泛传播，这样我们就能实现三方目标。 VHA 截肢护理系统 (ASoC) 旨在：1) 提供最先进的护理；2) 最大限度地提高健康水平； 独立；以及 3) 成为截肢退伍军人的首选医疗服务提供者 [VHA 指令 1172.03(1)]。