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）不成比例地影响我们国家的退伍军人，是 我们退伍军人的主要截肢者的主要贡献者。这些血管血管退伍军人在下面经历〜1000 每年的膝盖或跨性截肢。我们的退伍军人比年轻/健康的患者更有可能 截肢后的伤口愈合，疼痛以及不恢复卧床状态。 最近几十年的操作并没有发生太大变化，但是有许多令人兴奋的技术 尤因截肢（EA）是技术 修改跨位截肢的修改，可能能够通过重新创建来为您提供更好的肢体 激动剂拮抗剂肌肉界面（AMI）在胃瓣瓣下，并通过 创建再生周围神经再生界面（RPNI）。 EA已成功飞行员 在健康，高功能的个体中进行了测试，但尚未在血管血管患者中进行测试。这个建议 利用分阶段的临床试验RFA首先测试EA在一小组中退伍军人在退伍军人中的可行性 单个VA站点的患者。如果可行，3 VA研究将随机比较EA与标准的结果 截肢截肢。主要结果是假体的卧床。安全参数为30天 转化截肢的死亡率和修订率。次要结果是疼痛，平衡和质量 生活。积极的结果将在整个VAMC中传播。这样，我们将达到三方目标 VHA截肢系统的护理系统（ASOC）至：1）提供最先进的护理状态； 2）最大化健康和 独立; 3）成为截肢退伍军人的首选提供者[VHA指令1172.03（1）]。