Pain After Proximal Digital Amputation Prevention
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- bMHQ
研究概览
简要总结
Finger amputations are common and may be complicated by debilitating nerve pain. This study seeks to determine if nerve pain after digital amputation can be more effectively prevented with either of two new surgical techniques-targeted muscle reinnervation (TMR) or regenerative peripheral nerve interfaces (RPNI)-compared to standard treatment by traction neurectomy (TN).
详细描述
Patients who require proximal amputations will have the opportunity to enroll in the study, will be randomized intraoperatively to receiving one of the aforementioned treatments, and will be followed at 3 and 6 month for outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring single finger amputations at the level of the proximal interphalangeal joint or proximal (i.e., closer to the body than this joint).
- •Patients have the capacity to complete the informed consent process
排除标准
- •Patients less than 18 years of age, prisoner, or other vulnerable population
- •Patients with significant concomitant ipsilateral extremity injuries that would confound study
- •Patients requiring emergent, staged (guillotine-type) amputations of any kind
结局指标
主要结局
bMHQ
时间窗: 3 months postop minus preop; 6 months postop minus preop
Breif Michigan Hand Questionnaire Score difference
次要结局
- Grip strength(3 months postop minus preop; 6 months postop minus preop)
- NPS(3 months postop minus preop; 6 months postop minus preop)
研究者
Joshua Adkinson
Assistant Professor of Surgery
Indiana University