The Efficacy, Safety and Prognosis of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees: Study Protocol for a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- postamputation pain
研究概览
简要总结
The trial will be carried out in Peking University People's Hospital. The whole trial will last 3 years. Amputees from orthopedics and vascular surgery will be distributed into two groups randomly and receive different treatments including traditional resection and regenerative peripheral nerve interface(RPNI) surgery.The pain outcome,the impact of post-amputation pain on life and the utilization rate of prostheses will be collected to study the efficacy, safety and prognosis of preventive regenerative peripheral nerve interface reconstruction in amputees.
Investigators believe that RPNI can effectively reduce the incidence of post-amputation pain, reduce the degree of pain, improve the wearing rate of prostheses, and help patients return to normal life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The investigator who perform the operations cannot be blinded because of the use of manual techniques.
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Perform traditional amputation and nerve disconnection or RPNIs in Peking University People's Hospital
- •Age≥6 years
- •Follow-up time≥12 weeks
排除标准
- •Follow-up time<12 weeks
- •Age<6 years
- •Preoperative complications included cervical spondylosis, lumbar spinal stenosis, piriformis syndrome, cubital tunnel syndrome and other peripheral nerve entrapment syndrome
研究组 & 干预措施
The control group
The control group received traditional amputation.The proximal nerve is blocked with lidocaine and cut off. The end of the nerve retracted as far as possible and the bleeding point is ligated if necessary.
The experimental group（RPNIs group）
The experimental group received regenerative peripheral nerve interface（RPNI） surgery.
干预措施: preventive regenerative peripheral nerve interface reconstruction (Procedure)
结局指标
主要结局
postamputation pain
时间窗: 12 weeks at least after surgery
Patient-Reported Outcomes Measurement Information System (NRS, PROMIS) were used to assess postamputation pain.The intensity of pain is described by 11 points from 0 (painless) to 10 (the most severe pain).
次要结局
- Prosthesis wearing(12 weeks at least after surgery)
- Tumor recurrence and metastasis(12 weeks at least after surgery)
- Quality of life(12 weeks at least after surgery)
研究者
Li Guangxue
Deputy Chief Physician
Peking University People's Hospital