The Efficacy, Safety and Prognosis of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees: Study Protocol for a Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- postamputation pain
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
The investigator who perform the operations cannot be blinded because of the use of manual techniques.
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Perform traditional amputation and nerve disconnection or RPNIs in Peking University People's Hospital
- •Age≥6 years
- •Follow-up time≥12 weeks
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: preventive regenerative peripheral nerve interface reconstruction (Procedure)
Outcomes
Primary Outcomes
postamputation pain
Time Frame: 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).
Secondary Outcomes
- 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)
Investigators
Li Guangxue
Deputy Chief Physician
Peking University People's Hospital