The Efficacy of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees

Not Applicable

Recruiting

• Conditions: Amputation Neuroma
• Interventions: Procedure: preventive regenerative peripheral nerve interface reconstruction

• Registration Number: NCT05554900
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-12
• Status Verified: 2022-09
• Study First Submitted: 2022-09-03
• Study First Submitted QC: 2022-09-21
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The experimental group（RPNIs group）	preventive regenerative peripheral nerve interface reconstruction	The experimental group received regenerative peripheral nerve interface（RPNI） surgery.

Primary Outcome Measures

Name	Time	Method
postamputation pain	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 Outcome Measures

Name	Time	Method
Tumor recurrence and metastasis	12 weeks at least after surgery	Whether there is tumor recurrence or metastasis.
Prosthesis wearing	12 weeks at least after surgery	Whether the subject wears a prosthetic limb, and if so, what kind of prosthetic limb is worn.
Quality of life	12 weeks at least after surgery	The medical outcomes study-short from(MOS-SF 36) is used to evaluate the difference between the RPNIs group and the control group in the quality of life after amputation.The SF-36 scale consists of 36 questions with eight dimensions:physiological function, role-physiological, physical pain, general health, vitality, social function, role-emotional, and mental health. The scoring method was used for each dimension, ranging from 0 to 100 points. The higher the score, the better the health status.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China