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

Peking University

Status: Enrolling

Conditions: Amputation Neuroma

Treatments: Procedure: preventive regenerative peripheral nerve interface reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT05554900

lgx2022

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups

The control group

No Intervention group

Description:

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）

Experimental group

Description:

The experimental group received regenerative peripheral nerve interface（RPNI） surgery.

Treatment:

Procedure: preventive regenerative peripheral nerve interface reconstruction