The Efficacy, Safety and Prognosis of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees: Study Protocol for a Cohort Study

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    Peking University People's Hospital
Updated on 18 October 2022


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.

Condition Amputation Neuroma
Treatment preventive regenerative peripheral nerve interface reconstruction
Clinical Study IdentifierNCT05554900
SponsorPeking University People's Hospital
Last Modified on18 October 2022


Yes No Not Sure

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
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