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

Last updated: September 21, 2022
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05554900
lgx2022
  • Ages > 6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Perform traditional amputation and nerve disconnection or RPNIs in Peking UniversityPeople's Hospital
  • Age≥6 years
  • Follow-up time≥12 weeks

Exclusion

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 entrapmentsyndrome

Study Design

Total Participants: 200
Study Start date:
May 12, 2020
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Peking University People's Hospital

    Beijing,
    China

    Active - Recruiting

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