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

P

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

Trial contacts and locations

1

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Central trial contact

Guangxue Li

Data sourced from clinicaltrials.gov

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