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

September 21, 2022 updated by: Li Guangxue, Peking University People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: The control group
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.
EXPERIMENTAL: The experimental group（RPNIs group）
The experimental group received regenerative peripheral nerve interface（RPNI） surgery.
Procedure: preventive regenerative peripheral nerve interface reconstruction
Each RPNI unit consists of nerve stump and free autologous muscle graft that is cut off from healthy muscle of the amputated limb. The muscle graft is approximately 30×15×5 mm.The ends of the transected nerve are placed within the muscle belly of the free muscle grafts in an orientation that is parallel to the muscle fibers. Next, the nerve is secured distally with 6-0 non-absorbable monofilament sutures in an epimysial-to-epineurial fashion. The nerve is then wrapped around completely via muscle graft and epimysial securing sutures. All RPNI units are placed in areas remote from the surgical incision and from the weight-bearing surface of the limb.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postamputation pain
Time Frame: 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).
12 weeks at least after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosthesis wearing
Time Frame: 12 weeks at least after surgery
Whether the subject wears a prosthetic limb, and if so, what kind of prosthetic limb is worn.
12 weeks at least after surgery
Tumor recurrence and metastasis
Time Frame: 12 weeks at least after surgery
Whether there is tumor recurrence or metastasis.
12 weeks at least after surgery
Quality of life
Time Frame: 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.
12 weeks at least after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 12, 2020

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

September 3, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (ACTUAL)

September 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lgx2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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