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Trial Title:
The Efficacy of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees
NCT ID:
NCT05554900
Condition:
Amputation Neuroma
Conditions: Official terms:
Neuroma
Conditions: Keywords:
Amputation
Regenerative peripheral nerve interface
Neuroma
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Care Provider, Outcomes Assessor)
Masking description:
The investigator who perform the operations cannot be blinded because of the use of
manual techniques.
Intervention:
Intervention type:
Procedure
Intervention name:
preventive regenerative peripheral nerve interface reconstruction
Description:
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.
Arm group label:
The experimental group（RPNIs group）
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
6 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Guangxue Li
Phone:
13581763702
Email:
luckylgx1012@163.com
Start date:
May 12, 2020
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05554900
