The Efficacy of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees
Primary Purpose
Amputation Neuroma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
preventive regenerative peripheral nerve interface reconstruction
Sponsored by
About this trial
This is an interventional prevention trial for Amputation Neuroma focused on measuring Amputation, Regenerative peripheral nerve interface, Neuroma
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
Sites / Locations
- Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
The control group
The experimental group(RPNIs group)
Arm 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 received regenerative peripheral nerve interface(RPNI) surgery.
Outcomes
Primary Outcome Measures
postamputation pain
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).
Secondary Outcome Measures
Prosthesis wearing
Whether the subject wears a prosthetic limb, and if so, what kind of prosthetic limb is worn.
Tumor recurrence and metastasis
Whether there is tumor recurrence or metastasis.
Quality of life
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.
Full Information
NCT ID
NCT05554900
First Posted
September 3, 2022
Last Updated
September 21, 2022
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05554900
Brief Title
The Efficacy of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees
Official Title
The Efficacy, Safety and Prognosis of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees: Study Protocol for a Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation Neuroma
Keywords
Amputation, Regenerative peripheral nerve interface, Neuroma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
The investigator who perform the operations cannot be blinded because of the use of manual techniques.
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The control group
Arm Type
No Intervention
Arm 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.
Arm Title
The experimental group(RPNIs group)
Arm Type
Experimental
Arm Description
The experimental group received regenerative peripheral nerve interface(RPNI) surgery.
Intervention Type
Procedure
Intervention Name(s)
preventive regenerative peripheral nerve interface reconstruction
Intervention 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.
Primary Outcome Measure Information:
Title
postamputation pain
Description
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).
Time Frame
12 weeks at least after surgery
Secondary Outcome Measure Information:
Title
Prosthesis wearing
Description
Whether the subject wears a prosthetic limb, and if so, what kind of prosthetic limb is worn.
Time Frame
12 weeks at least after surgery
Title
Tumor recurrence and metastasis
Description
Whether there is tumor recurrence or metastasis.
Time Frame
12 weeks at least after surgery
Title
Quality of life
Description
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.
Time Frame
12 weeks at least after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guangxue Li
Phone
13581763702
Email
luckylgx1012@163.com
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangxue Li
Phone
13581763702
Email
luckylgx1012@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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The Efficacy of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees
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