Clinical trial NCT05554900: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Amputation Neuroma
Keywords: Amputation
Regenerative peripheral nerve interface
Neuroma
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: postamputation pain
timeFrame: 12 weeks at least after surgery
Secondary outcomes:
measure: Prosthesis wearing
timeFrame: 12 weeks at least after surgery
measure: Tumor recurrence and metastasis
timeFrame: 12 weeks at least after surgery
measure: Quality of life
timeFrame: 12 weeks at least after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
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