Clinical trial · Interventional
The Efficacy of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees
The Efficacy, Safety and Prognosis of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees: Study Protocol for a Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Amputation Neuroma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| preventive regenerative peripheral nerve interface reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- The control 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.
- type
- EXPERIMENTAL
- label
- The experimental group（RPNIs group）
- description
- The experimental group received regenerative peripheral nerve interface（RPNI） surgery.
- interventionNames
- Procedure: preventive regenerative peripheral nerve interface reconstruction
Primary outcomes (1)
- measure
- postamputation pain
- timeFrame
- 12 weeks at least after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
Show eligibility criteria text
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
References
Publications (17)
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- BACKGROUNDBowsher D. Human "autotomy". Pain. 2002 Jan;95(1-2):187-9. doi: 10.1016/s0304-3959(01)00389-x. PMID 11790481
- BACKGROUNDNiederberger E, Kuhlein H, Geisslinger G. Update on the pathobiology of neuropathic pain. Expert Rev Proteomics. 2008 Dec;5(6):799-818. doi: 10.1586/14789450.5.6.799. PMID 19086860
- BACKGROUNDMcFarland LV, Hubbard Winkler SL, Heinemann AW, Jones M, Esquenazi A. Unilateral upper-limb loss: satisfaction and prosthetic-device use in veterans and servicemembers from Vietnam and OIF/OEF conflicts. J Rehabil Res Dev. 2010;47(4):299-316. doi: 10.1682/jrrd.2009.03.0027. PMID 20803400
- BACKGROUNDDavis RW. Phantom sensation, phantom pain, and stump pain. Arch Phys Med Rehabil. 1993 Jan;74(1):79-91. PMID 8380543
- BACKGROUNDVlot MA, Wilkens SC, Chen NC, Eberlin KR. Symptomatic Neuroma Following Initial Amputation for Traumatic Digital Amputation. J Hand Surg Am. 2018 Jan;43(1):86.e1-86.e8. doi: 10.1016/j.jhsa.2017.08.021. Epub 2017 Sep 23. PMID 28951100
- BACKGROUNDIves GC, Kung TA, Nghiem BT, Ursu DC, Brown DL, Cederna PS, Kemp SWP. Current State of the Surgical Treatment of Terminal Neuromas. Neurosurgery. 2018 Sep 1;83(3):354-364. doi: 10.1093/neuros/nyx500. PMID 29053875