NCT05554900

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

3.6 years

First QC Date

September 3, 2022

Last Update Submit

September 21, 2022

Conditions

Amputation Neuroma

Keywords

AmputationRegenerative peripheral nerve interfaceNeuroma

Outcome Measures

Primary Outcomes (1)

  • 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).

    12 weeks at least after surgery

Secondary Outcomes (3)

  • Prosthesis wearing

    12 weeks at least after surgery

  • Tumor recurrence and metastasis

    12 weeks at least after surgery

  • Quality of life

    12 weeks at least after surgery

Study Arms (2)

The control group

NO INTERVENTION

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（RPNIs group）

EXPERIMENTAL

The experimental group received regenerative peripheral nerve interface（RPNI） surgery.

Procedure: preventive regenerative peripheral nerve interface reconstruction

Interventions

preventive regenerative peripheral nerve interface reconstructionPROCEDURE

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.

The experimental group（RPNIs group）

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Perform traditional amputation and nerve disconnection or RPNIs in Peking University People's Hospital
  • Age≥6 years
  • Follow-up time≥12 weeks

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

Related Publications (17)

  • Watson J, Gonzalez M, Romero A, Kerns J. Neuromas of the hand and upper extremity. J Hand Surg Am. 2010 Mar;35(3):499-510. doi: 10.1016/j.jhsa.2009.12.019.

    PMID: 20193866BACKGROUND

  • Zimmermann M. Pathobiology of neuropathic pain. Eur J Pharmacol. 2001 Oct 19;429(1-3):23-37. doi: 10.1016/s0014-2999(01)01303-6.

    PMID: 11698024BACKGROUND

  • Bowsher D. Human "autotomy". Pain. 2002 Jan;95(1-2):187-9. doi: 10.1016/s0304-3959(01)00389-x.

    PMID: 11790481BACKGROUND

  • Niederberger 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: 19086860BACKGROUND

  • McFarland 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: 20803400BACKGROUND

  • Davis RW. Phantom sensation, phantom pain, and stump pain. Arch Phys Med Rehabil. 1993 Jan;74(1):79-91.

    PMID: 8380543BACKGROUND

  • Vlot 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: 28951100BACKGROUND

  • Ives 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: 29053875BACKGROUND

  • Poppler LH, Parikh RP, Bichanich MJ, Rebehn K, Bettlach CR, Mackinnon SE, Moore AM. Surgical interventions for the treatment of painful neuroma: a comparative meta-analysis. Pain. 2018 Feb;159(2):214-223. doi: 10.1097/j.pain.0000000000001101.

    PMID: 29189515BACKGROUND

  • Barbour JR, Yee A, Moore AM, Trulock EP, Buchowski JM, Mackinnon SE. Cadaveric nerve allotransplantation in the treatment of persistent thoracic neuralgia. Ann Thorac Surg. 2015 Apr;99(4):1414-7. doi: 10.1016/j.athoracsur.2014.06.092.

    PMID: 25841822BACKGROUND

  • Elliot D. Surgical management of painful peripheral nerves. Clin Plast Surg. 2014 Jul;41(3):589-613. doi: 10.1016/j.cps.2014.03.004.

    PMID: 24996473BACKGROUND

  • Lipinski LJ, Spinner RJ. Neurolysis, neurectomy, and nerve repair/reconstruction for chronic pain. Neurosurg Clin N Am. 2014 Oct;25(4):777-87. doi: 10.1016/j.nec.2014.07.002. Epub 2014 Aug 14.

    PMID: 25240664BACKGROUND

  • Kuiken TA, Miller LA, Lipschutz RD, Lock BA, Stubblefield K, Marasco PD, Zhou P, Dumanian GA. Targeted reinnervation for enhanced prosthetic arm function in a woman with a proximal amputation: a case study. Lancet. 2007 Feb 3;369(9559):371-80. doi: 10.1016/S0140-6736(07)60193-7.

    PMID: 17276777BACKGROUND

  • Peters BR, Russo SA, West JM, Moore AM, Schulz SA. Targeted muscle reinnervation for the management of pain in the setting of major limb amputation. SAGE Open Med. 2020 Sep 15;8:2050312120959180. doi: 10.1177/2050312120959180. eCollection 2020.

    PMID: 32974021BACKGROUND

  • Santosa KB, Oliver JD, Cederna PS, Kung TA. Regenerative Peripheral Nerve Interfaces for Prevention and Management of Neuromas. Clin Plast Surg. 2020 Apr;47(2):311-321. doi: 10.1016/j.cps.2020.01.004. Epub 2020 Feb 1.

    PMID: 32115057BACKGROUND

  • Kubiak CA, Kemp SWP, Cederna PS, Kung TA. Prophylactic Regenerative Peripheral Nerve Interfaces to Prevent Postamputation Pain. Plast Reconstr Surg. 2019 Sep;144(3):421e-430e. doi: 10.1097/PRS.0000000000005922.

    PMID: 31461024BACKGROUND

  • Woo SL, Urbanchek MG, Cederna PS, Langhals NB. Revisiting nonvascularized partial muscle grafts: a novel use for prosthetic control. Plast Reconstr Surg. 2014 Aug;134(2):344e-346e. doi: 10.1097/PRS.0000000000000317. No abstract available.

    PMID: 25068369BACKGROUND

MeSH Terms

Conditions

Neuroma

Condition Hierarchy (Ancestors)

Nerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Guangxue Li

CONTACT

13581763702luckylgx1012@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The investigator who perform the operations cannot be blinded because of the use of manual techniques.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief Physician

Study Record Dates

First Submitted

September 3, 2022

First Posted

September 26, 2022

Study Start

May 12, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 26, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)