The Efficacy of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees

Amputation Neuroma Clinical Trial

Official title:

The Efficacy, Safety and Prognosis of Preventive Regenerative Peripheral Nerve Interface(RPNI) Reconstruction in Amputees: Study Protocol for a Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554900
• Other study ID #: lgx2022
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Peking University People's Hospital
• Contact: Guangxue Li
• Phone: 13581763702
• Email: luckylgx1012[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation Neuroma
• Neuroma

Intervention

Procedure:
• preventive regenerative peripheral nerve interface reconstruction
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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (17)

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. — View Citation

Bowsher D. Human "autotomy". Pain. 2002 Jan;95(1-2):187-9. — View Citation

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

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Niederberger E, Kühlein 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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Zimmermann M. Pathobiology of neuropathic pain. Eur J Pharmacol. 2001 Oct 19;429(1-3):23-37. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prosthesis wearing	Whether the subject wears a prosthetic limb, and if so, what kind of prosthetic limb is worn.	12 weeks at least after surgery
Secondary	Tumor recurrence and metastasis	Whether there is tumor recurrence or metastasis.	12 weeks at least after surgery
Secondary	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.	12 weeks at least after surgery