Does RPNI Reduce Incidence of Neuroma Formation Following Sural Nerve Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-12-31

Brief Summary

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The purpose of our project is to determine if incorporating preventative surgical techniques such as regenerative peripheral nerve interfaces (RPNI) into sural nerve biopsy can reduce the incidence of symptomatic neuroma formation. Findings from this study will inform best practice guidelines and can dramatically impact patient care, improve patient quality of life, and reduce the number of required repeat operations.

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Detailed Description

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Neuromas are a known complication from traumatic injury or surgery, including nerve biopsies. Neuromas are formed by non-neoplastic aberrant proliferation of injured nerves that cannot innervate an end target resulting in a neuroma bulb made of free nerve ends, fibrotic tissue, and blood vessels. Neuromas can cause significant, debilitating pain resulting in decreased quality of life for patients and potential repeat operative interventions. The incidence rate of neuroma formation following injury is not well described but previous literature reports rates up to 30% with 14% of patients requiring repeat operation. In order to address this problem, numerous preventative and therapeutic measures have been explored. Nonsurgical management options such as desensitization, anesthetic and/or steroid injections, analgesia, and nerve stimulation have yielded mixed results.10 Therefore there is a need for reproducible and reliable prevention and treatment strategies for painful neuroma. Currently, the main surgical interventions consist of targeted muscle reinnervation (TMR) and regenerative peripheral nerve interface (RPNI). In TMR, free nerve ends are transferred onto recipient motor nerves, whereas in RPNI, free nerve ends are wrapped in a free muscle graft. Both methods provide denervated muscle targets for nerve ends. Compared to TMR, and other microsurgical measures such as primary repair or nerve grafting, RPNI is a much simpler operation that can easily be performed in the minor procedures or ward setting where nerve biopsies are usually completed. Given the functional impact from painful neuromas and subsequent burden on operative resources, efforts should be taken to prevent neuroma formation with RPNI at time of biopsy. Our project could directly improve patient care by substantiating the need for preventative measures for neuroma formation during for sural nerve biopsy thereby changing the standard of care. Given the significant pain, decreased quality of life, and need for repeat interventions, incorporating RPNI could have dramatic impacts on patient care and reduce operative and resources burdens.

Conditions

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Neuroma of Lower Limb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Patients will be unaware whether they undergo sural nerve and muscle biopsy alone vs sural nerve, muscle biopsy, and RPNI

Study Groups

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Biopsy Alone

Patients in this group will only undergo sural nerve and muscle biopsy

Group Type ACTIVE_COMPARATOR

Biopsy Alone

Intervention Type PROCEDURE

Sural nerve and muscle biopsy performed in the standard fashion.

Biopsy and RPNI

Patients in this group will undergo RPNI during their sural nerve and muscle biopsy

Group Type EXPERIMENTAL

Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy

Intervention Type PROCEDURE

RPNI is a surgical technique which wraps denervated muscle targets around severed nerve ends.

Interventions

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Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy

RPNI is a surgical technique which wraps denervated muscle targets around severed nerve ends.

Intervention Type PROCEDURE

Biopsy Alone

Sural nerve and muscle biopsy performed in the standard fashion.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient 18 years old and older who are referred for sural nerve and muscle biopsy to the University of British Columbia Division of Plastic Surgery from January 2025 onwards for diagnostic or prognostic clarification of a medical condition.

Exclusion Criteria

* Patients with previous nerve trauma (traumatic injury, surgery, or repeat biopsy) of biopsied nerve.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Danielle Cohen

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jenna-Lynn Senger, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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UBC Division of Plastic Surgery

Vancouver, British Columbia, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Saint Pauls Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Central Contacts

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Danielle Cohen, MD

Role: CONTACT

[email protected]

7782236829

Facility Contacts

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Zaima Chowdhury

Role: primary

[email protected]

604-446-683

Zaima Chowdhury

Role: primary

[email protected]

604-446-6831

Danielle Cohen, MD

Role: backup

Zaima Chowdhury

Role: primary

[email protected]

604-446-6831

Jenna-Lynn Senger

Role: backup

References

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Lans J, Gamo L, DiGiovanni CW, Chen NC, Eberlin KR. Etiology and Treatment Outcomes for Sural Neuroma. Foot Ankle Int. 2019 May;40(5):545-552. doi: 10.1177/1071100719828375. Epub 2019 Feb 2.

Reference Type BACKGROUND

PMID: 30712380 (View on PubMed)

Radtke C, Kocsis JD, Reimers K, Allmeling C, Vogt PM. Sural nerve defects after nerve biopsy or nerve transfer as a sensory regeneration model for peripheral nerve conduit implantation. Med Hypotheses. 2013 Sep;81(3):500-2. doi: 10.1016/j.mehy.2013.06.020. Epub 2013 Jul 16.

Reference Type BACKGROUND

PMID: 23867139 (View on PubMed)

Ducic I, Yoon J, Buncke G. Chronic postoperative complications and donor site morbidity after sural nerve autograft harvest or biopsy. Microsurgery. 2020 Sep;40(6):710-716. doi: 10.1002/micr.30588. Epub 2020 Apr 10.

Reference Type BACKGROUND

PMID: 32277511 (View on PubMed)

Hilton DA, Jacob J, Househam L, Tengah C. Complications following sural and peroneal nerve biopsies. J Neurol Neurosurg Psychiatry. 2007 Nov;78(11):1271-2. doi: 10.1136/jnnp.2007.116368. Epub 2007 Jun 5.

Reference Type BACKGROUND

PMID: 17550992 (View on PubMed)

Chang BL, Mondshine J, Fleury CM, Attinger CE, Kleiber GM. Incidence and Nerve Distribution of Symptomatic Neuromas and Phantom Limb Pain after Below-Knee Amputation. Plast Reconstr Surg. 2022 Apr 1;149(4):976-985. doi: 10.1097/PRS.0000000000008953.

Reference Type BACKGROUND

PMID: 35188944 (View on PubMed)

Aslami ZV, Leland CR, Strike SA, Forsberg JA, Morris CD, Levin AS, Tuffaha SH. Symptomatic Neuroma Development following En Bloc Resection of Skeletal and Soft-Tissue Tumors: A Retrospective Analysis of 331 Cases. Plast Reconstr Surg. 2024 Apr 1;153(4):873-883. doi: 10.1097/PRS.0000000000010659. Epub 2023 May 18.

Reference Type BACKGROUND

PMID: 37199679 (View on PubMed)

Cychosz CC, Eisenberg J, Glass N, Fleury I, Buckwalter V JA, Phisitkul P, Femino JE. Outcomes of Surgical Treatment for Sural Neuritis: A Retrospective Case Series. Foot Ankle Int. 2023 Sep;44(9):845-853. doi: 10.1177/10711007231184472. Epub 2023 Jul 21.

Reference Type BACKGROUND

PMID: 37477149 (View on PubMed)

Leach GA, Dean RA, Kumar NG, Tsai C, Chiarappa FE, Cederna PS, Kung TA, Reid CM. Regenerative Peripheral Nerve Interface Surgery: Anatomic and Technical Guide. Plast Reconstr Surg Glob Open. 2023 Jul 17;11(7):e5127. doi: 10.1097/GOX.0000000000005127. eCollection 2023 Jul.

Reference Type BACKGROUND

PMID: 37465283 (View on PubMed)

Yang H, Dong Y, Wang Z, Lai J, Yao C, Zhou H, Alhaskawi A, Hasan Abdullah Ezzi S, Kota VG, Hasan Abdulla Hasan Abdulla M, Lu H. Traumatic neuromas of peripheral nerves: Diagnosis, management and future perspectives. Front Neurol. 2023 Jan 11;13:1039529. doi: 10.3389/fneur.2022.1039529. eCollection 2022.

Reference Type BACKGROUND

PMID: 36712443 (View on PubMed)

Hooper RC, Cederna PS, Brown DL, Haase SC, Waljee JF, Egeland BM, Kelley BP, Kung TA. Regenerative Peripheral Nerve Interfaces for the Management of Symptomatic Hand and Digital Neuromas. Plast Reconstr Surg Glob Open. 2020 Jun 4;8(6):e2792. doi: 10.1097/GOX.0000000000002792. eCollection 2020 Jun.

Reference Type BACKGROUND

PMID: 32766027 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 28951100 (View on PubMed)

Wang Z, Yi XZ, Yu AX. Regenerative peripheral nerve interface prevents neuroma formation after peripheral nerve transection. Neural Regen Res. 2023 Apr;18(4):814-818. doi: 10.4103/1673-5374.353498.

Reference Type BACKGROUND

PMID: 36204848 (View on PubMed)

van der Avoort DJ, Hovius SE, Selles RW, van Neck JW, Coert JH. The incidence of symptomatic neuroma in amputation and neurorrhaphy patients. J Plast Reconstr Aesthet Surg. 2013 Oct;66(10):1330-4. doi: 10.1016/j.bjps.2013.06.019. Epub 2013 Jul 8.

Reference Type BACKGROUND

PMID: 23845907 (View on PubMed)

Wolvetang NHA, Lans J, Verhiel SHWL, Notermans BJW, Chen NC, Eberlin KR. Surgery for Symptomatic Neuroma: Anatomic Distribution and Predictors of Secondary Surgery. Plast Reconstr Surg. 2019 Jun;143(6):1762-1771. doi: 10.1097/PRS.0000000000005664.

Reference Type BACKGROUND

PMID: 30907815 (View on PubMed)

Senger JL, Thorkelsson A, Wang BY, Chan KM, Kemp SWP, Webber CA. Comparison of 2 Regenerative Peripheral Nerve Interface Techniques for the Treatment of Rat Neuroma Pain. Plast Reconstr Surg. 2024 Aug 1;154(2):346-349. doi: 10.1097/PRS.0000000000010911. Epub 2023 Jul 4.

Reference Type BACKGROUND

PMID: 37400949 (View on PubMed)

Mauch JT, Kao DS, Friedly JL, Liu Y. Targeted muscle reinnervation and regenerative peripheral nerve interfaces for pain prophylaxis and treatment: A systematic review. PM R. 2023 Nov;15(11):1457-1465. doi: 10.1002/pmrj.12972. Epub 2023 May 28.

Reference Type BACKGROUND

PMID: 36965013 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 32115057 (View on PubMed)

Hu Y, Ursu DC, Sohasky RA, Sando IC, Ambani SLW, French ZP, Mays EA, Nedic A, Moon JD, Kung TA, Cederna PS, Kemp SWP, Urbanchek MG. Regenerative peripheral nerve interface free muscle graft mass and function. Muscle Nerve. 2021 Mar;63(3):421-429. doi: 10.1002/mus.27138. Epub 2020 Dec 20.

Reference Type BACKGROUND

PMID: 33290586 (View on PubMed)

Schoeller T, Huemer GM, Shafighi M, Gurunluoglu R, Wechselberger G, Piza-Katzer H. Microsurgical repair of the sural nerve after nerve biopsy to avoid associated sensory morbidity: a preliminary report. Neurosurgery. 2004 Apr;54(4):897-900; discussion 900-1. doi: 10.1227/01.neu.0000114143.07529.a6.

Reference Type BACKGROUND

PMID: 15046656 (View on PubMed)

Kang J, Yang P, Zang Q, He X. Traumatic neuroma of the superficial peroneal nerve in a patient: a case report and review of the literature. World J Surg Oncol. 2016 Sep 10;14(1):242. doi: 10.1186/s12957-016-0990-6.

Reference Type BACKGROUND

PMID: 27613606 (View on PubMed)

Other Identifiers

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H24-03129

Identifier Type: -

Identifier Source: org_study_id

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Does RPNI Reduce Incidence of Neuroma Formation Following Sural Nerve Biopsy

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Surgical Treatment of Chronic Neuropathic Pain

Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries

NTX-001 to Repair Peripheral Nerve Transection(s)

Spinal Cord Stimulation in Small Fibre Neuropathy

Enhancement of Functional Recovery After Peripheral Nerve Injury With Tacrolimus

Detailed Description

Conditions

Study Design

Study Groups

Biopsy Alone

Biopsy Alone

Biopsy and RPNI

Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy

Interventions

Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy

Biopsy Alone

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

University of British Columbia

Responsible Party

Danielle Cohen

Principal Investigators

Jenna-Lynn Senger, MD

Locations

UBC Division of Plastic Surgery

Vancouver General Hospital

Saint Pauls Hospital

Countries

Central Contacts

Danielle Cohen, MD

Facility Contacts

Zaima Chowdhury

Zaima Chowdhury

Danielle Cohen, MD

Zaima Chowdhury

Jenna-Lynn Senger

References

Lans J, Gamo L, DiGiovanni CW, Chen NC, Eberlin KR. Etiology and Treatment Outcomes for Sural Neuroma. Foot Ankle Int. 2019 May;40(5):545-552. doi: 10.1177/1071100719828375. Epub 2019 Feb 2.

Radtke C, Kocsis JD, Reimers K, Allmeling C, Vogt PM. Sural nerve defects after nerve biopsy or nerve transfer as a sensory regeneration model for peripheral nerve conduit implantation. Med Hypotheses. 2013 Sep;81(3):500-2. doi: 10.1016/j.mehy.2013.06.020. Epub 2013 Jul 16.

Ducic I, Yoon J, Buncke G. Chronic postoperative complications and donor site morbidity after sural nerve autograft harvest or biopsy. Microsurgery. 2020 Sep;40(6):710-716. doi: 10.1002/micr.30588. Epub 2020 Apr 10.

Hilton DA, Jacob J, Househam L, Tengah C. Complications following sural and peroneal nerve biopsies. J Neurol Neurosurg Psychiatry. 2007 Nov;78(11):1271-2. doi: 10.1136/jnnp.2007.116368. Epub 2007 Jun 5.

Chang BL, Mondshine J, Fleury CM, Attinger CE, Kleiber GM. Incidence and Nerve Distribution of Symptomatic Neuromas and Phantom Limb Pain after Below-Knee Amputation. Plast Reconstr Surg. 2022 Apr 1;149(4):976-985. doi: 10.1097/PRS.0000000000008953.

Cychosz CC, Eisenberg J, Glass N, Fleury I, Buckwalter V JA, Phisitkul P, Femino JE. Outcomes of Surgical Treatment for Sural Neuritis: A Retrospective Case Series. Foot Ankle Int. 2023 Sep;44(9):845-853. doi: 10.1177/10711007231184472. Epub 2023 Jul 21.

Leach GA, Dean RA, Kumar NG, Tsai C, Chiarappa FE, Cederna PS, Kung TA, Reid CM. Regenerative Peripheral Nerve Interface Surgery: Anatomic and Technical Guide. Plast Reconstr Surg Glob Open. 2023 Jul 17;11(7):e5127. doi: 10.1097/GOX.0000000000005127. eCollection 2023 Jul.

Hooper RC, Cederna PS, Brown DL, Haase SC, Waljee JF, Egeland BM, Kelley BP, Kung TA. Regenerative Peripheral Nerve Interfaces for the Management of Symptomatic Hand and Digital Neuromas. Plast Reconstr Surg Glob Open. 2020 Jun 4;8(6):e2792. doi: 10.1097/GOX.0000000000002792. eCollection 2020 Jun.

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.

Wang Z, Yi XZ, Yu AX. Regenerative peripheral nerve interface prevents neuroma formation after peripheral nerve transection. Neural Regen Res. 2023 Apr;18(4):814-818. doi: 10.4103/1673-5374.353498.

van der Avoort DJ, Hovius SE, Selles RW, van Neck JW, Coert JH. The incidence of symptomatic neuroma in amputation and neurorrhaphy patients. J Plast Reconstr Aesthet Surg. 2013 Oct;66(10):1330-4. doi: 10.1016/j.bjps.2013.06.019. Epub 2013 Jul 8.

Wolvetang NHA, Lans J, Verhiel SHWL, Notermans BJW, Chen NC, Eberlin KR. Surgery for Symptomatic Neuroma: Anatomic Distribution and Predictors of Secondary Surgery. Plast Reconstr Surg. 2019 Jun;143(6):1762-1771. doi: 10.1097/PRS.0000000000005664.

Senger JL, Thorkelsson A, Wang BY, Chan KM, Kemp SWP, Webber CA. Comparison of 2 Regenerative Peripheral Nerve Interface Techniques for the Treatment of Rat Neuroma Pain. Plast Reconstr Surg. 2024 Aug 1;154(2):346-349. doi: 10.1097/PRS.0000000000010911. Epub 2023 Jul 4.

Mauch JT, Kao DS, Friedly JL, Liu Y. Targeted muscle reinnervation and regenerative peripheral nerve interfaces for pain prophylaxis and treatment: A systematic review. PM R. 2023 Nov;15(11):1457-1465. doi: 10.1002/pmrj.12972. Epub 2023 May 28.

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.

Hu Y, Ursu DC, Sohasky RA, Sando IC, Ambani SLW, French ZP, Mays EA, Nedic A, Moon JD, Kung TA, Cederna PS, Kemp SWP, Urbanchek MG. Regenerative peripheral nerve interface free muscle graft mass and function. Muscle Nerve. 2021 Mar;63(3):421-429. doi: 10.1002/mus.27138. Epub 2020 Dec 20.

Schoeller T, Huemer GM, Shafighi M, Gurunluoglu R, Wechselberger G, Piza-Katzer H. Microsurgical repair of the sural nerve after nerve biopsy to avoid associated sensory morbidity: a preliminary report. Neurosurgery. 2004 Apr;54(4):897-900; discussion 900-1. doi: 10.1227/01.neu.0000114143.07529.a6.

Kang J, Yang P, Zang Q, He X. Traumatic neuroma of the superficial peroneal nerve in a patient: a case report and review of the literature. World J Surg Oncol. 2016 Sep 10;14(1):242. doi: 10.1186/s12957-016-0990-6.

Other Identifiers

H24-03129

More Related Trials