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Neuroma of Lower LimbNBxPilotNCT06754969

Does RPNI Reduce Incidence of Neuroma Formation Following Sural Nerve Biopsy

A study testing Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy and Biopsy Alone in people with Neuroma of Lower Limb, run by University of British Columbia at 3 sites in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroma of Lower Limb
What is being tested?
Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy and Biopsy Alone
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesCanada
Study dates
Mar 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Danielle Cohen, MD contact

7782236829

cohen6@student.ubc.ca

Canada3 sites
  • UBC Division of Plastic Surgery

    Vancouver, British Columbia, V5Z1M9

    Zaima Chowdhury, 604-446-683, zaima.chowdhury@vch.ca

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z1M9

    Zaima Chowdhury, 604-446-6831, zaima.chowdhury@vch.ca

    Danielle Cohen, MD

  • Saint Pauls Hospital

    Vancouver, British Columbia, V6Z 1Y6

    Zaima Chowdhury, 604-446-6831, zaima.chowdhury@vch.ca

    Jenna-Lynn Senger

Other trials in Canada

About this study

Official title: Does RPNI Reduce Incidence of Neuroma Formation Following Sural Nerve Biopsy: a Pilot Study

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.

Read the detailed description

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.

Being tested
Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy, Biopsy Alone
Keywords
Sural Nerve Biopsy, Regenerative Peripheral Nerve Biopsy, RPNI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle BiopsyProcedure or surgery

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

  • Biopsy AloneProcedure or surgery

    Sural nerve and muscle biopsy performed in the standard fashion.

Study groups in NCT06754969
Study groupRoleWhat they receive
Biopsy AloneActive comparatorPatients in this group will only undergo sural nerve and muscle biopsy
Receives: Procedure: Biopsy Alone
Biopsy and RPNIExperimentalPatients in this group will undergo RPNI during their sural nerve and muscle biopsy
Receives: Procedure: Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptomatic neuroma formation (sensation)

    Change From Baseline in Subjective Sensation on a 10-Point Scale at 6 Months

    Measured: 6 months post-op

  2. Symptomatic neuroma formation (pain)

    Change From Baseline in Pain Scores on the Numerical Pain Rating Scale at 6 Months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2025
  2. Study startMar 2025 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06754969
Sponsor's protocol ID
H24-03129
Acronym
NBxPilot
Status last verified
Dec 2024
First submitted
22 Oct 2024
Last updated
1 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30712380
  • 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.

    PubMed 23867139
  • 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.

    PubMed 32277511
  • 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.

    PubMed 17550992
  • 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.

    PubMed 35188944
  • 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.

    PubMed 37199679
  • 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.

    PubMed 37477149
  • 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.

    PubMed 37465283
  • 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.

    PubMed 36712443
  • 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.

    PubMed 32766027
  • 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.

    PubMed 28951100
  • 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.

    PubMed 36204848
  • 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.

    PubMed 23845907
  • 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.

    PubMed 30907815
  • 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.

    PubMed 37400949

Questions about this trial

What is this clinical trial studying?

A study testing Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy and Biopsy Alone in people with Neuroma of Lower Limb, run by University of British Columbia at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Danielle Cohen, MD (7782236829, cohen6@student.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptomatic neuroma formation (sensation) (time frame: 6 months post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06754969, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.

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