Does RPNI Reduce Incidence of Neuroma Formation Following Sural Nerve Biopsy (NBxPilot)

December 23, 2024 updated by: Danielle Cohen, University of British Columbia

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Vancouver General Hospital
        • Contact:
        • Contact:
          • Danielle Cohen, MD
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Saint Pauls Hospital
        • Contact:
        • Contact:
          • Jenna-Lynn Senger
      • Vancouver, British Columbia, Canada, V5Z1M9
        • UBC Division of Plastic Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Biopsy Alone
Patients in this group will only undergo sural nerve and muscle biopsy
Procedure: Biopsy Alone
Sural nerve and muscle biopsy performed in the standard fashion.
Experimental: Biopsy and RPNI
Patients in this group will undergo RPNI during their sural nerve and muscle biopsy
Procedure: Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy
RPNI is a surgical technique which wraps denervated muscle targets around severed nerve ends.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic neuroma formation (sensation)
Time Frame: 6 months post-op
Change From Baseline in Subjective Sensation on a 10-Point Scale at 6 Months
6 months post-op
Symptomatic neuroma formation (pain)
Time Frame: 6 months
Change From Baseline in Pain Scores on the Numerical Pain Rating Scale at 6 Months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Jenna-Lynn Senger, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H24-03129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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