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NCT Number: NCT06754969

Does RPNI Reduce Incidence of Neuroma Formation Following Sural Nerve Biopsy

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Pauls Hospital, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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

Biopsy Alone

Procedure

Sural nerve and muscle biopsy performed in the standard fashion.

Primary outcomes

  1. Symptomatic neuroma formation (sensation)

    Time frame: 6 months post-op

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

  2. Symptomatic neuroma formation (pain)

    Time frame: 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Cohen, MD

CONTACT

[email protected]

7782236829

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Acronym: NBxPilot

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 1, 2025
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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