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Does RPNI Reduce Incidence of Neuroma Formation Following Sural Nerve Biopsy

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06754969
Acronym
NBxPilot
Enrollment
20
Registered
2025-01-01
Start date
2025-03-31
Completion date
2026-12-31
Last updated
2025-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroma of Lower Limb

Keywords

Sural Nerve Biopsy, Regenerative Peripheral Nerve Biopsy, RPNI

Brief 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. 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.

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.

Interventions

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

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

PROCEDUREBiopsy Alone

Sural nerve and muscle biopsy performed in the standard fashion.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Symptomatic neuroma formation (sensation)6 months post-opChange From Baseline in Subjective Sensation on a 10-Point Scale at 6 Months
Symptomatic neuroma formation (pain)6 monthsChange From Baseline in Pain Scores on the Numerical Pain Rating Scale at 6 Months

Countries

Canada

Contacts

Primary ContactDanielle Cohen, MD
cohen6@student.ubc.ca7782236829

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026