Does RPNI Reduce Incidence of Neuroma Formation Following Sural Nerve Biopsy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of British Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

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

  • Biopsy Alone

    Procedure/Surgery

    Sural nerve and muscle biopsy performed in the standard fashion.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Biopsy AloneActive comparator 1 intervention
Group B: Biopsy and RPNIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Symptomatic neuroma formation (sensation)

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

Time frame
6 months post-op
2

Symptomatic neuroma formation (pain)

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

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: