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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Peripheral Nerve Regenerative Interface (RPNI) and Nerve/Muscle Biopsy
Procedure/SurgeryRPNI is a surgical technique which wraps denervated muscle targets around severed nerve ends.
Biopsy Alone
Procedure/SurgerySural nerve and muscle biopsy performed in the standard fashion.
Treatment groups
Trial outcomes
Primary outcomes
Symptomatic neuroma formation (sensation)
Change From Baseline in Subjective Sensation on a 10-Point Scale at 6 Months
Symptomatic neuroma formation (pain)
Change From Baseline in Pain Scores on the Numerical Pain Rating Scale at 6 Months
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: