Peripheral Nerve Regenerative Interface for Neuroma
(NBxPilot Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJenna-Lynn Senger, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of British Columbia

No Placebo Group

Trial Summary

What is the purpose of 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 is for individuals who are undergoing sural nerve biopsy due to conditions like neuroma, including Morton's Neuroma. The study aims to see if a special surgical technique called RPNI can prevent painful nerve growths after the biopsy.

Inclusion Criteria

I am 18 or older and referred for a nerve and muscle biopsy at UBC for diagnosis.

Exclusion Criteria

I have had previous nerve damage due to injury, surgery, or multiple biopsies.

Treatment Details

Interventions

Peripheral Nerve Regenerative Interface (RPNI) (Procedure)

Trial OverviewThe trial is testing whether adding a procedure called Regenerative Peripheral Nerve Interface (RPNI) during sural nerve biopsies can reduce the chances of developing symptomatic neuromas compared to just having the biopsy alone.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Biopsy and RPNIExperimental Treatment1 Intervention

Patients in this group will undergo RPNI during their sural nerve and muscle biopsy

Group II: Biopsy AloneActive Control1 Intervention

Patients in this group will only undergo sural nerve and muscle biopsy