Not yet recruitingNAINTERVENTIONAL

Does RPNI Reduce Incidence of Neuroma Formation Following Sural Nerve Biopsy

This study aims to discover if a new preventative surgical technique, called Regenerative Peripheral Nerve Interface (RPNI), can stop painful nerve growths (neuromas) from developing after a nerve biopsy. Neuromas can cause significant pain and may require more surgery. Doctors are hoping that by using RPNI when they do a sural nerve biopsy, they can reduce the number of patients who experience this complication. Participants will either receive the standard biopsy or the biopsy with the added RPNI technique. The findings could lead to better care, improve quality of life for patients, and potentially decrease the need for repeat operations, making a real difference to future patient treatment.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of British Columbia

Enrolment target

Start

01 Mar 2025

Estimated completion

01 Dec 2026

Neuroma of Lower Limb

What is this study about?

Imagine you have a small nerve biopsy, which is a common procedure where doctors take a tiny piece of nerve to look at under a microscope. Sometimes, after this, the cut nerve can grow in a jumbled, painful way, like a tangled ball of wires. This is called a neuroma, and it can cause a lot of discomfort.

This research project is exploring a new, simple surgical approach during the biopsy itself. It's called Regenerative Peripheral Nerve Interface (RPNI). Think of it like giving the cut ends of the nerve a proper target to grow towards, rather than letting them tangle up. In RPNI, doctors wrap the nerve ends in a small piece of muscle. This helps guide the nerve regeneration and aims to prevent these painful neuromas from forming.

Currently, painful neuromas can be tricky to treat, and sometimes people need more surgery. By using RPNI at the time of the initial biopsy, doctors hope to dramatically reduce the chance of neuromas developing. If this study shows RPNI works, it could change how nerve biopsies are done, improve the quality of life for many patients by preventing pain, and potentially reduce the need for future operations.

Key takeaways

The study investigates a new way to prevent painful nerve growths (neuromas) after a nerve biopsy.
It uses a technique called RPNI, where nerve ends are wrapped in muscle tissue.
The goal is to improve patient comfort and reduce the need for more surgery.
Participants will receive either the standard biopsy or the biopsy with RPNI.
Findings could inform future best practices for nerve biopsies.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You must also be scheduled to have a sural nerve and muscle biopsy at the University of British Columbia Division of Plastic Surgery for diagnostic or prognostic clarification of a medical condition from January 2025 onwards.

However, you won't be able to join if you have previously had an injury, surgery, or another biopsy on the specific nerve that will be biopsied for this study. This is to make sure the results are as clear as possible and aren't affected by previous issues with that nerve.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for a sural nerve and muscle biopsy at the specified hospital?
Have you had any previous injury or surgery on the sural nerve being biopsied?
Have you had a previous biopsy on this specific sural nerve?

Answer every question to see your result.

What does participation involve?

This study involves a single procedure which is your planned sural nerve and muscle biopsy. You will either have your biopsy done in the standard way, or you will have the RPNI technique added during your biopsy. The study will then follow up on your progress following the procedure to see if the RPNI technique was effective in preventing neuromas. The total duration of your participation will depend on the follow-up schedule designed for the study, which would be explained in full detail by the research team.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of preventing a painful neuroma from forming after your sural nerve biopsy, which could improve your future comfort and potentially avoid further surgeries. As with any medical procedure, there are always some risks involved, which your care team will discuss with you. These risks will be carefully explained, balancing them against the potential benefits. Remember, joining any research study is completely your choice, and you are free to withdraw at any time without it affecting your medical care.

Locations (3)

UBC Division of Plastic Surgery
Verified postcode
Vancouver, Canada
Vancouver General Hospital
Verified postcode
Vancouver, Canada
Saint Pauls Hospital
Verified postcode
Vancouver, Canada

Common questions

What is a neuroma?

A neuroma is like a tangled ball of nerve tissue that can form after a nerve is cut or injured, often causing pain.

What is a sural nerve biopsy?

A sural nerve biopsy is a procedure where a small piece of the sural nerve (in your lower leg) is removed for examination under a microscope.

What is RPNI?

RPNI stands for Regenerative Peripheral Nerve Interface. It's a surgical technique where the cut nerve ends are wrapped in a small piece of muscle to help them heal correctly and reduce pain.

Will I know if I'm getting RPNI or the standard biopsy?

The study design will explain how this decision is made, and it will be discussed with you during the consent process.

Does taking part affect my regular medical care?

No, your decision to participate or not will not affect the standard medical care you receive for your condition.

How to find out more

Danielle Cohen, MD

cohen6@student.ubc.ca 7782236829 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.