Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation

Recruiting at 1 trial location

Overseen By Isaac C Fleming

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to demonstrate the effectiveness of Regenerative Peripheral Nerve Interfaces (RPNI) surgery in treating symptomatic neuromas of the hand and digits following amputation compared to standard of care using a Prospective, Observational Trial

Research Team

Aviram M Giladi, MS, MD

Principal Investigator

Medstar Union Memorial Hospital

Eligibility Criteria

Inclusion Criteria

Following standard of care (SOC), confirmation through a local block and/or ultrasound imaging will be performed if indicated

Must be seen by a hand therapist for at least 6-week trial of desensitization therapy

You have lost one or more fingers or part of your hand in the past.

Exclusion Criteria

Women pregnant at time of enrollment

Prisoners

Adults who are unable to consent

Treatment Details

Interventions

• Regenerative Peripheral Nerve Interface (RPNI) surgery

Participant Groups

Group I: Traction Neurectomy Experimental Treatment 1 Intervention

simple excision and traction neurectomy

Group II: Regenerative Peripheral Nerve Interface Experimental Treatment 1 Intervention

symptomatic neuroma is excised, and the end of the peripheral nerve is implanted into a small denervated free muscle graft harvested from the patient

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+