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NCT05008185RecruitingAccepts Healthy Volunteers

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

Medstar Health Research Institute

Start Date

10/5/2021

Completion Date

8/1/2025

Summary

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

Detailed Description

This will be a prospective observational study that seeks to provide a comprehensive assessment of the outcomes after RPNI surgery compared to standard of care by utilizing multiple established and validated patient-reported outcomes measures, carefully tracking pre- and post-operative pain regimens, and performing functional and physiologic tests.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 18 years or older * History of unilateral digit, multiple digit, or partial hand amputation * Discrete neuroma pain on clinical exam * 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 Exclusion Criteria: * Patients with previous surgical treatment for symptomatic neuromas of the digits or hand * Patients with other major injuries more proximal in the ipsilateral extremity that cause chronic pain or functional loss * women pregnant at time of enrollment * prisoners * adults who are unable to consent

Interventions

PROCEDURE

Regenerative Peripheral Nerve Interface (RPNI) surgery

PROCEDURE

Traction Neurectomy

Interested in This Trial?

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Conditions

Neuroma

Locations

The Curtis National Hand Center at Medstar Union Memorial Hospital

Baltimore, Maryland 21218

United States

University of Michigan Plastic Surgery

Ann Arbor, Michigan 48109

United States