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

Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation: A Prospective Observational Trial"

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

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

About the study

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

What is being tested

• Regenerative Peripheral Nerve Interface (RPNI) surgery (procedure)
• Traction Neurectomy (procedure)

Sponsor: Medstar Health Research Institute · Participants: 80 · Started: Oct 5, 2021

Contact the study team

• Isaac C Fleming · Phone: 410-554-2486

Official record on ClinicalTrials.gov — NCT05008185

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.