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"
Medstar Health Research Institute
80 participants
Oct 5, 2021
OBSERVATIONAL
Conditions
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
Eligibility
Inclusion Criteria5
- 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 Criteria5
- 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
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Interventions
Surgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision
Surgeons will perform neuroma resection and traction neurectomy,
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05008185