Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation: A Prospective Observational Trial"
Medstar Health Research Institute
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
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 function…
Interventions
- ProcedureRegenerative Peripheral Nerve Interface (RPNI) surgery
Surgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision
- ProcedureTraction Neurectomy
Surgeons will perform neuroma resection and traction neurectomy,
Locations (2)
- The Curtis National Hand Center at Medstar Union Memorial HospitalBaltimore, Maryland
- University of Michigan Plastic SurgeryAnn Arbor, Michigan