Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation
Purpose
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
Condition
- Neuroma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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 functional loss - women pregnant at time of enrollment - prisoners - adults who are unable to consent
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Regenerative Peripheral Nerve Interface | symptomatic neuroma is excised, and the end of the peripheral nerve is implanted into a small denervated free muscle graft harvested from the patient |
|
| Traction Neurectomy | simple excision and traction neurectomy |
|
Recruiting Locations
The Curtis National Hand Center at Medstar Union Memorial Hospital
Baltimore, Maryland 21218
Baltimore, Maryland 21218
More Details
- Status
- Recruiting
- Sponsor
- Medstar Health Research Institute
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.