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

MedStar Health

Status: Enrolling

Conditions: Neuroma

Treatments: Procedure: Regenerative Peripheral Nerve Interface (RPNI) surgery; Procedure: Traction Neurectomy

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05008185

Pro00049513

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Regenerative Peripheral Nerve Interface

Description:

symptomatic neuroma is excised, and the end of the peripheral nerve is implanted into a small denervated free muscle graft harvested from the patient

Treatment:

Procedure: Regenerative Peripheral Nerve Interface (RPNI) surgery

Traction Neurectomy

Description:

simple excision and traction neurectomy

Treatment:

Procedure: Traction Neurectomy