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

ArmDescriptionAssigned 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
  • Procedure: Regenerative 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
Traction Neurectomy simple excision and traction neurectomy
  • Procedure: Traction Neurectomy
    Surgeons will perform neuroma resection and traction neurectomy,

Recruiting Locations

The Curtis National Hand Center at Medstar Union Memorial Hospital
Baltimore, Maryland 21218
Contact:
Ike Fleming
410-554-2486
ike.c.fleming@medstar.net

More Details

Status
Recruiting
Sponsor
Medstar Health Research Institute

Study Contact

Isaac C Fleming
410-554-2486
ike.c.fleming@medstar.net

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.