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

ConditionNeuroma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedstar Health Research Institute

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Regenerative Peripheral Nerve Interface (RPNI) surgery
  • Traction Neurectomy

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Medstar Health Research Institute

Lead sponsor

United States Department of Defense

Collaborator

University of Michigan

Collaborator