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

Medstar Health Research Institute · with United States Department of Defense, University of Michigan · NCT05008185

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
80
US sites recruiting
1
Study start
October 5, 2021
Record last updated
November 29, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is 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

Being studied: Regenerative Peripheral Nerve Interface (RPNI) surgery; Traction Neurectomy

Conditions: Neuroma

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • The Curtis National Hand Center at Medstar Union Memorial Hospital

    Baltimore, MD 21218

    Site contact: Ike Fleming · 410-554-2486 · ike.c.fleming@medstar.net

Study contacts (from the official record)

  • Isaac C Fleming · 410-554-2486 · ike.c.fleming@medstar.net
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Regenerative Peripheral Nerve Interfaces to Treat Painful Digit… (NCT05008185) | Bored Studies