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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Medstar Health Research Institute
Study ID
NCT05008185
Status
Recruiting
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Conditions

  • Neuroma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Regenerative Peripheral Nerve Interface (RPNI) surgery — PROCEDURE
    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 — PROCEDURE
    Surgeons will perform neuroma resection and traction neurectomy,

Study Details

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

Key Dates

Start date
Oct 5, 2021
Status verified
Nov 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: 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
  • Arm: Traction Neurectomy
    simple excision and traction neurectomy

Primary Outcome Measure

Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) [ Time Frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Curtis National Hand Center at Medstar Union Memorial HospitalBaltimoreMaryland21218
Ike Fleming
[email protected]
410-554-2486
Alessandra Butanis
[email protected]
410-554-2123
Aviram M Gildai, MD, MS (PRINCIPAL_INVESTIGATOR)
University of Michigan Plastic SurgeryAnn ArborMichigan48109
Jenni Hammill, M.P.H
[email protected]
570-559-7912
Theodore A Kung, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The Curtis National Hand Center at Medstar Union Memorial Hospital· Baltimore, MDUniversity of Michigan Plastic Surgery· Ann Arbor, MI

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