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

NCT05008185 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-11-29

No results posted yet for this study

Summary

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

Conditions

  • Neuroma

Interventions

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

PROCEDURE

Traction Neurectomy

Surgeons will perform neuroma resection and traction neurectomy,

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Michigan

    collaborator OTHER

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Aviram M Giladi, MS, MD · Medstar Union Memorial Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-05
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05008185 on ClinicalTrials.gov