Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow

Last updated: July 11, 2024
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Subcutaneous anterior transposition

Simple decompression

Clinical Study ID

NCT04254185
HUM00133613
U01AR073485
  • Ages > 18
  • All Genders

Study Summary

This research is studying two surgical procedures in a large group of people to learn about how well these procedures work as a treatment for ulnar neuropathy at the elbow (UNE). Researchers want to see which surgery is more helpful for people with ulnar neuropathy. This research will determine if one surgery is better than the other to alleviate symptoms.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A clinical diagnosis or suspected diagnosis of isolated ulnar neuropathy at theelbow

  • Confirmation of ulnar neuropathy using the American Association of ElectrodiagnosticMedicine criteria for electrodiagnostic studies at the elbow. (Participants mustmeet at least 1 of the criteria to be enrolled (absolute motor nerve conduction fromabove elbow (AE) to below elbow (BE) of less than 50 m/s; An AE to BE segmentgreater than 10 m/s slower than BE to wrist segment; A decrease in compound muscleaction potential (CMAP) negative peak amplitude from BE to AE greater than 20%)

  • Stated willingness to comply with all study procedures and availability for theduration of the study

  • Able to read, understand and complete the questionnaires in English

Exclusion

Exclusion Criteria:

  • Previous elbow fracture requiring surgical fixation

  • Patients who have not attempted conservative management for UNE (e.g. nightsplinting)

  • Subluxation of ulnar nerve on preoperative exam

  • Recurrent UNE after previous surgery

  • Concomitant neuropathic conditions such as Carpal Tunnel Syndrome or cervical orbrachial plexus abnormalities

  • Participants with severe comorbid conditions that prohibit surgery

Study Design

Total Participants: 378
Treatment Group(s): 2
Primary Treatment: Subcutaneous anterior transposition
Phase:
Study Start date:
February 18, 2020
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Emory Healthcare

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Norton Healthcare

    Louisville, Kentucky 40241
    United States

    Active - Recruiting

  • Curtis National Hand Center

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21093
    United States

    Terminated

  • Michigan Medicine

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • OrthoCarolina Research Institute, Inc.

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma 73126
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

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