Back to Trials
NCT04254185NARecruiting

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

University of Michigan

Start Date

2/18/2020

Completion Date

10/31/2027

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

Age Range: 18 years to No maximum

Inclusion Criteria: * A clinical diagnosis or suspected diagnosis of isolated ulnar neuropathy at the elbow * Confirmation of ulnar neuropathy using the American Association of Electrodiagnostic Medicine criteria for electrodiagnostic studies at the elbow. (Participants must meet at least 1 of the criteria to be enrolled (absolute motor nerve conduction from above elbow (AE) to below elbow (BE) of less than 50 m/s; An AE to BE segment greater than 10 m/s slower than BE to wrist segment; A decrease in compound muscle action potential (CMAP) negative peak amplitude from BE to AE greater than 20%) * Stated willingness to comply with all study procedures and availability for the duration of the study * Able to read, understand and complete the questionnaires in English Exclusion Criteria: * Previous elbow fracture requiring surgical fixation * Patients who have not attempted conservative management for UNE (e.g. night splinting) * Subluxation of ulnar nerve on preoperative exam * Recurrent UNE after previous surgery * Concomitant neuropathic conditions such as Carpal Tunnel Syndrome or cervical or brachial plexus abnormalities * Participants with severe comorbid conditions that prohibit surgery

Interventions

PROCEDURE

Simple decompression

PROCEDURE

Subcutaneous anterior transposition

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Neuropathy Ulnar

Locations

Emory Healthcare

Atlanta, Georgia 30329

United States

Norton Healthcare

Louisville, Kentucky 40241

United States

Johns Hopkins University

Baltimore, Maryland 21093

United States

Curtis National Hand Center

Baltimore, Maryland 21218

United States

Michigan Medicine

Ann Arbor, Michigan 48109

United States

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina 28207

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States

Ohio State University

Columbus, Ohio 43210

United States

University of Oklahoma

Oklahoma City, Oklahoma 73126

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213

United States