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

Recruiting now · Not applicable

Conditions studied: Neuropathy Ulnar

In brief

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.

Key facts

Study ID

NCT04254185

Run by

University of Michigan

People needed

378

Starts

2020-02-18

Expected to finish

2027-10-31

Last updated by the study team

2025-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Norton Healthcare — Louisville, Kentucky, United States (enrolling)
• Emory Healthcare — Atlanta, Georgia, United States (enrolling)
• Curtis National Hand Center — Baltimore, Maryland, United States (enrolling)
• Michigan Medicine — Ann Arbor, Michigan, United States (enrolling)
• OrthoCarolina Research Institute, Inc. — Charlotte, North Carolina, United States (enrolling)
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• University of Oklahoma — Oklahoma City, Oklahoma, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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