NCT04254185 Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
| NCT ID | NCT04254185 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Neuropathy Ulnar |
| Study Type | INTERVENTIONAL |
| Enrollment | 378 participants |
| Start Date | 2020-02-18 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 378 participants in total. It began in 2020-02-18 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Kevin Chung, MD, MS
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT04254185 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuropathy Ulnar. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04254185 currently recruiting?
Yes, NCT04254185 is actively recruiting participants. Contact the research team at smalay@umich.edu for enrollment information.
Where is the NCT04254185 trial being conducted?
This trial is being conducted at Atlanta, United States, Louisville, United States, Baltimore, United States, Baltimore, United States and 6 additional locations.
Who is sponsoring the NCT04254185 clinical trial?
NCT04254185 is sponsored by University of Michigan. The principal investigator is Kevin Chung, MD, MS at University of Michigan. The trial plans to enroll 378 participants.