Comparing two surgical procedures for ulnar nerve issues at the elbow
Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
This study is testing which of two surgical methods works better to relieve symptoms for people with ulnar nerve problems at the elbow.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 378 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 10 sites (Atlanta, Georgia and 9 other locations) |
| Trial ID | NCT04254185 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of two surgical techniques, simple decompression and subcutaneous anterior transposition, for treating ulnar neuropathy at the elbow. The study aims to determine which procedure provides better symptom relief for patients diagnosed with this condition. Participants will undergo electrodiagnostic studies to confirm their diagnosis and will be monitored throughout the study to assess outcomes. The findings could help refine surgical approaches for ulnar nerve issues.
Who should consider this trial
Good fit: Ideal candidates are individuals with a clinical diagnosis of isolated ulnar neuropathy at the elbow confirmed by electrodiagnostic criteria.
Not a fit: Patients who have not attempted conservative management for their ulnar neuropathy or have previous elbow fractures requiring surgical fixation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical options for patients suffering from ulnar neuropathy, enhancing their quality of life.
How similar studies have performed: Other studies have explored surgical interventions for ulnar neuropathy, indicating potential for success, but this specific comparison of techniques is less common.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 9 other locations
- Emory Healthcare — Atlanta, Georgia, United States (Recruiting)
- Norton Healthcare — Louisville, Kentucky, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Terminated)
- Curtis National Hand Center — Baltimore, Maryland, United States (Recruiting)
- Michigan Medicine — Ann Arbor, Michigan, United States (Recruiting)
- OrthoCarolina Research Institute, Inc. — Charlotte, North Carolina, United States (Recruiting)
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- University of Oklahoma — Oklahoma City, Oklahoma, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kevin Chung, MD, MS — University of Michigan
- Study coordinator: Sunitha Malay
- Email: smalay@umich.edu
- Phone: 734-763-1834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.