Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- University of Michigan
- Study ID
- NCT04254185
- Status
- Recruiting
Conditions
- Neuropathy Ulnar
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Simple decompression — PROCEDURESurgical technique
- Subcutaneous anterior transposition — PROCEDURESurgical technique
Study Details
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 Dates
- Start date
- Feb 18, 2020
- Status verified
- Aug 2025
- Primary completion
- Oct 31, 2027
- Completion
- Oct 31, 2027
Study Design
- Enrollment
- 378 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Simple decompressionIn-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve.
- Active Comparator: Subcutaneous anterior transpositionAnterior transposition repositions the ulnar nerve, providing decompression and lengthening by moving the nerve anterior to the axis of elbow rotation
Primary Outcome Measure
Effectiveness of surgery as measured by the Michigan Hand Outcomes Questionnaire (MHQ) summary score [ Time Frame: 1 year ]
Central Contacts
- Sunitha Malay734-763-1834
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Emory Healthcare | Atlanta | Georgia | 30329 | Eric Wagner, MD (PRINCIPAL_INVESTIGATOR) |
| Norton Healthcare | Louisville | Kentucky | 40241 | Ethan W Blackburn, MD (PRINCIPAL_INVESTIGATOR) |
| Curtis National Hand Center | Baltimore | Maryland | 21218 | Aviram Giladi, MD, MS (PRINCIPAL_INVESTIGATOR) |
| Johns Hopkins University | Baltimore | Maryland | 21093 | - |
| Michigan Medicine | Ann Arbor | Michigan | 48109 | Kevin Chung, MD, MS (PRINCIPAL_INVESTIGATOR) |
| OrthoCarolina Research Institute, Inc. | Charlotte | North Carolina | 28207 | R. Glenn Gaston, MD (PRINCIPAL_INVESTIGATOR) |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | Zhongyu Li, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Ohio State University | Columbus | Ohio | 43210 | Sonu A Jain, MD (PRINCIPAL_INVESTIGATOR) |
| University of Oklahoma | Oklahoma City | Oklahoma | 73126 | Thomas Lehman, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | John R. Fowler, MD (PRINCIPAL_INVESTIGATOR) |