RECRUITINGINTERVENTIONAL
Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
PROCEDURE
Simple decompression
Surgical technique
PROCEDURE
Subcutaneous anterior transposition
Surgical technique
Locations (10)
Emory Healthcare
Atlanta, Georgia, United States
Norton Healthcare
Louisville, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Curtis National Hand Center
Baltimore, Maryland, United States
Michigan Medicine
Ann Arbor, Michigan, United States
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States