Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

Ulnar neuropathy at the elbow (UNE) is a common compressive neuropathy condition that can cause pain, tingling, and muscle loss in hand. If left untreated, it can lead to disability and job loss. Conservative treatment fails in 60% of cases, and most patients require surgery, which is often recommended to eliminate symptoms, but controversy exists over the best procedure. The two most common surgical procedures are in-situ (simple) decompression and subcutaneous anterior transposition. This study plans to conduct a multicenter randomized clinical trial to compare outcomes for two commonly used surgical procedures and develop an optimal surgical plan for individual patients.

Several studies comparing the two procedures, including underpowered randomized controlled trials (RCTs) and meta-analyses, have been unable to detect a difference in outcomes. Determining the best surgery for individual patients is imperative because revision surgery for failed UNE release is often ineffective. Currently, the choice of procedure type is often based on physician training and preferences owing to the lack of evidence-based guidelines for UNE surgery. This proposed study is a double-blind RCT with 10 clinical sites. Subjects diagnosed with UNE will be randomized to in-situ decompression or subcutaneous anterior transposition and followed for one year. This trial is novel because subjects will be blinded regarding their surgery and the researchers performing the functional assessments will also be blinded to yield the most objective assessment of outcomes. The specific aims of the study are to compare outcomes between the two procedures using functional and validated patient- reported outcomes, recovery trends, and complications. The ultimate goal is to develop an evidence-based treatment algorithm to determine the best procedure for individual patients with unique disease severity.

ELIGIBILITY CRITERIA:

Ages Eligible for Study:           18 Years and older (Adult, Older Adult)

Sexes Eligible for Study:          All

Accepts Healthy Volunteers:  No

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

 

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Double (Participant, Investigator)

Primary Purpose: Treatment

Study Location(s):

Emory Healthcare, Atlanta, Georgia, United States, 30329

Norton Healthcare, Louisville, Kentucky, United States, 40241

Johns Hopkins Medicine, Baltimore, Maryland, United States, 21093

Curtis National Hand Center, Baltimore, Maryland, United States, 21218

Michigan Medicine, Ann Arbor, Michigan, United States, 48109

OrthoCarolina, Charlotte, North Carolina, United States, 28207

Wake Forest Baptist Health, Winston-Salem, North Carolina, United States, 27157

Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15213

Study Website:

https://clinicaltrials.gov/ct2/show/NCT04254185?term=NCT04254185&draw=2&rank=1

 

 

Last Updated: March 2020