Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04254185

Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow

Led by University of Michigan · Updated on 2025-09-05

378

Participants Needed

10

Research Sites

401 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

N

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clinical Trial for Surgery of the Ulnar Nerve (SUN) at the Elbow

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (meeting at least one of the specific nerve conduction criteria)
  • Willingness to comply with all study procedures and be available for the duration of the study
  • Ability to read, understand, and complete questionnaires in English
Not Eligible

You will not qualify if you...

  • Previous elbow fracture requiring surgical fixation
  • No attempt at conservative management for ulnar neuropathy at the elbow (e.g., night splinting)
  • Subluxation of ulnar nerve on preoperative exam
  • Recurrent ulnar neuropathy at the elbow after previous surgery
  • Other neuropathic conditions such as Carpal Tunnel Syndrome or cervical or brachial plexus abnormalities
  • Severe other health conditions that prevent surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Emory Healthcare

Atlanta, Georgia, United States, 30329

Actively Recruiting

2

Norton Healthcare

Louisville, Kentucky, United States, 40241

Actively Recruiting

3

Johns Hopkins University

Baltimore, Maryland, United States, 21093

Terminated

4

Curtis National Hand Center

Baltimore, Maryland, United States, 21218

Actively Recruiting

5

Michigan Medicine

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

6

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, United States, 28207

Actively Recruiting

7

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

8

Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

9

University of Oklahoma

Oklahoma City, Oklahoma, United States, 73126

Actively Recruiting

10

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

S

Sunitha Malay

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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