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RecruitingNot ApplicableNCT04254185

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

Sponsor

University of Michigan

Enrollment

378 participants

Start Date

Feb 18, 2020

Study Type

INTERVENTIONAL

Conditions

Neuropathy Ulnar

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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

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Interventions

PROCEDURESimple decompression

Surgical technique

PROCEDURESubcutaneous 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

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NCT04254185