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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    378
  • sponsor
    University of Michigan
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Updated on 19 February 2024
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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.

Details
Condition Ulnar neuropathy
Age 18-100 years
Treatment Simple decompression, Subcutaneous anterior transposition
Clinical Study IdentifierNCT04254185
SponsorUniversity of Michigan
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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