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RecruitingNCT04254185

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

Trial Parameters

ConditionNeuropathy Ulnar
SponsorUniversity of Michigan
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment378
SexALL
Min Age18 Years
Max AgeN/A
Start Date2020-02-18
Completion2027-10-31
Interventions
Simple decompressionSubcutaneous anterior transposition

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Brief 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 Criteria

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

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