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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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 details
    Neuropathy Ulnar

NCT04254185

University of Michigan

28 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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