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

  • STATUS
    Recruiting
  • days left to enroll
    69
  • participants needed
    378
  • sponsor
    University of Michigan
Updated on 19 February 2024

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 18years - 100years
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.