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Elbow nerve surgery showdown: which procedure works best?

NCT ID NCT04254185

Symptom relief Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study compares two common surgeries for ulnar neuropathy at the elbow: simple decompression and subcutaneous anterior transposition. Researchers will enroll 378 adults with confirmed ulnar nerve issues to see which surgery better improves hand function and reduces pain. Participants will be followed for up to 24 months after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Simple decompression (in-situ decompression) or subcutaneous anterior transposition (surgical techniques)
What this could lead to
If this trial succeeds, it could show which surgery is more effective for relieving ulnar nerve symptoms, helping doctors choose the best approach for patients.
What could go wrong
This is a comparative effectiveness trial, not a test of a new cure. Results may show only modest differences, and individual outcomes can vary. Risks include surgical complications like infection or nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 378 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2020

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

cubital tunnel syndrome ulnar neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neuropathy ulnar

Contacts and locations

Locations

  • Curtis National Hand Center

    Baltimore, Maryland, 21218, United States

  • Emory Healthcare

    Atlanta, Georgia, 30329, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21093, United States

  • Michigan Medicine

    Ann Arbor, Michigan, 48109, United States

  • Norton Healthcare

    Louisville, Kentucky, 40241, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • OrthoCarolina Research Institute, Inc.

    Charlotte, North Carolina, 28207, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73126, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States