RECRUITING

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

Conditions

Neuropathy Ulnar Decompression Anterior Subcutaneous Transposition Elbow Ulnar Nerve

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-02-18

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04254185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Sunitha Malay

CONTACT

734-763-1834

smalay@umich.edu

Principal Investigator

Kevin Chung, MD, MS

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

Emory Healthcare

Atlanta, Georgia, 30329

United States

Norton Healthcare

Louisville, Kentucky, 40241

United States

Johns Hopkins University

Baltimore, Maryland, 21093

United States

Curtis National Hand Center

Baltimore, Maryland, 21218

United States

Michigan Medicine

Ann Arbor, Michigan, 48109

United States

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, 28207

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Ohio State University

Columbus, Ohio, 43210

United States

University of Oklahoma

Oklahoma City, Oklahoma, 73126

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: University of Michigan

Kevin Chung, MD, MS, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-18

Study Completion Date2025-08

Study Record Updates

Study Start Date2020-02-18

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

Decompression
Anterior Subcutaneous Transposition
Elbow
Ulnar Nerve

Additional Relevant MeSH Terms

Neuropathy Ulnar