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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Emory Healthcare
RECRUITING
Atlanta
Kentucky
Norton Healthcare
RECRUITING
Louisville
Maryland
Curtis National Hand Center
RECRUITING
Baltimore
Johns Hopkins University
TERMINATED
Baltimore
Michigan
Michigan Medicine
RECRUITING
Ann Arbor
North Carolina
OrthoCarolina Research Institute, Inc.
RECRUITING
Charlotte
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Ohio
Ohio State University
RECRUITING
Columbus
Oklahoma
University of Oklahoma
RECRUITING
Oklahoma City
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Contact Information
Primary
Sunitha Malay
smalay@umich.edu
734-763-1834
Time Frame
Start Date: 2020-02-18
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 378
Treatments
Active_comparator: Simple decompression
In-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve.
Active_comparator: Subcutaneous anterior transposition
Anterior transposition repositions the ulnar nerve, providing decompression and lengthening by moving the nerve anterior to the axis of elbow rotation
Sponsors
Collaborators: Wake Forest University Health Sciences, Curtis National Hand Center, Norton Healthcare, OrthoCarolina Research Institute, Inc., Emory Healthcare, University of Oklahoma, Johns Hopkins University, University of Pittsburgh Medical Center, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Ohio State University
Leads: University of Michigan

This content was sourced from clinicaltrials.gov