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Surgery Techniques for Ulnar Nerve Entrapment
N/A
Recruiting
Led By Kevin Chung, MD, MS
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis or suspected diagnosis of isolated ulnar neuropathy at the elbow
Able to read, understand and complete the questionnaires in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is comparing two surgeries for ulnar neuropathy and determining which is more effective.
Who is the study for?
This trial is for people with ulnar nerve entrapment at the elbow who have tried non-surgical treatments like night splinting. They must meet specific diagnostic criteria and be able to follow study procedures. It's not for those with previous elbow surgery, other neuropathies, or conditions that make surgery too risky.Check my eligibility
What is being tested?
The study compares two surgeries: 'simple decompression' and 'subcutaneous anterior transposition,' to see which one better relieves symptoms of ulnar neuropathy at the elbow. Participants will be randomly assigned to one of these surgical options.See study design
What are the potential side effects?
Potential side effects from both surgeries may include pain at the surgery site, infection risk, numbness or weakness in the hand or arm, and complications related to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have or might have a pinched nerve in my elbow.
Select...
I can read, understand, and fill out questionnaires in English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Operative Surgical Procedures
Secondary outcome measures
Complication rates for both surgical procedures assessed using a checklist
Difference in Grip Strength (unaffected hand - affected hand) measured by a Jamar dynamometer
Difference in Pinch Strength (unaffected hand - affected hand) as measured by a pinch gauge
+6 moreTrial Design
2Treatment groups
Active Control
Group I: Subcutaneous anterior transpositionActive Control1 Intervention
Anterior transposition repositions the ulnar nerve, providing decompression and lengthening by moving the nerve anterior to the axis of elbow rotation
Group II: Simple decompressionActive Control1 Intervention
In-situ decompression releases only the compressive ligamentous structures overlying the ulnar nerve.
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,795 Previous Clinical Trials
6,373,558 Total Patients Enrolled
University of OklahomaOTHER
455 Previous Clinical Trials
97,232 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
483 Previous Clinical Trials
1,086,562 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My UNE has come back after surgery.Your ulnar nerve is out of place during the preoperative exam.You have a specific nerve condition in your elbow, confirmed by tests that measure the speed of nerve signals and muscle responses.I have conditions like Carpal Tunnel Syndrome affecting my nerves.I cannot undergo surgery due to severe health conditions.I have or might have a pinched nerve in my elbow.I had surgery for a broken elbow in the past.I have not tried any basic treatments like night splints for my elbow nerve issue.I can read, understand, and fill out questionnaires in English.
Research Study Groups:
This trial has the following groups:- Group 1: Subcutaneous anterior transposition
- Group 2: Simple decompression
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there multiple locations offering this experiment in the state?
"There are 10 research sites authorized to conduct this clinical trial, such as Johns Hopkins University in Baltimore, the OrthoCarolina Research Institute Inc. in Charlotte and the University of Oklahoma located in Oklahoma City, with other approved locations across the US."
Answered by AI
Are there vacancies left for volunteers to enroll in this experiment?
"According to clinicaltrials.gov, this ongoing medical research project commenced on the 18th of February 2020 and was most recently edited on 12 July 2022. Patients are actively being sought for participation."
Answered by AI
How many participants are currently being admitted to this medical experiment?
"This clinical trial requires 378 individuals who qualify for the stated inclusion criteria. Patients can partake in this study at either Johns Hopkins University located in Baltimore, Maryland or University of Oklahoma which is situated in Oklahoma City, Oklahoma."
Answered by AI
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