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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
Must not have
Recurrent UNE after previous surgery
Participants with severe comorbid conditions that prohibit surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine which of two surgeries is more effective in treating ulnar neuropathy at the elbow and reducing symptoms.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My UNE has come back after surgery.
Select...
I cannot undergo surgery due to severe health conditions.
Select...
I had surgery for a broken elbow in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Operative Surgical Procedures
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Ulnar Nerve Entrapment include decompression and transposition surgeries. Decompression involves relieving pressure on the ulnar nerve by removing any constrictive tissues or structures, which helps to restore normal nerve function and alleviate symptoms.
Transposition surgery involves relocating the ulnar nerve to a position where it is less likely to be compressed or irritated, often moving it from behind the medial epicondyle to a more anterior position. These treatments are crucial for patients as they directly address the mechanical compression of the nerve, which is the primary cause of pain, numbness, and muscle weakness associated with Ulnar Nerve Entrapment.
By alleviating this pressure, these surgical interventions can significantly improve nerve function and patient quality of life.
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,849 Previous Clinical Trials
6,431,106 Total Patients Enrolled
University of OklahomaOTHER
472 Previous Clinical Trials
93,265 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
495 Previous Clinical Trials
1,089,114 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.
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