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SLAP Repair vs. Biceps Tenodesis for Shoulder Labral Tear
N/A
Waitlist Available
Led By Laith Jazrawi, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-30
Be between 18 and 65 years old
Must not have
Age > 30, or < 18
Associated rotator cuff tear requiring arthroscopic repair
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-op, 24 months post-op
Awards & highlights
No Placebo-Only Group
Summary
This trial is comparing two surgeries for treating a SLAP tear. One surgery (SLAP repair) is common and the other (biceps tenodesis) is newer and thought to be better. They want to see if the newer surgery is actually better by comparing the two in a group of patients.
Who is the study for?
This trial is for young adults aged 18-30 who have a specific shoulder injury called a SLAP tear and are able to give consent. It's not open to those under 18 or over 30, pregnant individuals, people with past shoulder surgeries, or those needing repair for an associated rotator cuff tear.
What is being tested?
The study compares two surgical treatments for SLAP tears in the shoulder: Self-Locking Tenotomy (SLAP repair) and Biceps Tenodesis. The goal is to see which surgery offers better outcomes in managing pain and stiffness after the operation.
What are the potential side effects?
Potential side effects from both procedures may include pain at the surgery site, stiffness in the shoulder, possible nerve damage, infection risk at incision sites, and complications related to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 30 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am older than 30 or younger than 18.
Select...
I need surgery for a torn rotator cuff.
Select...
I have had shoulder surgery before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post-op, 24 months post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-op, 24 months post-op
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Score on Visual Analogue Scale (VAS) Scale
Secondary study objectives
Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale
Change in Score on Kerlan-Jobe Orthopaedic Clinical Shoulder & Elbow (KJOC) Questionnaire
Change in Score on Shoulder Instability-Return to Sport after Injury (SIRSI) Questionnaire
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Biceps TenodesisExperimental Treatment1 Intervention
Group II: SLAP Repair (Control)Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biceps Tenodesis
2013
N/A
~220
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,410 Previous Clinical Trials
855,506 Total Patients Enrolled
Laith Jazrawi, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
117 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 30 years old.I am older than 30 or younger than 18.I need surgery for a torn rotator cuff.I have had shoulder surgery before.You are pregnant.My main diagnosis is a SLAP tear.
Research Study Groups:
This trial has the following groups:- Group 1: SLAP Repair (Control)
- Group 2: Biceps Tenodesis
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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