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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 below
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I am between 18 and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am older than 30 or younger than 18.
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I need surgery for a torn rotator cuff.
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I have had shoulder surgery before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-op, 24 months post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-op, 24 months post-op for reporting.

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
1,415 Previous Clinical Trials
855,977 Total Patients Enrolled
Laith Jazrawi, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
117 Total Patients Enrolled

Media Library

Biceps Tenodesis Clinical Trial Eligibility Overview. Trial Name: NCT04494932 — N/A
Shoulder Labral Tear Research Study Groups: SLAP Repair (Control), Biceps Tenodesis
Shoulder Labral Tear Clinical Trial 2023: Biceps Tenodesis Highlights & Side Effects. Trial Name: NCT04494932 — N/A
Biceps Tenodesis 2023 Treatment Timeline for Medical Study. Trial Name: NCT04494932 — N/A
~19 spots leftby Dec 2025
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