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Rotator Interval Closure in Bankart Repair for Shoulder Dislocation

N/A
Waitlist Available
Research Sponsored by University of Western Ontario, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least one episode of demonstrated dislocation
Bankart lesion of the anterior glenoid labrum
Must not have
Posterior instability or the need for posterior surgical reconstruction
Presence of other pathologic conditions of the shoulder (excluding SLAP lesions)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3,6 weeks;3,6 months; 1,2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether adding rotator interval closure to Bankart lesion repair improves outcomes. The investigators suspect that patients who undergo the additional procedure will have lower quality of life and less external rotation.

Who is the study for?
This trial is for individuals aged 15 to 50 who have had at least one shoulder dislocation and a specific injury called a Bankart lesion. They must not have other shoulder injuries, fractures, or significant bone lesions on the humeral head.
What is being tested?
The study compares two treatments for shoulder instability after dislocation: arthroscopic repair of the Bankart lesion alone versus the same procedure with additional closure of the rotator interval. The goal is to see if there's a difference in quality of life and arm movement.
What are the potential side effects?
Potential side effects may include decreased range of motion, particularly in external rotation, discomfort at the surgery site, and general risks associated with surgical procedures such as infection or reaction to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least one dislocation.
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I have a specific shoulder injury known as a Bankart lesion.
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I am between 15 and 50 years old.
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I do not have any other injuries to my tendons or capsules.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need surgery for instability at the back of my body.
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I have a shoulder condition, but it's not a SLAP lesion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3,6 weeks;3,6 months; 1,2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3,6 weeks;3,6 months; 1,2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Western Ontario Shoulder Instability Index
Secondary study objectives
4-Item Pain Intensity Measure
Range of Motion
Recurrence
+1 more

Awards & 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: Arthroscopic Bankart Repair & Rotator Interval ClosureActive Control1 Intervention
Group II: Arthoscopic Bankart Repair aloneActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of Western Ontario, CanadaLead Sponsor
166 Previous Clinical Trials
319,216 Total Patients Enrolled
Dianne Bryant, PhDStudy DirectorThe University of Western Ontario
3 Previous Clinical Trials
140 Total Patients Enrolled

Media Library

Arthroscopic Bankart Repair alone Clinical Trial Eligibility Overview. Trial Name: NCT01620619 — N/A
Bankart Lesion Research Study Groups: Arthroscopic Bankart Repair & Rotator Interval Closure, Arthoscopic Bankart Repair alone
Bankart Lesion Clinical Trial 2023: Arthroscopic Bankart Repair alone Highlights & Side Effects. Trial Name: NCT01620619 — N/A
Arthroscopic Bankart Repair alone 2023 Treatment Timeline for Medical Study. Trial Name: NCT01620619 — N/A
~9 spots leftby Dec 2025
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