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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3,6 weeks;3,6 months; 1,2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
164 Previous Clinical Trials
319,104 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being accepted as part of this trial?

"This trial's entrance requirements stipulate that prospective participants must be between 15 and 51 years of age. If one is younger than fifteen or older than fifty-one, there are two other clinical trials for minors and seniors respectively."

Answered by AI

Are there any opportunities available for individuals to participate in this trial?

"As indicated on clinicaltrials.gov, this medical venture is no longer recruiting participants. It was first listed in February 2010 and last updated April 24th 2014, yet there are 3 other trials still actively seeking enrollees."

Answered by AI

Do I fulfill the criteria to participate in this medical experiment?

"To attend this medical trial, potential participants need to have bankart lesions and be between 15-51 years in age. Approximately 142 people are necessary for the study's success."

Answered by AI
~9 spots leftby Apr 2025