Actively Recruiting
Randomized Trial Evaluating First Time Shoulder Dislocation: Surgery vs Conservative Care
Led by McMaster University · Updated on 2025-09-26
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients aged 14 to 40 years who have experienced a first-time anterior shoulder dislocation within the past 3 months. The study aims to evaluate whether arthroscopic soft tissue stabilization surgery compared to non-operative management affects the risk of recurrent dislocations and functional outcomes over a 24-month period. This pilot trial will also assess feasibility factors such as recruitment, adherence to protocols, and participant follow-up. Participants who agree to randomization will be assigned to either arthroscopic capsuloligamentous repair (including Bankart and possibly Remplissage procedures) or non-operative management involving physical therapy. Additionally, a non-randomized group will include patients who choose their preferred treatment. Both groups will be followed for two years with outcomes measured at 6 weeks, 6 months, 12 months, and 24 months. This design allows inclusion of patient preferences and enhances the study's real-world relevance. During the study, participants will undergo baseline assessments including medical history, physical examination, and completion of shoulder function and quality of life questionnaires such as the Western Ontario Shoulder Instability Index and American Shoulder and Elbow Society score. Researchers will monitor recurrence of dislocations, symptoms of instability, range of motion, return to activity and work, pain, satisfaction, and adverse events. Safety and treatment adherence will be closely tracked throughout the 24-month follow-up period.
CONDITIONS
Brief Title
RCT Evaluating First Time Shoulder Dislocation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 14 to 40 years
- First-time anterior shoulder dislocation within the past 3 months confirmed by imaging or documented reduction and physical exam
- Able to provide informed consent
You will not qualify if you...
- Unable to undergo surgery or anesthesia
- Other shoulder injuries such as rotator cuff tear or fracture
- Previous shoulder surgery
- Likely to have difficulty maintaining follow-up or incarcerated
- Epilepsy or seizure disorder
- Pregnancy
- Multidirectional shoulder instability
- Bony glenoid defect greater than 10% on imaging
- Dislocations without trauma or with hyper laxity or atraumatic instability
- Involvement in litigation or workplace insurance claims
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive either arthroscopic capsuloligamentous repair (Bankart +/- Remplissage Procedure) or non-operative physical therapy to manage their first-time anterior shoulder dislocation.
1 to 2 visits for surgery scheduling and treatment initiation
Duration - 24 months
Participants are followed for 24 months after treatment to monitor shoulder stability, function, pain, and return to activity, with assessments including questionnaires and physical exams.
Visits at 6 weeks, 6 months, 12 months, and 24 months post-treatment
Trial Site Locations
Total: 1 location
1
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
Research Team
D
Danielle Dagher, MSc
M
Moin Khan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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