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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 14Years - 40Years
All Genders
ID05715021

Study Comparing Arthroscopic Surgery Versus Physical Therapy for First-Time Anterior Shoulder Dislocation in Patients Aged 14 to 40

Led by McMaster University · Updated on 2025-09-26

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

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 studys 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

Research Team

D

Danielle Dagher, MSc

M

Moin Khan, MD

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