Clinical Research Directory
Browse clinical research sites, groups, and studies.
Surgical Treatment of Recurrent Shoulder Dislocations
Sponsor: Nova Scotia Health Authority
Summary
This is a pilot multi-centre, double blinded randomized controlled trial. The primary outcome of this pilot trial will be feasibility. Prior to conducting a large definitive trial, the investigators will conduct this pilot trial comparing arthroscopic Bankart repair with arthroscopic anatomic glenoid reconstruction (AAGR), evaluating recurrent dislocation rates and functional outcomes over a 24-month period. The feasibility objectives are: (1) to evaluate the investigators ability to recruit patients across multiple sites and (2) to assess study protocol adherence and ability to follow patients to 24 months. Clinical objectives for the pilot trial are exploratory only. The investigators wish to gather means and standard deviations for clinical outcomes to power their future definitive trial. The objectives of the definitive trial will include a comparison of patient-reported outcomes at the two-year post-operative time point, differences in recurrence rates, complication rates, functional shoulder assessments, and return to work/sport.
Official title: The Arthroscopic Treatment of Anterior Shoulder Instability (ATRASI): A Pilot Multicentre Randomized Controlled Trial
Key Details
Gender
All
Age Range
16 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-04-25
Completion Date
2027-12-31
Last Updated
2024-08-22
Healthy Volunteers
Yes
Conditions
Interventions
Bankart Repair
Patients Randomized to Bankart Repair Group
Anatomic Glenoid Reconstruction
Patients Randomized to Anatomic Glenoid Reconstruction Group
Locations (1)
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada