About this trial
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.
Eligibility criteria
Qualifiers
Recurrent anterior glenohumeral dislocation (two or more incidents)
Presence of glenoid and/or humerus bone loss on imaging (x Ray, CT or MRI)
Disqualifiers
Uncontrolled diabetes (Hgb A1C >7%)
Prior surgery of affected shoulder
Pregnancy
Multidirectional instability
Trial design
Treatments tested in this trial
- Bankart Repair
- Anatomic Glenoid Reconstruction
Treatment groups
Sponsors and collaborators
Nova Scotia Health Authority
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
NYU Langone Health
Collaborator
Panam Clinic
Collaborator
Vancouver Coastal Health
Collaborator
University of British Columbia
Collaborator
Ottawa Hospital Research Institute
Collaborator
Children's Hospital of Eastern Ontario Research Institute
Collaborator
Horizon Health Network
Collaborator
Research St. Joseph's - Hamilton
Collaborator
London Health Sciences Centre Research Institute
Collaborator
University of Utah
Collaborator
Orlando Health, Inc.
Collaborator
TSAOG Orthopaedics and Spine
Collaborator
The Hawkins Foundation
Collaborator