Surgical Treatment of Recurrent Shoulder Dislocations

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-40
SponsorNova Scotia Health Authority

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

200 Participants
are divided into 2 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