The Arthroscopic Treatment of Anterior Shoulder Instability (ATRASI): A Pilot Multicentre Randomized Controlled Trial
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.
Description
The glenohumeral joint has the greatest range of motion of any major articulation in the human body. This increased mobility leaves the joint vulnerable to dislocation and the development of instability and osteoarthritis, both of which can have drastic effects on work productivity and quality of life. Symptomatic instability following anterior glenohumeral dislocation is especially common among young people. In patients under 20 years of age, recurrent dislocation rates may be as high as 90%. The high incidence of recurrent dislocation negatively affects the individual and society in general.…
Eligibility
- Age range
- 16–40 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Recurrent anterior glenohumeral dislocation (two or more incidents) * Presence of glenoid and/or humerus bone loss on imaging (x Ray, CT or MRI) Exclusion Criteria: * Uncontrolled diabetes (Hgb A1C \>7%) * Prior surgery of affected shoulder * Pregnancy * Multidirectional instability * Posterior instability * Paralysis of the shoulder * Cancer * Severe systemic illness * Presence of massive rotator cuff tear * Patients that present with \< 10% or \> 25% bone loss under preoperative imaging. * Generalized laxity (\>5/9 Beighton Score)
Interventions
- ProcedureBankart Repair
Patients Randomized to Bankart Repair Group
- ProcedureAnatomic Glenoid Reconstruction
Patients Randomized to Anatomic Glenoid Reconstruction Group
Locations (2)
- NYU Langone HealthNew York, New York
- Nova Scotia Health AuthorityHalifax, Nova Scotia