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Surgical Treatment of Recurrent Shoulder Dislocations

RecruitingNAAges 16 Years - 40 YearsAllNova Scotia Health Authority
NCT05564494 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • Bankart Repair
  • Anatomic Glenoid Reconstruction
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Where

2 sites
NYU Langone Health
New York, United States
Nova Scotia Health Authority
Halifax, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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