RecruitingNot ApplicableNCT05564494

Surgical Treatment of Recurrent Shoulder Dislocations

The Arthroscopic Treatment of Anterior Shoulder Instability (ATRASI): A Pilot Multicentre Randomized Controlled Trial


Sponsor

Nova Scotia Health Authority

Enrollment

200 participants

Start Date

Apr 25, 2023

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 16 YearsMax Age: 40 Years

Inclusion Criteria2

  • Recurrent anterior glenohumeral dislocation (two or more incidents)
  • Presence of glenoid and/or humerus bone loss on imaging (x Ray, CT or MRI)

Exclusion Criteria11

  • 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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Interventions

PROCEDUREBankart Repair

Patients Randomized to Bankart Repair Group

PROCEDUREAnatomic Glenoid Reconstruction

Patients Randomized to Anatomic Glenoid Reconstruction Group


Locations(1)

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

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NCT05564494