Surgical Treatment of Recurrent Shoulder Dislocations
Recruiting now · Not applicable
Conditions studied: Shoulder Instability
In brief
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.
Key facts
- Study ID
- NCT05564494
- Run by
- Nova Scotia Health Authority
- People needed
- 200
- Starts
- 2023-04-25
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-05-04
Who can join
Age: 16 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Recurrent anterior glenohumeral dislocation (two or more incidents)
- Presence of glenoid and/or humerus bone loss on imaging (x Ray, CT or MRI)
You may not qualify if…
- 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)
Where it is running
- NYU Langone Health — New York, New York, United States (enrolling)
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (enrolling)
Full record on ClinicalTrials.gov
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