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Surgical Treatment of Recurrent Shoulder Dislocations

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 1 to 2v5
  2. Primary completion date: Dec 31, 2026 to Dec 31, 2028
    • Study completion date: Dec 31, 2027 to Dec 31, 2028
    • Collaborators: 1 to 14
    v4
  3. Primary completion date: Aug 31, 2025 to Dec 31, 2026
    • Study completion date: Aug 31, 2025 to Dec 31, 2027
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 12, 2022 to Apr 25, 2023
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05564494
Lead Sponsor Nova Scotia Health Authority
Collaborators: Canadian Institutes of Health Research (CIHR), NYU Langone Health, Panam Clinic, Vancouver Coastal Health, University of British Columbia, Ottawa Hospital Research Institute, Children's Hospital of Eastern Ontario Research Institute, Horizon Health Network, Research St. Joseph's - Hamilton, London Health Sciences Centre Research Institute, University of Utah, Orlando Health, Inc., TSAOG Orthopaedics and Spine, The Hawkins Foundation
Conditions
(from sponsor)		 Shoulder Instability
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov