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RECRUITING
NCT05564494
NA

Surgical Treatment of Recurrent Shoulder Dislocations

Sponsor: Nova Scotia Health Authority

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

16 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-04-25

Completion Date

2027-12-31

Last Updated

2024-08-22

Healthy Volunteers

Yes

Interventions

PROCEDURE

Bankart Repair

Patients Randomized to Bankart Repair Group

PROCEDURE

Anatomic Glenoid Reconstruction

Patients Randomized to Anatomic Glenoid Reconstruction Group

Locations (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada