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

Conditions

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Anatomic Glenoid Reconstruction and a procedure called Bankart Repair for people with shoulder instability. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 16 Years to 40 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBankart Repair

Patients Randomized to Bankart Repair Group

PROCEDUREAnatomic Glenoid Reconstruction

Patients Randomized to Anatomic Glenoid Reconstruction Group


Locations(2)

NYU Langone Health

New York, New York, United States

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05564494


Related Trials