Surgical treatment for recurrent shoulder dislocations
The Arthroscopic Treatment of Anterior Shoulder Instability (ATRASI): A Pilot Multicentre Randomized Controlled Trial
NA · Nova Scotia Health Authority · NCT05564494
This study is testing two different surgical methods to see which one works better for people with recurring shoulder dislocations.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 16 Years to 40 Years |
| Sex | All |
| Sponsor | Nova Scotia Health Authority (other) |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT05564494 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate the feasibility of comparing two surgical techniques, arthroscopic Bankart repair and arthroscopic anatomic glenoid reconstruction, for treating recurrent shoulder dislocations. The study will assess the ability to recruit patients across multiple sites and adherence to the study protocol over a 24-month follow-up period. While the primary focus is on feasibility, the trial will also gather data on dislocation rates and functional outcomes to inform a larger definitive trial in the future.
Who should consider this trial
Good fit: Ideal candidates are individuals under 20 years old with recurrent anterior glenohumeral dislocations and evidence of bone loss on imaging.
Not a fit: Patients with uncontrolled diabetes, prior shoulder surgery, or other specific exclusions such as severe systemic illness or cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical options and outcomes for patients suffering from recurrent shoulder dislocations.
How similar studies have performed: Previous studies have shown that surgical management of shoulder instability can significantly reduce recurrence rates, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Recurrent anterior glenohumeral dislocation (two or more incidents) * Presence of glenoid and/or humerus bone loss on imaging (x Ray, CT or MRI) Exclusion Criteria: * 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 this trial is running
New York, New York and 1 other locations
- NYU Langone Health — New York, New York, United States (RECRUITING)
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (RECRUITING)
Study contacts
- Principal investigator: Ivan H Wong, MD — Nova Scotia Health Authority
- Study coordinator: Matt Miller, PhD
- Email: research@drivanwong.com
- Phone: 9024737626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Shoulder Instability, Arthroscopy, Multiple Dislocations