Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared with Latarjet Procedure Evaluation - STABLE Definitive Trial

Launched by MCMASTER UNIVERSITY · Jan 27, 2023

Keywords

ClinConnect Summary

The STABLE trial is a study designed to compare two different surgical treatments for patients who frequently experience shoulder dislocations, particularly after sports injuries. The two procedures being studied are the Bankart Procedure, which repairs the shoulder's ligaments, and the Latarjet Procedure, which involves transferring a small piece of bone to help stabilize the shoulder. The goal is to see which method helps patients recover better over a period of 24 months.

To participate in this trial, you need to be an adult aged 18 to 50 who has had at least two documented shoulder dislocations. You should have some bone loss in the shoulder joint but not too much, and you need to be able to agree to participate in the study. Unfortunately, if you've had other shoulder injuries, prior surgeries, or certain medical conditions, you won’t be eligible. Participants can expect regular follow-ups to monitor their recovery and will have the opportunity to contribute to important research that could help others with similar shoulder issues in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults ages 18-50 years;
• • 2. Diagnosis of post-traumatic recurrent anterior dislocation. This will require a minimum of 2 episodes of documented dislocations either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms;
• • 3. Subcritical glenoid bone loss as defined on CT by standardized and reproducible best-fit circle technique (\>10% but \<20%);
• • 4. Provision of informed consent.
• Exclusion Criteria:
• • 1. Patients with concomitant injuries of the index shoulder (cuff tear, greater tuberosity fracture);
• • 2. Previous shoulder surgery;
• • 3. Patients that will likely have problems, in the judgment of the investigators, with maintaining follow-up;
• • 4. Epilepsy/seizure disorder;
• • 5. Patients who are currently incarcerated;
• • 6. Diagnosis of multidirectional instability;
• • 7. Cases involving litigation or workplace insurance claims (e.g. WSIB);
• • 8. Confirmed connective tissue disorder (Ehlers-Danlos, Marfans) or Beighton hypermobility score \> 6.
• • 9. Pregnancy.