Comparing two surgical methods for recurrent shoulder dislocations

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

This study is testing which of two shoulder surgeries works better for adults with repeated shoulder dislocations to help them recover and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: McMaster University (Academic / other)
• Locations: 1 site (Hamilton, Ontario)
• Trial ID: NCT05705479 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the functional recovery of patients with recurrent shoulder dislocations after being treated with either the Bankart + Remplissage procedure or the Latarjet procedure. The study will assess outcomes at 24 months post-surgery, focusing on the effectiveness of each surgical approach in stabilizing the shoulder and improving patient quality of life. The trial includes adults aged 18-50 with a history of post-traumatic recurrent anterior dislocation and specific eligibility criteria regarding bone loss and previous injuries. By comparing these two surgical techniques, the study seeks to determine which method offers better long-term results for patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-50 who have experienced at least two documented episodes of anterior shoulder dislocation.

Not a fit: Patients with concomitant shoulder injuries, previous shoulder surgeries, or those with multidirectional instability may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical options for patients suffering from recurrent shoulder dislocations, enhancing their recovery and quality of life.

How similar studies have performed: Previous studies have suggested varying success rates for the Latarjet procedure compared to the Bankart + Remplissage procedure, indicating that this trial is exploring a relevant and potentially impactful comparison.

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.

Where this trial is running

Hamilton, Ontario

• St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Moin Khan, MD — McMaster University
• Study coordinator: Miriam Garrido Clua, MSc

Conditions Shoulder Dislocation; Sport Injuries; Anterior Dislocation