Evaluating treatment options for first-time shoulder dislocation

Randomized Trial Evaluating First Time Shoulder Dislocation: Surgery vs Conservative Care

This study is testing whether a surgical option or a non-surgical approach works better for young people who have just dislocated their shoulder for the first time.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 14 Years to 40 Years
• Sex: All
• Sponsor: McMaster University (other)
• Locations: 1 site (Hamilton, Ontario)
• Trial ID: NCT05715021 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess the feasibility of a larger trial comparing arthroscopic soft tissue stabilization to non-operative management for patients experiencing their first anterior shoulder dislocation. The study will focus on the risk of recurrent dislocation and functional outcomes over a 24-month period. It targets individuals aged 14 to 40 who have had a dislocation within the past three months, utilizing both clinical assessments and imaging to confirm diagnoses. The findings will help determine the best management strategies for this common injury.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 14 to 40 who have experienced a first-time anterior shoulder dislocation within the last three months.

Not a fit: Patients with previous shoulder surgeries, significant concomitant injuries, or those unable to undergo surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols that reduce the risk of recurrent shoulder dislocations and enhance functional recovery for patients.

How similar studies have performed: While there is existing literature on shoulder dislocations, this specific comparison of surgical versus non-operative management in first-time dislocators is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients ages 14-40 years;
2. Diagnosis of first-time shoulder anterior dislocation having occurred within the past 3 months confirmed 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. Provision of informed consent.

Exclusion Criteria:

1. Patients that cannot undergo surgery or anesthesia;
2. Patients with concomitant injuries (rotator cuff tear, fracture)
3. Previous shoulder surgery;
4. Patients that will likely have problems with maintaining follow-up or are incarcerated;
5. Epilepsy/seizure disorder;
6. Pregnancy;
7. Diagnosis of multidirectional instability;
8. Bony glenoid defect (bony Bankart) \>10% as measured on preop imaging;
9. Dislocation without trauma, in a context of hyper laxity or atraumatic instability;
10. Cases involving litigation or workplace insurance claims (e.g., WSIB).

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: Danielle Dagher, MSc

Conditions: Shoulder Dislocation, Sport Injury, Anterior Dislocation