Comparing two surgical methods for recurrent shoulder dislocation
Arthroscopic Bankart Repair and Remplissage Versus Latarjet Coracoid Transfer for Recurrent Anterior Glenohumeral Instability With Subcritical Bone Loss - A Randomized Controlled Trial
This study is testing which of two shoulder surgeries works better for people with repeated shoulder dislocations and some bone loss to see if it helps them feel more stable and reduce the chance of dislocating again.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 15 Years to 60 Years |
| Sex | All |
| Sponsor | Western University, Canada Academic / other |
| Locations | 2 sites (Winnipeg, Manitoba and 1 other locations) |
| Trial ID | NCT03453710 on ClinicalTrials.gov |
What this trial studies
This pilot study is a prospective, randomized controlled trial that compares the effectiveness of arthroscopic Bankart repair with Remplissage against open Latarjet coracoid transfer for treating recurrent anterior shoulder instability with subcritical bone loss. The study aims to address the lack of consensus guidelines for surgical management of this condition and to improve patient outcomes by evaluating these two surgical approaches. It focuses on patients with combined 'bipolar' bone loss, where individual defects are not critical in size but may still lead to instability. The trial will assess the rates of recurrence and overall joint stability following each surgical intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 and older with a history of anterior shoulder instability and evidence of a Hill-Sachs defect, but with less than 20% glenoid bone loss.
Not a fit: Patients with more than 20% glenoid bone loss or significant shoulder comorbidities 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 dislocation.
How similar studies have performed: While there is ongoing research in this area, the specific comparison of these two surgical methods for this patient population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * anterior shoulder instability (\>1 dislocation) * age \>14 years * evidence of a Hill-Sachs defect on MRI or CT, * \< 20% anteroposterior glenoid bone loss Exclusion Criteria: * \>20% anteroposterior glenoid bone loss * significant shoulder comorbidities (i.e., osteoarthritis, previous surgery other than previous instability), active joint or systemic infection, significant muscle paralysis, rotator cuff or Charcot's arthropathy, * significant medical comorbidity that may alter effectiveness of surgical intervention * major medical illness, * unable to speak French or English, * psychiatric illness that precludes informed consent, * unwilling to be followed for 2 years
Where this trial is running
Winnipeg, Manitoba and 1 other locations
- Pan Am Clinic — Winnipeg, Manitoba, Canada (Recruiting)
- Fowler Kennedy Sport Medicine Clinic — London, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Stacey Wanlin
- Email: swanlin@uwo.ca
- Phone: 519-661-3111
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.