Actively Recruiting
Latarjet vs Anatomic Glenoid Reconstruction for Treatment of Anterior Shoulder Instability With Glenoid Bone Loss: a Prospective Multi-centre Randomized Trial
Led by Nova Scotia Health Authority · Updated on 2024-08-22
68
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Anterior shoulder dislocations cause pain, stiffness, and glenoid bone loss, leading to a high risk of recurrence if untreated. This trial compares two surgical treatments, the Latarjet procedure and the Anatomic Glenoid Reconstruction (AGR), to evaluate their clinical and radiographic outcomes. The study aims to determine which approach better addresses shoulder instability due to bone loss, focusing on reducing recurrence and complications. The trial involves two procedures: the Latarjet, where the coracoid process is transferred and fixed to the glenoid to increase stability, and the AGR, which uses a distal tibia allograft inserted arthroscopically through a special portal to restore the glenoid size. Both surgeries aim to improve shoulder function and reduce instability, but AGR may offer fewer complications and less muscle damage. The study will randomize 68 participants to receive one of these treatments. Participants will be monitored with clinical assessments and imaging over two years. Outcomes include complication rates, recurrent instability, patient-reported function scores, and radiographic measures of muscle volume, graft condition, and glenoid size. Safety and effectiveness will be evaluated through questionnaires and scans at multiple time points. The total study period includes pre-operative assessment and follow-up visits up to two years after surgery.
CONDITIONS
Brief Title
Latarjet vs Anatomic Glenoid Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with one or more instances of anterior shoulder dislocation
- Pre-operative CT scan showing greater than 20% glenoid bone loss
- Age between 16 and 40 years
- Able to provide informed consent
You will not qualify if you...
- Posterior shoulder instability
- Multidirectional shoulder instability
- Massive rotator cuff tears confirmed by MRI
- History of substance abuse
- Unable or unwilling to provide informed consent
- Refusal of randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus immediate post-operative period
Participants undergo either the Latarjet procedure or the Anatomic Glenoid Reconstruction surgery to treat anterior shoulder instability with glenoid bone loss.
1 surgical visit and immediate post-operative care visits
Duration - Up to 2 years after surgery
Participants are monitored through a series of clinical and radiographic assessments to evaluate complication rates, recurrence of instability, and shoulder function.
Approximately 6 follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Nova Scotia Health QEII Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 2E1
Actively Recruiting
Research Team
I
Ivan Wong, MD
S
Sarah Remedios, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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