Actively Recruiting
Randomized Trial Comparing Latarjet Versus Modified Eden-Hybinette Surgery for Recurrent Anterior Shoulder Dislocation
Led by University of Sao Paulo · Updated on 2026-01-29
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo
Lead Sponsor
F
Faculdade de Medicina de Jundiaí
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two surgical techniques, Latarjet and Modified Eden-Hybinette, to treat patients with recurrent traumatic anterior shoulder dislocation. This clinical trial focuses on which procedure may offer better outcomes for patients experiencing repeated dislocations, especially those with significant bone loss. The study highlights the strengths and risks of each method, noting that prior research lacks direct comparisons between these two surgeries. The trial involves two groups: one receiving the Latarjet procedure, which uses a coracoid bone graft fixed with screws and relies on a dynamic sling effect for shoulder stability; the other undergoing the Modified Eden-Hybinette surgery, which uses an iliac bone crest graft with capsular repair and screw fixation. Both surgeries aim to restore shoulder stability by addressing bone loss but differ in technique and potential complications. Participants will be followed for two years with assessments including the Western Ontario Shoulder Instability Index (WOSI), ROWE score, pain scales, dislocation recurrence, and shoulder function evaluations. Imaging with tomography and radiography will also be performed. Researchers will monitor complications and reoperations, measuring how well each surgery maintains shoulder stability and function over time.
CONDITIONS
Brief Title
Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of one or more previous episodes of traumatic glenohumeral dislocation
- Anterior glenoid bone loss greater than 20% of its diameter
- Recurrence of shoulder dislocation after arthroscopic Bankart repair
- Instability Severity Index Score (ISIS) of 4 or more with anterior glenoid bone loss over 13.5%
- Hill-Sachs lesion and glenoid considered "off-track"
You will not qualify if you...
- Hill-Sachs lesion larger than 40% of the humeral head diameter
- Untreated seizures
- Previously diagnosed complete rotator cuff tear
- Fractures of the proximal humerus (except Hill-Sachs lesions)
- Multidirectional instability
- Advanced glenohumeral osteoarthritis (grade 3 Samilson and Pietro)
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 - Up to 2 weeks or until discharge
Participants undergo either the Latarjet or Modified Eden-Hybinette surgical procedures to treat anterior shoulder dislocation, followed by immediate post-operative care.
1 hospital stay and approximately 3 post-operative visits
Duration - Up to 2 years
Participants attend follow-up visits to monitor recovery, assess pain and shoulder function, and evaluate any complications or recurrence of dislocation.
Multiple visits including assessments at 6 weeks, 3 months, and regular visits up to 2 years
Trial Site Locations
Total: 1 location
1
Instituto de Ortopedia e Traumatologia
São Paulo, São Paulo, Brazil, 05403-010
Actively Recruiting
Research Team
M
Mauro EC Gracitelli, PhD
E
Eduardo A Malavolta, PhD
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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