Comparing Latarjet and Modified Eden-Hybinette shoulder stabilization surgeries

Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette

This tests whether Latarjet or Modified Eden‑Hybinette surgery better prevents repeat anterior shoulder dislocations in people with recurrent traumatic dislocation and significant glenoid bone loss.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: University of Sao Paulo (other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT02913352 on ClinicalTrials.gov

What this trial studies

This is a randomized, parallel 1:1 surgical trial at a single center comparing the Latarjet procedure to a modified Eden‑Hybinette bone graft with capsular repair for recurrent traumatic anterior glenohumeral dislocation. Eligible patients have recurrent dislocations with substantial anterior glenoid bone loss or off‑track Hill‑Sachs lesions, including failures after prior arthroscopic Bankart repair. The Latarjet offers a sling effect and historically low recurrence but has risks such as neurologic injury and graft resorption, while the Eden‑Hybinette restores glenoid surface without coracoid osteotomy but lacks the sling. Outcomes will focus on recurrence, graft healing/complications, and shoulder function to determine which approach gives better stability and fewer adverse events.

Who should consider this trial

Good fit: People with recurrent traumatic anterior shoulder dislocation and anterior glenoid bone loss greater than 20%, or off‑track Hill‑Sachs lesions or recurrence after prior Bankart repair, are ideal candidates.

Not a fit: Patients with very large Hill‑Sachs defects (>40% of the humeral head), untreated seizures, multidirectional instability, complete rotator cuff tears, or advanced glenohumeral arthritis are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the trial could identify which surgery gives better long‑term shoulder stability and fewer complications, helping surgeons choose the best option for patients with bone loss.

How similar studies have performed: Observational studies report low recurrence with Latarjet but notable complication and graft‑resorption rates, while Eden‑Hybinette data are limited and no prior randomized head‑to‑head comparisons have been published.

Eligibility criteria

Inclusion Criteria:

* History of one or more previous episodes of traumatic glenohumeral dislocation;
* Anterior glenoid bone loss superior to 20% of its diameter, regardless of the ISIS score;
* Recurrence of glenohumeral dislocation in cases previously treated with arthroscopic Bankart repair, regardless of the ISIS score and severity of bone lesion of the glenoid;
* Borderline bipolar bone lesions:
* Instability Severity Index Score of (ISIS) greater than or equal to 4 points, with anterior glenoid bone loss (bone Bankart lesion) greater than 13.5% of their diameter, measured by the method described by Sugaya et al.;
* Hill-Sachs lesion and glenoid considered "off-track".

Exclusion Criteria:

* Hill-Sachs lesion greater than 40% of the humeral head diameter (measured by the preoperative CT);
* Untreated seizures;
* Previously diagnosed rotator cuff complete tear;
* Fractures of the proximal humerus (except for Hill-Sachs lesions);
* Multidirectional instability;
* Advanced glenohumeral osteoarthritis (grade 3 Samilson and Pietro)

Where this trial is running

São Paulo, São Paulo

• Instituto de Ortopedia e Traumatologia — São Paulo, São Paulo, Brazil (RECRUITING)

Study contacts

• Study coordinator: Mauro EC Gracitelli, PhD

Conditions: Shoulder Dislocation