Comparing Latarjet and Modified Eden-Hybinette shoulder stabilization surgeries
Official title: Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette
Run by University of Sao Paulo · NCT02913352 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | September 1, 2016 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2029 |
| Registry record updated | January 29, 2026 |
| Trial ID | NCT02913352 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Instituto de Ortopedia e Traumatologia
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Mauro EC Gracitelli, PhD
- Email: mgracitelli@gmail.com
- Phone: +55 11 2661-2486
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Sling vs Dynamic Shoulder Brace After Shoulder Stabilization
This pilot randomized trial tests whether a dynamic shoulder orthosis helps people recover faster after arthroscopic stabilization for anterior shoulder instability compared with a standard sling.
-
Evaluating treatment options for first-time shoulder dislocation
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.
-
Comparing two surgical methods for shoulder dislocation treatment
This study is testing which of two shoulder surgeries, the Latarjet procedure or Anatomic Glenoid Reconstruction, works better for people with significant bone loss after multiple dislocations.
-
Comparing surgical methods for shoulder instability with bone loss
This study tests which of three different shoulder surgeries works best for military and civilian patients with some bone loss, to help them recover faster and get back to their activities.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.