Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Latarjet procedure, Modified Eden-Hybinette.
- Who it may be relevant to
- Registry conditions: Shoulder Dislocation. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette
Overview
Randomized clinical trial, parallel 1:1, comparing Latarjet to Modified Eden-Hybinette (iliac bone crest + capsular repair) for recurrent traumatic anterior glenohumeral dislocation.
Detailed description
The Latarjet technique has proven reliable for the treatment of dislocations, with lower recurrence rates (5%) even in the presence of bone lesions. This technique allows a stable fixation of the graft, with 2 screws, and the dynamic effect of the conjoint tendon, the sling effect. However, several complications are described, such as neurological injuries, nonunion and graft resorption. Hamel et al, showed that vascularization of the coracoid graft is impaired during the course of Latarjet procedure. Together with the small thickness of the coracoid, it may justify its high rate of resorption.
The Eden-Hybinette surgery does not have the potential advantages of the sling effect. However, it allows a better restoration of the area of the glenoid, without the risks related to the coracoid osteotomy. All clinical studies about the different bone grafting techniques have a low quality. Furthermore, there is no comparative study of the techniques of Latarjet and Eden-Hybinette.
Interventions
- Procedure Latarjet procedure
Open anterior glenoid bone graft from coracoid process - Procedure Modified Eden-Hybinette
Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation
Primary outcome measures
- Western Ontario Shoulder Instability Index (WOSI) [Time frame: 2 years]
Secondary outcome measures (12)
- ROWE score [Time frame: 2 years]
- Visual analog scale (VAS) for shoulder pain [Time frame: 2 years]
- VAS for iliac pain [Time frame: 6 weeks]
- VAS for iliac pain [Time frame: 3 months]
- VAS for iliac pain [Time frame: 2 years]
- Single Assessment Numeric Evaluation (SANE) [Time frame: 2 years]
- Dislocation recurrence rate [Time frame: 2 years]
- Rate of complications and reoperations [Time frame: 2 years]
- Kible scale for Scapular movement [Time frame: 2 years]
- Categoric evaluation for scapular movement [Time frame: 2 years]
- Tomographic evaluation [Time frame: 2 years]
- Radiographic evaluation [Time frame: 2 years]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Instituto de Ortopedia e Traumatologia — São Paulo
Identifiers
NCT: NCT02913352 · Latarjet vs Eden