Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Shoulder Dislocation

Intervention / Treatment
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* Procedure: Latarjet procedure
* Procedure: Modified Eden-Hybinette


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Latarjet procedure<br>Open Latarjet-Patte procedure. Surgery. Anterior glenoid bone graft from coracoid. Fixation with 2 screws. | Procedure: Latarjet procedure<br>* Open anterior glenoid bone graft from coracoid process<br>|
| Experimental: Modified Eden-Hybinette Procedure<br>Surgery. Modified Eden-Hybinette surgery, with capsular repair on the iliac bone Anterior glenoid bone graft from iliac bone. Fixation with 2 screws. | Procedure: Modified Eden-Hybinette<br>* Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario Shoulder Instability Index (WOSI) | Instability score | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROWE score |  | 2 years | 
| Visual analog scale (VAS) for shoulder pain |  | 2 years | 
| VAS for iliac pain |  | 6 weeks | 
| VAS for iliac pain |  | 3 months | 
| VAS for iliac pain |  | 2 years | 
| Single Assessment Numeric Evaluation (SANE) |  | 2 years | 
| Dislocation recurrence rate |  | 2 years | 
| Rate of complications and reoperations |  | 2 years | 
| Kible scale for Scapular movement | Scale for scapular positioning. Clinical measurement | 2 years | 
| Categoric evaluation for scapular movement | Video evaluation for normal or dyskinesis of the scapula movement | 2 years | 
| Tomographic evaluation | Graft union, graft position and resorption | 2 years | 
| Radiographic evaluation | Graft union, graft position and resorption | 2 years | 
| Degree of Shoulder Involvement in Sports (DOSIS ) scale | return to sport scale | 2 years |