Shoulder Dislocation
Conditions
Brief summary
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
PROCEDURELatarjet procedure
Open anterior glenoid bone graft from coracoid process
PROCEDUREModified Eden-Hybinette
Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation
Sponsors
University of Sao Paulo
Faculdade de Medicina de Jundiaí
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Shoulder Instability Index (WOSI) | 2 years | Instability score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic evaluation | 2 years | Graft union, graft position and resorption |
| Kible scale for Scapular movement | 2 years | Scale for scapular positioning. Clinical measurement |
| Degree of Shoulder Involvement in Sports (DOSIS ) scale | 2 years | return to sport scale |
| Categoric evaluation for scapular movement | 2 years | Video evaluation for normal or dyskinesis of the scapula movement |
| Rate of complications and reoperations | 2 years | — |
| ROWE score | 2 years | — |
| Visual analog scale (VAS) for shoulder pain | 2 years | — |
| VAS for iliac pain | 6 weeks | — |
| Single Assessment Numeric Evaluation (SANE) | 2 years | — |
| Tomographic evaluation | 2 years | Graft union, graft position and resorption |
| Dislocation recurrence rate | 2 years | — |
Countries
Brazil
Contacts
CONTACTMauro EC Gracitelli, PhD
CONTACTEduardo A Malavolta, PhD
Outcome results
None listed