Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Sao Paulo
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Western Ontario Shoulder Instability Index (WOSI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Latarjet procedure
Open Latarjet-Patte procedure. Surgery. Anterior glenoid bone graft from coracoid. Fixation with 2 screws.
Intervention: Latarjet procedure (Procedure)
Modified Eden-Hybinette Procedure
Surgery. Modified Eden-Hybinette surgery, with capsular repair on the iliac bone Anterior glenoid bone graft from iliac bone. Fixation with 2 screws.
Intervention: Modified Eden-Hybinette (Procedure)
Outcomes
Primary Outcomes
Western Ontario Shoulder Instability Index (WOSI)
Time Frame: 2 years
Instability score
Secondary Outcomes
- Rate of complications and reoperations(2 years)
- Tomographic evaluation(2 years)
- ROWE score(2 years)
- Single Assessment Numeric Evaluation (SANE)(2 years)
- Dislocation recurrence rate(2 years)
- Degree of Shoulder Involvement in Sports (DOSIS ) scale(2 years)
- Categoric evaluation for scapular movement(2 years)
- Visual analog scale (VAS) for shoulder pain(2 years)
- VAS for iliac pain(2 years)
- Radiographic evaluation(2 years)
- Kible scale for Scapular movement(2 years)
- VAS for iliac pain(6 weeks)
- VAS for iliac pain(3 months)
Investigators
Mauro Gracitelli
PhD
University of Sao Paulo