Clinical trial NCT02913352: Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation
Official title: Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Dislocation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Western Ontario Shoulder Instability Index (WOSI)
timeFrame: 2 years
Secondary outcomes:
measure: ROWE score
timeFrame: 2 years
measure: Visual analog scale (VAS) for shoulder pain
timeFrame: 2 years
measure: VAS for iliac pain
timeFrame: 6 weeks
measure: VAS for iliac pain
timeFrame: 3 months
measure: VAS for iliac pain
timeFrame: 2 years
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: 2 years
measure: Dislocation recurrence rate
timeFrame: 2 years
measure: Rate of complications and reoperations
timeFrame: 2 years
measure: Kible scale for Scapular movement
timeFrame: 2 years
measure: Categoric evaluation for scapular movement
timeFrame: 2 years
measure: Tomographic evaluation
timeFrame: 2 years
measure: Radiographic evaluation
timeFrame: 2 years
measure: Degree of Shoulder Involvement in Sports (DOSIS ) scale
timeFrame: 2 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Ortopedia e Traumatologia
state: SP
Study officials:
References: