Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

Not Applicable

• Conditions: Shoulder Dislocation
• Interventions: Procedure: Latarjet procedure; Procedure: Modified Eden-Hybinette

• Registration Number: NCT02913352
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-29
• Last Update Posted: 2017-10-31
• Primary Completion: 2021-09
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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".

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Latarjet procedure	Latarjet procedure	Open Latarjet-Patte procedure. Surgery. Anterior glenoid bone graft from coracoid. Fixation with 2 screws.
Modified Eden-Hybinette Procedure	Modified Eden-Hybinette	Surgery. Modified Eden-Hybinette surgery, with capsular repair on the iliac bone Anterior glenoid bone graft from iliac bone. Fixation with 2 screws.

Primary Outcome Measures

Name	Time	Method
Western Ontario Shoulder Instability Index (WOSI)	2 years	Instability score

Secondary Outcome Measures

Name	Time	Method
Categoric evaluation for scapular movement	2 years	Video evaluation for normal or dyskinesis of the scapula movement
Visual analog scale (VAS) for shoulder pain	2 years
VAS for iliac pain	2 years
Rate of complications and reoperations	2 years
Tomographic evaluation	2 years	Graft union, graft position and resorption
Radiographic evaluation	2 years	Graft union, graft position and resorption
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	return to sport scale
Kible scale for Scapular movement	2 years	Scale for scapular positioning. Clinical measurement

Trial Locations

Locations (1)

Instituto de Ortopedia e Traumatologia; 🇧🇷 São Paulo, SP, Brazil