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Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

NCT ID: NCT02913352

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2022-01-31

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.

Conditions

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Shoulder Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Latarjet procedure

Open Latarjet-Patte procedure. Surgery. Anterior glenoid bone graft from coracoid. Fixation with 2 screws.

Group Type ACTIVE_COMPARATOR

Latarjet procedure

Intervention Type PROCEDURE

Open anterior glenoid bone graft from coracoid process

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.

Group Type EXPERIMENTAL

Modified Eden-Hybinette

Intervention Type PROCEDURE

Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation

Interventions

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Latarjet procedure

Open anterior glenoid bone graft from coracoid process

Intervention Type PROCEDURE

Modified Eden-Hybinette

Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation

Intervention Type PROCEDURE

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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Mauro Gracitelli

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto de Ortopedia e Traumatologia

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Mauro EC Gracitelli, PhD

Role: CONTACT

Phone: +55 11 2661-2486

Email: [email protected]

Eduardo A Malavolta, PhD

Role: CONTACT

Phone: +55 11 2661-2486

Email: [email protected]

Other Identifiers

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Latarjet vs Eden

Identifier Type: -

Identifier Source: org_study_id