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Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02913352
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : October 31, 2017
Information provided by (Responsible Party):
Mauro Gracitelli, 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.

Condition or disease Intervention/treatment Phase
Shoulder Dislocation Procedure: Latarjet procedure Procedure: Modified Eden-Hybinette Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette
Study Start Date : September 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Latarjet procedure
Open Latarjet-Patte procedure. Surgery. Anterior glenoid bone graft from coracoid. Fixation with 2 screws.
Procedure: Latarjet procedure
Open anterior glenoid bone graft from coracoid process

Experimental: 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.
Procedure: Modified Eden-Hybinette
Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation

Primary Outcome Measures :
  1. Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 2 years ]
    Instability score

Secondary Outcome Measures :
  1. ROWE score [ Time Frame: 2 years ]
  2. Visual analog scale (VAS) for shoulder pain [ Time Frame: 2 years ]
  3. VAS for iliac pain [ Time Frame: 6 weeks ]
  4. VAS for iliac pain [ Time Frame: 3 months ]
  5. VAS for iliac pain [ Time Frame: 2 years ]
  6. Single Assessment Numeric Evaluation (SANE) [ Time Frame: 2 years ]
  7. Dislocation recurrence rate [ Time Frame: 2 years ]
  8. Rate of complications and reoperations [ Time Frame: 2 years ]
  9. Kible scale for Scapular movement [ Time Frame: 2 years ]
    Scale for scapular positioning. Clinical measurement

  10. Categoric evaluation for scapular movement [ Time Frame: 2 years ]
    Video evaluation for normal or dyskinesis of the scapula movement

  11. Tomographic evaluation [ Time Frame: 2 years ]
    Graft union, graft position and resorption

  12. Radiographic evaluation [ Time Frame: 2 years ]
    Graft union, graft position and resorption

  13. Degree of Shoulder Involvement in Sports (DOSIS ) scale [ Time Frame: 2 years ]
    return to sport scale

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02913352

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Contact: Mauro EC Gracitelli, PhD +55 11 2661-2486
Contact: Eduardo A Malavolta, PhD +55 11 2661-2486

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Instituto de Ortopedia e Traumatologia Recruiting
São Paulo, SP, Brazil, 05403-010
Principal Investigator: Mauro EC Gracitelli, MD         
Sponsors and Collaborators
University of Sao Paulo
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Responsible Party: Mauro Gracitelli, PhD, University of Sao Paulo Identifier: NCT02913352    
Other Study ID Numbers: Latarjet vs Eden
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Joint Dislocations
Shoulder Dislocation
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries