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NCT Number: NCT02913352

Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

Randomized clinical trial, parallel 1:1, comparing Latarjet to Modified Eden-Hybinette (iliac bone crest + capsular repair) for recurrent traumatic anterior glenohumeral dislocation.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Ortopedia e Traumatologia

São Paulo, 05403-010, Brazil

Location status: Recruiting

Location contact

Mauro EC Gracitelli, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Latarjet procedure

Procedure

Open anterior glenoid bone graft from coracoid process

Modified Eden-Hybinette

Procedure

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

Primary outcomes

  1. Western Ontario Shoulder Instability Index (WOSI)

    Time frame: 2 years

    Instability score

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Eduardo A Malavolta, PhD

CONTACT

[email protected]

+55 11 2661-2486

Mauro EC Gracitelli, PhD

CONTACT

[email protected]

+55 11 2661-2486

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Faculdade de Medicina de Jundiaí

Registry information

Official study title

Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette

Important dates

Study start
2016
Primary completion
2027
Study completion
2029
First posted
Sep 23, 2016
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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