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RecruitingNCT02913352Updated Jan 29, 2026

Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

An interventional study of Latarjet procedure and Modified Eden-Hybinette in Shoulder Dislocation, sponsored by University of Sao Paulo. Recruiting at 1 site in Brazil. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Shoulder Dislocation

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03

In context

Shoulder Dislocation

105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 71 interventional studies indexed under Shoulder Dislocation.

Browse Shoulder Dislocation studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Latarjet procedure

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

    Procedure: Latarjet procedure

  • 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

Interventions

  • ProcedureLatarjet procedure

    Open anterior glenoid bone graft from coracoid process

  • ProcedureModified Eden-Hybinette

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

06

What researchers measure

Primary outcomes

  1. Western Ontario Shoulder Instability Index (WOSI)

    Instability score

    Time frame: 2 years

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

    Scale for scapular positioning. Clinical measurement

    Time frame: 2 years

  10. Categoric evaluation for scapular movement

    Video evaluation for normal or dyskinesis of the scapula movement

    Time frame: 2 years

  11. Tomographic evaluation

    Graft union, graft position and resorption

    Time frame: 2 years

  12. Radiographic evaluation

    Graft union, graft position and resorption

    Time frame: 2 years

  13. Degree of Shoulder Involvement in Sports (DOSIS ) scale

    return to sport scale

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Instituto de Ortopedia e Traumatologia
    São Paulo, São Paulo 05403-010, Brazil
    Recruiting
    • Mauro EC Gracitelli, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02913352
Collaborators
Faculdade de Medicina de Jundiaí
Responsible party
Mauro Gracitelli (PhD, University of Sao Paulo) — Principal investigator
First posted
Sep 23, 2016
Start date
Sep 1, 2016
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
Jan 29, 2026

Study contacts

Mauro EC Gracitelli, PhD
Contact
mgracitelli@gmail.com
+55 11 2661-2486
Eduardo A Malavolta, PhD
Contact
eduardomalavolta@gmail.com
+55 11 2661-2486

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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