Shoulder DislocationNCT02913352
Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation
A study testing Latarjet procedure and Modified Eden-Hybinette in people with Shoulder Dislocation, run by University of Sao Paulo at 1 site in Brazil.
Trial 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 more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- Latarjet procedure and Modified Eden-Hybinette
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2016to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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".
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Ortopedia e Traumatologia
São Paulo, São Paulo, 05403-010
Mauro EC Gracitelli, MD
About this study
Official title: Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette
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.
- Conditions
- Shoulder Dislocation
- Being tested
- Latarjet procedure, Modified Eden-Hybinette
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latarjet procedureProcedure or surgery
Open anterior glenoid bone graft from coracoid process
Modified Eden-HybinetteProcedure or surgery
Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation
| Study group | Role | What they receive |
|---|---|---|
| Latarjet procedure | Active comparator | Open Latarjet-Patte procedure. Surgery. Anterior glenoid bone graft from coracoid. Fixation with 2 screws. Receives: Procedure: Latarjet procedure |
| Modified Eden-Hybinette Procedure | Experimental | Surgery. Modified Eden-Hybinette surgery, with capsular repair on the iliac bone Anterior glenoid bone graft from iliac bone. Fixation with 2 screws. Receives: Procedure: Modified Eden-Hybinette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Shoulder Instability Index (WOSI)
Instability score
Measured: 2 years
Secondary outcomes (13)
ROWE score
Measured: 2 years
Visual analog scale (VAS) for shoulder pain
Measured: 2 years
VAS for iliac pain
Measured: 6 weeks
VAS for iliac pain
Measured: 3 months
VAS for iliac pain
Measured: 2 years
Single Assessment Numeric Evaluation (SANE)
Measured: 2 years
Dislocation recurrence rate
Measured: 2 years
Rate of complications and reoperations
Measured: 2 years
Kible scale for Scapular movement
Scale for scapular positioning. Clinical measurement
Measured: 2 years
Categoric evaluation for scapular movement
Video evaluation for normal or dyskinesis of the scapula movement
Measured: 2 years
Tomographic evaluation
Graft union, graft position and resorption
Measured: 2 years
Radiographic evaluation
Graft union, graft position and resorption
Measured: 2 years
Degree of Shoulder Involvement in Sports (DOSIS ) scale
return to sport scale
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Faculdade de Medicina de Jundiaí
- Responsible party
- Principal investigator, Mauro Gracitelli, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913352
- Sponsor's protocol ID
- Latarjet vs Eden
- Status last verified
- Jan 2026
- First submitted
- 16 Sep 2016
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette
- ClinicalTrials.gov ID
- NCT02913352
- Acronym / sponsor ID
- Latarjet vs Eden
- Conditions
- Shoulder Dislocation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Faculdade de Medicina de Jundiaí
- Study start
- 1 Sep 2016
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latarjet procedure | Active comparator | Procedure: Latarjet procedureOpen Latarjet-Patte procedure. Surgery. Anterior glenoid bone graft from coracoid. Fixation with 2 screws. |
| Modified Eden-Hybinette Procedure | Experimental | Procedure: Modified Eden-HybinetteSurgery. Modified Eden-Hybinette surgery, with capsular repair on the iliac bone Anterior glenoid bone graft from iliac bone. Fixation with 2 screws. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Latarjet procedureOpen anterior glenoid bone graft from coracoid process | Procedure or surgery | Latarjet procedure |
| Modified Eden-HybinetteOpen anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation | Procedure or surgery | Modified Eden-Hybinette Procedure |
Primary outcome
Western Ontario Shoulder Instability Index (WOSI)
Time frame: 2 years
Instability score
13 secondary outcomes
ROWE score
Time frame: 2 years
Visual analog scale (VAS) for shoulder pain
Time frame: 2 years
VAS for iliac pain
Time frame: 6 weeks
VAS for iliac pain
Time frame: 3 months
VAS for iliac pain
Time frame: 2 years
Single Assessment Numeric Evaluation (SANE)
Time frame: 2 years
Dislocation recurrence rate
Time frame: 2 years
Rate of complications and reoperations
Time frame: 2 years
Kible scale for Scapular movement
Time frame: 2 years
Categoric evaluation for scapular movement
Time frame: 2 years
Tomographic evaluation
Time frame: 2 years
Radiographic evaluation
Time frame: 2 years
Degree of Shoulder Involvement in Sports (DOSIS ) scale
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Shoulder Dislocation
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
RecruitingObservational study
Prospective Descriptive Study of Injuries Associated to Anterior Shoulder Dislocations in Patients Over 40 Years
Anterior Glenohumeral Dislocations
Not yet recruiting
Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode.
Shoulder Dislocation
Recruiting
Validation of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation
Return to Sport, Shoulder Dislocation or Subluxation
RecruitingObservational study
Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Proximal Humeral Fracture, Fracture Dislocation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latarjet procedure and Modified Eden-Hybinette in people with Shoulder Dislocation, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mauro EC Gracitelli, PhD (+55 11 2661-2486, mgracitelli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Shoulder Instability Index (WOSI) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.