NCT02913352 Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation
| NCT ID | NCT02913352 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo |
| Condition | Shoulder Dislocation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2016-09-01 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2016-09-01 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT02913352 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Shoulder Dislocation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02913352 currently recruiting?
Yes, NCT02913352 is actively recruiting participants. Contact the research team at mgracitelli@gmail.com for enrollment information.
Where is the NCT02913352 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT02913352 clinical trial?
NCT02913352 is sponsored by University of Sao Paulo. The trial plans to enroll 60 participants.