Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

NCT02913352 | Recruiting

• 1 other identifier: Latarjet vs Eden
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Dislocation

Outcome Measures

Primary Outcomes (1)

• Western Ontario Shoulder Instability Index (WOSI)

  Instability score

  2 years

Secondary Outcomes (13)

• ROWE score

  2 years

• Visual analog scale (VAS) for shoulder pain

  2 years

• VAS for iliac pain

  6 weeks

• VAS for iliac pain

  3 months

• VAS for iliac pain

  2 years

Study Arms (2)

Latarjet procedure

ACTIVE COMPARATOR

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

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.

Procedure: Modified Eden-Hybinette

Interventions

Modified Eden-Hybinette PROCEDURE

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

Modified Eden-Hybinette Procedure

Latarjet procedure PROCEDURE

Open anterior glenoid bone graft from coracoid process

Latarjet procedure

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sao Paulo: lead
• Faculdade de Medicina de Jundiaí: collaborator

Study Sites (1)

Instituto de Ortopedia e Traumatologia

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Central Study Contacts

Mauro EC Gracitelli, PhD

CONTACT

+55 11 2661-2486; mgracitelli@gmail.com

Eduardo A Malavolta, PhD

CONTACT

+55 11 2661-2486; eduardomalavolta@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: September 23, 2016
• Study Start: September 1, 2016
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

BR (1)