Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Procedure: Latarjet procedure; Procedure: Modified Eden-Hybinette

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mauro EC Gracitelli, PhD; Phone Number: +55 11 2661-2486; Email: mgracitelli@gmail.com
• Study Contact Backup: Name: Eduardo A Malavolta, PhD; Phone Number: +55 11 2661-2486; Email: eduardomalavolta@gmail.com

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05403-010
      • Recruiting
      • Instituto de Ortopedia e Traumatologia
      • Principal Investigator: Mauro EC Gracitelli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Latarjet procedure; Open Latarjet-Patte procedure. Surgery. Anterior glenoid bone graft from coracoid. Fixation with 2 screws.	Procedure: Latarjet procedure; Open anterior glenoid bone graft from coracoid process
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; Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario Shoulder Instability Index (WOSI)	Instability score	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Single Assessment Numeric Evaluation (SANE)		2 years
Dislocation recurrence rate		2 years
Rate of complications and reoperations		2 years
Kible scale for Scapular movement	Scale for scapular positioning. Clinical measurement	2 years
Categoric evaluation for scapular movement	Video evaluation for normal or dyskinesis of the scapula movement	2 years
Tomographic evaluation	Graft union, graft position and resorption	2 years
Radiographic evaluation	Graft union, graft position and resorption	2 years
Degree of Shoulder Involvement in Sports (DOSIS ) scale	return to sport scale	2 years

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Faculdade de Medicina de Jundiaí

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: September 16, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimated): September 23, 2016

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: Latarjet vs Eden

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No