Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

Shoulder Dislocation Clinical Trial

Official title:

Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02913352
• Other study ID #: Latarjet vs Eden
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2016
• Last updated: October 29, 2017
• Start date: September 2016
• Est. completion date: January 2022

Study information

• Verified date: October 2017
• Source: University of Sao Paulo
• Contact: Mauro EC Gracitelli, PhD
• Phone: +55 11 2661-2486
• Email: mgracitelli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

Procedure:
• Latarjet procedure
Open anterior glenoid bone graft from coracoid process
• Modified Eden-Hybinette
Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation

Locations

Country	Name	City	State
Brazil	Instituto de Ortopedia e Traumatologia	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario Shoulder Instability Index (WOSI)	Instability score	2 years
Secondary	ROWE score		2 years
Secondary	Visual analog scale (VAS) for shoulder pain		2 years
Secondary	VAS for iliac pain		6 weeks
Secondary	VAS for iliac pain		3 months
Secondary	VAS for iliac pain		2 years
Secondary	Single Assessment Numeric Evaluation (SANE)		2 years
Secondary	Dislocation recurrence rate		2 years
Secondary	Rate of complications and reoperations		2 years
Secondary	Kible scale for Scapular movement	Scale for scapular positioning. Clinical measurement	2 years
Secondary	Categoric evaluation for scapular movement	Video evaluation for normal or dyskinesis of the scapula movement	2 years
Secondary	Tomographic evaluation	Graft union, graft position and resorption	2 years
Secondary	Radiographic evaluation	Graft union, graft position and resorption	2 years
Secondary	Degree of Shoulder Involvement in Sports (DOSIS ) scale	return to sport scale	2 years