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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02913352
Other study ID # Latarjet vs Eden
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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