Clinical Trial: Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: University of Sao Paulo

Current Primary Outcome: Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 2 years ]

Instability score


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ROWE score [ Time Frame: 2 years ]
  • Visual analog scale (VAS) for shoulder pain [ Time Frame: 2 years ]
  • VAS for iliac pain [ Time Frame: 6 weeks ]
  • VAS for iliac pain [ Time Frame: 3 months ]
  • VAS for iliac pain [ Time Frame: 2 years ]
  • Single Assessment Numeric Evaluation (SANE) [ Time Frame: 2 years ]
  • Dislocation recurrence rate [ Time Frame: 2 years ]
  • Rate of complications and reoperations [ Time Frame: 2 years ]
  • Kible scale for Scapular movement [ Time Frame: 2 years ]
    Scale for scapular positioning. Clinical measurement
  • Categoric evaluation for scapular movement [ Time Frame: 2 years ]
    Video evaluation for normal or dyskinesis of the scapula movement
  • Tomographic evaluation [ Time Frame: 2 years ]
    Graft union, graft position and resorption
  • Radiographic evaluation [ Time Frame: 2 years ]
    Graft union, graft position and resorption
  • Degree of Shoulder Involvement in Sports (DOSIS ) scale [ Time Frame: 2 years ]
    return to sport scale


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: September 16, 2016
Date Started: September 2016
Date Completion: January 2022
Last Updated: September 23, 2016
Last Verified: September 2016