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Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

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ClinicalTrials.gov Identifier: NCT02913352
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Mauro Gracitelli, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE September 16, 2016
First Posted Date  ICMJE September 23, 2016
Last Update Posted Date October 31, 2017
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 2 years ]
Instability score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Shoulder Dislocation
Intervention  ICMJE
  • Procedure: Latarjet procedure
    Open anterior glenoid bone graft from coracoid process
  • Procedure: Modified Eden-Hybinette
    Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation
Study Arms  ICMJE
  • Active Comparator: Latarjet procedure
    Open Latarjet-Patte procedure. Surgery. Anterior glenoid bone graft from coracoid. Fixation with 2 screws.
    Intervention: Procedure: Latarjet procedure
  • 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.
    Intervention: Procedure: Modified Eden-Hybinette
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mauro EC Gracitelli, PhD +55 11 2661-2486 mgracitelli@gmail.com
Contact: Eduardo A Malavolta, PhD +55 11 2661-2486 eduardomalavolta@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02913352
Other Study ID Numbers  ICMJE Latarjet vs Eden
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mauro Gracitelli, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Sao Paulo
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP