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Trial record 2 of 14 for:    Recruiting, Not yet recruiting, Available Studies | "Shoulder Dislocation"

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

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.

Condition or disease Intervention/treatment Phase
Shoulder Dislocation Procedure: Latarjet procedure Procedure: Modified Eden-Hybinette Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette
Study Start Date : September 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 2 years ]
    Instability score


Secondary Outcome Measures :
  1. ROWE score [ Time Frame: 2 years ]
  2. Visual analog scale (VAS) for shoulder pain [ Time Frame: 2 years ]
  3. VAS for iliac pain [ Time Frame: 6 weeks ]
  4. VAS for iliac pain [ Time Frame: 3 months ]
  5. VAS for iliac pain [ Time Frame: 2 years ]
  6. Single Assessment Numeric Evaluation (SANE) [ Time Frame: 2 years ]
  7. Dislocation recurrence rate [ Time Frame: 2 years ]
  8. Rate of complications and reoperations [ Time Frame: 2 years ]
  9. Kible scale for Scapular movement [ Time Frame: 2 years ]
    Scale for scapular positioning. Clinical measurement

  10. Categoric evaluation for scapular movement [ Time Frame: 2 years ]
    Video evaluation for normal or dyskinesis of the scapula movement

  11. Tomographic evaluation [ Time Frame: 2 years ]
    Graft union, graft position and resorption

  12. Radiographic evaluation [ Time Frame: 2 years ]
    Graft union, graft position and resorption

  13. Degree of Shoulder Involvement in Sports (DOSIS ) scale [ Time Frame: 2 years ]
    return to sport scale



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913352


Contacts
Contact: Mauro EC Gracitelli, PhD +55 11 2661-2486 mgracitelli@gmail.com
Contact: Eduardo A Malavolta, PhD +55 11 2661-2486 eduardomalavolta@gmail.com

Locations
Brazil
Instituto de Ortopedia e Traumatologia Recruiting
São Paulo, SP, Brazil, 05403-010
Principal Investigator: Mauro EC Gracitelli, MD         
Sponsors and Collaborators
University of Sao Paulo

Responsible Party: Mauro Gracitelli, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02913352     History of Changes
Other Study ID Numbers: Latarjet vs Eden
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Joint Dislocations
Shoulder Dislocation
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries