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Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

Primary Purpose

Shoulder Dislocation

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Latarjet procedure
Modified Eden-Hybinette
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Instituto de Ortopedia e TraumatologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Latarjet procedure

Modified Eden-Hybinette Procedure

Arm Description

Open Latarjet-Patte procedure. Surgery. Anterior glenoid bone graft from coracoid. Fixation with 2 screws.

Surgery. Modified Eden-Hybinette surgery, with capsular repair on the iliac bone Anterior glenoid bone graft from iliac bone. Fixation with 2 screws.

Outcomes

Primary Outcome Measures

Western Ontario Shoulder Instability Index (WOSI)
Instability score

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2016
Last Updated
October 29, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02913352
Brief Title
Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation
Official Title
Randomized Trial for the Treatment of Recurrent Anterior Dislocation of the Shoulder: Latarjet Versus Modified Eden-Hybinette
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Latarjet procedure
Arm Type
Active Comparator
Arm Description
Open Latarjet-Patte procedure. Surgery. Anterior glenoid bone graft from coracoid. Fixation with 2 screws.
Arm Title
Modified Eden-Hybinette Procedure
Arm Type
Experimental
Arm Description
Surgery. Modified Eden-Hybinette surgery, with capsular repair on the iliac bone Anterior glenoid bone graft from iliac bone. Fixation with 2 screws.
Intervention Type
Procedure
Intervention Name(s)
Latarjet procedure
Intervention Description
Open anterior glenoid bone graft from coracoid process
Intervention Type
Procedure
Intervention Name(s)
Modified Eden-Hybinette
Intervention Description
Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation
Primary Outcome Measure Information:
Title
Western Ontario Shoulder Instability Index (WOSI)
Description
Instability score
Time Frame
2 years
Secondary Outcome Measure Information:
Title
ROWE score
Time Frame
2 years
Title
Visual analog scale (VAS) for shoulder pain
Time Frame
2 years
Title
VAS for iliac pain
Time Frame
6 weeks
Title
VAS for iliac pain
Time Frame
3 months
Title
VAS for iliac pain
Time Frame
2 years
Title
Single Assessment Numeric Evaluation (SANE)
Time Frame
2 years
Title
Dislocation recurrence rate
Time Frame
2 years
Title
Rate of complications and reoperations
Time Frame
2 years
Title
Kible scale for Scapular movement
Description
Scale for scapular positioning. Clinical measurement
Time Frame
2 years
Title
Categoric evaluation for scapular movement
Description
Video evaluation for normal or dyskinesis of the scapula movement
Time Frame
2 years
Title
Tomographic evaluation
Description
Graft union, graft position and resorption
Time Frame
2 years
Title
Radiographic evaluation
Description
Graft union, graft position and resorption
Time Frame
2 years
Title
Degree of Shoulder Involvement in Sports (DOSIS ) scale
Description
return to sport scale
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mauro EC Gracitelli, PhD
Phone
+55 11 2661-2486
Email
mgracitelli@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo A Malavolta, PhD
Phone
+55 11 2661-2486
Email
eduardomalavolta@gmail.com
Facility Information:
Facility Name
Instituto de Ortopedia e Traumatologia
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro EC Gracitelli, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

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