Health TrialsbyHealthPanel

Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation

ConditionShoulder Dislocation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of Sao Paulo

About this trial

Randomized clinical trial, parallel 1:1, comparing Latarjet to Modified Eden-Hybinette (iliac bone crest + capsular repair) for recurrent traumatic anterior glenohumeral dislocation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

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.;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Latarjet procedure

    Procedure/Surgery

    Open anterior glenoid bone graft from coracoid process

  • Modified Eden-Hybinette

    Procedure/Surgery

    Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Latarjet procedureActive comparator 1 intervention
Group B: Modified Eden-Hybinette ProcedureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Western Ontario Shoulder Instability Index (WOSI)

Instability score

Time frame
2 years

Secondary outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo

Lead sponsor

Faculdade de Medicina de Jundiaí

Collaborator

Source ClinicalTrials.gov
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