Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization

Study Overview
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Brief Summary
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The risk of recurrence and chronic instability after an initial episode of anterior glenohumeral dislocation is high, the risk is higher the younger the patient is. Most patients with recurrences develop this instability during the first 2 years. Several studies have shown that an initial arthroscopic surgical treatment (Bankart intervention) decreased the risk of recurrence and therefore of chronic instability, but this attitude is not usual in France and none randomized study comparing intervention of arthroscopic Bankart and immobilization was published by a French team. The primary objective was to evaluate at 2 years the efficacy on the rate of recurrent instability of the first-line arthroscopic repair of prior capsulo-labral lesions compared to conservative treatment by immobilization for patients under 25 years having an initial episode of anterior glenohumeral dislocation Material and method : We conducted a randomized controlled, open-label, parallel-group study (conservative treatment group by immobilizing VS surgical treatment group) in patients aged 18 to 25 with anterior glenohumeral primo luxation. Patients were clinically reassessed at 2 years with functional scores (WOSI, DuplayWalch, DASH), mobility and instability recurrence. Hypothesis: reduction of the recurrence rate in the surgically treated group

Official Title
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First Episode of Anterior Glenohumeral Dislocation in Adult Patients Under 25 Years of Age: Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization 

Conditions
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Bankart Lesion

Intervention / Treatment
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* Procedure: Bankart repair
* Procedure: Immobilization interne rotation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with inclusive on the day of dislocation. First episode of anterior glenohumeral dislocation without associated humeral fracture confirmed by a standard radiograph. Exclusion Criteria: Dislocation without trauma, in a context of hyper laxity with a Beighton score ≥4 / 97.8. In these patients post-dislocation MRI was performed in the Robinson study, which found no capsulo-labral lesion. Bone glenoid defect> 25% at the scanner (Bony Bankart). Delay greater than 15 days between luxation and surgical treatment Against indication to anesthesia Pregnant or nursing women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bankart repair<br>Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. The procedure must be performed within 15 days of dislocation. | Procedure: Bankart repair<br>* Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique.<br>|
| Active Comparator: Immobilization interne rotation<br>Immobilization of the shoulder during 3 weeks | Procedure: Immobilization interne rotation<br>* Immobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of occurrence of a recurrence during the follow-up period of 2 years |  | at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of recidivism of dislocation with the necessity of reduction by a third person |  | at 3 months, 6 months, 1 years and 2 years | 
| number of episodes of subluxations reported by the patient at the interview |  | at 3 months, 6 months, 1 years and 2 years | 
| Goniometer measurement of the angle in the ankle joint |  | at 3 months, 6 months, 1 years and 2 years | 
| Walch Duplay Score | Auto questionnaire designed to measure the impact of shoulder instability, activity, pain mobility.total point up to 100 : excellent, good, medium, poor | at 3 months, 6 months, 1 years and 2 years | 
| Disabilities of the Arm, Shoulder and Hand (DASH) Score | Auto questionnaire designed to measure the quality of life of patients. | at 3 months, 6 months, 1 years and 2 years | 
| Western Ontario Shoulder Instability (WOSI) Score. | Auto questionnaire designed to measure the impact of shoulder instability on the quality of life of patients. percentage of lifestyle, emotion, physical symptome. | at 3 months, 6 months, 1 years and 2 years | 
| Likert Scale | Overall patient satisfaction | at 2 years | 
| The duration of work stoppage |  | at 2 years | 
| Time lapse - resumption of sports activities and level of sport practiced |  | At 6 months, 1 years and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glenohumeral dislocation, Arthroscopic, capsular lesions