Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization

Not Applicable

Completed

• Conditions: Bankart Lesion
• Interventions: Procedure: Immobilization interne rotation; Procedure: Bankart repair

• Registration Number: NCT03315819
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-27
• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-20
• Status Verified: 2019-02
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immobilization interne rotation	Immobilization interne rotation	Immobilization of the shoulder during 3 weeks
Bankart repair	Bankart repair	Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. The procedure must be performed within 15 days of dislocation.

Primary Outcome Measures

Name	Time	Method
Number of occurrence of a recurrence during the follow-up period of 2 years	at 2 years

Secondary Outcome Measures

Name	Time	Method
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	at 3 months, 6 months, 1 years and 2 years	Auto questionnaire designed to measure the impact of shoulder instability, activity, pain mobility.total point up to 100 : excellent, good, medium, poor
Disabilities of the Arm, Shoulder and Hand (DASH) Score	at 3 months, 6 months, 1 years and 2 years	Auto questionnaire designed to measure the quality of life of patients.
Western Ontario Shoulder Instability (WOSI) Score.	at 3 months, 6 months, 1 years and 2 years	Auto questionnaire designed to measure the impact of shoulder instability on the quality of life of patients. percentage of lifestyle, emotion, physical symptome.
Likert Scale	at 2 years	Overall patient satisfaction
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

Trial Locations

Locations (1)

Hôpital Roger Salengro; 🇫🇷 Lille, France