Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization (BANKART)

University Hospital, Lille

Status: Completed

Conditions: Bankart Lesion

Treatments: Procedure: Bankart repair; Procedure: Immobilization interne rotation

Study type: Interventional

Funder types: Other

Identifiers

NCT03315819

2013_30

2013-A01720-45 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Bankart repair

Experimental group

Description:

Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. The procedure must be performed within 15 days of dislocation.

Treatment:

Procedure: Bankart repair

Immobilization interne rotation

Active Comparator group

Description:

Immobilization of the shoulder during 3 weeks

Treatment:

Procedure: Immobilization interne rotation