First Episode of Anterior Glenohumeral Dislocation in Adult Patients Under 25 Years of Age: Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization "
| Registry | NCT03315819, acronym BANKART |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 40 (Actual) |
| Sponsor | University Hospital, Lille (Other) |
| Conditions | Bankart Lesion |
| Interventions | Bankart repair, Immobilization interne rotation (Procedure) |
| Dates | start 2014-03-27, primary completion 2019-03-26, completion 2019-03-26, first posted 2017-10-20, last updated 2025-12-22 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Bankart Lesion All trials of Bankart repair All trials of Immobilization interne rotation
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Bankart repair | Experimental | Procedure: Bankart repair | Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. The procedure must be performed within 15 days of dislocation. |
| Immobilization interne rotation | Active comparator | Procedure: Immobilization interne rotation | Immobilization of the shoulder during 3 weeks |
Sex: All, ages: 18 Years to 25 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hôpital Roger Salengro | Lille | France |