Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization
NCT ID: NCT03315819
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2014-03-27
2019-03-26
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bankart repair
Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. The procedure must be performed within 15 days of dislocation.
Bankart repair
Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique.
Immobilization interne rotation
Immobilization of the shoulder during 3 weeks
Immobilization interne rotation
Immobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation
Interventions
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Bankart repair
Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique.
Immobilization interne rotation
Immobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation
Eligibility Criteria
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Inclusion Criteria
* First episode of anterior glenohumeral dislocation without associated humeral fracture confirmed by a standard radiograph.
Exclusion Criteria
* 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
18 Years
25 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Cécile Pougès, Dr
Role: PRINCIPAL_INVESTIGATOR
CHRU LILLE
Locations
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Hôpital Roger Salengro
Lille, , France
Countries
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References
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Pouges C, Hardy A, Vervoort T, Amouyel T, Duriez P, Lalanne C, Szymanski C, Deken V, Chantelot C, Upex P, Maynou C. Arthroscopic Bankart Repair Versus Immobilization for First Episode of Anterior Shoulder Dislocation Before the Age of 25: A Randomized Controlled Trial. Am J Sports Med. 2021 Apr;49(5):1166-1174. doi: 10.1177/0363546521996381. Epub 2021 Mar 11.
Pouges C, Boutry M, Maynou C, Chantelot C, Vervoort T, Amouyel T, Lalanne C, Malandri-Ghipponi P. Arthroscopic Bankart Repair Versus Immobilization for a First Episode of an Anterior Shoulder Dislocation Before the Age of 25 Years: A Randomized Controlled Trial With 6-Year Follow-up. Am J Sports Med. 2025 Aug;53(10):2289-2297. doi: 10.1177/03635465251350151. Epub 2025 Jul 2.
Other Identifiers
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2013-A01720-45
Identifier Type: OTHER
Identifier Source: secondary_id
2013_30
Identifier Type: -
Identifier Source: org_study_id