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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01720-45 | Other Identifier | ID-RCB number, ANSM |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bankart repair | Experimental | 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 | Immobilization of the shoulder during 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bankart repair | Procedure | Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of occurrence of a recurrence during the follow-up period of 2 years | at 2 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cécile Pougès, Dr | CHRU LILLE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Roger Salengro | Lille | 59000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33705240 | Result | 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. | |
| 40605377 |
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| ID | Term |
|---|---|
| D000070896 | Bankart Lesions |
| D012783 | Shoulder Dislocation |
| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| Immobilization interne rotation | Procedure | Immobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation |
|
| 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 |
| 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. |
| D004204 |
| Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |