An interventional study of Bankart repair and Immobilization interne rotation in Bankart Lesion, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Treatment
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
105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 71 interventional studies indexed under Shoulder Dislocation.
Browse Shoulder Dislocation studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
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Exclusion Criteria:
Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. The procedure must be performed within 15 days of dislocation.
Procedure: Bankart repair
Immobilization of the shoulder during 3 weeks
Procedure: Immobilization interne rotation
Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique.
Immobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation
Number of occurrence of a recurrence during the follow-up period of 2 years
Time frame: at 2 years
Number of recidivism of dislocation with the necessity of reduction by a third person
Time frame: at 3 months, 6 months, 1 years and 2 years
number of episodes of subluxations reported by the patient at the interview
Time frame: at 3 months, 6 months, 1 years and 2 years
Goniometer measurement of the angle in the ankle joint
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: at 3 months, 6 months, 1 years and 2 years
Likert Scale
Overall patient satisfaction
Time frame: at 2 years
The duration of work stoppage
Time frame: at 2 years
Time lapse - resumption of sports activities and level of sport practiced
Time frame: At 6 months, 1 years and 2 years
Ran from Mar 2014 to primary completion in Mar 2019, 59 months.
Of 39 non-industry interventional studies with no phase under Shoulder Dislocation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's 59 months is above that.
Counting every sponsor, half of 39 studies reached it within 22 months; a quarter within 11 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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