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Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization

First Episode of Anterior Glenohumeral Dislocation in Adult Patients Under 25 Years of Age: Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03315819
Acronym
BANKART
Enrollment
40
Registered
2017-10-20
Start date
2014-03-27
Completion date
2019-03-26
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bankart Lesion

Keywords

glenohumeral dislocation, Arthroscopic, capsular lesions

Brief summary

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

Interventions

Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique.

PROCEDUREImmobilization interne rotation

Immobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of occurrence of a recurrence during the follow-up period of 2 yearsat 2 years

Secondary

MeasureTime frameDescription
number of episodes of subluxations reported by the patient at the interviewat 3 months, 6 months, 1 years and 2 years
Goniometer measurement of the angle in the ankle jointat 3 months, 6 months, 1 years and 2 years
Walch Duplay Scoreat 3 months, 6 months, 1 years and 2 yearsAuto questionnaire designed to measure the impact of shoulder instability, activity, pain mobility.total point up to 100 : excellent, good, medium, poor
Disabilities of the Arm, Shoulder and Hand (DASH) Scoreat 3 months, 6 months, 1 years and 2 yearsAuto questionnaire designed to measure the quality of life of patients.
Number of recidivism of dislocation with the necessity of reduction by a third personat 3 months, 6 months, 1 years and 2 years
Likert Scaleat 2 yearsOverall patient satisfaction
The duration of work stoppageat 2 years
Time lapse - resumption of sports activities and level of sport practicedAt 6 months, 1 years and 2 years
Western Ontario Shoulder Instability (WOSI) Score.at 3 months, 6 months, 1 years and 2 yearsAuto questionnaire designed to measure the impact of shoulder instability on the quality of life of patients. percentage of lifestyle, emotion, physical symptome.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026