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Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization (BANKART)

Primary Purpose

Bankart Lesion

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Bankart repair

Immobilization interne rotation

About this trial

This is an interventional treatment trial for Bankart Lesion focused on measuring glenohumeral dislocation, Arthroscopic, capsular lesions

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Roger Salengro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bankart repair

Immobilization interne rotation

Arm Description

Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. The procedure must be performed within 15 days of dislocation.

Immobilization of the shoulder during 3 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of recidivism of dislocation with the necessity of reduction by a third person

number of episodes of subluxations reported by the patient at the interview

Goniometer measurement of the angle in the ankle joint

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

Disabilities of the Arm, Shoulder and Hand (DASH) Score

Auto questionnaire designed to measure the quality of life of patients.

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.

Likert Scale

Overall patient satisfaction

The duration of work stoppage

Time lapse - resumption of sports activities and level of sport practiced

Full Information

NCT ID

NCT03315819

First Posted

October 16, 2017

Last Updated

December 2, 2019

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT03315819

Brief Title

Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization

Acronym

BANKART

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

March 27, 2014 (Actual)

Primary Completion Date

March 26, 2019 (Actual)

Study Completion Date

March 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bankart Lesion

Keywords

glenohumeral dislocation, Arthroscopic, capsular lesions

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bankart repair

Arm Type

Experimental

Arm Description

Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. The procedure must be performed within 15 days of dislocation.

Arm Title

Immobilization interne rotation

Arm Type

Active Comparator

Arm Description

Immobilization of the shoulder during 3 weeks

Intervention Type

Procedure

Intervention Name(s)

Bankart repair

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Immobilization interne rotation

Intervention Description

Immobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation

Primary Outcome Measure Information:

Title

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

Time Frame

at 2 years

Secondary Outcome Measure Information:

Title

Number of recidivism of dislocation with the necessity of reduction by a third person

Time Frame