Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization

Bankart Lesion Clinical Trial

— 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 "

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03315819
• Other study ID #: 2013_30
• Secondary ID: 2013-A01720-45
• Status: Completed
• Phase: N/A
• Start date: March 27, 2014
• Est. completion date: March 26, 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 26, 2019
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Bankart Lesion
• Bankart Lesions

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Hôpital Roger Salengro	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of occurrence of a recurrence during the follow-up period of 2 years		at 2 years
Secondary	Number of recidivism of dislocation with the necessity of reduction by a third person		at 3 months, 6 months, 1 years and 2 years
Secondary	number of episodes of subluxations reported by the patient at the interview		at 3 months, 6 months, 1 years and 2 years
Secondary	Goniometer measurement of the angle in the ankle joint		at 3 months, 6 months, 1 years and 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Likert Scale	Overall patient satisfaction	at 2 years
Secondary	The duration of work stoppage		at 2 years
Secondary	Time lapse - resumption of sports activities and level of sport practiced		At 6 months, 1 years and 2 years