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

December 2, 2019 updated by: University Hospital, Lille

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59000
        • Hôpital Roger Salengro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bankart repair
Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique. The procedure must be performed within 15 days of dislocation.
Procedure: Bankart repair
Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique.
ACTIVE_COMPARATOR: Immobilization interne rotation
Immobilization of the shoulder during 3 weeks
Procedure: Immobilization interne rotation
Immobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of occurrence of a recurrence during the follow-up period of 2 years
Time Frame: at 2 years
at 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
at 3 months, 6 months, 1 years and 2 years
Walch Duplay Score
Time Frame: at 3 months, 6 months, 1 years and 2 years
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
Time Frame: at 3 months, 6 months, 1 years and 2 years
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.
Time Frame: at 3 months, 6 months, 1 years and 2 years
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
Time Frame: at 2 years
Overall patient satisfaction
at 2 years
The duration of work stoppage
Time Frame: at 2 years
at 2 years
Time lapse - resumption of sports activities and level of sport practiced
Time Frame: At 6 months, 1 years and 2 years
At 6 months, 1 years and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Cécile Pougès, Dr, CHRU Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 27, 2014

Primary Completion (ACTUAL)

March 26, 2019

Study Completion (ACTUAL)

March 26, 2019

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (ACTUAL)

October 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2019

Last Update Submitted That Met QC Criteria

December 2, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013_30
  • 2013-A01720-45 (OTHER: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bankart Lesion

Clinical Trials on Bankart repair

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe