Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion

December 19, 2012 updated by: Pelet Stephane, Hopital de l'Enfant-Jesus

First Time Anterior Glenohumeral Joint Dislocation With a Bankart Lesion in Young Patients: Which Type of Immobilization Should be Chosen? A Prospective Randomized Study

Glenohumeral joint dislocation is the most frequent joint dislocation with a prevalence of 1.7/100000 citizens/year. It is treated by reduction, under sedation or anaesthesia, followed by an immobilization of the arm.

The purpose of the study is to evaluate the healing of the labrum in first time anterior glenohumeral joint dislocation with a Bankart lesion in young patients by comparing an external rotation brace to an internal rotation brace to immobilize the injured arm.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

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 Contact

  • Name: Hélène Côté, Res Nurse
  • Phone Number: 3165 1-418-649-0252
  • Email: helco3@hotmail.com

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1J 1Z4
        • Recruiting
        • CHA-Pavillon Enfant-Jésus

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • > 18 years old
  • < 40 years old
  • anterior glenohumeral joint dislocation proved by radiography
  • dislocation needing a reduction manoeuvre
  • home close to evaluation site for 24 months follow-up visits
  • signed consent form

Exclusion Criteria:

  • associated fracture
  • Hill-Sachs lesion = or > than 30%
  • neurovascular deficit
  • hypermobility
  • pre-existing instability of the injured shoulder
  • systemic neurological disease
  • allergy to gadolinium
  • functional sequel to the shoulder due to previous injury
  • incapacitated adult patient
  • minor patient
  • home far from evaluation site
  • refusal to sign the consent form

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: external rotation immobilization
Patient will wear an external rotation brace to immobilize the injured arm.
Device: Donjoy ER brace
Patients will wear an external rotation brace, the Donjoy ER brace, during treatment.
Active Comparator: internal rotation immobilization
Patient will wear an internal rotation brace to immobilize the injured arm.
Device: Thoraco brachial brace
Patients will wear an internal rotation brace, a thoraco brachial brace, during treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomical healing of the labrum
Time Frame: 3 months after dislocation
An MRI with usual cuts in ABER and ADIR positions are performed to demonstrate the anatomical healing of the labrum.
3 months after dislocation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in relapse rate
Time Frame: 3 months after dislocation
Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
3 months after dislocation
Decrease in relapse rate
Time Frame: 12 months after dislocation
Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
12 months after dislocation
Decrease in relapse rate
Time Frame: 24 months after dislocation
Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
24 months after dislocation

Collaborators and Investigators

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

Sponsor

Hopital de l'Enfant-Jesus

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

July 1, 2007

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

April 22, 2010

First Submitted That Met QC Criteria

April 23, 2010

First Posted (Estimate)

April 27, 2010

Study Record Updates

Last Update Posted (Estimate)

December 20, 2012

Last Update Submitted That Met QC Criteria

December 19, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEJ-399

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.

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