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Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Hopital de l'Enfant-Jesus
Sponsor:
Information provided by (Responsible Party):
Pelet Stephane, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier:
NCT01111500
First received: April 22, 2010
Last updated: December 19, 2012
Last verified: December 2012

April 22, 2010
December 19, 2012
July 2007
February 2013   (final data collection date for primary outcome measure)
Anatomical healing of the labrum [ Time Frame: 3 months after dislocation ] [ Designated as safety issue: No ]
An MRI with usual cuts in ABER and ADIR positions are performed to demonstrate the anatomical healing of the labrum.
Anatomical healing of the labrum [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
An MRI with usual cuts in ABER and ADIR positions are performed to demonstrate the anatomical healing of the labrum.
Complete list of historical versions of study NCT01111500 on ClinicalTrials.gov Archive Site
  • Decrease in relapse rate [ Time Frame: 3 months after dislocation ] [ Designated as safety issue: No ]
    Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
  • Decrease in relapse rate [ Time Frame: 12 months after dislocation ] [ Designated as safety issue: No ]
    Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
  • Decrease in relapse rate [ Time Frame: 24 months after dislocation ] [ Designated as safety issue: No ]
    Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
  • Decrease in relapse rate [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
  • Decrease in relapse rate [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
  • Decrease in relapse rate [ Time Frame: 24 months after surgery ] [ Designated as safety issue: No ]
    Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
Not Provided
Not Provided
 
Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glenohumeral Joint Dislocation
  • Device: Donjoy ER brace
    Patients will wear an external rotation brace, the Donjoy ER brace, during treatment.
  • Device: Thoraco brachial brace
    Patients will wear an internal rotation brace, a thoraco brachial brace, during treatment.
  • Active Comparator: external rotation immobilization
    Patient will wear an external rotation brace to immobilize the injured arm.
    Intervention: Device: Donjoy ER brace
  • Active Comparator: internal rotation immobilization
    Patient will wear an internal rotation brace to immobilize the injured arm.
    Intervention: Device: Thoraco brachial brace
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
February 2015
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact: Hélène Côté, Res Nurse 1-418-649-0252 ext 3165 helco3@hotmail.com
Contact: Stéphane Pelet, MD, PhD 1-418-649-0252 ext 3165 stephane.pelet.ortho@gmail.com
Canada
 
NCT01111500
PEJ-399
No
Pelet Stephane, Hopital de l'Enfant-Jesus
Hopital de l'Enfant-Jesus
Not Provided
Principal Investigator: Stéphane Pelet, MD, PhD Hôpital Enfant-Jésus
Hopital de l'Enfant-Jesus
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP