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Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Pelet Stephane, Hopital de l'Enfant-Jesus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01111500
First Posted: April 27, 2010
Last Update Posted: December 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pelet Stephane, Hopital de l'Enfant-Jesus
  Purpose

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.


Condition Intervention
Glenohumeral Joint Dislocation Device: Donjoy ER brace Device: Thoraco brachial brace

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First Time Anterior Glenohumeral Joint Dislocation With a Bankart Lesion in Young Patients: Which Type of Immobilization Should be Chosen? A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Pelet Stephane, Hopital de l'Enfant-Jesus:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

  • 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

  • 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


Estimated Enrollment: 50
Study Start Date: July 2007
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111500


Contacts
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

Locations
Canada, Quebec
CHA-Pavillon Enfant-Jésus Recruiting
Québec, Quebec, Canada, G1J 1Z4
Contact: Stéphane Pelet, MD, PhD    1-418-649-0252 ext 3165    stephane.pelet.ortho@gmail.com   
Sponsors and Collaborators
Hopital de l'Enfant-Jesus
Investigators
Principal Investigator: Stéphane Pelet, MD, PhD Hôpital Enfant-Jésus
  More Information

Responsible Party: Pelet Stephane, Dr Stephane Pelet MD, PhD Orthopedic surgeon, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier: NCT01111500     History of Changes
Other Study ID Numbers: PEJ-399
First Submitted: April 22, 2010
First Posted: April 27, 2010
Last Update Posted: December 20, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Joint Dislocations
Bankart Lesions
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Fractures
Fractures, Bone
Shoulder Injuries