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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Hopital de l'Enfant-Jesus:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 22, 2010
Last Updated: December 19, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Dislocations
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014