Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion

Glenohumeral Joint Dislocation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01111500
• Other study ID #: PEJ-399
• Status: Recruiting
• Phase: N/A
• First received: April 22, 2010
• Last updated: December 19, 2012
• Start date: July 2007
• Est. completion date: February 2015

Study information

• Verified date: December 2012
• Source: Hopital de l'Enfant-Jesus
• Contact: Hélène Côté, Res Nurse
• Phone: 1-418-649-0252
• Email: helco3[@]hotmail.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2015
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dislocations
• Glenohumeral Joint Dislocation

Intervention

Device:
• Donjoy ER brace
Patients will wear an external rotation brace, the Donjoy ER brace, during treatment.
• Thoraco brachial brace
Patients will wear an internal rotation brace, a thoraco brachial brace, during treatment.

Locations

Country	Name	City	State
Canada	CHA-Pavillon Enfant-Jésus	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital de l'Enfant-Jesus

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical healing of the labrum	An MRI with usual cuts in ABER and ADIR positions are performed to demonstrate the anatomical healing of the labrum.	3 months after dislocation	No
Secondary	Decrease in relapse rate	Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position	3 months after dislocation	No
Secondary	Decrease in relapse rate	Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position	12 months after dislocation	No
Secondary	Decrease in relapse rate	Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position	24 months after dislocation	No