Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion

Not Applicable

• Conditions: Glenohumeral Joint Dislocation
• Interventions: Device: Donjoy ER brace; Device: Thoraco brachial brace

• Registration Number: NCT01111500
• Lead Sponsor: Hopital de l'Enfant-Jesus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-23
• Study First Posted: 2010-04-27
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20
• Primary Completion: 2013-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
external rotation immobilization	Donjoy ER brace	Patient will wear an external rotation brace to immobilize the injured arm.
internal rotation immobilization	Thoraco brachial brace	Patient will wear an internal rotation brace to immobilize the injured arm.

Primary Outcome Measures

Name	Time	Method
Anatomical healing of the labrum	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

Name	Time	Method
Decrease in relapse rate	24 months after dislocation	Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position

Trial Locations

Locations (1)

CHA-Pavillon Enfant-Jésus; 🇨🇦 Québec, Quebec, Canada