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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01111500

Enrollment

Registered

2010-04-27

Start date

2007-07-31

Completion date

2015-02-28

Last updated

2012-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glenohumeral Joint Dislocation

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.

Interventions

DEVICEDonjoy ER brace

Patients will wear an external rotation brace, the Donjoy ER brace, during treatment.

DEVICEThoraco brachial brace

Patients will wear an internal rotation brace, a thoraco brachial brace, during treatment.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Decrease in relapse rate	3 months after dislocation	Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position

Countries

Canada

Contacts

Primary ContactHélène Côté, Res Nurse

helco3@hotmail.com1-418-649-0252

Backup ContactStéphane Pelet, MD, PhD

stephane.pelet.ortho@gmail.com1-418-649-0252

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026