Back to results

Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion

Primary Purpose

Glenohumeral Joint Dislocation

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Donjoy ER brace

Thoraco brachial brace

About this trial

This is an interventional treatment trial for Glenohumeral Joint Dislocation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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

Sites / Locations

CHA-Pavillon Enfant-JésusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

external rotation immobilization

internal rotation immobilization

Arm Description

Patient will wear an external rotation brace to immobilize the injured arm.

Patient will wear an internal rotation brace to immobilize the injured arm.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Decrease in relapse rate

Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position

Decrease in relapse rate

Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position

Decrease in relapse rate

Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position

Full Information

NCT ID

NCT01111500

First Posted

April 22, 2010

Last Updated

December 19, 2012

Sponsor

Hopital de l'Enfant-Jesus

1. Study Identification

Unique Protocol Identification Number

NCT01111500

Brief Title

Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Unknown status

Study Start Date

July 2007 (undefined)

Primary Completion Date

February 2013 (Anticipated)

Study Completion Date

February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hopital de l'Enfant-Jesus

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glenohumeral Joint Dislocation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

external rotation immobilization

Arm Type

Active Comparator

Arm Description

Patient will wear an external rotation brace to immobilize the injured arm.

Arm Title

internal rotation immobilization

Arm Type

Active Comparator

Arm Description

Patient will wear an internal rotation brace to immobilize the injured arm.

Intervention Type

Device

Intervention Name(s)

Donjoy ER brace

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Thoraco brachial brace

Intervention Description

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

Primary Outcome Measure Information:

Title

Anatomical healing of the labrum

Description

An MRI with usual cuts in ABER and ADIR positions are performed to demonstrate the anatomical healing of the labrum.

Time Frame

3 months after dislocation

Secondary Outcome Measure Information:

Title

Decrease in relapse rate

Description

Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position

Time Frame

3 months after dislocation

Title

Decrease in relapse rate

Description

Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position

Time Frame

12 months after dislocation

Title

Decrease in relapse rate

Description

Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position

Time Frame

24 months after dislocation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hélène Côté, Res Nurse

Phone

1-418-649-0252

Ext

3165

helco3@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Stéphane Pelet, MD, PhD

Phone

1-418-649-0252

Ext

3165

stephane.pelet.ortho@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stéphane Pelet, MD, PhD

Organizational Affiliation

Hôpital Enfant-Jésus

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHA-Pavillon Enfant-Jésus

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stéphane Pelet, MD, PhD

Phone

1-418-649-0252

Ext

3165

stephane.pelet.ortho@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion

We'll reach out to this number within 24 hrs