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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 22, 2010
CompletedFirst Posted
Study publicly available on registry
April 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedDecember 20, 2012
December 1, 2012
5.6 years
April 22, 2010
December 19, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Decrease in relapse rate
3 months after dislocation
Decrease in relapse rate
12 months after dislocation
Decrease in relapse rate
24 months after dislocation
Study Arms (2)
external rotation immobilization
ACTIVE COMPARATORPatient will wear an external rotation brace to immobilize the injured arm.
internal rotation immobilization
ACTIVE COMPARATORPatient will wear an internal rotation brace to immobilize the injured arm.
Interventions
Patients will wear an external rotation brace, the Donjoy ER brace, during treatment.
Patients will wear an internal rotation brace, a thoraco brachial brace, during treatment.
Eligibility Criteria
You may qualify if:
- \> 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHA-Pavillon Enfant-Jésus
Québec, Quebec, G1J 1Z4, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Stéphane Pelet, MD, PhD
Hôpital Enfant-Jésus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Stephane Pelet MD, PhD Orthopedic surgeon
Study Record Dates
First Submitted
April 22, 2010
First Posted
April 27, 2010
Study Start
July 1, 2007
Primary Completion
February 1, 2013
Study Completion
February 1, 2015
Last Updated
December 20, 2012
Record last verified: 2012-12