Glenohumeral Joint DislocationNCT01111500
Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion
A study testing Donjoy ER brace and Thoraco brachial brace in people with Glenohumeral Joint Dislocation, run by Hopital de l'Enfant-Jesus at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Glenohumeral Joint Dislocation
- What is being tested?
- Donjoy ER brace and Thoraco brachial brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2007to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- > 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
Who cannot join
- associated fracture
- Hill-Sachs lesion = or > than 30%
- neurovascular deficit
- hypermobility
- pre-existing instability of the injured shoulder
- systemic neurological disease
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHA-Pavillon Enfant-Jésus
Québec, Quebec, G1J 1Z4
Stéphane Pelet, MD, PhD, 1-418-649-0252 ext. 3165, stephane.pelet.ortho@gmail.com
About this study
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
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.
- Conditions
- Glenohumeral Joint Dislocation
- Being tested
- Donjoy ER brace, Thoraco brachial brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donjoy ER braceDevice
Patients will wear an external rotation brace, the Donjoy ER brace, during treatment.
Thoraco brachial braceDevice
Patients will wear an internal rotation brace, a thoraco brachial brace, during treatment.
| Study group | Role | What they receive |
|---|---|---|
| external rotation immobilization | Active comparator | Patient will wear an external rotation brace to immobilize the injured arm. Receives: Device: Donjoy ER brace |
| internal rotation immobilization | Active comparator | Patient will wear an internal rotation brace to immobilize the injured arm. Receives: Device: Thoraco brachial brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after dislocation
Secondary outcomes (3)
Decrease in relapse rate
Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
Measured: 3 months after dislocation
Decrease in relapse rate
Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
Measured: 12 months after dislocation
Decrease in relapse rate
Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
Measured: 24 months after dislocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startJul 2007
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glenohumeral Joint DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital de l'Enfant-Jesus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelet Stephane, Hopital de l'Enfant-Jesus
- Investigators
- Stéphane Pelet, MD, PhD, Principal investigator, Hôpital Enfant-Jésus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111500
- Sponsor's protocol ID
- PEJ-399
- Status last verified
- Dec 2012
- First submitted
- 22 Apr 2010
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01111500
- Acronym / sponsor ID
- PEJ-399
- Conditions
- Glenohumeral Joint Dislocation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hopital de l'Enfant-JesusUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| external rotation immobilization | Active comparator | Device: Donjoy ER bracePatient will wear an external rotation brace to immobilize the injured arm. |
| internal rotation immobilization | Active comparator | Device: Thoraco brachial bracePatient will wear an internal rotation brace to immobilize the injured arm. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (12 listed)
- associated fracture
- Hill-Sachs lesion = or > than 30%
- neurovascular deficit
- hypermobility
- pre-existing instability of the injured shoulder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donjoy ER bracePatients will wear an external rotation brace, the Donjoy ER brace, during treatment. | Device | external rotation immobilization |
| Thoraco brachial bracePatients will wear an internal rotation brace, a thoraco brachial brace, during treatment. | Device | internal rotation immobilization |
Primary outcome
Anatomical healing of the labrum
Time frame: 3 months after dislocation
An MRI with usual cuts in ABER and ADIR positions are performed to demonstrate the anatomical healing of the labrum.
3 secondary outcomes
Decrease in relapse rate
Time frame: 3 months after dislocation
Decrease in relapse rate
Time frame: 12 months after dislocation
Decrease in relapse rate
Time frame: 24 months after dislocation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Pelet, MD, PhD principal investigator
Hôpital Enfant-Jésus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donjoy ER brace and Thoraco brachial brace in people with Glenohumeral Joint Dislocation, run by Hopital de l'Enfant-Jesus at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hélène Côté, Res Nurse (1-418-649-0252 ext. 3165, helco3@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical healing of the labrum (time frame: 3 months after dislocation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.