Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion
This study is currently recruiting participants.
Verified December 2012 by Hopital de l'Enfant-Jesus
Sponsor:
Hopital de l'Enfant-Jesus
Information provided by (Responsible Party):
Pelet Stephane, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier:
NCT01111500
First received: April 22, 2010
Last updated: December 19, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Glenohumeral Joint Dislocation |
Device: Donjoy ER brace Device: Thoraco brachial brace |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hopital de l'Enfant-Jesus:
Primary Outcome Measures:
- Anatomical healing of the labrum [ Time Frame: 3 months after dislocation ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months after dislocation ] [ Designated as safety issue: No ]Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
- Decrease in relapse rate [ Time Frame: 12 months after dislocation ] [ Designated as safety issue: No ]Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
- Decrease in relapse rate [ Time Frame: 24 months after dislocation ] [ Designated as safety issue: No ]Evidence of a significant decrease in the relapse rate when the arm is immobilized in an external rotation position
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: external rotation immobilization
Patient will wear an external rotation brace to immobilize the injured arm.
|
Device: Donjoy ER brace
Patients will wear an external rotation brace, the Donjoy ER brace, during treatment.
|
|
Active Comparator: internal rotation immobilization
Patient will wear an internal rotation brace to immobilize the injured arm.
|
Device: Thoraco brachial brace
Patients will wear an internal rotation brace, a thoraco brachial brace, during treatment.
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111500
Contacts
| Contact: Hélène Côté, Res Nurse | 1-418-649-0252 ext 3165 | helco3@hotmail.com |
| Contact: Stéphane Pelet, MD, PhD | 1-418-649-0252 ext 3165 | stephane.pelet.ortho@gmail.com |
Locations
| Canada, Quebec | |
| CHA-Pavillon Enfant-Jésus | Recruiting |
| Québec, Quebec, Canada, G1J 1Z4 | |
| Contact: Stéphane Pelet, MD, PhD 1-418-649-0252 ext 3165 stephane.pelet.ortho@gmail.com | |
Sponsors and Collaborators
Hopital de l'Enfant-Jesus
Investigators
| Principal Investigator: | Stéphane Pelet, MD, PhD | Hôpital Enfant-Jésus |
More Information
No publications provided
| Responsible Party: | Pelet Stephane, Dr Stephane Pelet MD, PhD Orthopedic surgeon, Hopital de l'Enfant-Jesus |
| ClinicalTrials.gov Identifier: | NCT01111500 History of Changes |
| Other Study ID Numbers: | PEJ-399 |
| Study First Received: | April 22, 2010 |
| Last Updated: | December 19, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Dislocations Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013