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Procedure
Latarjet Procedure vs Anatomic Glenoid Reconstruction for Shoulder Dislocation
N/A
Recruiting
Led By Ivan Wong, MD
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two surgeries for stabilizing shoulders that frequently dislocate due to bone loss. One method moves a piece of bone and tendon, while the other uses a donor bone graft. The goal is to see which method is safer and more effective.
Who is the study for?
This trial is for individuals who have experienced one or more anterior shoulder dislocations and show over 20% bone loss on a pre-operative CT scan. It's not suitable for those with posterior or multidirectional instability, massive rotator cuff tears, substance abuse history, or inability to consent or accept random treatment assignment.
What is being tested?
The study compares two surgical methods for treating recurrent shoulder dislocation due to bone loss: Latarjet procedure (coracoid transfer) versus Anatomic Glenoid Reconstruction using distal tibia allograft with Bankart repair. The goal is to assess which surgery offers better clinical and radiographic outcomes post-operation.
What are the potential side effects?
Potential side effects of the surgeries may include pain, stiffness in the shoulder joint, infection risk at the surgical site, nerve damage around the operated area, and complications related to grafting such as graft failure or arthritis development.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 and 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complication reporting
Secondary study objectives
American Shoulder and Elbow Surgeon (ASES) Assessment Form
EQ5D-5L
Radiographic measure - glenoid size
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Anatomic Glenoid ReconstructionExperimental Treatment1 Intervention
An allograft will be used for the patients in this group, inserted through a new portal and fixed to the anterior rim of the glenoid to recreate the size of the glenoid.
Group II: LatarjetActive Control1 Intervention
The Latarjet involves the use of a auto-graft to be fixated to the anterior portion of the glenoid to recreate the size of the glenoid.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The Latarjet procedure and Anatomic Glenoid Reconstruction (AGR) are surgical treatments designed to address recurrent shoulder dislocations by reconstructing the glenoid, the socket part of the shoulder joint. The Latarjet procedure involves transferring a piece of bone with an attached tendon from the shoulder blade to the front of the glenoid, which increases the glenoid's surface area and provides a physical block to prevent dislocation.
AGR, on the other hand, uses a bone graft to anatomically restore the original shape and size of the glenoid. Both procedures aim to reduce the risk of recurrent dislocations, improve shoulder stability, and enhance overall shoulder function.
These treatments are crucial for patients as they address the underlying structural issues that contribute to recurrent dislocations, thereby reducing pain, improving function, and preventing further joint damage.
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Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
288 Previous Clinical Trials
94,494 Total Patients Enrolled
2 Trials studying Shoulder Dislocation
220 Patients Enrolled for Shoulder Dislocation
Ivan Wong, MDPrincipal InvestigatorNova Scotia Health Authority, Orthopaedic Surgeon
4 Previous Clinical Trials
142 Total Patients Enrolled
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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