Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation
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|ClinicalTrials.gov Identifier: NCT03585491|
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Dislocation Sport Injuries Shoulder Anterior Dislocation||Procedure: Latarjet Procedure Procedure: Bankart Procedure||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||January 1, 2022|
Experimental: Bankart Procedure
Bankart Procedure: the participant will be placed in the lateral decubitus or beach chair position. Standard diagnostic arthroscopy will be performed. The anterior capsulolabral complex will be freed from the anterior aspect of the scapular neck. The anterior aspect of the scapular neck will be decorticated using a motorized burr. A capsuloligamentous repair will be performed with the capsule shifted from inferior to superior and repaired on the glenoid face. The number of anchors used for the repair will be left to the discretion of the surgeon. Patients will be given a sling for 4 weeks, and participation in sports will not be allowed for 6 months.
Procedure: Bankart Procedure
Participants will undergo arthroscopic stabilization.
Experimental: Latarjet Procedure
Open or Arthroscopic coracoid transfer (Latarjet Procedure): This procedure may be performed through small incisions (minimally invasive) but may require a larger incision in some cases. It involves the transfer of a nearby bony structure (the coracoid process) to the front of the shoulder joint (glenoid). This bone will then provide support to prevent the shoulder joint from dislocating.
Procedure: Latarjet Procedure
Participants will undergo open or arthroscopic Latarjet procedure.
- Recruitment Feasibility [ Time Frame: 10 months ]Number of patients recruited
- Protocol Adherence [ Time Frame: 2 years ]Number of errors in randomization
- Follow-up [ Time Frame: 2 years ]Proportion of participants followed at two years
- Rate of Recurrence [ Time Frame: 2 years ]Rate of recurrent dislocation and symptomatic instability between patients randomized to (capsuloligamentous repair +/- remplissage) and those receiving open Latarjet procedure.
- Clinical Outcome [ Time Frame: 2 years ]Measured by Western Ontario Shoulder Instability (WOSI) Index
- Clinical Outcome [ Time Frame: 2 years ]Measured by American Shoulder and Elbow Society (ASES) score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585491
|Contact: Nazanin Barkhordariemail@example.com|
|Contact: Moin Khan, MD||905-522-1155 ext firstname.lastname@example.org|
|St. Joseph's Healthcare Hamilton||Recruiting|
|Hamilton, Ontario, Canada, L8N 4A6|
|Contact: Nazanin Barkhordari 4166279367 email@example.com|
|Principal Investigator: Moin Khan, MD, MSc,FRCSC|
|Principal Investigator:||Moin Khan, MD||McMaster University|