The Arthroscopic Treatment of Recurrent Anterior Shoulder Instability (ATRASI)
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|ClinicalTrials.gov Identifier: NCT02510625|
Recruitment Status : Recruiting
First Posted : July 29, 2015
Last Update Posted : February 9, 2017
The objective of this study is to investigate arthroscopic treatments of recurrent anterior shoulder instability. Functional outcomes of arthroscopic anatomic glenoid reconstruction with bone graft will be compared to the gold standard, arthroscopic Bankart repair. The investigators hypothesize that arthroscopic anatomic glenoid reconstruction with bone graft will provide better functional outcomes and decreased risk of recurrent dislocation/subluxation.
This will be a single center, double blinded, randomized controlled trial performed in Halifax, Nova Scotia, Canada. The primary outcome measured will be the Western Ontario Shoulder Instability (WOSI) score. Secondary outcomes will be subluxation, re-dislocation, and range of motion. A minimum of 200 patients will be enrolled in the study as determined by sample size calculation. Routine radiographs as well as a pre-operative CT with 3D reconstruction and MRI are obtained for all patients. The patients will then undergo a clinical examination and complete a variety of functional and quality of life surveys. Randomization will be based on surgeon skill. Two groups (Bankart repair and anatomic glenoid reconstruction) will be selected with 100 subjects each. Postoperatively, patients in both groups will follow a standardized rehabilitation protocol. The patient will follow-up with the attending surgeon at 2 weeks post-operatively for a wound check. At the 3, 6, 12, and 24 month visits the patient will again undergo the structured clinical examination conducted by a physiotherapist who is blinded to the patients' treatment group. The patient will also complete the questionnaires at each of these follow-up appointments. Complications, and subluxation/dislocation events will be documented at each follow-up evaluation. On the basis of a clinical examination and patient history, the surgeon will diagnose recurrent instability and categorize it as a traumatic or atraumatic subluxation or dislocation.
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Dislocation||Procedure: Anatomic Glenoid Reconstruction Procedure: Arthroscopic bankart Repair||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Arthroscopic Treatment of Recurrent Anterior Shoulder Instability: A Randomized Controlled Trial|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2022|
Active Comparator: Bankart repair
Arthroscopic bankart repair
Procedure: Arthroscopic bankart Repair
Arthroscopic bankart Repair
Experimental: Anatomic Glenoid Reconstruction
Arthroscopic distal tibia bone graft
Procedure: Anatomic Glenoid Reconstruction
Distal tibia bone graft
Other Name: Cannulated Bristow-Latarjet Instability Shoulder System (Depuy-Mitek, MA, USA).
- WOSI Score [ Time Frame: 2 years ]
- Recurrent Instability [ Time Frame: 2 years ]subluxation/dislocation events will be documented at each follow-up evaluation. On the basis of a clinical examination and patient history, the surgeon will diagnose recurrent instability and categorize it as a traumatic or atraumatic subluxation or dislocation.
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): NCT02510625
|Contact: Nicole Paquet||(902)firstname.lastname@example.org|
|Canada, Nova Scotia|
|Nova Scotia Health Authority||Recruiting|
|Halifax, Nova Scotia, Canada, B3H2E1|
|Contact: Nicole Paquet (902)473-7626 email@example.com|
|Principal Investigator:||Dr. Ivan Wong, MD||Dalhousie University|