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Sponsors and Collaborators: |
Hamilton Health Sciences CIHR The Physicians' Services Incorporated Foundation |
Information provided by: | Hamilton Health Sciences |
ClinicalTrials.gov Identifier: | NCT00128076 |
This study will compare two different surgical techniques for repairing a tear in the muscles of the shoulder (rotator cuff). The investigators will determine whether an arthroscopic or mini-open technique provides better quality of life and repair integrity.
Condition | Intervention | Phase |
Shoulder Pain Rotator Cuff Tear |
Procedure: All-Arthroscopic repair Procedure: Mini-open repair |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears |
Estimated Enrollment: | 225 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | December 2010 |
Arms | Assigned Interventions |
1: Active Comparator
All-arthroscopic repair
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Procedure: All-Arthroscopic repair
joint techniques and repair are both performed entirely through the arthroscope
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2: Active Comparator
Mini-open repair
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Procedure: Mini-open repair
repair is performed though a small incision and the arthroscope can be used to address problems within the joint (as per traditional diagnostic procedures)
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Background:
Rotator cuff tears are the most common source of shoulder pain and disability. Only poor quality studies have compared mini-open to arthroscopic repair, leaving surgeons with inadequate evidence to support optimal, minimally-invasive repair.
Methods/Design:
This randomized, multi-centre, national trial will determine whether an arthroscopic or mini-open repair provides better quality of life for patients with small or moderate sized rotator cuff tears. A national consensus meeting of investigators in Joints Orthopaedic Initiative for Shoulder Trials (JOINTS) identified this question as the top priority for shoulder surgeons across Canada. The primary outcome measure is a valid quality-of-life scale (Western Ontario Rotator Cuff (WORC) that addresses 5 domains of health affected by rotator cuff disease. Secondary outcomes will assess rotator cuff functionality (ROM, strength, constant score), secondary dimensions of health (general health status (SF-12) and work limitations) and repair integrity (MRI). Outcomes are measured at baseline, at 6 weeks, 3, 6, 12 and 24 months postoperatively by blinded research assistants and musculoskeletal radiologists. Patients (n=250) with small or medium-sized cuff tears identified by clinical examination and MRI who meet eligibility criteria will be recruited. This sample size will provide 80% power to detect (statistically) a clinically important difference of 20% in WORC scores between procedures after controlling for baseline WORC score ("=0.05). A central methods centre will manage randomization, data management and monitoring under supervision of experienced epidemiologists. Surgeons will participate in either conventional or expertise-based designs according to defined criteria, to avoid biases from differential surgeon expertise. Mini-open or all-arthroscopic repair procedures, will be performed according to a standardized protocol. Central Adjudication (of cases), Trial Oversight and Safety Committees will monitor trial conduct. The investigators will use an analysis of covariance (ANCOVA), where the baseline WORC score is used as a covariate, to compare the quality of life (WORC score) at 2-years post-operatively. As a secondary analysis the investigators will conduct the same statistical test but will include age and tear size as covariates with the baseline score. Enrollment will require 2 years and follow-up an additional 2-years. The trial will commence when funding is in place.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The full-thickness rotator cuff tears of supraspinatus and infraspinatus will be classified into 2 categories based on area of longest dimension.
Exclusion Criteria:
Pre-Operative Exclusion Criteria
Intra-Operative Exclusion Criteria
Contact: Joy C MacDermid, PhD | 905-525-9140 ext 22524 | macderj@mcmaster.ca |
Contact: Dianne Bryant, PhD | 519-661-2111 ext 83947 | Dianne.Bryant@uwo.ca |
Canada, Alberta | |||||
Walter Mackenzie Centre | Recruiting | ||||
Edmonton, Alberta, Canada, T6B 2G7 | |||||
Contact: Kyle Kemp kyle.kemp@capitalhealth.ca | |||||
Sub-Investigator: Dr. Robert Balyk | |||||
University of Calgary Sport Medicine Centre | Recruiting | ||||
Calgary, Alberta, Canada, T2N 1N4 | |||||
Contact: Kristie Pletsch kdpletsc@ucalgary.ca | |||||
Sub-Investigator: Dr. Richard Boorman | |||||
Sub-Investigator: Dr. Robert Hollinshead | |||||
Sub-Investigator: Dr. Ian Lo | |||||
Sub-Investigator: Dr. Nicholas Mohtadi | |||||
Canada, British Columbia | |||||
Royal Columbian Hospital | Recruiting | ||||
New Westminster, British Columbia, Canada, V3S 3W7 | |||||
Contact: Mauri Zomar sfof@direct.ca | |||||
Sub-Investigator: Dr. Robert McCormack | |||||
Sub-Investigator: Dr. Farhad Moola | |||||
Canada, Ontario | |||||
St. Joseph's Healthcare Hamilton | Recruiting | ||||
Hamilton, Ontario, Canada, L8N 4A6 | |||||
Contact: Margaret Lomotan lomotam@mcmaster.ca | |||||
Sub-Investigator: Dr. Jaydeep Moro | |||||
St. Joseph's Health Care London | Recruiting | ||||
London, Ontario, Canada, N6A 4V2 | |||||
Contact: Kate Iosipchuk kate.iosipchuk@sjhc.london.on.ca | |||||
Sub-Investigator: Dr. Darren Drosdowech | |||||
Sub-Investigator: Dr. Ken Faber | |||||
Sub-Investigator: Dr. George Athwal | |||||
Fowler Kennedy Sports Medicine Clinic | Recruiting | ||||
London, Ontario, Canada, N6A 3K7 | |||||
Contact: Sharon Griffin stdshg@uwo.ca | |||||
Sub-Investigator: Dr. Robert Litchfield | |||||
Sub-Investigator: Dr. Marie-Eve Lebel | |||||
Sub-Investigator: Dr. Kevin Willits | |||||
Orthopaedic and Arthritic Hospital | Recruiting | ||||
Toronto, Ontario, Canada | |||||
Contact: Richard Holtby, MD richard.holtby@sw.ca | |||||
Contact: Helen Razmjou helen.razmjou@sw.ca | |||||
Principal Investigator: Richard Holtby, MD | |||||
Sub-Investigator: Helen Razmjou |
Hamilton Health Sciences |
CIHR |
The Physicians' Services Incorporated Foundation |
Principal Investigator: | Joy C MacDermid, PhD | McMaster University, University of Western Ontario |
Responsible Party: | McMaster University ( Joy MacDermid, Associate Professor ) |
Study ID Numbers: | MCT-82335 |
First Received: | August 5, 2005 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00128076 |
Health Authority: | Canada: Health Canada |
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