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Trial NCT00128076

Resource URI: http://static.linkedct.org/resource/trials/NCT00128076
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/1680>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/18632>
linkedct:brief_title All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/8146>
linkedct:condition <http://static.linkedct.org/resource/condition/11677>
linkedct:condition <http://static.linkedct.org/resource/condition/12081>
linkedct:criteria Inclusion Criteria: - The investigators will recruit patients with small or medium rotator cuff tears as determined by clinical examination and diagnostic imaging (magnetic resonance imaging [MRI]) prior to surgery. - The full-thickness rotator cuff tears of supraspinatus and infraspinatus will be classified into 2 categories based on area of longest dimension. - SMALL= 0-1 cm; - MODERATE =1-3 cm. - Definitive measurement of tear size will be made in surgery and used as a covariate in analysis. (JOINTS measurement protocol will be used) Exclusion Criteria: Pre-Operative Exclusion Criteria - Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder or previous surgery of the affected shoulder, - Evidence of significant cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations, - Major medical illness (life expectancy less then 2 years or unacceptably high operative risk), - Unable to speak or read English, - Psychiatric illness that precludes informed consent, - Unwilling to be followed for 2 years. Intra-Operative Exclusion Criteria - Large, massive or irreparable cuff tears, extending into the subscapularis or teres minor, which cannot be mobilized to the articular margin or repaired using one or both of the techniques (all arthroscopic or mini-open), - Teres minor or subscapularis tears, - Inelastic and immobile tendon, which cannot be advanced to articular margin, - Co-existing labral pathologies requiring repair with sutures (superior labral anterior posterior [SLAP] II-IV), Bankart lesions requiring repair, partial tears of biceps (more than 60% of thickness) requiring tenodesis or release.
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date December 2010
linkedct:enrollment 225 (xsd:int)
linkedct:firstreceived_date August 5, 2005
linkedct:has_dmc Yes
linkedct:id NCT00128076
linkedct:intervention <http://static.linkedct.org/resource/intervention/59167>
linkedct:intervention <http://static.linkedct.org/resource/intervention/61436>
rdfs:label Trial NCT00128076
linkedct:lastchanged_date September 23, 2009
linkedct:lead_sponsor_agency Hamilton Health Sciences
linkedct:location <http://static.linkedct.org/resource/location/15539>
linkedct:location <http://static.linkedct.org/resource/location/19826>
linkedct:location <http://static.linkedct.org/resource/location/21031>
linkedct:location <http://static.linkedct.org/resource/location/21121>
linkedct:location <http://static.linkedct.org/resource/location/22061>
linkedct:location <http://static.linkedct.org/resource/location/22397>
linkedct:location <http://static.linkedct.org/resource/location/22779>
linkedct:nct_id NCT00128076
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears
linkedct:org_study_id MCT-82335
linkedct:overall_contact_email macderj@mcmaster.ca
linkedct:overall_contact_last_name Joy C MacDermid, PhD
linkedct:overall_contact_phone 905-525-9140
linkedct:overall_contact_phone_ext 22524
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/30664>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/415>
foaf:page <http://clinicaltrials.gov/show/NCT00128076>
linkedct:phase Phase 3
linkedct:primary_completion_date December 2010
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/77474>
linkedct:reference <http://static.linkedct.org/resource/reference/30289>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/105167>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/105498>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/107259>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/133633>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/32640>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/7940>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/94274>
linkedct:source McMaster University
linkedct:start_date August 2006
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date September 2009