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ISRCTN
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ISRCTN75566721
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ClinicalTrials.gov identifier
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Public title
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Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for primary osteoarthritis
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Scientific title
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Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for primary osteoarthritis: a randomised controlled trial
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Acronym
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N/A
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Serial number at source
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UCT-48088
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Study hypothesis
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Our hypothesis is that uncemented fixation of the humerus will result in better disease-specific quality of life, decreased incidence of radiographic loosening, decrease operative time and no increase in complications.
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Lay summary
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Ethics approval
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Review Board for Health Sciences Research Involving Human Subjects in the University of Western Ontario gave approval on the 25th April 2001
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Primary osteoarthritis of the shoulder
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Participants - inclusion criteria
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1. Primary osteoarthritis of the shoulder of grade III or higher (Kellgren and Lawrence modified for the shoulder)
2. Aged 18 years and older, either sex
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Participants - exclusion criteria
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Patients who have failed standard conservative management of their shoulder osteoarthritis
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Anticipated start date
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01/04/2002
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Anticipated end date
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30/04/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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160
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Interventions
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Group 1: Cemented fixation of the humeral component in total shoulder arthroplasty
Group 2: Uncemented fixation of the humeral component in total shoulder arthroplasty
Trial details received: 12 Sept 2005
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Primary outcome measure(s)
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The main evaluation of patient outcome is disease specific quality of life comparing the 2 groups at 2 years using several shoulder function rating scales. These include the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), the Constant Score and American Shoulder and Elbow Surgeons (ASES) Standardised Shoulder Assessment form. Overall global health status will be measured and compared at 2 years using the Short Form-12 which has previously been shown to be the most appropriate instrument for evaluating global health status in orthopaedic clinical research.
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Secondary outcome measure(s)
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The evaluation of radiolucent lines indicative of implant loosening and the incidence of revision surgery complications will be monitored during the 2 year post-operative course.
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Sources of funding
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1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-48088)
2. Zimmer (Canada)
3. Zimmer (USA)
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Trial website
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Publications
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Contact name
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Dr
Robert Bruce
Litchfield
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Address
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Fowler Kennedy Sport Medicine Clinic
3M Centre
University of Western Ontario
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City/town
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London
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Zip/Postcode
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N6A 3K7
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Country
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Canada
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Tel
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+1 519 661 4156
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Fax
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+1 519 661 4052
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Email
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rlitchf@uwo.ca
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Sponsor
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The University of Western Ontario (Canada)
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Address
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Research Accounting, SLB, UWO
1151 Richmond Street North
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City/town
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London
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Zip/Postcode
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N6A 5B8
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Country
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Canada
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Sponsor website:
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http://www.uwo.ca/
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Date applied
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26/09/2005
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Last edited
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04/03/2009
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Date ISRCTN assigned
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26/09/2005
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