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ISRCTN
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ISRCTN03013488
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ClinicalTrials.gov identifier
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Public title
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Total or Partial Knee Arthroplasty Trial
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Scientific title
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Clinical and cost-effectiveness of total knee replacements versus partial knee replacements for patients with medial compartment osteoarthritis: a multicentre randomised controlled trial
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Acronym
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TOPKAT
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Serial number at source
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HTA 08/14/08; Version 1
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Study hypothesis
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To assess the clinical and cost-effectiveness of total knee replacements versus partial knee replacements for patients with medial compartment osteoarthritis.
Please note that, as of 17/09/2009, the start and end dates of this trial have been updated from 01/06/2009 and 01/06/2023 to 01/11/2009 and 31/10/2016, respectively.
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Ethics approval
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Oxfordshire REC C, approved on 04/09/2009 (ref: 09/H606/88)
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Study design
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Multicentre prospective superiority randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Osteoarthritis/ avascular necrosis
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Participants - inclusion criteria
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1. Medial osteoarthritis with exposed bone on both femur and tibia or avascular necrosis
2. Functionally intact anterior cruciate ligament (superficial damage or splitting is acceptable)
3. Full thickness lateral cartilage
4. Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament)
5. Medically fit showing an American Society of Anaesthesiologists (ASA) grade 1 or 2
6. Expectancy of over 10 years of active life
7. Aged 40 years or over, either sex
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Participants - exclusion criteria
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1. Require revision knee replacement surgery
2. Have rheumatoid arthritis or other inflammatory disorders
3. Are likely to benefit from a specific prosthesis type
4. Are unlikely to be able to perform required clinical assessment tasks
5. Have symptomatic foot, hip or spinal pathology
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Anticipated start date
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01/11/2009
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Anticipated end date
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31/10/2016
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Status of trial
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Ongoing |
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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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500
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Interventions
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Total knee replacement surgery versus unicompartmental knee replacement surgery. Patients will be followed up for 10 years post surgery. Going on the average waiting list times of 3 months, the approximate involvement in the study for each participant (recruitment, treatment and follow up) would be 10 years and 3 months.
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Primary outcome measure(s)
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Oxford Knee Score: a patient based validated and effective measure of change over time questionnaire. Both the absolute and the change scores will be analysed at 5- and 10-year points post-operation.
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Secondary outcome measure(s)
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1. American Knee Society Score: to measure the range of motion and function of the knee, measured at 2 months, 1, 5 and 10 years post-surgery
2. UCLA Activity Score: to measure how active the patient is, measured at 2 months, 1, 5 and 10 years post-surgery
3. X-ray to check for immediate problems, assess the outcome of surgery, complications and make long-term predictions, measured at 2 months, 1, 5 and 10 years post-surgery
4. EQ-5D: to provide data for the economic evaluation, measured at 2 months, 1, 2, 3, 4, 5, 7 and 10 years post-surgery
5. Lund Score: to measure patient satisfaction, measured at 2 months, 1, 2, 3, 4, 5, 7 and 10 years post-surgery
6. Other outcomes, e.g., kinematic and gait assessments, measured at 2 months, 1, 5 and 10 years post-surgery
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Contact name
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Dr
David
Beard
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Address
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Nuffield Department of Orthopaedic, Rheumatology & Musculoskeletal Sciences
Windmill Road
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LD
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Country
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United Kingdom
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Tel
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+44 (0)1865 227695
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Fax
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+44 (0)1865 227671
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Email
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david.beard@ndorms.ox.ac.uk
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Sponsor
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University of Oxford (UK)
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Address
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Clinical Trials and Research Governance Unit
Manor House
John Radcliffe Hospital
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 9DZ
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Country
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United Kingdom
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Tel
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+44 (0)1865 743002
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Email
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heather.house@admin.ox.ac.uk
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Sponsor website:
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http://www.admin.ox.ac.uk/rso/clinical
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Date applied
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08/04/2009
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Last edited
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22/09/2009
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Date ISRCTN assigned
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09/04/2009
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