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ISRCTN
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ISRCTN66721986
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ClinicalTrials.gov identifier
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Public title
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A randomised trial of ankle joint replacements
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0284126103
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Study hypothesis
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To compare the long term performance of ankle joint replacements - STAR and BP. Current literature states that there is no long term difference between the two prosthesis
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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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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Surgery: Ankle replacement
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Participants - inclusion criteria
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Patients with Scandinavian Total Ankle Replacement (STAR) and Buechel-Pappas (BP) total ankle replacements
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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03/01/2000
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Anticipated end date
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03/01/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Long term follow up, in terms of range of motion, x-ray assessment and gait analysis on selected patients. Recruit over two years and follow up for 10 years
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Primary outcome measure(s)
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A long term clinical comparison of two ankle replacements
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Wrightington, Wigan and Leigh NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Mr
Peter
Wood
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Address
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Wrightington, Wigan & Leigh NHS Trust, Wright
Wrightington Hospital
Hall Lane
Appley Bridge
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City/town
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Wigan
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Zip/Postcode
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WN6 9EP
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Country
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United Kingdom
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Email
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peter.wood@wiganlhs-tr.nwest.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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07/03/2008
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Date ISRCTN assigned
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30/09/2004
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