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ISRCTN
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ISRCTN68112133
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ClinicalTrials.gov identifier
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Public title
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Valgus knee bracing for medical compartment osteoarthritis (OA)
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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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N0436151092
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Study hypothesis
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The aim of this project is to ascertain the improvements in function and pain in patients with osteoarthritis of the knee, using valgus offloading knee braces. These braces are currently use for osteoarthritis within the department of orthopaedics in Leeds by some surgeons, however we do not have a prospective controlled trial to determine the benefit, if any, of using the braces available to us.
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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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Musculoskeletal Diseases: Osteoarthritis of the knee
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Participants - inclusion criteria
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The patients will be selected from new patient referrals seen in the orthopaedic outpatient clinic under Mr Calder at Leeds General Infirmary. They will be patients diagnosed with knee arthritis. If they fulfil the inclusion criteria then they will be given the option of taking part in the study and be consented accordingly.
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Participants - exclusion criteria
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Previous knee surgery in last 12 months, arthritis other than OA, hip disease, previous tibial/femoral fracture, morbid obesity BMI>35 (difficulty in brace fitting), PVD or skin disorder preventing brace use.
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Anticipated start date
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21/06/2004
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Anticipated end date
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21/11/2005
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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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20
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Interventions
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Questionnaire; Randomised controlled trial
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Primary outcome measure(s)
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The patients will be assessed using one of the most internationally validated scoring systems, the WOMAC score, and also a Visual Analogue Pain Scale
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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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Leeds Teaching Hospitals NHS Trust
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
Simon
Boyle
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Address
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Orthopaedic Surgery
Leeds Teaching Hospital
Beckett Street
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City/town
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Leeds
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Zip/Postcode
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LS9 7TF
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Country
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United Kingdom
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Tel
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+44 (0)7739 490649
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Fax
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+44
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Email
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r&d@leedsth.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 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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30/09/2005
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Last edited
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03/10/2005
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Date ISRCTN assigned
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30/09/2005
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