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ISRCTN
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ISRCTN43185756
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ClinicalTrials.gov identifier
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Public title
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Comparative study between intraarticular ostenil versus orthovisc
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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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N0237142757
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Study hypothesis
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Which one is most effective in providing short to medium term relief for patients with osteoarthritis of the knee either ostenil or orthovisc, if used as a single course?
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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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Prospective masked observer 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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73 patients will be entered in each arm of the trial. Selection of the study group will be from the group of patients diagnosed to have osteoarthritis of the knee. All eligible patients both male and female would be invited to participate. The total number of patients involved will be 146
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Participants - exclusion criteria
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1. Other known inflammatory arthropathies eg psoriasis, sero-negative arthropathies
2. Grade 4 osteoarthritis on the Kellgren score
3. Previous intra articular injections (except previous steroids or local anaesthetic)
4. Laxity or deformity
5. Uncontrolled diabetes, pregnancy, major existing medical problems, liver and renal diseases
6. Immunosuppressed and those on high dose steroids for any reason
7. Local infection at site and patients with gross pedal oedema
8. Patients with hypersensitivity to hyaluronic acid
9. Patients unwilling to participate or unable to give consent
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Anticipated start date
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01/05/2004
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Anticipated end date
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31/12/2006
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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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146
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Interventions
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Intraarticular ostenil versus orthovisc
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Primary outcome measure(s)
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1. WOMAC - Western Ontario and McMaster Universities Arthritis Index
2. VAS - 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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St Helens and Knowsley Hospitals NHS Trust (UK) 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
VS
Dachepalli
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Address
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St Helens & Knowsley Hospitals NHS Trust
Orthopaedics
Whiston Hospital
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City/town
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Prescot
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Zip/Postcode
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L35 5DR
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Country
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United Kingdom
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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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Fax
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+44 (0)20 7307 2623
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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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12/04/2011
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Date ISRCTN assigned
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30/09/2005
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