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ISRCTN
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ISRCTN21215727
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ClinicalTrials.gov identifier
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Public title
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Effect of sodium hyaluranate on recovery after arthroscopic knee surgery
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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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N0155126378
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Study hypothesis
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To determine effect of single post-operative intra-articular injection of sodium hyaluranate on the pain and joint function following arthroscopic knee surgery.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Added July 2008: approved by Oldham Local Ethics Research Committee
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Study design
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Prospective randomised controlled single blinded single centre 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: Knee
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Participants - inclusion criteria
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Male and female patients 18-60 waiting for their arthroscopic knee surgery will be invited to participate.
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Participants - exclusion criteria
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1. Infection
2. Inflammatory arthropathy
3. Patellofemoral disease
4. Allergy to Viscoseal
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Anticipated start date
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10/04/2003
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Anticipated end date
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31/08/2003
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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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25 patients approx
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Interventions
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Single post-operative intra-articular injection of sodium hyaluranate vs placebo
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Primary outcome measure(s)
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Added July 2008:
Pain on weight bearing as measured on 10 point Visual Analogue score.
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Secondary outcome measure(s)
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Added July 2008:
1. Pain on rest and squatting, as measured on 10 point Visual Analogue score
2. SF-12 and WOMAC score
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Sources of funding
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Pennine Acute Hospitals NHS Trust (UK)
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Trial website
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Publications
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2004 poster results in http://www.trbchemedica.co.uk/docs/Anand%20OARSI%202004%20poster%20.pdf
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Contact name
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Mr
S
Anand
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Address
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Orthopaedics Department
Royal Oldham Hospital
Rochdale Road
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City/town
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Oldham
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Zip/Postcode
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OL1 2JH
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Country
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United Kingdom
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Tel
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+44 (0)161 624 0420
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Email
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sanjeevanand65@hotmail.com
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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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19/10/2011
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Date ISRCTN assigned
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30/09/2004
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