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ISRCTN
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ISRCTN78578486
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ClinicalTrials.gov identifier
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Public title
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A multicentre randomised controlled study of primary femoral fixation versus delayed definitive femoral fixation in patients with multiple trauma
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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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N0436125527
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Study hypothesis
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This study aims to compare the effects of early primary intramedullary nailing and delayed femoral intramedullary nailing in patients who have sustained a femoral shaft fracture and multiple injuries with an injury severity score of >16. It will be in particular studying the rates of complications such as multi-organ failure and acute respiratory distress syndrome to see if there is a difference in the incidence of these between the two techniques.
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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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Injury, Occupational Diseases, Poisoning: Femoral shaft fracture
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Participants - inclusion criteria
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10-20 patients who have sustained polytrauma
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/08/2002
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Anticipated end date
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01/08/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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20
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Interventions
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Randomised controlled trial
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Primary outcome measure(s)
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Mean ventilation
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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 (UK)
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Trial website
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Publications
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Contact name
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Dr
P V
Giannoudis
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Address
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Academic Department of Orthopaedic Surgery
Level 5, Clinical Sciences Building
St James's University 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)113 206 7068
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Fax
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+44 (0)113 242 6496
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Email
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Peter.Giannoudis@leedsth.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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26/05/2010
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Date ISRCTN assigned
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30/09/2004
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