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ISRCTN
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ISRCTN98524302
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ClinicalTrials.gov identifier
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Public title
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Lumbosacral fusion study
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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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940139
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Study hypothesis
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The main objective of this study is to measure the difference in outcome when internal fixation techniques are used to augment the spinal fusion.
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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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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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Spinal conditions, lumbosacral joint fixation.
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Participants - inclusion criteria
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200 patients admitted to the Spinal Surgery Unit for L5-S1 and L4-S1 fusion for back pain and one of the following diagnostic groups will be entered into the trial:
1. Discogenic back pain
2. Lumbar spondylolysis
3. Degenerative spondylolisthesis
4. Isthmic spondylolisthesis
5. Segmental instability
6. Degenerative scoliosis
7. Failed decompressive surgery
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Participants - exclusion criteria
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Patients who have predominantly root symptoms, who have had previous fusion or stabilisation surgery or who are aged more than 60.
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Anticipated start date
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01/02/1995
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Anticipated end date
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31/01/1998
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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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200
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Interventions
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1. Standard posterior lumbosacral fusion without instrumentation, using corticocancellous autograft from the patient's own iliac crest
2. An identical operation will be performed, with the addition of pedicle screw fixation system
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Primary outcome measure(s)
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Not provided at time of registration
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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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NHS Executive Trent (UK)
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Trial website
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Publications
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Contact name
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Mr
John
O'Dowd
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Address
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Spinal Disorder Unit
University Hospital NHS Trust
D Floor
West Block
Queen's Medical Centre
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Tel
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+44 (0)115 924 9924
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Email
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Sponsor
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NHS R&D Regional Programme Register - 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.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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25/07/2011
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Date ISRCTN assigned
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23/01/2004
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