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ISRCTN
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ISRCTN99771224
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DOI
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10.1186/ISRCTN99771224
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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UK FixDT: Fixation of Distal Tibia fractures
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Scientific title
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UK FixDT – A Randomised Controlled Trial for patients with a displaced fracture of the distal tibia, is there a clinical and cost-effectiveness difference between ‘locking’ plate fixation and intramedullary nail fixation
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Acronym
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UK FixDT
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Serial number at source
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HTA: 11/136/04, Version 2.0
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Study hypothesis
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Null hypothesis: There is no difference in the Disability Rating Index (DRI) at 6 months after injury between adults with a displaced fracture of the distal tibia treated with ‘locking’-plate fixation versus intramedullary nail fixation.
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Lay summary
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Lay summary under review 2
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Ethics approval
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NRES Committee West Midlands - Coventry & Warwickshire, 06 November 2012, REC Reference: 12/WM/0340
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Study design
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Multi-centre randomised clinical 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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Distal Tibia Fractures / Injuries & Accidents
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Participants - inclusion criteria
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1. Aged 16 years or over, either sex
2. Any fracture which involves the distal tibial metaphysis – defined as a fracture extending within 2 Muller squares of the ankle joint17
3. In the opinion of the attending surgeon, the patient would benefit from internal fixation of the fracture
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Participants - exclusion criteria
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1. In the opinion of the attending surgeon, there is a contraindication to intra-medullary nailing
2. The fracture is open with a Gustillo grade of more than 1
3. There is a contra-indication to anaesthesia
4. There is evidence that the patient would be unable to adhere to trial procedures or complete postal questionnaires
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Anticipated start date
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01/03/2013
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Anticipated end date
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28/02/2017
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Status of trial
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Ongoing |
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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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Minimum of 320
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Interventions
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Comparing two techniques for the operative fixation of fractures of the distal tibia.
Intramedullary Nailing
The intramedullary nail is inserted at the proximal end of the tibia and passed down the centre of the bone in order to hold the fracture in the correct (anatomical) position. The reduction technique, the surgical approach, the type and size of the nail, the configuration of the proximal and distal inter-locking screws and any supplementary device or technique will be left entirely to the discretion of the surgeon as per standard clinical practice.
'Locking’ plate fixation
The ‘locking’ plate is inserted at the distal end of the tibia and passed under the skin on the surface of the bone. Again, the details of the reduction technique, the surgical approach, the type and position of the plate, the number and configuration of fixed-angle screws and any supplementary device or technique will be left to the discretion of the surgeon. The only stipulation is that fixed-angle screws must be used in at least some of the distal screw holes – this is standard practice with all distal tibia ‘locking’ plates.
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Primary outcome measure(s)
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To quantify and draw inferences on observed differences in the Disability Rating Index between the trial treatment groups at 6 months after injury
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Secondary outcome measure(s)
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1. To quantify and draw inferences on observed differences early functional status at 3 months and later functional status at 12 months
2.To quantify and draw inferences on observed differences in the radiological outcomes: non-union, mal-alignment and shortening
3. To identify any differences in health-related quality of life between the trial treatment groups in the first year after the injury. EQ-5D; The EQ-5D is a validated, generic health-related quality of life measure consisting of 5 dimensions each with a 3-level answer possibility. Each combination of answers can be converted into a health utility score. It has good test-retest reliability, is simple for patients to use, and gives a single preference-based index value for health status that can be used for broader cost-effectiveness comparative purposes.
4. To determine the complication rate of intramedullary nail fixation versus ‘locking’- plate fixation in the first year after the injury. all complications will be recorded, including malunion, delayed/non-union, infection, wound complications, vascular and neurological injury and venous thrombo-embolism. A record will also be kept of any other surgery required in relation to the index fracture, including removal of any metalwork.
5. To investigate, using appropriate statistical and economic analytical methods, the resource use, costs and comparative cost effectiveness of intramedullary nail fixation versus ‘locking’-plate fixation
Olerud and Molander (OMAS) is a self-administered patient questionnaire. It is a good outcome tool for assessing symptoms after an ankle fracture. The score is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living. The scoring system correlates well with parameters considered to summarise the results after this type of injury and is therefore recommended for use in scientific investigations.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK) ref: 11/136/04
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Trial website
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Publications
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Contact name
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Prof
Matthew
Costa
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Address
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Warwick Clinical Trials Unit
Division of Health Sciences
University of Warwick
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City/town
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Coventry
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Zip/Postcode
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CV4 7AL
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Country
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United Kingdom
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Tel
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+44 (0)24 7615 1721
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Email
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matthew.costa@warwick.ac.uk
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Sponsor
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University of Warwick (UK)
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Address
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Research Support Services
University House
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City/town
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Coventry
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Zip/Postcode
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CV4 7AL
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Country
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United Kingdom
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Tel
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+44 (0)24 7652 3716
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Email
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p.a.hedges@warwick.ac.uk
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Sponsor website:
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http://www2.warwick.ac.uk/
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Date applied
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07/01/2013
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Last edited
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10/01/2013
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Date ISRCTN assigned
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10/01/2013
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