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ISRCTN
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ISRCTN08249684
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ClinicalTrials.gov identifier
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Public title
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A randomised clinical pilot trial comparing intramedullary nailing with plate and screw fixation in the treatment of patients with an acute fracture of the distal tibia
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Scientific title
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Acronym
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Management of Distal Tibia
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Serial number at source
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7111
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Study hypothesis
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The aim of the project is to perform a pragmatic pilot trial comparing two modes of treatments of distal tibia fractures. The two commonest treatment modalities are intramedullary nailing (where the nail is inserted in the tibia across the fracture) and screw and plate fixation. There is no agreement in the literature as to which treatment is best. The literature has shown that complications following the treatments mentioned above are very similar between the two modalities (infection, mal-union and non-union and re-operations) but no one has looked at the actual function of the patients following one treatment compared to the other. The objective is therefore to compare the two modes of treatments for distal tibia fractures, in terms of patient disability rating and quality of life.
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Lay summary
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Ethics approval
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MREC approved (ref: 8/H1210/1)
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Study design
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Single centre randomised interventional treatment 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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Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/03/2008
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Anticipated end date
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30/09/2010
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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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Planned Sample Size: 24
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Interventions
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1. Intramedullary nailing: a nail is inserted in the tibia across the fracture
2. Screw and plate fixation: a plate and screw are used to fix the fracture
Follow-up length: 12 months
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Primary outcome measure(s)
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Disability Rating Index. The principle measurement of the primary outcome measure will be at one year after injury.
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Secondary outcome measure(s)
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1. American Orthopaedic Foot and Ankle Society Hind foot Scale at 3, 6 and 12 months post-injury
2. Complications including wound dehiscence, infection, mal-union, non-union, reoperations, time in hospital and return
3. EQ-5D at 3, 6 and 12 months post-injury
4. Olerud and Molander ankle score at 3, 6 and 12 months post-injury
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Sources of funding
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AO Foundation (Switzerland)
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Trial website
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Publications
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Contact name
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Dr
Juul
Achten
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Address
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Clifford Bridge Road
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City/town
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Coventry
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Zip/Postcode
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CV2 2DX
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Country
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United Kingdom
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Email
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j.achten@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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Gibbet Hill Road
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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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Sponsor website:
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http://www2.warwick.ac.uk
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Date applied
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14/07/2010
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Last edited
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14/07/2010
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Date ISRCTN assigned
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14/07/2010
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