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Trial of acute femoral fracture fixation (TrAFFix) : study protocol for a randomised controlled feasibility trial
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Griffin, Xavier L., Costa, Matthew L., Achten, Juul, Dritsaki, Melina, Baird, Janis and Parsons, Nicholas R. (2017) Trial of acute femoral fracture fixation (TrAFFix) : study protocol for a randomised controlled feasibility trial. Trials, 18 (1). 538. doi:10.1186/s13063-017-2265-0 ISSN 1745-6215.
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Official URL: http://dx.doi.org/10.1186/s13063-017-2265-0
Abstract
Distal femoral fractures are a source of considerable morbidity and best treatment is currently uncertain. The Trial of Acute Femoral Fracture Fixation (TrAFFix) is a randomised, parallel-group feasibility study designed to inform the design of a later, definitive clinical trial comparing intramedullary nails and locking plates for the treatment of distal femoral fractures.
Methods/design
Patients aged 50 years and older with a femoral fracture within the distal two Müller squares are potentially eligible for inclusion. Participants are randomly allocated to receive fixation with either an intramedullary nail or a distal locking plate. Measurements (EuroQol 5 Dimensions, Dementia Quality of Life, Disability Rating Index) are collected at baseline, 6 weeks and 4 months. The recruitment rate will be assessed across seven participating centres over a total of 52 centre-months which is expected after 10 months of recruitment. Objectives are – feasibility phase, to assess recruitment rate and completion rate of the primary outcome measure; process evaluation, to assess the generalisability and likely success of a future trial; definitive trial, quantify and draw inferences on observed differences in health-related quality of life at 4 months between the study intervention groups (nail versus plate). A favourable opinion was granted by the Wales Research Ethics Committee (16/WA/0225), study-wide NHS approval was given by the Health Research Authority (IRAS 206745), and participating NHS trusts provided local approvals. This study was funded by the National Institute for Health Research Health Technology Assessment (HTA 15/59/22).
Item Type: | Journal Article | ||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||
Journal or Publication Title: | Trials | ||||||
Publisher: | Biomed Central | ||||||
ISSN: | 1745-6215 | ||||||
Official Date: | 14 November 2017 | ||||||
Dates: |
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Volume: | 18 | ||||||
Number: | 1 | ||||||
Article Number: | 538 | ||||||
DOI: | 10.1186/s13063-017-2265-0 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Open Access (Creative Commons) |
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