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Costa ML, Achten J, Hennings S, et al. Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT. Southampton (UK): NIHR Journals Library; 2018 May. (Health Technology Assessment, No. 22.25.)

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Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT.

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Acknowledgements

The Fixation of Distal Tibia Fractures trial team

Chief investigator and applicant

Professor Matthew Costa.

Trial co-applicants

Dr Juul Achten, Dr Nick Parsons, Professor Stavros Petrou, Professor Ian Pallister and Professor Sarah E Lamb.

Senior project manager

Susie Hennings.

Trial co-ordinators and data entry clerk

Nafisa Boota, Katie McGuiness, Ann-Marie Brennan and Jo Walter.

Trial statisticians

James Griffin and Dr Nick Parsons.

Health economists

Mandy Maredza, Professor Stavros Petrou and Melina Dritsaki.

Rehabilitation lead

Professor Sarah E Lamb.

Collaborators

Mr Alan Johnstone (Aberdeen Royal Infirmary); Mr Andrew Carrothers (Addenbrookes Hospital); Mr Mike McNicholas (Aintree University Hospital); Mr Nigel Rossiter (Basingstoke & North Hampshire Hospital); Mr Nikhil Kharwadkar and Miss Anna Chapman (Heartlands Hospital); Mr Tim White (Royal Infirmary of Edinburgh); Mr James Murray (Frenchay Hospital); Mr Mark Blyth (Glasgow Royal Infirmary); Mr Shivkumar Gopal (Hull Royal Infirmary); Mr Ian McMurtry (James Cook Hospital); Mr David Noyes (John Radcliffe Hospital); Mr Adel Tavakkolizadeh (King’s College Hospital); Professor Peter Giannoudis (Leeds Teaching Hospital); Mr Aradhyula Murty (North Tyneside General Hospital & Wansbeck General); Mr Ben Ollivere (Nottingham University Hospitals); Mr Mark Westwood (Derriford Hospital); Mr Mark Farrar (Poole Hospital); Miss Charlotte Lewis (Queen Alexandra Hospital); Mr Andrew McAndrew (Royal Berkshire Hospital); Mr Benedict Rogers (Royal Sussex County Hospital); Mr Andrew Gray and Mr Stephen Aldridge (Royal Victoria Infirmary); Mr Paul Dixon (Sunderland Royal Hospital); Miss Caroline Hing (St George’s Hospital); Mr John Kendrew (University Hospitals of Birmingham); Mr Jonathan Young (University Hospitals Coventry & Warwickshire); Mr Ashwin Kulkarni (University Hospitals of Leicester); Mr Gorav Datta (Southampton General Hospital); and Mr Kevin Smith (Royal Stoke University Hospital).

Research associates/fellows/nurses/assistants

Carol Carnegie, Simone Hargreaves, Melanie Harrison, Cara Kennelly, Safia Begum, Ewan Goudie, Steven Barnfield, Emma Sharp, Lisa Wilson, Alanna Milne, Louise Spoors, Sarah Brannigan, Bernadette Cook, Chris Herriot, Jessica Nightingale, Rosalyn Squire, Carrie Colvin, Sheeba Babu, Emily Bannister, Carrie Ridley, Karen Smith, Tracey Robson, Agne Sekmokaite, Lauren Day-Cooper, Louise Clarkson, Manjit Attwal, Maria Letts and Racquel Carpio.

Trial Steering Committee

Professor Matthew Costa, chief investigator.

Professor James Mason, chairperson.

Professor Simon Donell, independent member.

Mr Tim Chesser, independent member (subsequently chairperson).

Mrs Suzanne Jones-Griffith, independent lay member.

Mrs Ceri Jones, sponsor representative (observing).

Data Monitoring Committee

Dr Dawn Teare (chairperson).

Mr Richard Gibson.

Mrs Smitaa Patel.

Contributions of authors

Matthew L Costa (Professor of Orthopaedic Trauma Surgery, Chief Investigator) participated in the study conception and design, clinical responsibility, writing and reviewing the report.

Juul Achten (Research Manager, Co-Applicant) developed the protocol, is a member of the TMG, and participated in writing and reviewing the report.

Susie Hennings (Senior Project Manager) is a member of the TMG, and participated in writing and reviewing the report.

Nafisa Boota (Trial Co-Ordinator) is a member of the TMG, and participated in writing and reviewing the report.

James Griffin (Research Associate, Trial Statistician) is a member of the TMG, was responsible for the statistical analysis of the trial, and participated in writing and reviewing the report.

Stavros Petrou (Professor of Health Economics, Co-Applicant) participated in the protocol development and writing and reviewing the report, was a member of the TMG and is responsible for the economic analysis of the trial.

Mandy Maredza (Research Fellow, Health Economist) is a member of the TMG, was responsible for the economic analysis of the trial, and participated in writing and reviewing the report.

Melina Dritsaki (Senior Research Fellow, Health Economist) was a former member of the TMG, conducted the early stages of the economic analysis of the trial, and participated in writing and reviewing the report.

Thomas Wood (Clinical Research Fellow) conducted the main radiographic analysis and participated in writing and reviewing the report.

James Masters (Clinical Research Fellow) participated in the review of the operation details and late infection data and writing and reviewing the report.

Ian Pallister (Professor of Trauma Surgery, Co-Applicant) participated in protocol development and writing and reviewing the report.

Sarah E Lamb (Professor of Rehabilitation, Co-Applicant) was a member of the TMG and participated in protocol development and in writing and reviewing the report.

Nick R Parsons (Associate Professor Medical Statistics, Co-Applicant) developed the protocol, is a member of the TMG and is responsible for the statistical analysis of the trial and writing and reviewing the report.

Publications

Mauffrey C, McGuinness K, Parsons N, Achten J, Costa ML. A randomised pilot trial of ‘locking plate’ fixation versus intramedullary nailing for extra-articular fractures of the distal tibia. J Bone Joint Surg 2012;94-B:704.

Achten J, Parsons NR, McGuinness KR, Petrou S, Lamb SE, Costa ML. UK Fixation of Distal Tibia Fractures (UK FixDT): protocol for a randomised controlled trial of ‘locking’ plate fixation versus intramedullary nail fixation in the treatment of adult patients with a displaced fracture of the distal tibia. BMJ Open 2015;5:e009162.

Costa ML, Achten J, Griffin J, Petrou S, Pallister I, Lamb SE, et al. Effect of locking plate fixation vs intramedullary nail fixation on 6-month disability among adults with displaced fracture of the distal tibia: the UK FixDT randomized clinical trial. JAMA 2017;318:1767–76.

Data sharing statement

Requests for data sharing for secondary research purposes can be addressed to the corresponding author.

Patient data

This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care.

Copyright © Queen’s Printer and Controller of HMSO 2018. This work was produced by Costa et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Bookshelf ID: NBK500129

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