Willett, Keith, Keene, David J., Morgan, Lesley, Gray, Bridget, Handley, Robert, Chesser, Tim, Pallister, Ian, Tutton, Elizabeth, Knox, Christopher R., Lall, Ranjit, Briggs, Andrew H. and Lamb, S. E. (Sallie E.) (2014) Ankle injury management (AIM) : design of a pragmatic multi-centre equivalence randomised controlled trial comparing close contact casting (CCC) to open surgical reduction and internal fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years. BMC musculoskeletal disorders, Volume 15 (Number 1). Article number 79. doi:10.1186/1471-2474-15-79 ISSN 1471-2474.

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Abstract

Background:
Ankle fractures account for 9% of all fractures with a quarter of these occurring in adults over 60 years. The short term disability and long-term consequences of this injury can be considerable. Current opinion favours open reduction and internal fixation (ORIF) over non-operative treatment (fracture manipulation and the application of a standard moulded cast) for older people. Both techniques are associated with complications but the limited published research indicates higher complication rates of fracture malunion (poor position at healing) with casting. The aim of this study is to compare ORIF with a modification of existing casting techniques, Close Contact Casting (CCC). We propose that CCC may offer an equivalent functional outcome to ORIF and avoid the risks associated with surgery.

Methods/Design:
This study is a pragmatic multi-centre equivalence randomised controlled trial. 620 participants will be randomised to receive ORIF or CCC after sustaining an isolated displaced unstable ankle fracture. Participants will be recruited from a minimum of 20 National Health Service (NHS) acute hospitals throughout England and Wales. Participants will be aged over 60 years and be ambulatory prior to injury. Follow-up will be at six weeks and six months after randomisation. The primary outcome is the Olerud & Molander Ankle Score, a functional patient reported outcome measure, at 6 months. Follow-up will also include assessments of mobility, ankle range of movement, health related quality of life and complications. The six-month follow-up will be conducted face-to-face by an assessor blinded to the allocated intervention. A parallel economic evaluation will consider both a health service and a broader societal perspective including the individual and their family. In order to explore patient experience of their treatment and recovery, a purposive sample of 40 patients will also be interviewed using a semi-structured interview schedule between 6-10 weeks post treatment.

Item Type:	Journal Article
Subjects:	R Medicine > RD Surgery
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Ankle -- Fractures -- Treatment, Older people -- Care
Journal or Publication Title:	BMC musculoskeletal disorders
Publisher:	Biomed Central
ISSN:	1471-2474
Official Date:	12 March 2014
Dates:	Date Event 12 March 2014 Published 29 January 2014 Accepted 7 January 2014 Submitted
Volume:	Volume 15
Number:	Number 1
Number of Pages:	9
Article Number:	Article number 79
DOI:	10.1186/1471-2474-15-79
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)
Date of first compliant deposit:	28 December 2015
Date of first compliant Open Access:	28 December 2015
Funder:	National Institute for Health Research (Great Britain) (NIHR)
Grant number:	07/37/61 (NIHR)

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