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Open Access Study protocol

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

Keith Willett1*, David J Keene1, Lesley Morgan1, Bridget Gray1, Robert Handley2, Tim Chesser3, Ian Pallister4, Elizabeth Tutton1, Christopher Knox5, Ranjit Lall5, Andrew Briggs6 and Sarah E Lamb15

Author Affiliations

1 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Kadoorie Centre for Critical Care Research and Education, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK

2 Oxford Trauma Service, John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Oxford OX3 9DU, UK

3 Department of Orthopaedic Surgery, Frenchay Hospital, North Bristol NHS Trust, Bristol BS16 1LE, UK

4 Department of Orthopaedic Surgery, Morriston Hospital, Swansea SA6 6NL, UK

5 Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK

6 Faculty of Medicine, University of Glasgow, Glasgow G12 8RZ, UK

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BMC Musculoskeletal Disorders 2014, 15:79  doi:10.1186/1471-2474-15-79

Published: 12 March 2014

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.

Discussion

This multicentre study was open to recruitment July 2010 and recruitment is due to be completed in December 2013.

Trial registration

Current Controlled Trials ISRCTN04180738.

Keywords:
Ankle; Fracture; Trauma; Orthopaedics; Cast; Surgery; Conservative; Operative; Adult