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

Willett, K. et al. (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, 15, 79. (doi:10.1186/1471-2474-15-79) (PMID:24621174) (PMCID:PMC4234276)

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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.<p></p> 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 and 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.<p></p> Discussion This multicentre study was open to recruitment July 2010 and recruitment is due to be completed in December 2013.<p></p>

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Briggs, Professor Andrew
Authors: Willett, K., Keene, D. J., Morgan, L., Gray, B., Handley, R., Chesser, T., Pallister, I., Tutton, E., Knox, C., Lall, R., Briggs, A., and Lamb, S. E.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Health Economics and Health Technology Assessment
Journal Name:BMC Musculoskeletal Disorders
Publisher:BioMed Central Ltd.
ISSN:1471-2474
ISSN (Online):1471-2474
Copyright Holders:Copyright © 2014 The Authors
First Published:First published in BMC Musculoskeletal Disorders 15:79
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
484302Comparison of close contact cast (CCC) technique to open surgical internal fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 yearsAndrew BriggsNational Coordinating Cent for Health Tech Assessment (NCC-HTA)07/37/61IHW - HEALTH ECON & TECH ASSESSMENT