title: 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.
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
  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.
  
  
  CONCLUSIONS
  This multicentre study was open to recruitment July 2010 and recruitment is due to be completed in December 2013.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN04180738.
authors.affiliation: 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. keith.willett@ndorms.ox.ac.uk.
authors.forename: Keith
authors.initials: K
authors.lastname: Willett
authors.forename: David J
authors.initials: DJ
authors.lastname: Keene
authors.forename: Lesley
authors.initials: L
authors.lastname: Morgan
authors.forename: Bridget
authors.initials: B
authors.lastname: Gray
authors.forename: Robert
authors.initials: R
authors.lastname: Handley
authors.forename: Tim
authors.initials: T
authors.lastname: Chesser
authors.forename: Ian
authors.initials: I
authors.lastname: Pallister
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Tutton
authors.forename: Christopher
authors.initials: C
authors.lastname: Knox
authors.forename: Ranjit
authors.initials: R
authors.lastname: Lall
authors.forename: Andrew
authors.initials: A
authors.lastname: Briggs
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Lamb
mesh_terms: D000367:Age Factors; D064386:Ankle Fractures; D000843:Ankle Joint / Q000503:physiopathology / Q000601:surgery*; D001696:Biomechanical Phenomena; D002370:Casts, Surgical / Q000009:adverse effects / Q000191:economics; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004739:England; D005592:Fracture Fixation / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D005593:Fracture Fixation, Internal / Q000009:adverse effects / Q000191:economics; D017102:Fracture Healing; D017048:Health Care Costs; D006801:Humans; D007103:Immobilization / Q000009:adverse effects / Q000379:methods*; D007593:Joint Instability / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000601:surgery*; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life; D016059:Range of Motion, Articular; D020127:Recovery of Function; D012107:Research Design; D013222:State Medicine; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014852:Wales