Comparison of close contact cast (CCC) technique to open surgical reduction and internal fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years

Ankle fractures account for 9% of all fractures with a quarter of these occurring in adults over 60. The short term disability and long-term consequences on restoring independence are considerable in this older age group where multiple co-morbidities are common; and a threefold increase is predicted by 2030. The current treatment options for the older patient are open reduction and internal fixation (ORIF) and traditional moulded plaster of Paris but both are associated with complications including malunion and soft tissue healing. We will compare ORIF with a modification of the traditional casting treatment - close contact casting (CCC) which provides better fracture stabilisation potential and lower skin damage risk. It is a technique developed from the "total contact casting" used extensively and successfully for more than 20 years in treating leg ulcers in diabetics who have the frailest of skin. Participants will be randomised to receive ORIF or CCC after emergency admission for surgery for displaced unstable ankle fractures in the Trauma and Orthopaedic Surgery Departments of a minimum of 20 NHS acute hospitals throughout the UK. Ankle fracture healing takes 6-8 weeks and recovery is achieved to a steady state by 6 months; this defines the study duration and time points for data collection in this trial. The 6 month review will be undertaken to monitor changes in mobility, function, health related quality of life, complication rates, and resource use associated with each of the interventions. That review will be conducted face to face by an assessor blinded to the intervention. The parallel economic evaluation will consider both an NHS perspective and a broader societal perspective including the individual and their family.