Details of HTA project in progress
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Primary Research (e.g. trial) |
Project title: |
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 |
Project ref: |
07/37/61 |
Cost: |
£2,260,183 |
Chief Investigator : |
Professor Keith Willett, Professor of Orthopaedic Trauma Surgery, Trauma Unit, University of Oxford |
Start Date: |
January 2010 |
Estimated date of publication in HTA journal series: |
Early 2016. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
25% of those who present with an ankle fracture are over the age of 60. The proven treatments suitable in young patients are not necessarily appropriate in later life. The ankle bones, leg circulation and skin quality all become more fragile with age. To achieve the optimum result in treating ankle fractures, the key objective must be to ensure the bones around the ankle joint heal in the best position to maintain function. For most patients, this requires an operation to set the bones back into position by inserting a metal plate and screws. However, some patients may be treated by manipulating the bones back into position under anaesthesia and then applying a close contact cast, which is a standard plaster cast applied by a specialised technique. Both of these treatments have advantages and disadvantages in the older patient. The plates and screws are good at holding the exact position but can fail if the bone is weak or if the surgical wound does not heal or becomes infected. The alternative, manipulation and a plaster cast, has been found to be less good at holding the position in some people. It can also cause skin problems from the pressure of the plaster. In the past, most patients have been treated with plate and screw surgery. However, a plaster cast technique developed to treat diabetic patients who have the very poorest skin has now been sucessfully modified for use in older patients with unstable ankle fractures. The purpose of this study is to determine whether this modified cast treatment using a 'close contact cast' is equivalent to the operation using plates and screws, i.e. it gives the same results without the need for open surgery and the risks of wound healing problems and infection. We will test the results by comparing healing of the bone and skin and how well theankle moves and how well the patient is managing overall 6 months after injury. |
Project Abstract: |
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. |
ISRCTN* number: | ISRCTN 04180738 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN04180738 |
Project Protocol: |
Project protocol (pdf format, 322 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1781 |
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