For patients with a displaced fracture of the distal tibia, is there a clinical and cost-effectiveness difference between ‘locking’ plate fixation and intramedullary nail fixation? (FixDT)
Surgeons in UK trauma centres are randomly assigning patients with broken shinbones just above the ankle to receive either a locking plate or an intramedullary nail, to see which method gets them back on their feet faster. The problem is that both techniques are widely used, but no one knows which one works better for this specific fracture. Plates sit on the outside of the bone and can cause wound problems; nails go inside the bone canal and may lead to more knee pain. Without clear evidence, surgeons choose based on personal preference, and patients may end up with a slower recovery or more complications than necessary. If the trial shows one technique is clearly superior, trauma units across the NHS could adopt that method as standard. That would mean fewer follow-up surgeries, less time off work, and lower costs for the health service. Even a modest reduction in complications would free up operating theatre time and reduce pressure on fracture clinics. The economic analysis will tell the NHS whether the better clinical outcome is also the cheaper option.
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Design: The proposed project is a multi-centre randomised clinical trial comparing two techniques for the operative fixation of fractures of the distal tibia Setting: Patients will be recruited from Major Trauma Centres and Trauma Units accross the UK Target population: Adult patients with an extra-articular fracture of the distal tibia. Health technologies being assessed: Intramedullary nailing versus locking plate fixation Measurements of cost and outcomes: The primary outcome measure for this study is the Disability Rating Index. The DRI score is a validated questionnaire which is self-reported. It consists of 12 items specifically related to function of the lower limb. The secondary outcome measures in this trial are: Olerud and Molander (OMAS) is a self-administered patient questionnaire. It is a good outcome tool for assessing symptoms after an ankle fracture. The score is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living. The scoring system correlates well with parameters considered to summarise the results after this type of injury and is therefore recommended for use in scientific investigations. EQ-5D; a validated, generalised, quality of life questionnaire consisting of 5 domains related to daily activities with a 3-level answer possibility. The combination of answers leads to the QoL score. Complications; all complications will be recorded. Radiographic evaluation; Standard anterior-posterior and lateral radiographs of the tibia and fibula will be taken at baseline, 6-weeks and 12 months after the injury. Resource use will be monitored for the economic analysis. NHS costs associated with each arm of the trial will be estimated using data from the finance departments of the hospitals and services concerned and national sources. The cost consequences following discharge, including NHS costs and patients' out-of-pocket expenses will be recorded via a short questionnaire which will be administered at 3, 6 and 12 months post surgery. Patient self-reported information on service use has been shown to be accurate in terms of the intensity of use of different services.
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