A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures. A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.Aims
Methods
Diagnostic and operative codes are routinely collected for every patient admitted to hospital in the English NHS. Data on post-operative complications following foot and ankle surgery have not previously been available in large numbers. Data on symptomatic venous thromboembolism events and mortality within 90 days were extracted for patients undergoing fixation of an ankle fracture, first metatarsal osteotomy, hindfoot fusions and total ankle replacement over a period of 42 months. For ankle fracture surgery (45 949 patients), the rates of deep-vein thrombosis (DVT), pulmonary embolism and mortality were 0.12%, 0.17% and 0.37%, respectively. For first metatarsal osteotomy (33 626 patients), DVT, pulmonary embolism and mortality rates were 0.01%, 0.02% and 0.04%, and for hindfoot fusions (7033 patients) the rates were 0.03%, 0.11% and 0.11%, respectively. The rate of pulmonary embolism in 1633 total ankle replacement patients was 0.06%, and there were no recorded DVTs and no deaths. Statistical analysis could only identify risk factors for venous thromboembolic events of increasing age and multiple comorbidities following fracture surgery. Venous thromboembolism following foot and ankle surgery is extremely rare, but this subset of fracture patients is at a higher risk. However, there is no evidence that thromboprophylaxis reduces this risk, and these national data suggest that prophylaxis is not required in most of these patients.
