A multicentre, randomised, parallel group, superiority study to compare the clinical and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults: protocol for the ACTIVE randomised controlled trial

Aims A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5-7% of all tibial fractures), this injury causes amongst 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. Methods A randomised 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 selfreported assessment of physical disability) at 12 months. This will also be measured at baseline, 3, 6 and 24 months after randomisation. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the EQ-5D-5L score, 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. Discussion The two treatments being compared are the most commonly used for this injury, however there is uncertainty over which is most clinically and cost-effective. ACTIVE is a sufficiently powered and rigorously designed study to inform clinical decisions for the treatment of adults with this injury. Clinical relevance of the paper Recent reviews of the literature and NICE treatment guidance have identified the need for robust RCTs to assess whether internal or external fixation is better for management of pilon fractures. The outcome of this study will directly influence clinical decision-making and health policy by informing international and United Kingdom national guidance, improve outcomes for patients and reduce the financial burden associated with the injury. A systematic review by NICE identified no economic evaluations, which this study is addressing