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

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% to 7% all tibial fractures), this causes among the worst functional and health outcomes any skeletal injury, with high risk serious complications long-term disability, devastating consequences on patients’ quality life financial prospects. Robust evidence guide treatment currently lacking. This study aims evaluate clinical cost-effectiveness two surgical interventions that are most commonly used treat fractures. Methods randomized controlled trial (RCT) 334 adult patients diagnosed closed type C will be conducted. Internal locking plate fixation compared external frame fixation. The primary outcome endpoint Disability Rating Index (a patient self-reported assessment physical disability) at 12 months. also measured baseline, three, six, 24 months after randomization. Secondary include Olerud Molander Ankle Score (OMAS), five-level EuroQol five-dimenison score (EQ-5D-5L), (including bone healing), resource use, work impact, preference. acceptability treatments design care professionals explored through qualitative methods. Discussion being for however there uncertainty over which clinically cost-effective. Articular Pilon Fracture (ACTIVE) Trial sufficiently powered rigorously designed inform decisions adults injury. Cite article: Bone Jt Open 2021;2(3):150–163.