Design considerations for randomised trials in orthopaedic fracture surgery

Summary In the hierarchy of research designs, the results of randomised controlled trials are considered the highest level of evidence. Randomisation is the only method for controlling for both known and unknown prognostic factors between comparison groups. However, there are a number of challenges to conducting trials to evaluate surgical interventions. These include patient and surgeon preferences, inability to blind surgeons and difficulties blinding patients, difficulties in obtaining adequate sample sizes, and a lack of standardisation of surgical procedures. In this paper we address these issues and offer potential solutions within the context of conducting fracture trials in orthopaedics. Careful planning can help identify methodological issues, promote adaptive study designs, and lower the risk of bias to objectively assess new or existing surgical therapies.