Emerging designs in orthopaedics: expertise-based randomized controlled trials.

In this article, we discuss the limitations of conventional randomized controlled trials (RCTs) in the surgical field. Surgeons are often believers in certain surgical techniques and therefore can be reluctant to learn new interventions. In expertise-based trials, the patients are randomized to surgeons with expertise in the intervention under investigation. In conventional RCTs, patients are randomized to an intervention, and surgeons will perform this intervention regardless of whether this is the surgery they typically undertake. Conventional randomization may lead to surgery performed by a less experienced or less motivated surgeon, resulting in differential expertise bias. Expertise-based trials can overcome these limitations if potential pitfalls are taken into account.