Treatment Allocation

In orthopedics, randomized controlled trials (RCT) constitute the highest level of evidence (Level 1) and the proportion of articles published based on RCTs in the field of orthopedic sports medicine have steadily risen to approximately 10% during the last 20 years [1]. Conducting an RCT comparing the efficacy of different interventions requires thorough understanding of several key concepts pertinent to the treatment allocation process. Evaluating the effects of interventions requires the carefully planned elimination of potential residual biases, which may lead to invalid conclusions about the efficacy of the therapy being evaluated. Surgical trials are inherently difficult to randomize, and blinding of all individuals involved in the investigation is often impossible. Additionally, potential subjects may be less likely to be open to random allocation of treatment choice, especially when an existing operative or non-operative intervention may already be well established. This chapter provides an overview of the concepts required to conduct patient allocation to treatment groups of a surgical RCT.