Non-inferiority Trials for Orthopaedic Implants

S. Raymond Golish, MD, PhD, and Paul A. Anderson, MD

An increasing trend in randomized controlled trials (RCTs), specifically those involving orthopaedic implants, is the use of non-inferiority trials. In these trials, a novel treatment is compared to a clinically established treatment to show that the effect of the novel treatment is not inferior to—or at least within a small margin—the effect of the established treatment.

Although non-inferiority trials can be valuable, interpreting the results may be challenging for clinicians assessing their implications for patient care, regulators, and payers making coverage decisions.

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