Visualizing the randomized sham-controlled trial in orthopedic research: proposed steps to conducting a total knee arthroplasty randomized controlled trial

Abstract

Performed more than 600,000 times annually in the USA alone, total knee arthroplasty is the one of the most common and costly elective operations in the world. A primary total knee arthroplasty is generally an elective procedure, for which total index hospitalization costs are estimated around $30,000 USD. Roughly four in five patients declare they are satisfied postoperatively, justifying the procedure’s frequency and high costs. It is sobering to realize, however, that the evidence base in favor of this procedure remains circumstantial. We as a profession lack randomized trials showing a subjective improvement over placebo intervention. We argue for the necessity of sham-controlled surgical trials in this setting and provide a surgical atlas showing how a sham operation may be performed.