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

These are peer-reviewed supplementary materials for the article 'Visualizing the randomized sham-controlled trial in orthopedic research: proposed steps to conducting a total knee arthroplasty randomized controlled trial' published in the Journal of Comparative Effectiveness Research.Table of Orthopedic Surgical Trials: 1Proposed Surgical Steps for Sham Surgery: 5Proposed Surgical Steps for Intervention Surgery: 12Performed 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.

本数据集为发表于《比较疗效研究杂志》的论文《骨科研究中随机安慰剂对照试验的可视化：进行全膝关节置换随机对照试验的步骤建议》的同行评审补充材料。骨科手术试验表：1. 建议的安慰剂手术步骤：5. 建议的干预手术步骤：仅在美国每年就有超过60万次全膝关节置换手术，它是全球最常见且成本最高的选择性手术之一。一次主要的全膝关节置换手术通常是一种选择性手术，其总住院费用估计约为30,000美元。大约五分之四的患者在术后表示满意，这证明了该手术的高频次和高成本是合理的。然而，令人深思的是，支持这一手术的证据基础仍然是不确定的。我们作为医学界，缺乏显示主观改善超过安慰剂干预的随机试验。我们主张在此环境下进行安慰剂对照手术试验的必要性，并提供了手术图谱，展示了安慰剂手术可能如何实施。