title: Design and execution of clinical trials in orthopaedic surgery.
abstract: High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding. Cite this article: Bone Joint Res 2014;3:161-8.
authors.affiliation: McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON L8L 8E7, Canada.
authors.forename: R
authors.initials: R
authors.lastname: Mundi
authors.affiliation: McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON L8L 8E7, Canada.
authors.forename: H
authors.initials: H
authors.lastname: Chaudhry
authors.affiliation: McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON L8L 8E7, Canada.
authors.forename: S
authors.initials: S
authors.lastname: Mundi
authors.affiliation: McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON L8L 8E7, Canada.
authors.forename: K
authors.initials: K
authors.lastname: Godin
authors.affiliation: McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON L8L 8E7, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Bhandari
keywords: Orthopaedics; Randomised Controlled Trials; Study Design