Design and execution of clinical trials in orthopaedic surgery Journal Articles

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

• Mundi, R
• Chaudhry, H
• Mundi, S
• Godin, K
• Bhandari, Mohit

status

• published 

publication date

• May 2014

has subject area

• 1103 Clinical Sciences (FoR)
• 1106 Human Movement and Sports Sciences (FoR)

published in

• Bone and Joint Research  Journal

keywords

• Orthopaedics
• Randomised Controlled Trials
• Study Design

Digital Object Identifier (DOI)

• 10.1302/2046-3758.35.2000280

start page

• 161

end page

• 168

volume

• 3

issue

• 5