Design and execution of clinical trials in orthopaedic surgery

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 surg...

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Bibliographic Details
Published in:Bone & joint research 2014-05, Vol.3 (5), p.161-168
Main Authors: Mundi, R, Chaudhry, H, Mundi, S, Godin, K, Bhandari, M
Format: Article
Language:English
Subjects:
Instructional Review–General Orthopaedics
Orthopaedics
Randomised Controlled Trials
Study Design
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Summary: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.
ISSN:2046-3758
2046-3758
DOI:10.1302/2046-3758.35.2000280