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Review
. 2014 May;3(5):161-8.
doi: 10.1302/2046-3758.35.2000280.

Design and execution of clinical trials in orthopaedic surgery

R Mundi  1 , H Chaudhry  1 , S Mundi  1 , K Godin  1 , M Bhandari  1
Affiliations
Review

Design and execution of clinical trials in orthopaedic surgery

R Mundi et al. Bone Joint Res. 2014 May.

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.

Keywords: Orthopaedics; Randomised Controlled Trials; Study Design.

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Conflict of interest statement

ICMJE Conflict of Interest:None declared

Figures

Fig. 1
Fig. 1
Image demonstrating the hierarchy of evidence
Fig. 2
Fig. 2
Flow diagrams showing conventional randomisation a) versus b) expertise-based randomisation.
Fig. 3
Fig. 3
Diagram showing the multicentre trial committee organisational framework
See this image and copyright information in PMC

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