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:
In the UK we have many surgeon inventors – surgeons who innovate and create new ways of doing things, who invent operations, who design new instruments to facilitate surgery or design new implants for using in patients. However truly successful surgeon inventors are a rare breed and they need to develop additional knowledge and skills during their career in order to push forward their devices and innovations. This article reviews my own experiences as a surgeon inventor and the highs and lows over the whole of my surgical career.
