Professor Damian Griffin of University of Warwick has recently completed one of the largest randomised controlled trials to be performed in orthopaedic surgery, looking into operative vs. non-operative treatment for heel fractures in the UK. This study is singled out because it was so hard to do – surgeons have strong opinions and the condition occurs infrequently; only around 2% of all fractures are to the heel bone (calcaneus). Many are severe, high-energy fractures, resulting from, for example, falling from a height or a road traffic incident. Surgical treatment began to be widely used following the advent of computerised topography (allowing for better understanding of fractures), and new techniques that allowed bone fragments to be realigned, fixed and restored.
The RCT randomly allocated 151 patients to receive either operative or non-operative treatment. The entry criterion was based on equipoise between surgery and a conservative option. At two year follow-up there were no symptomatic or functional advantages in patients who had undergone operative treatment – there was no significant difference in patient-reported pain and function scores, or in any secondary outcome (complications, hindfoot pain and function, general health, quality of life, clinical examination, walking speed, and gait symmetry). There were, however, significantly more complications and re-operations in the group that received operative treatment. Again, a treatment that makes sense intuitively turns out to do more harm than good.
— Richard Lilford, CLAHRC WM Director
- Griffen D, Parsons N, Kulikov Y, Hutchinson C, Thorogood M, Lamb SE. Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial. BMJ. 2014; 349: g4483.
- Lilford RJ. Ethics of clinical trials from a bayesian and decision analytic perspective: whose equipoise is it anyway? BMJ. 2003; 326: 980-1.