Griffin et al should be congratulated for the successful conclusion of the UK HeFT trial. I have been looking forward to seeing the results as I work in one of the trial recruiting hospitals, although not as a triallist, and have examined a PhD thesis generated from it (Kulikov). Randomised surgical trials are always difficult to undertake, and easy to find fault with. Compared to drugs trials success from a surgical intervention involves the entire package of care, of which the operation is only a part.
The other major problem is that surgeons, by nature, tend to have certainty. One of the important innovations in this trial, presented in the PhD, was how treatment was allocated, however this does not appear to be reported in the text of the paper. Put simply, a panel of the participating surgeons considered each patient and made a decision about how certain they felt about one treatment or the other. A formula was then applied to decide how much certainty or uncertainty there was in the management. At a certain level of uncertainty "equipoise" was concluded, and therefore the patient could be ethically randomised and was therefore eligible. This means that where the panel felt the patient should be treated conservatively, or be treated operatively, then they were not randomised.
This does not appear in the details of the flow diagram. If only those where there was equipoise were recruited it is not strictly correct to state, as on the front cover of the journal, "Calcaneal fractures: surgery provides no benefits" as the study was only on those patients where surgeons were not certain. Scammell's editorial concludes that "surgery for closed, displaced, intra-articular calcaneal fractures without gross displacement can no longer be justified" clearly hinting that she feels that there is a role for significantly displaced ones. It would be helpful if the authors could confirm how allocation was undertaken.
Griffin D, Parsons N, Shaw E, 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.
Kulikov Y. Patient Recruitment in Challenging Surgical Trials. PhD Thesis University of Warwick 2014.
Scammell BE. Calcaneal Fractures (Editorial). BMJ 2014; 349: g4779.
Competing interests: External examiner for PhD based on this study. Member, National Institute for Health Research Trauma Trials Network