Mr L. Parker, Senior Foot and Ankle Fellow, North Bristol NHS Trust
Mr I. G. Winson, Consultant Orthopaedic Foot and Ankle Surgeon, North Bristol NHS Trust, Past President European Foot and Ankle Society, British Orthopaedic Association Vice President Elect
We read with interest the report by the UK Heel Fracture Trial, after noting the rather alarming headline on the cover of the BMJ “Calcaneal fractures: surgery provides no benefits”.(1) In a journal with a wide readership, including the general public and journalists from more mainstream media there is a need for responsible publishing, not for headlines which will influence the thoughts of commissioners yet bear no resemblance to the scientific content of the journal. The results of the UK Heel Fracture Trial have been hotly anticipated but probably do little to guide our treatment of closed displaced calcaneal fractures. The trial certainly does NOT conclude that “surgery provides no benefit” and actually reviews a very specific group of selected patients with fractures that one would expect to have had acceptable outcome regardless of the treatment.
The major problem with the work is the cases. As highlighted in the full on-line article only 502 of 2006 patients with calcaneal fractures were deemed eligible for randomization in this trial and 151 of those agreed to take part in the study- a total of 7.5% of all of the calcaneal fractures attending the centres involved in the study. The trials exclusion criteria removes the outcomes of a significant volume of what would be considered “run of the mill” calcaneal fractures, such as those with gross displacement and ipsilateral lower limb trauma. The small number of fracture cases remaining after the exclusion criteria and the participation rate of 30% are reflected in the fact that 27 surgeons in 22 different hospitals only operated on a median of 2 fractures for this study. In light of this, it is a complete mis-representation of the research to publicise the trial on the cover of the BMJ as though its conclusions apply to all calcaneal fractures.
The infection rate of 19% of the surgically treated patients is hugely worrying. This is by no means the standard wound complication rate and raises questions about the nature of the surgery performed. Furthermore, with the advent of arthroscopically-assisted surgery and minimal access reduction techniques we have advanced considerably in minimizing the impact of the soft tissue trauma and consequent wound complications and infections that have blighted this type of surgery in years past.
In contrast to previous observations that initial fracture severity and fracture severity classifications do correlate with clinical outcome (2) the authors were unable to power the trial to investigate this, instead estimating through regression analysis but managing to draw the conclusion that there was no evidence (p=0.697) that the effect of surgery was affected by fracture severity. It is completely inappropriate to conclude this based on the selecting out of the more severe fractures requiring surgery as this trial has done.
One of the main justifications for undertaking surgery on displaced intra-articular calcaneal fractures is that surgery may delay the onset of disabling subtalar joint osteoarthritis. CT scanning was undertaken to assess the adequacy of reduction post-operatively in 72% of patients who had undergone surgery. We question the threshold of “no more than 2 mm articular step” in the subtalar joint as being indicative of a satisfactory reduction- indeed the indication for surgery itself would include such joint displacement. Considering there is evidence that restoration of Bohler’s angle and articular surface congruency may provide superior outcome , this data requires further interrogation.
The authors do highlight that their results may change over the duration of patient follow-up. In a similar muticentre randomized controlled trial in Sweden, clinical scores between operatively and non-operatively treated calcaneal fractures were similar at one year, however in the same cohort of patients there was a tendency toward improved Visual Analogue pain scores and the physical component of the SF-36 score at 8-12 years follow-up in addition to reduced incidence of radiographically detectable subtalar joint osteoarthritis in the operated group (a relative risk reduction of 41%).(3) A similar post hoc analysis of the Swedish study group has shown that there is a statistically significant correlation between the best results and surgery at 10 years.(4) Clearly therefore based on the two year results of the UK Heel fracture trial it is inappropriate to conclude that surgery provides no benefit to the treatment of calcaneal fractures.
1: Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial. BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g4483 (Published 24 July 2014). BMJ 2014;349:g4483
2: Rammelt S, Zwipp H, Schneiders W. et al. Severity of injury predicts subsequent function in surgically treated displaced intraarticular calcaneal fractures. Clin Orthop Relat Res. 471(9):2885-98, 2013
3: Agren PH, Wretenberg P, Sayed-Noor AS. Operative versus non-operative treatment of displaced intra-articular calcaneal fractures- a prospective, randomized, controlled multicenter trial. J Bone Joint Surg Am 95: 1351-7, 2013
4: Agren PH, Mukka S, Tullberg T, Wretenberg P, Sayed-Noor AS. Factors Affecting Long-Term Treatment Results of Displaced Intra-Articular Calcaneal Fractures. A Post-hoc Analysis of a Prospective, Randomized, Controlled Multicenter Trial. J Orthop Trauma. 2014 May 12. [Epub ahead of print]
Competing interests: No competing interests