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UK Heel Fracture Trial

Fractures of the calcaneus, or heel bone, make up about 2% of all fractures and are the commonest fracture of the tarsal bones. Some calcaneal fractures are minor injuries, but many are severe, high energy fractures. These more serious injuries usually occur after a fall from a height, often from scaffolding or a ladder, or as a result of a road traffic incident. In 2010, 2721 people in England, and 17 274 in the United States, were admitted to hospital with these serious injuries, typically with an inpatient stay of more than a week. The incidence is even higher in developing countries.

Published Paper

For more information, please download a copy of Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial published in the BMJ.

These calcaneal injuries are destructive, with fracture and displacement of the whole bone and its joint surfaces; the subtalar joint in particular may be severely disrupted. With conservative treatment the fracture fragments usually heal together, but the calcaneus remains deformed, the joint surfaces are incongruous, and the alignment of the leg through the ankle to the heel is lost. Severe, painful osteoarthritis of the subtalar joint often follows. Recovery is prolonged, typically taking two years. Even then, most patients have a painful, stiff, deformed foot, and are unable to wear a normal shoe; walking is painful and many need the assistance of a walking stick. These poor outcomes are especially problematic for the typical patient who is a labourer or outdoor worker, as they are unable to resume their occupation. This affect on working life was recognised as early as 1916: “Ordinarily speaking, the man who breaks his heel bone is done, so far as his industrial future is concerned.” In developing countries especially, this loss of economic potential has a negative effect on patients and their families. In developed countries, healthcare and societal costs are high because of the long hospital stay, extended treatment, delayed or non-return to work, and long term disability benefits.

Conservative, non-operative care includes elevation, application of ice, early mobilisation, and the use of a splint.6 Orthopaedic surgeons have aimed to treat severe calcaneal fractures to accelerate recovery and reduce pain and deformity. In the 1950s, operative treatment with a percutaneous “spike” became popular and was widely performed. In the 1960s, enthusiasm waned because of reported difficulties of the technique. In the 1980s, limited exposure of the subtalar joint and fixation with wires was attempted, but a randomised controlled trial showed no benefit from surgery. In the 1990s, computerised tomography allowed a better understanding of fracture patterns, and new surgical approaches were developed that allowed surgeons to realign the bone fragments, fix them with plates and screws, and restore the subtalar joint. Observational studies of these treatments reported low complication rates and better clinical outcomes than had been observed in historical non-operative series, and this new surgical treatment of severe calcaneal fractures rapidly spread in Europe, the United States, Canada, and Australia. It is now being promoted in developing countries.

Four independent systematic reviews, including a recent Cochrane review, have examined the controlled evidence for the effectiveness of this surgery. All four reviews remarked on the paucity of evidence and the poor quality of studies to date. One suggested that surgery might lead to better functional recovery than conservative care, but all noted the risk of complications after surgery, including infection and the need for reoperation. All concluded that the available evidence is insufficient to choose the best management strategy for these fractures.

The current situation is one of uncertainty. Some orthopaedic surgeons are enthusiastic about this surgery for calcaneal fractures, and recommend it to patients. Others consider the operations to be complex, expensive, risky, and without proved benefit, and so recommend non-operative care. The dilemma of how best to treat such patients is a familiar one in hospitals worldwide; whether a patient who sustains this fracture in the United Kingdom today undergoes surgery depends to an extent on the hospital and the surgeon.

We performed a large, pragmatic, randomised controlled trial in the UK National Health Service to assess whether operative care leads to better outcomes than non-operative care in patients with typical, closed, displaced intra-articular calcaneal fractures over two years after injury.

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Objective

To investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced, intra-articular calcaneal fractures.

Design

Pragmatic, multicentre, two arm, parallel group, assessor blinded randomised controlled trial (UK Heel Fracture Trial).

Setting

22 tertiary referral hospitals, United Kingdom. Participants

151 patients with acute displaced intra-articular calcaneal fractures randomly allocated to operative (n=73) or non-operative (n=78) treatment.

Main outcome measures

The primary outcome measure was patient reported Kerr-Atkins score for pain and function (scale 0-100, 100 being the best possible score) at two years after injury. Secondary outcomes were complications; hindfoot pain and function (American Orthopaedic Foot and Ankle Society score); general health (SF-36); quality of life (EQ-5D); clinical examination; walking speed; and gait symmetry. Analysis was by intention to treat.

Results

95% follow-up was achieved for the primary outcome (69 in operative group and 74 in non-operative group), and a complete set of secondary outcomes were available for 75% of participants. There was no significant difference in the primary outcome (mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group; adjusted 95% confidence interval of difference −7.1 to 7.0) or in any of the secondary outcomes between treatment groups. Complications and reoperations were more common in those who received operative care (estimated odds ratio 7.5, 95% confidence interval 2.0 to 41.8).

Conclusions

perative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus, and the risk of complications was higher after surgery. Based on these findings, operative treatment by open reduction and internal fixation is not recommended for these fractures.

Trial registration

Current Controlled Trials ISRCTN37188541.