No difference at 2 years out for patients with displaced calcaneal fractures vs non-operative and physical therapy.
Patients were eligible if they were aged 18 years or more, and able to give informed consent, with a recent (less than three weeks) closed, intra-articular, displaced (subtalar joint posterior facet displacement of at least 2 mm) calcaneal fracture. Exclusions were gross deformity of the hindfoot (which we called fibula impingement and defined as: such severe calcaneal varus that after healing patients would walk on the tip of the fibula; or such severe calcaneal valgus that the tip of the fibula was embedded in the lateral wall of the calcaneus).
Operative treatment was open reduction and internal fixation within three weeks of injury, performed through an extensile lateral approach, with interfragmentary screws and application of a neutralisation plate or plates to the lateral wall of the calcaneus. This surgical technique was chosen because it is considered to be the standard of care in the United States, United Kingdom, and most centres around the world.
Non-operative treatment began with gentle mobilisation of the ankle and subtalar joints as pain allowed, and the fitting of a removable splint. Participants were mobilised and non-weight bearing (on the affected side) for six weeks, followed by six weeks partial weight bearing. They were managed by the same standardised physiotherapy rehabilitation regimen as the operative treatment arm. Compliance with the physiotherapy protocol was assessed by a proforma completed by the treating physiotherapist, and by questions in the patient assessments at six weeks and six months.
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 Operative 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.
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