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Randomized Controlled Trial Multicenter Study Comparative Study
Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trial.
- Damian Griffin, Nick Parsons, Ewart Shaw, Yuri Kulikov, Charles Hutchinson, Margaret Thorogood, Sarah E Lamb, and UK Heel Fracture Trial Investigators.
- Warwick Medical School and Department of Statistics, University of Warwick, and University Hospital of Coventry and Warwickshire NHS Trust, Coventry, UK damian.griffin@warwick.ac.uk.
- BMJ. 2014 Jan 1;349:g4483.
ObjectiveTo investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced, intra-articular calcaneal fractures.DesignPragmatic, multicentre, two arm, parallel group, assessor blinded randomised controlled trial (UK Heel Fracture Trial).Setting22 tertiary referral hospitals, United Kingdom.Participants151 patients with acute displaced intra-articular calcaneal fractures randomly allocated to operative (n=73) or non-operative (n=78) treatment.Main Outcome MeasuresThe 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.Results95% 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).ConclusionsOperative 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.© Griffin et al 2014.
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