Operative versus non-operative treatment for closed, displaced, intra-articular fractures of the calcaneus: randomised controlled trialBMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g4483 (Published 24 July 2014) Cite this as: BMJ 2014;349:g4483
- Damian Griffin, professor of trauma and orthopaedic surgery,
- Nick Parsons, senior research fellow in medical statistics,
- Ewart Shaw, associate professor in statistics,
- Yuri Kulikov, clinical research fellow,
- Charles Hutchinson, professor of clinical imaging,
- Margaret Thorogood, professor of epidemiology,
- Sarah E Lamb, professor of rehabilitation
- for the UK Heel Fracture Trial (UK HeFT) investigators
- 1Warwick Medical School and Department of Statistics, University of Warwick, and University Hospital of Coventry and Warwickshire NHS Trust, Coventry, UK
- Correspondence to: D Griffin Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK
- Accepted 25 June 2014
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.
We thank Bernard Meggitt and David Johns who stimulated our interest in calcaneal fractures; Sarah Meredith, Richard Lilford, Richard Buckley, and Roger Atkins who influenced the design of the trial; the scientific committees of the British Orthopaedic Foot and Ankle Society and the British Trauma Society who supported the trial; and the participants who agreed to take part.
UK HeFT investigators
Clinicians: Andrew Robinson (Addenbrooke’s University Hospital Cambridge: ADH), Mike Hennessy, Simon Platt (Arrowe Park Hospital: APH), Clifford Butcher (Aintree University Hospital: AUH), James Ramos (Birmingham Heartlands Hospital: BHH), Declan O’Doherty, Sandeep Hemmadi (University Hospital Wales: CDF), Rick Brown (Cheltenham General Hospital: CGH), Matthew Henderson (Gloucester Royal Hospital: GRH), Tony Hui (James Cook University Hospital: JCH), Mark Phillips (King’s College Hospital: KCH), Peter Giannoudis (Leeds General Infirmary: LGI), Grahame Taylor (Leicester Royal Infirmary: LRI), Andrew Kelly (Musgrove Park Hospital Taunton: MPH), Chris Blundell, Mark Davies (Northern General Hospital Sheffield: NGH), AD Patel (Norfolk and Norwich University Hospital: NNH), Alistair Henderson (Royal Bolton Hospital: RBH), Ian Sharpe (Royal Devon and Exeter Hospital: RDE), Chris Walker (Royal Liverpool Hospital: RLH), John Barr (Royal Victoria Hospital: RVH), Andrew Adair (Ulster Hospital Belfast: ULS), Julian Cooper (Selly Oak Hospital Birmingham: SOH), Matthew Costa, Martin Blakemore (University Hospital Coventry and Warwickshire: UHCW), Patrick Laing, Nilesh Makwana (Wrexham Maelor Hospital: WMH)
Research associates: Troy Douglin (outcome measurement), Lynsey Brown, Sandra Carter, Jeanette Key, Joanne Bennett, Phil Clarke (ADH), Phil Dean, Angela Plant, Kerry Graves, Guy Kussabi (APH), John Moorehead, Jan Czumaj, Marie Williams, Ruth Alnwick, Ruth Lawler (AUH), Alison Miller (Tinsley), Nathan Humphries, Tim Williams (BHH), Paul Zirker, Lars Tiessen (CDF), Elaine Willmore, Sara Shannon, Kathryn Limberick (CGH), Terry Flemons, Helen Williams (GRH), Lucy Micklewright, Birgit Hanusch, Ben Cole, Kelly Willmore (JCH), Debbie Bond, Sarah Branigan (KCH), Nik Kanakaris, Tobias Lindner, Lorna Williams, Simon Aldous (LGI), Emad Mallick, Aashish Gulati, Barry Savage, Sharon Reeves (LRI), Sue Dundh, Lyndsay Osborne, Carole Chillmaid, Matt Beebee, Jenny Pickhaver, Katrina Baker (MPH), Ellen Paling, Chris Marquis, Jon Drabble, Anna Phillips (NGH), Sarah Price, Adele Cooper, Tracey Potter, Nicola Clemmence, Claire Barrett (NNH), Anne Ibberson, Lyndsay Hamlett, Angela Martin (Shore) (RBH), Anna Reffell, Robert Durman, Donna Batten, Laura Clark (RDE), Mat Hood, Michelle Nolan, Helen Haines, Suzy Broadbent, Katy Clay (RLH), Ruth Houston, Sinead McDonald, John McAlister, Denise McAuley, Christine McMillan (RVH), Katharine Dane, Heather McShane, Rachel Toland, Paula Cole (ULS), Jane Mason, Rosalyn Cooke, Stephanie Gommersall (SOH), Rebecca Kearney, Katie McGuinness, Catherine Richmond, Helen Rowlands, Julie Petchey, John Skidmore (UHCW), Jane Evans, Helen Golledge, Cindy Wakenshaw, Ritson Lloyd (WMH)
Trial management team: Juul Achten, research manager, Rose Jarvis and Jaclyn Brown, trial co-ordinators; Jane Stokes and Charlotte Kaye, data managers.
Trial steering committee and data monitoring committee (independent members)
David Marsh (TSC Chair), Ashley Blom, Caroline Doré, Ceri Jones, Lee Shepstone (DMC Chair), Marwan Bukhari, and Alister Hart.
Contributors: DG performed a pilot study and wrote the grant application for this trial. DG, MT, SL, and ES contributed to study design and set up of the trial. DG was the chief investigator, supported by MT and SL. CH was responsible for analysis and reporting of the radiological data. YK was involved in the trial set up and performed the recruitment audit. DG and NP drafted the final report; all of the UK HeFT investigators have been involved in revising the report, and all of the authors have seen and approved the final version. DG is the guarantor for this study.
Funding: UK HeFT was funded by a research grant from Arthritis Research UK (grant No 15964). UK HeFT was jointly sponsored by the University of Warwick and the University Hospitals of Coventry and Warwickshire NHS Trust.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This study was approved by the Oxfordshire research ethics committee A 06/Q1604/58.
Data sharing: The full dataset is available from the corresponding author at.
Transparency: The lead author affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned and registered have been explained.
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