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, UK Heel Fracture Trial Investigators, Andrew Robinson, Mike Hennessy, Simon Platt, Clifford Butcher, James Ramos, Declan O'Doherty, Sandeep Hemmadi, Rick Brown, Matthew Henderson, Tony Hui, Mark Phillips, Peter Giannoudis, Grahame Taylor, Andrew Kelly, Chris Blundell, Mark Davies, A D Patel, Alistair Henderson, Ian Sharpe, Chris Walker, John Barr, Andrew Adair, Julian Cooper, Matthew Costa, Martin Blakemore, Patrick Laing, Nilesh Makwana, Troy Douglin, Lynsey Brown, Sandra Carter, Jeanette Key, Joanne Bennett, Phil Clarke, Phil Dean, Angela Plant, Kerry Graves, Guy Kussabi, John Moorehead, Jan Czumaj, Marie Williams, Ruth Alnwick, Ruth Lawler, Alison Miller, Nathan Humphries, Tim Williams, Paul Zirker, Lars Tiessen, Elaine Willmore, Sara Shannon, Kathryn Limberick, Terry Flemons, Helen Williams, Lucy Micklewright, Birgit Hanusch, Ben Cole, Kelly Willmore, Debbie Bond, Sarah Branigan, Tobias Lindner, Lorna Williams, Simon Aldous, Emad Mallick, Aashish Gulati, Barry Savage, Sharon Reeves, Sue Dundh, Lyndsay Osborne, Carole Chillmaid, Matt Beebee, Jenny Pickhaver, Katrina Baker, Ellen Paling, Chris Marquis, Jon Drabble, Anna Phillips, Sarah Price, Adele Cooper, Tracey Potter, Nicola Clemmence, Claire Barrett, Anne Ibberson, Lyndsay Hamlett, Angela Martin, Anna Reffell, Robert Durman, Donna Batten, Laura Clark, Mat Hood, Michelle Nolan, Helen Haines, Suzy Broadbent, Katy Clay, Ruth Houston, Sinead McDonald, John McAlister, Denise McAuley, Christine McMillan, Katharine Dane, Heather McShane, Rachel Toland, Paula Cole, Jane Mason, Rosalyn Cooke, Stephanie Gommersall, Rebecca Kearney, Katie McGuinness, Catherine Richmond, Helen Rowlands, Julie Petchey, John Skidmore, Jane Evans, Helen Golledge, Cindy Wakenshaw, Ritson Lloyd, Juul Achten, Rose Jarvis, Jaclyn Brown, Jane Stokes, Charlotte Kaye, David Marsh, Ashley Blom, Caroline Doré, Ceri Jones, Lee Shepstone, Marwan Bukhari, Alister Hart, Damian Griffin, Nick Parsons, Ewart Shaw, Yuri Kulikov, Charles Hutchinson, Margaret Thorogood, Sarah E Lamb, UK Heel Fracture Trial Investigators, Andrew Robinson, Mike Hennessy, Simon Platt, Clifford Butcher, James Ramos, Declan O'Doherty, Sandeep Hemmadi, Rick Brown, Matthew Henderson, Tony Hui, Mark Phillips, Peter Giannoudis, Grahame Taylor, Andrew Kelly, Chris Blundell, Mark Davies, A D Patel, Alistair Henderson, Ian Sharpe, Chris Walker, John Barr, Andrew Adair, Julian Cooper, Matthew Costa, Martin Blakemore, Patrick Laing, Nilesh Makwana, Troy Douglin, Lynsey Brown, Sandra Carter, Jeanette Key, Joanne Bennett, Phil Clarke, Phil Dean, Angela Plant, Kerry Graves, Guy Kussabi, John Moorehead, Jan Czumaj, Marie Williams, Ruth Alnwick, Ruth Lawler, Alison Miller, Nathan Humphries, Tim Williams, Paul Zirker, Lars Tiessen, Elaine Willmore, Sara Shannon, Kathryn Limberick, Terry Flemons, Helen Williams, Lucy Micklewright, Birgit Hanusch, Ben Cole, Kelly Willmore, Debbie Bond, Sarah Branigan, Tobias Lindner, Lorna Williams, Simon Aldous, Emad Mallick, Aashish Gulati, Barry Savage, Sharon Reeves, Sue Dundh, Lyndsay Osborne, Carole Chillmaid, Matt Beebee, Jenny Pickhaver, Katrina Baker, Ellen Paling, Chris Marquis, Jon Drabble, Anna Phillips, Sarah Price, Adele Cooper, Tracey Potter, Nicola Clemmence, Claire Barrett, Anne Ibberson, Lyndsay Hamlett, Angela Martin, Anna Reffell, Robert Durman, Donna Batten, Laura Clark, Mat Hood, Michelle Nolan, Helen Haines, Suzy Broadbent, Katy Clay, Ruth Houston, Sinead McDonald, John McAlister, Denise McAuley, Christine McMillan, Katharine Dane, Heather McShane, Rachel Toland, Paula Cole, Jane Mason, Rosalyn Cooke, Stephanie Gommersall, Rebecca Kearney, Katie McGuinness, Catherine Richmond, Helen Rowlands, Julie Petchey, John Skidmore, Jane Evans, Helen Golledge, Cindy Wakenshaw, Ritson Lloyd, Juul Achten, Rose Jarvis, Jaclyn Brown, Jane Stokes, Charlotte Kaye, David Marsh, Ashley Blom, Caroline Doré, Ceri Jones, Lee Shepstone, Marwan Bukhari, Alister Hart

Abstract

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.

Conflict of interest statement

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.

© Griffin et al 2014.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4793586/bin/grid017770.f1_default.jpg
Fig 1 Trial profile
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4793586/bin/grid017770.f2_default.jpg
Fig 2 Kerr-Atkins scores for calcaneal fracture and 95% confidence intervals at baseline (before injury) and 6, 12, 18, and 24 months after injury for all participants and for those with type 2 and with type 3 or 4 fractures (Sanders classification)
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4793586/bin/grid017770.f3_default.jpg
Fig 3 Range of motion in degrees (group means and 95% confidence intervals) and gait symmetry data at 24 months post-injury for injured and non-injured feet
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4793586/bin/grid017770.f4_default.jpg
Fig 4 Gait metrics (group means and 95% confidence intervals) at 24 months post-injury for injured and non-injured feet

References

    1. Mitchell MJ, McKinley JC, Robinson CM. The epidemiology of calcaneal fractures. Foot (Edinb) 2009;19:197-200.
    1. NHS Information Centre. Hospital episode statistics: 2000-2012. .
    1. Agency for Healthcare Research and Quality. HCUP nationwide inpatient sample. 2010. .
    1. Dhillon MS, Aggarwal S, Dhatt S, Jain M. Epidemiological pattern of foot injuries in India: preliminary assessment of data from a tertiary hospital. J Postgrad Med Edu Res 2012;46:144-7.
    1. Tadros AM, Eid HO, Abu-Zidan FM. Epidemiology of foot injury in a high-income developing country. Injury 2010;41:137-40.
    1. Crosby LA, Fitzgibbons T. Intraarticular calcaneal fractures. Results of closed treatment. Clin Orthop Relat Res 1993;May (290):47-54.
    1. Cotton F, Henderson F. Results of fracture of the os calcis. J Bone Joint Surg Am 1916;s2-14:290-8.
    1. Schepers T, van Lieshout EMM, van Ginhoven TM, Heetveld MJ, Patka P. Current concepts in the treatment of intra-articular calcaneal fractures: results of a nationwide survey. Int Orthop 2008;32:711-5.
    1. Essex-Lopresti P. The mechanism, reduction technique, and results in fractures of the os calcis. Br J Surg 1952;39:395-419.
    1. Charnley J. The closed treatment of common fractures. Cambridge University Press, 2003.
    1. Ibrahim T, Rowsell M, Rennie W, Brown AR, Taylor GJ, Gregg PJ. Displaced intra-articular calcaneal fractures: 15-year follow-up of a randomised controlled trial of conservative versus operative treatment. Injury 2007;38:848-55.
    1. Eastwood DM, Langkamer VG, Atkins RM. Intra-articular fractures of the calcaneum. Part II: open reduction and internal fixation by the extended lateral transcalcaneal approach. J Bone Joint Surg Br 1993;75:189-95.
    1. Tennent TD, Calder PR, Salisbury RD, Allen PW, Eastwood DM. The operative management of displaced intra-articular fractures of the calcaneum: a two-centre study using a defined protocol. Injury 2001;32:491-6.
    1. Jain S, Jain AK, Kumar I. Outcome of open reduction and internal fixation of intraarticular calcaneal fracture fixed with locking calcaneal plate. Chin J Traumatol 2013;16:355-60.
    1. Bajammal S, Tornetta P, Sanders D, Bhandari M. Displaced intra-articular calcaneal fractures. J Orthop Trauma 2005;19:360-4.
    1. Gougoulias N, Khanna A, McBride DJ, Maffulli N. Management of calcaneal fractures: systematic review of randomized trials. Br Med Bull 2009;92:153-67.
    1. Jiang N, Lin Q-R, Diao X-C, Wu L, Yu B. Surgical versus nonsurgical treatment of displaced intra-articular calcaneal fracture: a meta-analysis of current evidence base. Int Orthop 2012;36:1615-22.
    1. Bruce J, Sutherland A. Surgical versus conservative interventions for displaced intra-articular calcaneal fractures. Cochrane Database Syst Rev 2013;1:CD008628.
    1. Folk JW, Starr AJ, Early JS. Early wound complications of operative treatment of calcaneus fractures: analysis of 190 fractures. J Orthop Trauma 1999;13:369-72.
    1. Sanders R, Fortin P, DiPasquale T, Walling A. Operative treatment in 120 displaced intraarticular calcaneal fractures. Results using a prognostic computed tomography scan classification. Clin Orthop Relat Res 1993;May(290):87-95.
    1. Epstein N, Chandran S, Chou L. Current concepts review: intra-articular fractures of the calcaneus. Foot Ankle Int 2012;33:79-86.
    1. Kerr PS, Prothero DL, Atkins RM. Assessing outcome following calcaneal fracture: a rational scoring system. Injury 1996;27:35-8.
    1. Pozo JL, Kirwan EO, Jackson AM. The long-term results of conservative management of severely displaced fractures of the calcaneus. J Bone Joint Surg Br 1984;66:386-90.
    1. Brooks R. EuroQol: the current state of play. Health Policy 1996;37:53-72.
    1. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.
    1. Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot midfoot hallux and lesser toes. Foot Ankle Int 1994;15:349-53.
    1. Menadue C, Raymond J, Kilbreath SL, Refshauge KM, Adams R. Reliability of two goniometric methods of measuring active inversion and eversion range of motion at the ankle. BMC Musculoskelet Disord 2006;7:60.
    1. Thornes BS, Collins AL, Timlin M, Corrigan J. Outcome of calcaneal fractures treated operatively and non-operatively. the effect of litigation on outcomes. Ir J Med Sci 2002;171:155-7.
    1. Buckley R, Tough S, McCormack R, Pate G, Leighton R, Petrie D, et al. Operative compared with nonoperative treatment of displaced intra-articular calcaneal fractures: a prospective randomized controlled multicenter trial. J Bone Joint Surg Am 2002;84-A:1733-44.
    1. Brookes ST, Whitley E, Peters TJ, Mulheran PA, Egger M, Davey Smith G. Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health Technol Assess 2001;5:1-56.
    1. Robinson RO, Herzog W, Nigg BM. Use of force platform variables to quantify the effects of chiropractic manipulation on gait symmetry. J Manipulative Physiol Ther 1987;10:172-6.
    1. Jenkinson C, Stewart-Brown S, Petersen S, Paice C. Assessment of the SF-36 version 2 in the United Kingdom. J Epidemiol Community Health 1999;53:46-50.
    1. Holecek T, Dedek T. Open versus closed method of operative treatment of calcaneal fractures. Eur J Trauma 2002;28(Supp 1):84.
    1. O’Farrell DA, O’Byrne JM, McCabe JP, Stephens MM. Fractures of the os calcis: improved results with internal fixation. Injury 1993;24:263-5.
    1. Thordarson DB, Krieger LE. Operative vs. nonoperative treatment of intra-articular fractures of the calcaneus: a prospective randomized trial. Foot Ankle Int 1996;17:2-9.
    1. Zelen M. A new design for randomized clinical trials. N Engl J Med 1979;300:1242-5.
    1. Agren P-H, Wretenberg P, Sayed-Noor AS. Operative versus nonoperative treatment of displaced intra-articular calcaneal fractures: a prospective randomized controlled multicenter trial. J Bone Joint Surg Am 2013;95:1351-7.

Source: PubMed

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