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Surgery for Type B Ankle Fracture Treatment: a Combined Randomised and Observational Study (CROSSBAT)
  1. Rajat Mittal,
  2. Ian A Harris,
  3. Sam Adie,
  4. Justine M Naylor
  5. for the CROSSBAT Study Group
    1. Orthopaedic Department, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Australia, Liverpool BC, New South Wales, Australia
    1. Correspondence to Dr Rajat Mittal; rajatmittal.syd{at}gmail.com

    Abstract

    Background Isolated type B ankle fractures with no injury to the medial side are the most common type of ankle fracture.

    Objective This study aimed to determine if surgery is superior to non-surgical management for the treatment of these fractures.

    Methods A pragmatic, multicentre, single-blinded, combined randomised controlled trial and observational study. Setting Participants between 18 and 65 years with a type B ankle fracture and minimal talar shift were recruited from 22 hospitals in Australia and New Zealand. Participants willing to be randomised were randomly allocated to undergo surgical fixation followed by mobilisation in a walking boot for 6 weeks. Those treated non-surgically were managed in a walking boot for 6 weeks. Participants not willing to be randomised formed the observational cohort. Randomisation stratified by site and using permuted variable blocks was administered centrally. Outcome assessors were blinded for the primary outcomes. Primary outcomes Patient-reported ankle function using the American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire (FAOQ) and the physical component score (PCS) of the SF-12v2 General Health Survey at 12 months postinjury. Primary analysis was intention to treat; the randomised and observational cohorts were analysed separately.

    Results From August 2010 to October 2013, 160 people were randomised (80 surgical and 80 non-surgical); 139 (71 surgical and 68 non-surgical) were analysed as intention to treat. 276 formed the observational cohort (19 surgical and 257 non-surgical); 220 (18 surgical and 202 non-surgical) were analysed. The randomised cohort demonstrated that surgery was not superior to non-surgery for the FAOQ (49.8 vs 53.0; mean difference 3.2 (95% CI 0.4 to 5.9), p=0.028), or the PCS (53.7 vs 53.2; mean difference 0.6 (−2.9 to 1.8), p=0.63). 23 (32%) and 10 (14%) participants had an adverse event in the surgical and non-surgical groups, respectively. Similar results were found in the observational cohort.

    Conclusions Surgery is not superior to non-surgical management for 44-B1 ankle fractures in the short term, and is associated with increased adverse events.

    Trial registration number NCT01134094.

    Statistics from Altmetric.com

    Footnotes

    • Collaborators CROSSBAT Study Group: SA, Liverpool Hospital, New South Wales, Australia, sam.adie@gmail.com; Paul Allcock, Lyell McEwin Hospital, South Australia, Australia, Paul.Allcock@health.sa.gov.au; Mustafa Alttahir, Campbelltown Hospital, New South Wales, Australia, Mustafa.alttahir@gmail.com; Zsolt Balogh, John Hunter Hospital, New South Wales, Australia, Zsolt.Balogh@hnehealth.nsw.gov.au; Aziz Bhimani, Wollongong Hospital, New South Wales, Australia, azizb@mac.com; Russell Bourne, Nambour Hospital, Queensland, Australia, bourner@bigpond.com; Richard Boyle, Royal Prince Alfred Hospital, New South Wales, Australia, rich_boyle@hotmail.com; David Broe, Prince of Wales Hospital, New South Wales, Australia, davebroe@lycos.com; Andrew Bucknill, Royal Melbourne Hospital, Victoria, Australia, andrew.bucknill@mh.org.au; Mellick Chehade, Royal Adelaide Hospital, South Australia, Australia, mellick.chehade@adelaide.edu.au; Raymond Chin, Liverpool Hospital, New South Wales, Australia, ray.chin@iinet.net.au; Andrew Clout, Campbelltown Hospital, New South Wales, Australia, a.j.clout@gmail.com; Frank Connon, St George Hospital, New South Wales, Australia, francisconnon@gmail.com; Cameron Cooke, Princess Alexandra Hospital, Queensland, Australia, cameroncooke@lowerlimb.com.au; Chandra Dave, Liverpool Hospital, New South Wales, Australia, chandradave61@gmail.com; Jaykar Dave, Liverpool Hospital, New South Wales, Australia, orthopod@optusnet.com.au; Mark Dekkers, Princess Alexandra Hospital, Queensland, Australia, mark_dekkers@health.qld.gov.au; Herwig Drobetz, Mackay Base Hospital, Queensland, Australia, drobo@aon.at; Richard Farrugia, Royal Melbourne Hospital, Victoria, Australia, richard.farrugia@mh.org.au; Brett Fritsch, Royal Prince Alfred Hospital, New South Wales, Australia, brett@brettfritsch.com.au; Sanjeev Gupta, Royal Prince Alfred Hospital, New South Wales, Australia, sanjeev.gupta@bigpond.com; IAH, Liverpool Hospital, New South Wales, Australia, iaharris1@gmail.com; Chris Hoffman, Wellington Hospital, Wellington, New Zealand, cwhoffman@xtra.co.nz; Michael Holt, Royal Brisbane Hospital, Queensland, Australia, mjholt@wesportsmed.com.au; Mark Horseley, Royal Prince Alfred Hospital, New South Wales, Australia, drmhorsley@gmail.com; Stephen Hutchinson, Prince of Wales Hospital, New South Wales, Australia, shutchin1978@gmail.com; Prajith Jeyaprakash, University of New South Wales, New South Wales, Australia, prajithjeyaprakash@gmail.com; Steven Kent, Wollongong Hospital, New South Wales, Australia, skent1985@gmail.com; Doug King, Princess Alexandra Hospital, Queenslnd, Australia, lloyd_king@health.qld.gov.au; Victoria Ko, Liverpool Hospital, New South Wales, Australia, vwmko@yahoo.com; Vinay Kulkarni, Campbelltown Hospital, New South Wales, Australia, vinay@doctor.id.au; Martin Laird, Liverpool Hospital, New South Wales, Australia, mlaird@gmp.usyd.edu.au; David Lieu, Liverpool Hospital, New South Wales, Australia, david.t.lieu@bigpond.com; Andreas Loefler, Prince of Wales Hospital, New South Wales, Australia, andreasloefler@optusnet.com.au; David Lunz, Prince of Wales Hospital, New South Wales, Australia, footandanklesurgery@yahoo.com; Genni Lynch, Princess Alexandra Hospital, Queensland, Australia, genni.lynch@health.qld.gov.au; Lawrie Malisano, Princess Alexandra Hospital, Queensland, Australia, l.malisano@uq.edu.au; Ian Meakin, Bankstown Hospital, New South Wales, Australia, imeakin@bigpond.net.au; Robert Molnar, Westmead Hospital, New South Wales, Australia, rmolnar@optusnet.com.au; Chris Morrey, Cairns Base Hospital, Queensland, Australia, cmorrey@coc.net.au; Jonathan Mulford, Prince of Wales Hospital, New South Wales, Australia, jonathanmulford1971@gmail.com; Ashish Munsif, University of New South Wales, New South Wales, Australia, z3288258@zmail.unsw.edu.au; Paul Muscio, Cairns Base Hospital, Queensland, Australia, paul_muscio@health.qld.gov.au; Alok Narayan, Wollongong Hospital, New South Wales, Australia, rahintern@yahoo.com.au; Alexander Nicholls, Canberra Hospital, Australian Capital Territory, Australia, alexandernicholls@gmail.com; JMN, University of New South Wales, New South Wales, Australia, Justine.Naylor@sswahs.nsw.gov.au; Fred Nouh, Campbelltown Hospital, New South Wales, Australia, frednouh@yahoo.com.au; Tim O’Carrigan, Campbelltown Hospital, New South Wales, Australia, Dr.Ocarrigan@sbjc.com.au; Ed O'Leary, St George Hospital, New South Wales, Australia, edmundoleary@hotmail.com; Peter Lorentzos, Westmead Hospital, New South Wales, Australia, peter.lorentzos@gmail.com; Sushil Pant, St George Hospital, New South Wales, Australia, sushpant@gmail.com; Diana Perriman, Canberra Hospital, Australian Capital Territory, Australia, Diana.perriman@act.gov.au; Jeffrey Petchell, Royal Prince Alfred Hospital, New South Wales, Australia, jfpetchell@aapt.net.au; Marinis Pirpiris, Royal Melbourne Hospital, Victoria, Australia, surgeons@orthopaedicsvictoria.com.au; Tony Pohl, Royal Adelaide Hospital, South Australia, Australia, anthony.pohl@adelaide.edu.au; Vaibhav Punjabi, Liverpool Hospital, New South Wales, Australia, vaibhav_punjabi@yahoo.com; Sunil Randhawa, Liverpool Hospital, New South Wales, Australia, sunil.randhawa@ausdoctors.net; Matthias Rau, Rockhampton Hospital, Queensland, Australia, gainsgorn@yahoo.com.au; Jennie Scarvell, Canberra Hospital, Australian Capital Territory, Australia, Jennie.Scarvell@canberra.edu.au; Michael Schuetz, Princess Alexandra Hospital, Queensland, Australia, m.schuetz@qut.edu.au; Ben Scwartz, Wollongong Hospital, New South Wales, Australia, drbenschwarz@gmail.com; Paul Smith, Canberra Hospital, Australian Capital Territory, Australia, psmith.admin@orthoact.com.au; Brahman Sivakumar, Campbelltown Hospital, New South Wales, Australia, brahman.sivakumar@gmail.com; Bogdan Solomon, Royal Adelaide Hospital, South Australia, Australia, bogdan.solomon@health.sa.gov.au; Jonathan Spencer, Sir Charles Gairdner Hospital, Western Australia, Australia, jonmfspencer@gmail.com; Paul Stalley, Royal Prince Alfred Hospital, New South Wales, Australia, pdstalley@optusnet.com.au; Mitchell Steele, Wollongong Hospital, New South Wales, Australia, mitchelljsteele@gmail.com; Mayuran Suthersan, Campbelltown Hospital, New South Wales, Australia, msuthersan@gmail.com; Zoltan Szomor, St George Hospital, New South Wales, Australia, zszomor@hotmail.com; Peter Tamblyn, Flinders Medical Centre, South Australia, Australia, Peter.Tamblyn@health.sa.gov.au; Seth Tarrant, John Hunter Hospital, New South Wales, Australia, sethtarrant@gmail.com; Kevin Tetsworth, Royal Brisbane Hospital, Queensland, Australia, kevin_tetsworth@health.qld.gov.au; Sameer Viswanathan, Campbelltown Hospital, New South Wales, Australia, sameerv@me.com; Richard Walker, Liverpool Hospital, New South Wales, Australia, drrmwalker@hotmail.com.

    • Contributors RM and IAH had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis and act as guarantors. RM, IAH, SA, JMN and CROSSBAT Study Group were involved in study, concept, design, acquisition, critical revision of the manuscript for important intellectual content. RM and IAH conducted statistical analysis and are responsible for the data analysis.

    • Funding This trial was supported in part by a grant from the Australian Orthopaedic Association Research Foundation. RM was supported by: a postgraduate scholarship from the National Health and Medical Research Council, Avant Doctors-in-training research scholarship and the Foundation for Surgery John Loewenthal Research Fellowship from the Royal Australasian College of Surgeons. None of the organisations had a direct role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.

    • Competing interests None declared.

    • Ethics approval This study was approved by the following ethics committees:

      • Central Regional Ethics Committee. Reference Number: CEN/12/06/030

      • Ethics of Human Research Committee (TQEH and LMH). Reference Number: 2010130

      • Flinders Clinical Research Ethics Committee. Reference Number: 358.10

      • Hunter New England Human Research Ethics Committee. Reference Number: 09/12/16/5.02

      • Melbourne Health Human Research Ethics Committee. Reference Number: 2010.027

      • Metro South Human Research Ethics Committee. Reference Number: HREC/11/QPAH/145

      • Royal Adelaide Hospital Research Ethics Committee. Reference Number: 100705

      • Sir Charles Gairdner Group Human Research Ethics Committee. Reference Number: 2010-092

      • University of New South Wales Human Research Ethics Committee. Reference Number: HC12187

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Additional data from the study can be obtained from the corresponding author at rajatmittal.syd@gmail.com

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