Surgery for Type B Ankle Fracture Treatment: a Combined Randomised and Observational Study (CROSSBAT)

Rajat Mittal, Ian A Harris, Sam Adie, Justine M Naylor, CROSSBAT Study Group, Paul Allcock, Mustafa Alttahir, Zsolt Balogh, Aziz Bhimani, Russell Bourne, Richard Boyle, David Broe, Andrew Bucknill, Mellick Chehade, Raymond Chin, Andrew Clout, Frank Connon, Cameron Cooke, Chandra Dave, Jaykar Dave, Mark Dekkers, Herwig Drobetz, Richard Farrugia, Brett Fritsch, Sanjeev Gupta, Chris Hoffman, Michael Holt, Mark Horseley, Stephen Hutchinson, Prajith Jeyaprakash, Steven Kent, Doug King, Victoria Ko, Vinay Kulkarni, Martin Laird, David Lieu, Andreas Loefler, David Lunz, Genni Lynch, Lawrie Malisano, Ian Meakin, Robert Molnar, Chris Morrey, Jonathan Mulford, Ashish Munsif, Paul Muscio, Alok Narayan, Alexander Nicholls, Fred Nouh, Tim O'Carrigan, Ed O'Leary, Peter Lorentzos, Sushil Pant, Diana Perriman, Jeffrey Petchell, Marinis Pirpiris, Tony Pohl, Vaibhav Punjabi, Sunil Randhawa, Matthias Rau, Jennie Scarvell, Michael Schuetz, Ben Scwartz, Paul Smith, Brahman Sivakumar, Bogdan Solomon, Jonathan Spencer, Paul Stalley, Mitchell Steele, Mayuran Suthersan, Zoltan Szomor, Peter Tamblyn, Seth Tarrant, Kevin Tetsworth, Sameer Viswanathan, Richard Walker, Rajat Mittal, Ian A Harris, Sam Adie, Justine M Naylor, CROSSBAT Study Group, Paul Allcock, Mustafa Alttahir, Zsolt Balogh, Aziz Bhimani, Russell Bourne, Richard Boyle, David Broe, Andrew Bucknill, Mellick Chehade, Raymond Chin, Andrew Clout, Frank Connon, Cameron Cooke, Chandra Dave, Jaykar Dave, Mark Dekkers, Herwig Drobetz, Richard Farrugia, Brett Fritsch, Sanjeev Gupta, Chris Hoffman, Michael Holt, Mark Horseley, Stephen Hutchinson, Prajith Jeyaprakash, Steven Kent, Doug King, Victoria Ko, Vinay Kulkarni, Martin Laird, David Lieu, Andreas Loefler, David Lunz, Genni Lynch, Lawrie Malisano, Ian Meakin, Robert Molnar, Chris Morrey, Jonathan Mulford, Ashish Munsif, Paul Muscio, Alok Narayan, Alexander Nicholls, Fred Nouh, Tim O'Carrigan, Ed O'Leary, Peter Lorentzos, Sushil Pant, Diana Perriman, Jeffrey Petchell, Marinis Pirpiris, Tony Pohl, Vaibhav Punjabi, Sunil Randhawa, Matthias Rau, Jennie Scarvell, Michael Schuetz, Ben Scwartz, Paul Smith, Brahman Sivakumar, Bogdan Solomon, Jonathan Spencer, Paul Stalley, Mitchell Steele, Mayuran Suthersan, Zoltan Szomor, Peter Tamblyn, Seth Tarrant, Kevin Tetsworth, Sameer Viswanathan, Richard Walker

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.

Keywords: ORTHOPAEDIC & TRAUMA SURGERY.

Conflict of interest statement

Competing interests: None declared.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Figures

Figure 1
Figure 1
Cohort ascertainment and retention. DVT, deep vein thrombosis.
Figure 2
Figure 2
Differences between surgical and non-surgical groups with respect to ankle function and general health for the randomised cohort. FAOQ, PCS and MCS are the scores of the SF-12v2 general health survey for the randomised and cohort. Higher value represents better function. Error bars represent 95% CI. Solid black line represents the non-surgical group while the dashed grey line represents the surgical group. FAOQ, American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire; MCS, mental component scores; PCS, physical component scores.

References

    1. Donken CC, Al-Khateeb H, Verhofstad Michael HJ et al. . Surgical versus conservative interventions for treating ankle fractures in adults. Cochrane Database Syst Rev 2012;(8):CD008470 10.1002/14651858.CD008470.pub2
    1. Court-Brown CM, Caesar B. Epidemiology of adult fractures: a review. Injury 2006;37:691–7. 10.1016/j.injury.2006.04.130
    1. Melton LJ III, Crowson CS, O'Fallon WM. Fracture incidence in Olmsted County, Minnesota: comparison of urban with rural rates and changes in urban rates over time. Osteoporos Int 1999;9:29–37. 10.1007/s001980050113
    1. Court-Brown CM, McBirnie J, Wilson G. Adult ankle fractures–an increasing problem? Acta Orthop Scand 1998;69:43–7. 10.3109/17453679809002355
    1. Martin AG. Weber B ankle fracture: an unnecessary fracture clinic burden. Injury 2004;35:805–8. 10.1016/j.injury.2003.12.013
    1. Clare MP. A rational approach to ankle fractures. Foot Ankle Clin 2008;13:593–610. 10.1016/j.fcl.2008.09.003
    1. Phillips WA, Schwartz HS, Keller CS et al. . A prospective, randomized study of the management of severe ankle fractures. J Bone Joint Surg Am 1985;67:67–78. 10.2106/00004623-198567010-00010
    1. Michelson JD. Fractures about the ankle. J Bone Joint Surg Am 1995;77:142–52. 10.2106/00004623-199501000-00020
    1. Michelson JD, Magid D, McHale K. Clinical utility of a stability-based ankle fracture classification system. J Orthop Trauma 2007;21:307–15.
    1. Van Schie-Van der Weert EM, Van Lieshout EMM, De Vries MR et al. . Determinants of outcome in operatively and non-operatively treated Weber-B ankle fractures. Arch Orthop Trauma Surg 2012;132:257–63. 10.1007/s00402-011-1397-z
    1. Murray AM, McDonald SE, Archbold P et al. . Cost description of inpatient treatment for ankle fracture. Injury 2011;42:1226–9. 10.1016/j.injury.2010.08.023
    1. SooHoo NF, Krenek L, Eagan MJ et al. . Complication rates following open reduction and internal fixation of ankle fractures. J Bone Joint Surg Am 2009;91:1042–9. 10.2106/JBJS.H.00653
    1. Slobogean GP, Marra CA, Sadatsafavi M et al. . on behalf of the Canadian Orthopedic Trauma S. Is surgical fixation for stress-positive unstable ankle fractures cost effective? Results of a multicenter randomized control trial. J Orthop Trauma 2012;26:652–8.
    1. Ansari U, Adie S, Harris IA et al. . Practice variation in common fracture presentations: a survey of orthopaedic surgeons. Injury 2011;42:403–7. 10.1016/j.injury.2010.11.011
    1. Koval KJ, Egol KA, Cheung Y et al. . Does a positive ankle stress test indicate the need for operative treatment after lateral malleolus fracture? A preliminary report. J Orthop Trauma 2007;21:449–55. 10.1097/BOT.0b013e31812eed25
    1. Egol KA, Amirtharajah M, Tejwani NC et al. . Ankle stress test for predicting the need for surgical fixation of isolated fibular fractures. J Bone Joint Surg Am 2004;86:2393–8. 10.2106/00004623-200411000-00005
    1. Johanson NA, Liang MH, Daltroy L et al. . American Academy of Orthopaedic Surgeons lower limb outcomes assessment instruments. Reliability, validity, and sensitivity to change. J Bone Joint Surg Am 2004;86-A:902–9.
    1. Suk M. Musculoskeletal outcomes measures and instruments. Thieme, 2009:1.
    1. Hunsaker FG, Cioffi DA, Amadio Peter C et al. . The American Academy of Orthopaedic Surgeons outcomes instruments: normative values from the general population. J Bone Joint Surg Am 2002;84-A:208–15.
    1. Ware JJ, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996;34:220–33.
    1. Ware JE Jr, Kosinski M, Turner-Bowker DM et al. . User's manual for the SF-12v2 health survey with a supplement documenting SF-12 health survey. Lincoln, RI: QualityMetric Incorporated, 2002.
    1. Sultan MJ, Zhing T, Morris J et al. . Compression stockings in the management of fractures of the ankle: a randomised controlled trial. Bone Joint J 2014;96-B:1062–9.
    1. So S, Harris IA, Naylor JM et al. . Correlation between metal allergy and treatment outcomes after ankle fracture fixation. J Orthop Surg (Hong Kong) 2011;19:309–13. 10.1177/230949901101900309
    1. Dindo D, Demartines N, Clavien P-A. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205–13. 10.1097/
    1. Resnick B, Nahm ES. Reliability and validity testing of the revised 12-item Short-Form Health Survey in older adults. J Nurs Meas 2001;9:151–61.
    1. Mittal R, Harris IA, Adie S et al. . Factors affecting patient participation in orthopaedic trials comparing surgery to non-surgical interventions. Contemp Clin Trials 2016;3:153–7.
    1. Timmermans S, Mauck A. The promises and pitfalls of evidence-based medicine. Health Affairs 2005;24:18–28. 10.1377/hlthaff.24.1.18
    1. Pakarinen HJ, Flinkkilä TE, Ohtonen PP et al. . Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study. Foot Ankle Int 2011;32:1103–9. 10.3113/FAI.2011.1103
    1. Kortekangas TH, Pakarinen HJ, Savola O et al. . Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study. Foot Ankle Int 2014;35:988–95. 10.1177/1071100714540894
    1. Bauer M, Bergstrom B, Hemborg A et al. . Malleolar fractures: nonoperative versus operative treatment. A controlled study. Clin Orthop 1985;199:17–27.
    1. Makwana NK, Bhowal B, Harper WM et al. . Conservative versus operative treatment for displaced ankle fractures in patients over 55 years of age. A prospective, randomised study.[see comment]. J Bone Joint Surg Br 2001;83:525–9. 10.1302/0301-620X.83B4.11522
    1. Rowley DI, Norris SH, Duckworth T. A prospective trial comparing operative and manipulative treatment of ankle fractures. J Bone Joint Surg Br 1986;68:610–13. 10.2106/00004623-198668040-00021
    1. Sanders DW, Tieszer C, Corbett B, Society OBOTCOT. Operative versus nonoperative treatment of unstable lateral malleolar fractures: a randomized multicenter trial. J Orthop Trauma 2012;26:129–34. 10.1097/BOT.0b013e3182460837
    1. Lin Chung-Wei C, Donkers Nicole AJ, Refshauge Kathryn M et al. . Rehabilitation for ankle fractures in adults. Cochrane Database Syst Rev 2012. [cited 2015 Oct 29].

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel