Three Week Versus Six Week Immobilisation for Stable Weber BMJ: First Published As 10.1136/Bmj.K5432 on 23 January 2019
RESEARCH Three week versus six week immobilisation for stable Weber BMJ: first published as 10.1136/bmj.k5432 on 23 January 2019. Downloaded from B type ankle fractures: randomised, multicentre, non-inferiority clinical trial Tero Kortekangas,1,2 Heidi Haapasalo,3 Tapio Flinkkilä,1,2 Pasi Ohtonen,2,4 Simo Nortunen,1,2 Heikki-Jussi Laine,3 Teppo LN Järvinen,5,6 Harri Pakarinen1,2 1Department of Surgery, ABSTRACT three week cast group, and 89.8 (SD 18.4) in the three Division of Orthopaedic and OBJECTIVE week orthosis group. The between group difference Trauma Surgery, Oulu University To determine whether treatment of isolated stable at 52 weeks for the three week cast versus six week Hospital, Kajaanintie 50, PO Box 21, FI 90029 OYS, Oulu, Weber B type ankle fractures with a cast or a simple cast was 3.6 points (95% confidence interval −1.9 to Finland orthotic device for three weeks produces non-inferior 9.1, P=0.20), and for the three week orthosis versus 2Medical Research Centre outcomes compared with conventional immobilisation six week cast was 1.7 points (−4.0 to 7.3, P=0.56). (MRC) Oulu, Oulu, Finland in a cast for six weeks. In both comparisons, the confidence intervals did 3 Department of Orthopaedics, not include the predefined inferiority margin of −8.8 Tampere University Hospital, DESIGN Tampere, Finland Randomised, pragmatic, non-inferiority, clinical trial points. The only statistically significant between group 4Division of Operative Care, with blinded outcome assessment. differences observed in the secondary outcomes and Oulu University Hospital, Oulu, harms in the two primary comparisons were slight SETTING Finland improvement in ankle plantar flexion and incidence of 5 Two major trauma centres in Finland, 22 December Finnish Centre for Evidence- deep vein thrombosis, both in the three week orthosis 2012 to 6 June 2016.
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