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Three Week Versus Six Week Immobilisation for Stable Weber BMJ: First Published As 10.1136/Bmj.K5432 on 23 January 2019

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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. Based Orthopaedics (FICEBO), group versus six week cast group. Department of Orthopaedics, PARTICIPANTS University of Helsinki, Helsinki, CONCLUSION 247 skeletally mature patients aged 16 years or older Finland Immobilisation for three weeks with a cast or orthosis 6 with an isolated Weber B type fibula fracture and Department of Orthopaedics was non-inferior to conventional cast immobilisation and Traumatology, Helsinki congruent ankle mortise in static ankle radiographs. University Hospital, Helsinki, for six weeks in the treatment of an isolated stable Finland INTERVENTIONS Weber B type fracture. Participants were randomly allocated to conventional Correspondence to: TRIAL REGISTRATION T Kortekangas six week cast immobilisation (n=84) or three week ClinicalTrials.gov NCT01758835. http://www.bmj.com/ [email protected] treatment either in a cast (n=83) or in a simple (ORCID 0000-0003-3498-8048) orthosis (n=80). Additional material is published Introduction online only. To view please visit MAIN OUTCOME MEASURES the journal online. The primary, non-inferiority, intention-to-treat Ankle fracture is a common injury, with an annual Cite this as: BMJ 2019;364:k5432 outcome was the Olerud-Molander Ankle Score incidence between 122 and 187 per 100 000 1-3 http://dx.doi.org/10.1136/bmj.k5432 at 12 months (OMAS; range 0-100; higher scores population. Seventy per cent of ankle fractures are Accepted: 28 November 2018 indicate better outcomes and fewer symptoms). The unimalleolar injuries and the Weber B type fibula on 24 September 2021 by guest. Protected copyright. predefined non-inferiority margin for the primary fracture is by far the most common type of ankle 1 3-8 outcome was −8.8 points. Secondary outcomes were fracture. These fractures can be either stable ankle function, pain, quality of life, ankle motion, and or unstable depending on the accompanying soft radiographic outcome. Follow-up assessments were tissue injury.6-16 The stability of the ankle mortise performed at 6, 12, and 52 weeks. has fundamental clinical relevance, as it dictates the 6-16 RESULTS treatment strategy. Stable ankle fractures can be 7 8 16-20 212 of 247 randomised participants (86%) completed treated non-surgically and account for about 13 the study. At 52 weeks, the mean OMAS was 87.6 (SD half of ankle fractures. 18.3) in the six week cast group, 91.7 (SD 12.9) in the It is recognised that it takes approximately six weeks to achieve sufficient fracture healing (bone union) to WHAT IS ALREADY KNOWN ON THIS TOPIC resist strains caused by weightbearing. In keeping with this belief, the traditional non-operative treatment of a Stable Weber B type fibula fracture—the most common ankle fracture type—can stable Weber B type fracture is a below-the-knee cast be successfully treated non-operatively with a cast applied below the knee for six for six weeks.8 16-22 Abundant evidence confirms that weeks this strategy leads to a high rate of fracture union,16-22 Although the clinical outcome of this treatment strategy has been shown to be but it is associated with harms, such as increased ankle generally favourable, prolonged cast immobilisation is associated with increased stiffness and deep vein thrombosis.21 23-26 Awareness of risk of adverse effects, prompting attempts to streamline the treatment this trade-off between benefits and harms has been a High quality evidence on the optimal duration of cast immobilisation for stable catalyst towards considering shorter, more functional Weber B type fibula fracture is lacking and less bothersome non-operative strategies that would still result in successful fracture healing.24 25 27-30 WHAT THIS STUDY ADDS Evidence from biomechanical studies suggests The duration of immobilisation for stable Weber B type fibula fracture can safely that an early mechanical stimulus is a critical factor be shortened from six to three weeks in the healing of stable fractures, warranting further the bmj | BMJ 2019;364:k5432 | doi: 10.1136/bmj.k5432 1 RESEARCH investigation of clinical response to shorter durations to the study protocol after the trial started. All patients BMJ: first published as 10.1136/bmj.k5432 on 23 January 2019. Downloaded from of immobilisation.31-33 A few small patient series gave written informed consent. have shown that isolated stable fibula fractures can be treated successfully even without sturdy external Participants ankle support.27-29 34 On the basis of these findings we All skeletally mature patients (16 years or older) with tested whether isolated fibular fractures identified as an isolated Weber B type fibular fracture (fig 1) and stable using an external rotation stress test11 could be congruent ankle mortise (medial clear space <4 mm treated by immobilisation for only three weeks—even and ≤1 mm wider than the superior clear space) in the using an orthosis that merely provides patients with primary radiographs (see supplementary appendix 1 some psychological support and comfort to enable figure S1) visiting the emergency departments of either immediate weightbearing. of the two participating university hospitals, were We conducted a pragmatic, multicentre, randomised, assessed for study eligibility. To assess the stability of non-inferiority trial to compare the conventional the fracture, the orthopaedic surgeon on-call carried strategy of immobilisation using a cast for six weeks out an external rotation stress test11 under fluoroscopy with immobilisation for three weeks (using either a cast (see supplementary appendix 1 figure S2). The fracture or an orthosis) for isolated stable Weber B type fibular was considered stable when the medial clear space fractures. We hypothesised that successful fracture was less than 5 mm under external rotation stress, healing of such fractures can be achieved safely after as measured between the lateral border of the medial only three weeks of immobilisation. malleolus and the medial border of the talus at the level of the talar dome11-13 (see supplementary appendix Methods 1 figure S2). Radiographs were calibrated using a 30 Trial design mm disk, with measurements made to an accuracy of We conducted a randomised, parallel group, non- 1 mm. Other inclusion criteria were the ability to walk inferiority study to compare traditional immobilisation unaided before the current trauma and enrolment by cast for six weeks with immobilisation for three fewer than seven days after the injury. We excluded weeks using either a cast or an orthosis for isolated patients with previous ankle fracture or suspicion stable Weber B type ankle fractures at two trauma of a previous deltoid ligament injury (a history of centres in Finland. The reporting of this study follows ankle twisting injury requiring cast treatment), other the CONSORT guidelines for non-inferiority trials.35 important fracture in the affected ankle or foot area, Supplementary appendix 1 shows the study protocol current bilateral ankle fracture, concomitant tibial http://www.bmj.com/ and statistical analysis plan. No changes were made fracture, pathological fracture, diabetic or other neuropathy, inadequate cooperation, or permanent residence outside the catchment area of the two study hospitals. Visual Abstract Immobilising ankle fractures How long should casts or orthoses be used Randomisation and blinding to restrict movement after a break? Randomised controlled trial Patients were randomly allocated (1:1:1 ratio) to the on 24 September 2021 by guest. Protected copyright. six week cast, three week cast, or three week orthosis Summary A shorter week period of immobilisation proved non-inferior to traditional weeks of cast immobilisation. group using sealed and consecutively numbered, opaque envelopes. A biostatistician who was not Population Skeletally mature patients with an isolated, stable Weber B type involved in the clinical care of the patients prepared fibula fracture the envelopes using a computerised random number 247 % male Age: – years Multicentre trial generator. Allocation was stratified by site and blocked within stratums using random permuted blocks Comparison 80 84 Control 83 (block size 6, 9, and 12). After consent had been obtained, the orthopaedic surgeon on-call individually randomised participants by opening the next available numbered envelope.
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