Use of cast immobilisation versus removable brace in adults with an ankle fracture: multicentre randomised controlled trial

Abstract

Objectives To assess function, quality of life, resource use, and complications in adults treated with plaster cast immobilisation versus a removable brace for ankle fracture. Design Multicentre randomised controlled trial. Setting 20 trauma units in the UK National Health Service. Participants 669 adults aged 18 years and older with an acute ankle fracture suitable for cast immobilisation: 334 were randomised to a plaster cast and 335 to a removable brace. Interventions A below the knee cast was applied and ankle range of movement exercises started on cast removal. The removable brace was fitted, and ankle range of movement exercises were started immediately. Main outcome measures Primary outcome was the Olerud Molander ankle score at 16 weeks, analysed by intention to treat. Secondary outcomes were Manchester-Oxford foot questionnaire, disability rating index, quality of life, and complications at 6, 10, and 16 weeks. Results The mean age of participants was 46 years (SD 17 years) and 381 (57%) were women. 502 (75%) participants completed the study. No statistically significant difference was found in the Olerud Molander ankle score between the cast and removable brace groups at 16 weeks (favours brace: 1.8, 95% confidence interval −2.0 to 5.6). No clinically significant differences were found in the Olerud Molander ankle scores at other time points, in the secondary unadjusted, imputed, or per protocol analyses. Conclusions Traditional plaster casting was not found to be superior to functional bracing in adults with an ankle fracture. No statistically difference was found in the Olerud Molander ankle score between the trial arms at 16 weeks. Trial registration ISRCTN registry ISRCTN15537280 .

Cost-utility analysis of cast compared to removable brace in the management of adult patients with ankle fractures

“…Further details on eligibility can be found in the protocol 7 and the main clinical results. 6 The AIR trial was approved by the UK National Research Ethics Committee (17/WM/0239). trial recruitment and demographics.…”

“…Further details on trial recruitment and demographic information of participants can be found in the clinical paper. 6 Resource use data. Data were recorded using case report forms at six, ten, 16, and 24 weeks, and 12 months postrandomization.…”

“…5 A recent randomized controlled trial (RCT) comparing these two management strategies demonstrated that there was no statistically significant difference in the patient-reported Olerud Molander ankle score at 16 weeks and removable brace management was safe. 6 To date, the cost-effectiveness of these alternatives is unknown, but such evidence should help inform resource allocation decisions in the NHS. 3 This is the first study to assess the cost-effectiveness of removable brace compared to cast in operatively and non-operatively managed adult patients with ankle fracture.…”

Assessing technical skill in ankle fracture surgery from the postoperative radiograph

“…The Ankle Injury Rehabilitation trial radiology manual was consulted with permission as part of the scoping review. 18,19 An e-Delphi exercise was undertaken to establish consensus on the FPA candidate items where no agreement exists. The consensus benchmark was set at ≥ 75% panel agreement, which is line with usual practice in the consensus setting literature.…”

“…The Ankle Injury Rehabilitation trial radiology manual was consulted with permission as part of the scoping review. 18 , 19 …”