The Ankle Recovery Trial (ART): clinical outcomes and patient experience of a pragmatic multicentre randomised controlled trial comparing cast versus removable boot for early mobilisation after ankle fracture surgical fixation
Aims: This study compares functional outcomes and patient experience between cast immobilisation and early mobilisation in a removable boot after ankle fracture fixation, with early weight-bearing encouraged in both groups.
Methods: This pragmatic multi-centre randomized controlled trial with qualitative component and economic evaluation was conducted across eight UK NHS hospitals. Adults with acute ankle fractures were randomized to receive a plaster cast or removable support boot two-weeks post-surgery. The primary outcome was ankle function measured by the Olerud and Molander Ankle Symptom Score (OMAS) seven weeks post-surgery. Secondary outcomes included function at 12 weeks, mechanistic measures, quality of life, complications and resource use. Subgroup analyses included fracture complexity and age. Patients’ views on both treatments were collected through semi-structured telephone interviews.
Results: 243 participants consented to be randomized (120 cast; 123 boot) of whom 173 (71.2%) completed the primary outcome. The mean difference in OMAS at seven weeks between groups was 4.9 points favouring the boot (95% confidence interval -1.0 to 10.7) which is below the minimal clinically important difference and failed to detect a difference between groups. Boot participants had better dorsiflexion, particularly those with comminuted fractures, and better plantarflexion, particularly older patients. Complication rates were low, albeit higher in the boot group (cast: 8/112; boot: 18/117); all were minor except one deep vein thrombosis in the boot group. Overall, we found low wound complications rates (7%). There were no differences for all other secondary measures. Patients expressed preference for boots at randomisation, point of withdrawal from the trial, and during interviews.
Conclusions: Patients managed in casts and boots had similar functional outcomes following ankle fracture fixation. Boots provided improved dorsiflexion and plantarflexion for some subgroups, but higher complication rates. Treatment modality decisions could therefore be informed by individual patient preference.
Journal Article Type
Article
Acceptance Date
Jul 10, 2025
Deposit Date
Jul 18, 2025
Journal
Bone and Joint Open
Print ISSN
2049-4394
Electronic ISSN
2049-4408
Publisher
British Editorial Society of Bone and Joint Surgery
Peer Reviewed
Peer Reviewed
Keywords
Ankle fracture, early mobilisation, plaster cast, air boot, RCT
