Early Motion And Directed Exercise (EMADE) versus usual-care, post ankle fracture fixation: 12 and 24-week results from a pragmatic randomised controlled trial

P. Matthews, B. Scammell, A. Ali, J. Nightingale, T. Coughlin, T. Khan, B. Ollivere, Orthopaedics and Trauma Group, University of Nottingham, UK

¹University of Nottingham, Academic Orthopaedics, Trauma, and Sports Medicine, Nottingham, United Kingdom

²Nottingham University Hospitals NHS Trust, Therapy Services, Nottingham, United Kingdom

³Nottingham University Hospitals NHS Trust, Trauma and Orthopaedics, Nottingham, United Kingdom 

Background: Ankle fractures are extremely common but unfortunately, over 20% fail to obtain good to excellent recovery. For those requiring surgical fixation, usual-care post-surgery has included six-weeks cast immobilisation and non-weightbearing. Disuse atrophy and joint stiffness are detrimental sequelae of this management. While rehabilitation, starting at two-weeks post-surgery is viewed as safe, the literature contains methodological flaws and a lack of focus on early exercise, perpetuating the controversy over the effectiveness of early exercise interventions.

Objectives: Our objectives were to determine if following operative fixation for Weber B fracture, the physiotherapy intervention, early motion and directed exercise (EMADE), applied in the clinical setting, were superior to Usual-care at 12-weeks (primary outcome) and 24-weeks.

Design and Methods: We undertook a pragmatic-RCT, recruiting 157 surgically fixed Weber B ankle fracture patients, to establish if EMADE was superior to the Usual-care of 6-weeks immobilisation. The EMADE physiotherapy intervention (between week-2 and 4 post-surgery) utilised a removable cast and combined non-weightbearing progressive home exercises with manual therapy, advice and education. The primary outcome measure was the OMAS at 12-weeks.

Results: 130 participants returned their 12-weeks post-surgery data, exceeding the 60/group threshold set by the a-priory power calculation. Group OMAS means were; 62.0 and 48.8 (SD 21, 22.5) EMADE, Usual-care respectively, yielding a clinically meaningful mean difference of 13.2 on the OMAS and a statistical difference (95% CI p< 0.001, 5.66 to 20.73). Both clinically meaningful and statistically significant findings were maintained at week-24. There were no intervention related or unexpected adverse events, including instability.

Conclusions: This clinic set pragmatic-RCT yielded both clinical and statistical outcomes at week-12 in favour of the EMADE physiotherapy intervention over the Usual-care of 6-weeks immobilisation, in surgically fixed Weber B ankle fracture patients. These positive findings were maintained at week-24 and justify EMADE physiotherapy as a viable treatment option.

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