Early motion and directed exercise (EMADE) in ankle fracture fixation
Research type
Research Study
Full title
Early motion and directed exercise (EMADE) post ankle fracture fixation. A pragmatic randomised controlled trial.
IRAS ID
89003
Contact name
Ben Ollivere
Contact email
Sponsor organisation
Nottingham Health Science Partners
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Ankle fractures are a common intra-articular injury in the UK. Like all intra-articular fractures, gold standard management for displaced fractures is open reduction and internal fixation. To allow the bone to heal, the usual postoperative care is 6 weeks post-operative immobilisation in a below-knee plaster-cast and non-weight bearing or limited weight-bearing through the cast. After the immobilisation period, weight bearing may commence, supplemented by physiotherapy.
A number of previous prospective studies have identified early active movements to be beneficial for earlier recovery (DiStasio et al., 1994; Egol et al., 2000; Sondenaa et al., 1986; Tropp and Norlin, 1995; Vioreanu et al., 2007). To date, only one randomised control trial has been conducted evaluating immediate mobilisation post ankle fracture surgery to the standard 6 weeks immobilisation (Lehtonen et al., 2003). However this study observed a large complication rate with 66% wound complications which could have impacted upon their finding. Vioreanu et al delayed early active mobilisation for two weeks following surgery in order to allow the surgical wound to heal. This dramatically reduced the wound complication rates (9%) (Vioreanu et al., 2007).
A systematic review of early mobilisation post ankle fracture fixation (Thomas et al., 2009) identified poor quality studies and inconclusive evidence which highlighted the need for a further well conducted randomised controlled trial. Trials included in this review were either prospective studies which did not reach sufficient power or the one randomised controlled trial which suffered from wound healing complications associated with immediate mobilisation (Lehtonen et al., 2003). Furthermore, a recent Cochrane study investigating the role of early mobilisation in ankle fracture patients portrayed a similar message concluding the imperative nature of a well-designed and adequately-powered study to elucidate current evidence (Lin et al., 2012).
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
14/EM/1213
Date of REC Opinion
4 Nov 2014
REC opinion
Favourable Opinion