Matthews, Paul
(2020)
Early motion and directed exercise (EMADE) following surgical fixation of Weber B ankle fractures in adults: A pragmatic randomised controlled trial.
PhD thesis, University of Nottingham.
Abstract
Introduction
Ankle fractures are extremely common and account for over 20% of all lower limb fractures and nearly 10% of all fracture types. For those requiring surgical fixation, usual-care post-surgery has included 6-weeks cast immobilisation and non-weightbearing. Disuse atrophy and joint stiffness are detrimental sequelae of this management. The rehabilitation literature contains methodological flaws and a lack of focus on early exercise, which perpetuates the controversy over the effectiveness of early exercise interventions.
Objectives
The primary objective of this thesis was to determine if, for those patients who have undergone surgical fixation following ankle fracture, was the physiotherapy intervention of early motion and directed exercise (EMADE), more effective care than usual-care, as measured on the Olerud and Molander Ankle Score (OMAS) patient reported outcome measure (PROM) at 12-weeks post-surgery. The usual-care was defined as 6-weeks cast immobilisation and non-weightbearing. Secondary objectives included analysis of the EQ-5D-5L index and the Ankle-Fracture Outcome of Rehabilitation Measure (A-FORM) PROMs at week-12 and all three PROMs at week-24 and 52 post-surgery. Tertiary objectives included: assessment of clinical and laboratory measures; exploration of the direct physiotherapy costs, return to driving and work; and finally, the reliability of retrospectively recorded PROMs.
Method
A pragmatic randomised controlled trial (pRCT) was undertaken and recruited 157 individuals who had undergone surgical fixation of Weber B ankle fractures. At 2-weeks post-surgery allocation took place to either EMADE or usual-care, the comparator which consisted of cast immobilisation. Both interventions were non-weightbearing until week-6.
The PROMs; OMAS, EQ-5D-5L and A-FROM data were collected at; week-2 (baseline), 6, 12, 24 and 52 post-surgery, with the OMAS at week-12 forming the primary outcome. Other forms of data included: a review of medical correspondence, clinical and laboratory measures, direct physiotherapy costs, return to work and driving, and a set of PROMs recorded retrospectively.
Results
One hundred and thirty participants returned their OMAS PROMs at week-12, exceeding the 60 per group threshold set by the a-priory power calculation. The results favoured the EMADE group (62.0 (SD 20.88) versus 48.8 (SD 22.52) p<0.001) by a difference in means of 13.2 (95% CI 5.7 to 20.7), exceeding the accepted MCID of 10 points on the OMAS. The A-FORM and EQ-5D-5L index data also yielded significant benefits for EMADE at week-12. Only the OMAS maintained significance at week-24, which was also clinically meaningful, but by week-52 there was a convergence of the means on PROMs. No intervention related or unexpected adverse events were identified.
Insufficient week-12 clinical and laboratory data were collected to permit analysis. While there were no group differences in rates of return to work or driving, the direct physiotherapy cost evaluation favoured EMADE. Collecting PROMs retrospectively did not demonstrate robust reliability.
Discussion
EMADE physiotherapy may be regarded as safe and effective at 12-weeks post-surgical fixation of Weber B ankle fractures, when compared to the usual-care of cast immobilisation and non-weightbearing. The week-52 group mean convergence indicated that in the long-term, neither intervention was better than the other. However, the positive results from EMADE at 12 and week-24 suggested that EMADE contributes to accelerated recovery.
There were pertinent developments during and following the EMADE trial, in the form of publication of NICE guidelines on fracture management and the COVID-19 pandemic. These developments may warrant further exploration of EMADE prior to a large scale multi-centre trial, such as a Health Technology Assessment (HTA), to assess if EMADE has sufficient clinical and economic effectiveness to influence NICE guidelines and be recommended for patient care.
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