Title: Does early mobilisation after Ankle fracture surgery enhance Recovery? A pragmatic multi-centre randomised controlled Trial with qualitative component and health economic analysis comparing the use of plaster versus support boot (ART)
Funder: Department of Health and Social Care

Abstract: Background to the research Large numbers of ankle fractures are treated operatively each year (197 in Poole in 2011, 76 in a six month period in 2009 and 80 in a six month period in 2010 in Portsmouth and 104 in Basingstoke last year). Nevertheless, there are inconsistencies in the post-operative management, despite evidence of the benefits of early active rehabilitation. However, previous studies have been inconclusive with a range of outcomes investigated. Although studies have looked at using boots, few have looked at the psychological and socio-economic implications of being in a plaster compared to earlier rehabilitation in a support boot. Therefore this trial is needed now since support boots have only been available in the last decade and clinicians are still establishing their trust in this device as a stable splint. Previous studies are limited by smaller numbers, less liberal mobilisation protocols, and less of a focus on psycho-social outcomes meaning that a well-designed definitive study is needed to provide the much needed guidance on best practice. Aims of the work The aim of this study is to evaluate two methods of rehabilitating ankle fractures following surgery (plaster versus a support boot allowing range of movement) in order to provide an evidence-base for recommendations to standardise care in clinical practice. The objectives are to address whether there are any differences in terms of function, complications (e.g. failure of fracture healing, wound infection, clots/embolism), quality of life, psychological impact, social impact, economic impact, and service costs and benefits, along with patient experiences between the two groups. Plan of investigation 246 patients aged 16 years and over in three centres (Poole, Portsmouth, and Basingstoke) will be randomised into one of the two treatment groups at their two week post-operative appointment. With this sample size, it should be possible to detect a 10-point difference on the subjective component of the Olerud and Molander ankle symptom scale as the primary outcome at four weeks after randomisation. Patients will be assessed for the primary outcome, complications, and quality of life at baseline (two weeks post-surgery), four weeks later when their plaster/boot is removed in clinic and at ten weeks after baseline (twelve weeks post-surgery) by a patient completed postal questionnaire. Anonymised analysis by multiple regression (incorporating study site as a factor) will be used to compare the mean primary outcome of the Olerud and Molander subjective ankle score between the two treatment groups. The four and ten week follow-up questionnaires will also collect data on the psychological impact, social and economic impact, and will include a resource use questionnaire. Up to 20 telephone interviews will be conducted to explore the experiences of a range of patients regarding their treatment. Interviews will be transcribed verbatim, anonymised, and analysed thematically. An economic evaluation will also be undertaken to determine the cost-effectiveness of the support boot versus plaster in terms of Quality Adjusted Life Years and using the subjective component of the Olerud and Molander ankle symptom scale. Potential benefits to patients and the National Health Service The findings will help to identify best practice and make recommendations for standardised care. They will also help to identify the most cost-effective way to manage ankle fractures and the most effective treatment for getting people back to full function and back to work. These issues are particularly timely to investigate given the current financial climate.

Lay abstract: Ankle fractures are common and many require surgery. After surgery, patients are managed in many different ways depending on their age, physical ability, fracture type, bone quality and surgeon. However, guidelines and evidence suggest that being able to actively move/use the ankle a couple of weeks after surgery in a removable boot might be advantageous. Furthermore, there is debate whether patients require prolonged periods of immobilisation of the ankle in plaster. The aim of this research is therefore to compare two methods of managing ankle fractures after surgery and to provide recommendations for best practice and standardised care. In this study, 246 patients, two weeks after their surgery, will either be managed in plaster or a support boot (a grey boot which is specially designed to provide full support around the lower leg). When patients attend their routine two week post-operative appointment, their initial (baseline) data will be collected and then they will be chosen by chance to receive either a plaster or support boot. All patients will further attend the Outpatient department four weeks later (six weeks post-surgery) when data will be collected again. Final follow-up data will be obtained by postal questionnaires returned ten weeks after baseline (twelve weeks post-surgery). Up to twenty patients will also be asked to take part in telephone interviews to describe their experiences of their treatment. These data will then be compared between the two groups in order to evaluate which treatment is best in terms of function, complications, quality of life, psychological, social, economic impact and patient experience as well as costs and benefits to the National Health Service, patients and society. The findings will then be used to determine which treatment is best and which, if any, can be recommended as standard care.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS