Plain English Summary
Background and study aims
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 the ankle a couple of weeks after surgery in a removable boot might be beneficial to the patient. The two methods being compared are plaster cast and an Aircast® boot. Managing an ankle fracture with a plaster cast means that patients keep their injured ankle relatively still (immobilised) whilst managing an ankle fracture with an Aircast® boot means that patients can move their injured ankle quite soon after surgery – this is called early mobilisation. The findings of this study will be used to determine which treatment is best and which, if any, can be recommended as standard care for patients who fracture their ankles and need surgery.
Who can participate?
Adults that have recently had surgery for an ankle fracture.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given a plaster cast. Those in group 2 are given a Aircast® boot. All participants then attend a clinic appointment 4 weeks later (6 weeks post-surgery) and assessments performed. Participants are asked to complete questionnaires at 5 weeks (7 weeks post- surgery) and (12 weeks post-surgery). Up to twenty patients are also asked to take part in telephone interviews to describe their experiences of their treatment. These data is compared between the two groups in order to evaluate which treatment is best in terms of function, quality of life, psychological, social, economic impact and patient experience as well as costs and benefits to the National Health Service, patients and society.
What are the possible benefits and risks of participating?
Whilst there are no immediate benefits for those people participating in the project, it is hoped that their participation will mean those in the future who experience a similar injury will receive the best/most appropriate treatment for their injury and will make the best use of NHS resources.
Where is the study run from?
Poole Hospital NHS Foundation Trust (lead site) and other NHS hospitals in the South East of England (UK)
When is the study starting and how long is it expected to run for?
February 2015 to January 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mr Lee Tbaily
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 Aircast® boot.
The aim of the study is to evaluate the relative effectiveness and cost-effectiveness of two methods of post-operative ankle fracture management (plaster versus Aircast® boot with range of movement) and to provide evidence-based recommendations for best care in clinical practice.
NRES Committee South Central – Hampshire A, 22/12/2014, ref: 14/SC/1409
Randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Topic: Musculoskeletal, Surgery; Subtopic: Musculoskeletal (all Subtopics), Surgery; Disease: Musculoskeletal, Surgery
1. Aircast® boot: Aircast® boot with range of movement for four weeks
2. Plaster Cast: Plaster below knee i.e. immobilised for four weeks
Primary outcome measures
Olerud and Molander Ankle Score; Timepoint(s): Five weeks post randomisation
Secondary outcome measures
1. Ankle functional data (range of movement, weight-bearing)
2. Standardised measure of general quality of life (EQ-5D-5L)
3. Healing status
5. Return to Usual Activities
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Received surgery for fixation of unstable ankle fracture
2. Provision of informed consent to participate
Target number of participants
Planned Sample Size: 246; UK Sample Size: 246
Participant exclusion criteria
1. Under 16 years old (skeletally immature)
2. Poor skin condition at operation site
3. Serious concomitant disease (e.g. stroke, osteoporosis, arthritis)
4. Diabetic neuropathy/other sensory neuropathy (lack of sensation)
5. Non-ambulatory prior to injury
6. Active leg ulceration
7. Patients who are unable to understand the study information or unable to complete the outcome questionnaires
8. Surgeon concerned about quality of fixation/integrity of wound
9. Fracture requiring further stabilisation in/around the ankle (e.g. syndesmosis).
10. Open ankle fracture (bone broken through skin)
11. Participant is a participant in other concurrent interventional research which may over-burden the participant or confound data collection
12. Concomitant injuries which will have a confounding effect on rehabilitation in the opinion of the investigator
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Poole Hospital NHS Foundation Trust
Dorset Research and Development Support Unit Cornelia House Longfleet Road
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
A number of scientific papers will be produced from the collated anonymised study data. Results will be published in peer reviewed journals aimed at both surgeons and physiotherapists (e.g. Annals of the Royal College of Surgeons, Journal of Bone and Joint Surgery and Physiotherapy. Papers will include messages about functional, socio-economic and psychological outcomes as well as the publication of the protocol. Results will also be published in the Health Service Journal, to authors of the Cochane review, and findings will be disseminated at conferences and via oral presentations at local, national and international trauma/orthopaedic and physiotherapy meetings. Participants and the general public will also be informed via via flyers, posters, Bournemouth University Clinical Research Unit website, Bournemouth University Research Blog, Twitter, podcast, press releases to the media.
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting