ART - V1.0
Research type
Research Study
Full 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 Aircast® boot.
IRAS ID
156083
Contact name
Bob Sangar
Contact email
Sponsor organisation
Poole Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 3 months, 30 days
Research summary
Research Summary
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 advantageous.
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.
In this study, 246 patients, two weeks after their surgery, will either be managed in plaster or a Aircast® boot. When patients attend their routine two week post-operative appointment, their initial (baseline) data will be collected and they will be chosen by chance to receive either a plaster or Aircast® boot.
All patients will further attend a clinic appointment 4 weeks later (6 weeks post-surgery) when assessements will be performed. Patients will be asked to complete questionnaires at 5 weeks (7 weeks post surgery) and (12 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, quality of life, psychological, social, economic impact and patient experience as well as costs and benefits to the National Health Service, patients and society.Summary of Results
After surgery for an ankle fracture, either a plaster cast or a removable inflatable boot can be used to support the ankle during recovery. We aimed to find out whether casts or boots are best for ankle recovery, safety, quality of life and satisfaction, cost (both to patients, society, and the NHS) and return to work/usual activities.
262 patients from 8 hospitals took part in the trial. All patients wore a temporary cast for two weeks while recovering from their ankle surgery and were then chosen randomly to wear a plaster cast or boot for the next four weeks. Both groups were allowed to walk on their ankles as they felt able and the patients receiving boots also did regular ankle exercises. We followed participants up for twelve weeks post-surgery, including questionnaires on ankle symptoms, quality of life, return to usual activities and support needs. We also measured how much movement they had in their injured versus uninjured ankles, and interviewed 16 participants about their experiences with the cast or boot.
Overall, both treatments were found to be similarly effective and the boot was slightly more expensive for the NHS. People in the boot group had greater ankle range of movement, but this was too small to be important to recovery. A small number of participants in boots had minor problems with wound healing; however, these resolved quickly. Patients in the boot group required less help from friends and family and felt more productive at work sooner. The participants we interviewed felt positively about the boots e.g. felt more comfortable & independent, while many in plaster felt their mobility and daily activities were impacted more.
In conclusion, this study suggests both treatments are safe and effective, and patient preference should be considered when choosing treatment to ensure the best experience.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
14/SC/1409
Date of REC Opinion
22 Dec 2014
REC opinion
Favourable Opinion