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 removable support 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 April 2019
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mr Lee Tbaily
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
18022
Study information
Scientific 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.
Acronym
ART V1.0
Study hypothesis
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.
Ethics approval(s)
NRES Committee South Central – Hampshire A, 22/12/2014, ref: 14/SC/1409
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Musculoskeletal, Surgery; Subtopic: Musculoskeletal (all Subtopics), Surgery; Disease: Musculoskeletal, Surgery
Intervention
Current Interventions as of 06/12/2017:
1. Removable support boot: Removable boot with range of movement for four weeks
2. Plaster Cast: Plaster below knee i.e. immobilised for four weeks
Previous Interventions:
1. Aircast® boot: Aircast® boot with range of movement for four weeks
2. Plaster Cast: Plaster below knee i.e. immobilised for four weeks
Intervention type
Procedure/Surgery
Primary outcome measure
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
4. Complications
5. Return to Usual Activities
Overall study start date
01/03/2015
Overall study end date
30/04/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Received surgery for fixation of unstable ankle fracture
2. Provision of informed consent to participate
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
Planned Sample Size: 246; UK Sample Size: 246
Total final enrolment
262
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
01/08/2015
Recruitment end date
31/08/2018
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Poole Hospital NHS Foundation Trust
Dorset Research and Development Support Unit
Cornelia House
Longfleet Road
Poole
BH15 2JB
United Kingdom
Study participating centre
Hampshire Hospitals NHS Foundation Trust
Basingstoke and North Hampshire Hos
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Study participating centre
Musgrove Park Hospital (taunton)
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Study participating centre
North West Anglia NHS Foundation Trust
Peterborough City Hospital
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Study participating centre
Queen Alexandras Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Study participating centre
Solent NHS Trust
Solent NHS Trust Headquarters
Highpoint Venue
Bursledon Road
Southampton
SO19 8BR
United Kingdom
Study participating centre
Salisbury District Hospital
Salisbury District Hospital
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Study participating centre
Torbay and South Devon NHS Foundation Trust
Torbay Hospital
Newton Road
Torquay
TQ2 7AA
United Kingdom
Study participating centre
Yeovil District Hospital
Yeovil District Hospital
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Sponsor information
Organisation
Poole Hospital NHS Foundation Trust
Sponsor details
Dorset Research and Development Support Unit
Cornelia House
Longfleet Road
Poole
BH15 2JB
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
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
30/04/2024
Individual participant data (IPD) Intention to share
No
IPD sharing plan
The data sharing plans for the current study are unknown and will be made available at a later date
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.6 | 05/03/2018 | 14/03/2023 | No | No |
| Statistical Analysis Plan | version 1.1 | 14/03/2023 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Cost-effectiveness analysis and qualitative findings | 11/01/2024 | 15/01/2024 | Yes | No |