Does early mobilisation after ankle fracture surgery enhance recovery?
| ISRCTN | ISRCTN15497399 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15497399 |
| Secondary identifying numbers | 18022 |
- Submission date
- 08/01/2015
- Registration date
- 08/01/2015
- Last edited
- 15/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Contact information
Scientific
Research & Innovation
Cornelia House
Poole Hospital NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB
United Kingdom
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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. |
| Study 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 |
| 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 |
Eligibility
| 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 inclusion criteria | 1. Received surgery for fixation of unstable ankle fracture 2. Provision of informed consent to participate |
| 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 centres
Cornelia House
Longfleet Road
Poole
BH15 2JB
United Kingdom
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Taunton
TA1 5DA
United Kingdom
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Highpoint Venue
Bursledon Road
Southampton
SO19 8BR
United Kingdom
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Newton Road
Torquay
TQ2 7AA
United Kingdom
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Sponsor information
Hospital/treatment centre
Dorset Research and Development Support Unit
Cornelia House
Longfleet Road
Poole
BH15 2JB
England
United Kingdom
"ROR" |
https://ror.org/03kdm3q80 |
|---|
Funders
Funder type
Government
Government organisation / National government
- 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
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will 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 |
Additional files
Editorial Notes
15/01/2024: Publication reference added.
14/03/2023: The following changes were made to the trial record:
1. Protocol, statistical analysis plan and total final enrolment added.
2. Hampshire Hospitals NHS Foundation Trust, Musgrove Park Hospital, North West Anglia NHS Foundation Trust, Queen Alexandras Hospital, Solent NHS Trust, Salisbury District Hospital, Torbay and South Devon NHS Foundation Trust, and Yeovil District Hospital were added as trial participating centres.
3. The intention to publish date was changed from 30/04/2020 to 30/04/2024.
04/10/2018: The following changes have been made to the trial record:
1. The recruitment end date has been changed from 30/08/2018 to 31/08/2018
2. The intention to publish date has been added
3. Participant level data has been changed from "Not provided at the time of registration" to "To be made available at a later date"
4. The IPD sharing statement has been added
06/12/17: The following changes were made: 1. Recruitment end date was changed from 30/09/2017 to 30/08/2018. 2. Overall trial end date was changed from 31/03/2018 to 30/04/2019. 3. Contact address and intervention were updated.
