Weight-bearing in ankle fractures

Plain English Summary

Background and study aims
There are around 170 ankle fractures each day in the UK. Many of these injuries heal with support in a plaster cast or splint, but some require surgery to restore the natural alignment of the bones and fix them in place with screws and plates. This improves how the ankle works once the fracture has healed. Following surgery for an ankle fracture, patients are commonly told not to walk on the affected leg for 6 weeks in order to allow the bones to heal. Restricting the weight put through the affected leg may reduce the chance of surgical complications such as infection, breakage of the plates and screws, and loss of alignment requiring revision surgery. However, this restriction has been associated with problems such as blood clots, muscle weakness, stiffness, and poor recovery. It is unclear that the traditional 6 weeks period of limited walking is of any benefit. A recent national review found that surgeons gave patients very varied instructions following ankle fracture surgery, indicating that overall, UK surgeons have differing opinions about the best extended treatment pathway. There has been little high-quality research in this area.

This study is asking should patients who have had surgery for an ankle fracture walk on their operated leg soon following surgery or wait 6 weeks before walking on the operated leg. It is a clinical trial, which is the best method to compare treatments to guide the care of patients.

Who can participate?
This study will include adults (aged 18 years or above) undergoing surgery for an ankle fracture.

What does the study involve?
All patients will be treated non-weight-bearing until their 2-week postoperative follow-up visit. They will then be instructed to either begin weight-bearing on the injured leg, or remain non-weight-bearing for an additional 4 weeks. The decision on which instruction they are given will be made by chance using a process called randomisation so that neither patients nor surgeons can influence the choice. All other care will be as per usual treatment. Patients will report how well their ankle is working and their quality of life using questionnaires at intervals over the first year following surgery. Differences in healthcare costs will also be compared. A small sample of patients and staff will also be interviewed to discuss their experience of the trial. These interviews will help understand how and why the different treatments may work and help design future studies.

What are the possible benefits and risks of participating?
Early weight-bearing, from two weeks after the operation, may reduce the inconvenience of having to use crutches and reduce immobility, length of hospital stay, and might lead to improved ability to walk, get back to work etc.. However, there is a small chance that putting weight through the ankle at an early stage may lead to the bone moving slightly or the skin around the injury and the incision made for the operation being damaged or causing infection, which might mean further treatment, such as an operation, is required.

Delayed weight-bearing, for up to 6 weeks after the operation, may reduce the risk of the bones slipping out of place, the skin around the injury being damaged and as such a need for further operations. However, it will be more inconvenient and it could lead to increased time off work and other activities. Participants will not be using the calf muscle and might lose some muscle mass and this means it might take longer after the initial 6 weeks to return to usual strength and activities. Finally, although highly unlikely, there may be a slightly increased chance of getting a blood clot in the calf or lung, which could require additional blood-thinning medication.

Where is the study run from?
The University of Oxford, UK

When is the study starting and how long is it expected to run for?
December 2019 to November 2022

Who is funding the study?
Research for Patient Benefit Programme, National Institute for Health Research (NIHR), UK

Who is the main contact?
1. Dr Susan Wagland (public), wax@ndorms.ox.ac.uk
2. Mr Chris Bretherton (scientific), christopher.bretherton@ndorms.ox.ac.uk

Study website

Contact information

Dr Susan Wagland
Public

Adult trials office
Lvl 3, Kadoorie Centre
John Radcliffe Hospital
Headley way
Oxford
OX3 9DU
United Kingdom

ORCID ID	0000-0002-5566-0925
Phone	+44 (0)1865 227318
Email	wax@ndorms.ox.ac.uk

Mr Chris Bretherton
Scientific

Adult trials office
Lvl 3, Kadoorie Centre
John Radcliffe Hospital
Headley way
Oxford
OX3 9DU
United Kingdom

ORCID ID	0000-0001-9569-0734
Phone	+44 (0)1865227318
Email	christopher.bretherton@ndorms.ox.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• United Kingdom
• Wales

Study participating centres

Sponsor information

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

11/06/2024: Publication reference added.
10/05/2024: The intention to publish date was changed from 30/04/2023 to 01/06/2024.
13/02/2023: The following changes were made to the trial record:
1. The overall end date was changed from 28/02/2023 to 18/11/2022.
2. The total final enrolment was added.
3. The participant level data sharing statement was added.
4. The contact was updated.
10/02/2023: The contact confirmed the record is up to date.
12/10/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The trial website was added.
09/02/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2021 to 28/10/2021.
2. The overall end date was changed from 30/06/2022 to 28/02/2023.
3. The intention to publish date was changed from 30/06/2022 to 30/04/2023.
4. The plain English summary was updated to reflect these changes.
29/06/2020: The following changes have been made:
1. Recruitment has resumed.
2. The plain English summary has been updated to reflect the previous change in the public contact.
16/04/2020: Due to current public health guidance, recruitment for this study has been paused.
20/03/2020: The following changes were made to the trial record:
1. The recruitment start date
2. The public contact was changed.
3. The trial participating centres "Altnagelvin Area Hospital, University Hospital of Wales, Medway Maritime Hospital" were removed and "East Surrey Hospital, Basingstoke and North Hampshire Hospital, Royal Cornwall Hospital, Conquest Hospital, University Hospital Llandough, Peterborough City Hospital, Leicester Royal Infirmary, Queen's Medical Centre, Craigavon Hospital, William Harvey Hospital" were added.
10/12/2019: Trial’s existence confirmed by South Central- Oxford A- Health Research Authority