Condition category
Musculoskeletal Diseases
Date applied
02/12/2019
Date assigned
10/12/2019
Last edited
29/06/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 June 2022

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

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

Trial website

Contact information

Type

Public

Primary contact

Miss Kate Herbert

ORCID ID

Contact details

Adult trials office
Lvl 3
Kadoorie Centre
John Radcliffe Hospital
Headley way
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 227318
wax@ndorms.ox.ac.uk

Type

Scientific

Additional contact

Mr Chris Bretherton

ORCID ID

http://orcid.org/0000-0001-9569-0734

Contact details

Adult trials office
Lvl 3
Kadoorie Centre
John Radcliffe Hospital
Headley way
Oxford
OX3 9DU
United Kingdom
+44 (0)1865227318
christopher.bretherton@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 43740, IRAS 265559

Study information

Scientific title

Weight Bearing in Ankle Fractures. A randomised clinical trial of weight-bearing following operatively treated ankle fracture

Acronym

WAX

Study hypothesis

Weight bearing at 2 weeks is not inferior to weight bearing at 6 weeks after surgically repaired unstable ankle fracture.

Ethics approval

Approved 01/12/2019, South Central- Oxford A- Health Research Authority (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; +44 (0)207 104 8041; nrescommittee.southcentral-oxforda@nhs.net), ref: 19/SC/0566

Study design

Multi-centre prospective randomised non-inferiority clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Surgically repaired unstable ankle fractures

Intervention

Early-weight bearing vs Delayed weight-bearing.

Initially patients will be instructed to be non-weight bearing in the immediate two weeks following surgery, as per usual clinical care, to allow the soft tissues to recover and wounds to heal. At two weeks, participants will be randomised (online using RRAMP) in a 1:1 ratio stratified by centre and whether they are aged under 60 or 60 and over, to either early weight-bearing (unrestricted weight-bearing group, begin weight-bearing immediately at 2 weeks after their operation) or to delayed weight-bearing (restricted weight-bearing group, wait until 6 weeks after the operation) for a period of four weeks. Participants will be given verbal and standardised written instructions dependant on their randomisation outcome. Both of these weight-bearing strategies are widely used within the NHS and all of the clinical teams in the chosen centres will be familiar with both instructions. At four weeks post-randomisation participants’ weight-bearing status will default back to routine clinical care. Patients will be followed up for four months.

Baseline demographic data and pre-injury functional data using the OMAS instrument will be collected. Participants will also be asked to complete the EuroQol EQ-5D-5L health-related quality-of-life questionnaire to indicate their typical pre-injury health status. At 4 weeks post-randomisation, the clinical team will perform a clinical assessment; participants will be asked to complete the OMAS and a record of any early adverse events made. Additionally, OMAS, EQ-5D-5L, Global rating of change (GRC), Pain self-efficacy questionnaire and Tampa scale of kinesphobia-11, adverse events and resource use questionnaires will be collected at 6 weeks, 4 and 12 months post randomisation.

Data will be collected via the clinical trial IT system REDCap, hosted by the University of Oxford, UK. Baseline data will be directly entered onto the database by the local research team. Participants will be contacted for follow-up using email and/or SMS text message prompts and invited to complete questionnaires through an online link, postal and telephone follow-up will be conducted for those who are not comfortable to, or cannot complete forms online.

A process evaluation will be performed. The main aim of this evaluation will be to identify barriers and facilitators in the delivery of the interventions, look for selection and researcher bias and to understand the generalizability of the trial, through a mixed methods approach. This will include qualitative interviews with staff and participants as well as a quantitative assessment of the characteristics of the sample and fidelity of the interventions. The interviews will be conducted by a student researcher (after sufficient training) and take place over the telephone, in clinic or hospital/university meeting rooms. Patients will be approached at the time of consent to the main trial to see if they would be happy to be contacted for the interview. Patient's who do not wish to take part in the main trial may still consent to be
approached and then complete the interview. All participants completing the interview will sign a separate consent form.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Ankle function outcomes measured by the Olerud and Molander Score (OMAS) at the 4 month follow-up time-point

Secondary outcome measures

1. OMAS at 6 weeks and 12 months
2. Health related quality of life (EQ-5D-5L) at 6 weeks, 4 months and 12 months
3. Resource use, costs and comparative cost utility (The Work Productivity and Activity Impairment) at 6 weeks, 4 months and 12 months
4. Difference in risk of adverse events (adverse events)
5. Investigate generalisability, acceptability and mechanism of action of the trial and interventions (CRF's, patient and staff interviews) 6 weeks, 12 months

Overall trial start date

01/09/2019

Overall trial end date

30/06/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 18 years and above
2. The patient has undergone operative fixation for an unstable ankle fracture
3. Surgery was performed within 14 days of the injury
4. In the opinion of the treating surgeon, the participant might benefit from early weight-bearing
5. Able and willing to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

436

Participant exclusion criteria

1. A lack of protective sensation (e.g. peripheral neuropathy)
2. Inability to adhere to trial procedures
3. Bilateral operatively treated ankle fractures
4. Already in a trial for ankle fracture
5. The patient has received a hindfoot nail to treat index fracture

Recruitment start date

23/12/2019

Recruitment end date

28/02/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Berkshire Hospital
Reading
RG1 5AN
United Kingdom

Trial participating centre

Salisbury District Hospital
Salisbury
SP2 8BJ
United Kingdom

Trial participating centre

Tunbridge Wells Hospital
Tunbridge Wells
TN2 4QJ
United Kingdom

Trial participating centre

Lewisham Hospital
London
SE13 6LW
United Kingdom

Trial participating centre

Royal United Hospitals Bath
Bath
BA1 3NG
United Kingdom

Trial participating centre

Ysbyty Gwynedd
Bangor
LL57 2PW
United Kingdom

Trial participating centre

University Hospital Coventry And Warwickshire
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Dorset County Hospital
Dorchester
DT1 2JY
United Kingdom

Trial participating centre

Gloucestershire Royal Hospital
Gloucester
GL1 3NN
United Kingdom

Trial participating centre

Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom

Trial participating centre

Princess Alexandra Hospital
Harlow
CM20 1QX
United Kingdom

Trial participating centre

Princess Royal University Hospital
Orpington
BR6 8ND
United Kingdom

Trial participating centre

Queen Alexandra Hospital
Portsmouth
PO6 3LY
United Kingdom

Trial participating centre

Royal Derby Hospital
Derby
DE22 3NE
United Kingdom

Trial participating centre

Royal Preston Hospital
Preston
PR2 9HT
United Kingdom

Trial participating centre

Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom

Trial participating centre

Salford Royal Hospital
Salford
M6 8HD
United Kingdom

Trial participating centre

Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Wexham Park
Slough
SL2 4HL
United Kingdom

Trial participating centre

East Surrey Hospital
Redhill
RH1 5RH
United Kingdom

Trial participating centre

Basingstoke and North Hampshire Hospital
Basingstoke
RG24 9NA
United Kingdom

Trial participating centre

Royal Cornwall Hospital
Truro
TR1 3HD
United Kingdom

Trial participating centre

Conquest Hospital
St Leonards-on-Sea
TN37 7RD
United Kingdom

Trial participating centre

University Hospital Llandough
Penarth
CF64 2XX
United Kingdom

Trial participating centre

Peterborough City Hospital
Peterborough
PE3 9GZ
United Kingdom

Trial participating centre

Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Craigavon Hospital
Portadown
BT63 5QQ
United Kingdom

Trial participating centre

William Harvey Hospital
Ashford
TN24 0LZ
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

CTRG
Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
United Kingdom
+44 (0)1865 572221
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Research for Patient Benefit Programme

Alternative name(s)

NIHR Research for Patient Benefit Programme, RfPB

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

30/06/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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