ODD SOCKS - Outcomes of Displaced Distal tibial fractures - Surgery Or Casts in KidS

Plain English Summary

Background and study aims
Broken ankles in children often involve the area from which the bone grows – the growth plate. Following growth plate injuries, the growth of the main shin bone in the lower leg (the tibia) can be altered permanently, which can cause the bone to not grow at all, or to grow wonky. Altered growth may affect how well the leg works. The younger the child at the time of injury (i.e. the more they have to grow), the worse the problem may become once the child has fully grown. There are different ways to treat this injury, but it is currently unclear whether one type of treatment is better than another. Some doctors believe that children with growth plate injuries need surgery to reset their bones to ensure that the growth plate is restored to its original position. They believe that this will lower the chance of abnormal growth. However, other doctors believe that attempting to reset the bones to restore the growth plate with surgery could bring about further damage. These doctors recommend the bones be treated in a plaster cast, without surgery to reset the bones. This study aims to look at whether when children aged between 8 and 15 years old break their ankles, surgery to reset the bones leads to better function than letting the bones heal using a plaster cast without resetting the bones. At the end of the study, the information will be combined about all the children that took part. This will help everyone to understand which treatment is best. To make sure people learn about the best treatment, the doctors who help with this study will talk to other doctors and other people in the NHS who write national guidelines. Patient co-investigators will help deliver the message to families and will be invited to share their experience of the study with medical professionals.

Who can participate?
Children aged between 8 and 15 years old who have a fracture through the growth plate at the bottom of the shin bone, where the bone ends have moved apart from each other.

What does the study involve?
In the study, half the children and young people will have their broken bones treated with surgery, whilst the other half will have a plaster cast with no surgery. Those who agree to join the study, with the support of their families, will be split fairly into two groups, using a research process called ‘randomisation’. Children will be assigned one of two treatments:
1. Surgical reduction – the children in this group will have an anaesthetic or be sedated so their bones can be reset in theatre, and a plaster cast put on their leg. Sometimes, if the doctor thinks it necessary, wires, screws or a plate and screws will be inserted to hold the broken bones in position.
2. Conservative treatment – the children in this group will not have the bones reset in position, they will receive a plaster cast for support to allow the bones to heal naturally. The plaster casts will stay on for around 4-6 weeks for both treatments.

All children will be followed up for two years to keep track of their function, and the length and appearance of the leg. They will be asked about pain, whether they needed any more surgery, school attendance, complications, the number of hospital visits, their quality of life and satisfaction with treatment. Follow-up will occur at 6 weeks, 3, 6, 12 & 24 months. Participant follow-up will be organised by the University of Oxford – either electronically by email or text message or by telephone

What are the possible benefits and risks of participating?
Each of the two routinely used treatments has potential advantages and disadvantages.

1. Resting the leg in a plaster cast for up to 6 weeks, to allow it to heal by itself. The benefit is avoiding surgery. However, the growth plate is not in the perfect position, which may mean that it doesn’t grow normally. This might cause a difference in the shape of the leg (i.e. the ankle could grow wonky) or the injured leg could become shorter than the uninjured leg. This may need future surgery to correct these problems and could cause pain and arthritis in the future.

2. Surgery to fix the bone, usually with screws and a plaster cast for up to 6 weeks. The benefit is that surgery puts the growth plate in the natural position, which many surgeons believe may help the leg grow normally. However, there are risks of surgery, such as the risk of an anaesthetic, infection, wound problems, pain or stiffness, injury to nerves supplying the foot and problems related to the metal implants. There is also still a chance that the leg doesn’t grow normally, and often a need for a second operation to remove any metal implants.

Where is the study run from?
Alder Hey Children’s NHS Foundation Trust is the sponsor for the study and has overall responsibility for the management of it. This study will be overseen by Oxford Clinical Trials Research Unit (OCTRU) with the day-to-day running of the study being completed by Oxford Trauma and Emergency Care at the University of Oxford.

The research team has a lot of experience in caring for children and young people with injuries and is active in health research. Parents and children have been involved in the development of this study, and are involved in the management.

When is the study starting and how long is it expected to run for?
September 2021 to May 2027

Who is funding the study?
The National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (Reference NIHR132675)

Who is the main contact?
Mr Nick Peterson: 0151 2284811, ODDSocks@ndorms.ox.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

Alder Hey Children's NHS Foundation Trust
Hospital/treatment centre

Sponsorship Office, Clinical Research Business Division
Liverpool
L14 5AB
England
United Kingdom

Phone	+44 (0)151 252 5570
Email	research@alderhey.nhs.uk
Website	https://www.alderhey.nhs.uk/
"ROR"	https://ror.org/00p18zw56

Funders

Funder type

Government

Results and Publications

Editorial Notes

15/11/2024: The study participating centres were added: Nottingham University Hospitals NHS Trust, Mid Yorkshire Teaching NHS Trust, Portsmouth Hospitals University NHS Trust, Lancashire Teaching Hospitals NHS Foundation Trust, West Suffolk NHS Foundation Trust, Betsi Cadwaladr University Health Board, South Tees Hospital NHS Foundation Trust, Sheffield Children’s NHS Foundation Trust, Mersey and West Lancashire Teaching Hospitals, University Hospitals of Leicester NHS Trust, Belfast Health and Social Care Trust, Royal Free London NHS Foundation Trust, Birmingham Women’s and Children’s NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, Barts Health NHS Trust, Maidstone and Tunbridge Wells NHS Trust, Kettering General Hospital NHS Foundation Trust.
23/05/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2024 to 22/05/2024.
2. The study participating centre Cheltenham General Hospital was changed to Gloucester Royal Hospital; St James's University Hospital was changed to Leeds General Infirmary; Walsgrave General Hospital was changed to University Hospital Coventry & Warwickshire; Queen Elizabeth the Queen Mother Hospital, Whiston Hospital were added.
01/05/2024: The recruitment start date was changed from 01/05/2024 to 01/06/2024.
05/04/2024: The recruitment start date was changed from 01/04/2024 to 01/05/2024.
08/03/2024: The recruitment start date was changed from 01/03/2024 to 01/04/2024.
5/02/2024: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).