RecruitingInterventional

A study evaluating whether immobilisation or no immobilisation affects pain scores in toddlers fractures

This study is investigating the best way to treat common shin bone breaks in young children, often called 'toddler's fractures.' These breaks usually heal well, but how they are treated varies a lot between hospitals. Some children get a cast or boot, while others might get a bandage or no support at all. The study will split children with these types of fractures into two groups. One group will have a cast or boot, and the other will not. Researchers will then check their pain levels, how quickly they recover, and how satisfied their families are with the treatment. The goal is to find out if treating these fractures without a cast is a safe and good option for children and their families, while also considering how much it costs the NHS.

At a glance

Status

Recruiting

Sponsor

Sheffield Children’s NHS Foundation Trust

Enrolment target

494

Start

30 Sep 2025

Estimated completion

30 Mar 2027

Toddler's fractures - non-displaced spiral fractures of the tibia

What is this study about?

Toddler's fractures are common breaks in the shin bone (tibia) that often happen when young children have a minor fall or twist. Even though these breaks are usually simple and heal well, there's no single way doctors treat them across all hospitals in the UK. Some doctors might put the child's leg in a cast or a special walking boot, while others might suggest just a bandage or no support at all. Both approaches have their own good points and things to consider, and this study aims to clear up which is most effective.

This research project wants to see if avoiding a cast altogether is a suitable option for children with these injuries. Doctors will be looking closely at a few key things: how much pain the child experiences, how easy the treatment is for the child and their family, and if it offers good value for money to the NHS. By comparing different treatment methods, the study hopes to provide clear answers on the best way to help toddlers recover from these common fractures.

Ultimately, the results of this study could help doctors across the country agree on a standard way to treat toddler's fractures. This would mean that no matter which hospital a child goes to, they would receive the treatment that has been shown to work best for pain, recovery, and family convenience. It's about making sure all children get the best possible care for their broken leg.

Key takeaways

The study compares cast treatment versus no cast for toddler's shin bone fractures.
It aims to find the best balance of pain relief, convenience, and recovery for children.
Children aged 9 months to 4 years with specific shin bone breaks can participate.
Participation involves being randomly assigned to a treatment group and completing short questionnaires.
The study explores common treatments, both with known benefits and potential downsides.
The results could help improve care for many children with these types of fractures.

Who may be eligible?

This study is looking for children aged between 9 months and up to their 4th birthday who have, or are thought to have, a specific type of shin bone break called a toddler's fracture. This means the break is in the lower part of the shin bone towards the ankle, and it's not a severe break.

However, some children cannot take part. This includes children who have more than one injury, or if there's any concern about how the injury happened. Children with certain bone problems, limb differences, or a displaced fibula bone break alongside the shin bone break, will also not be able to join the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child aged between 9 months and just under 4 years old?
Does my child have a suspected or confirmed simple shin bone break near the ankle (toddler's fracture)?
Does my child NOT have multiple injuries or any concerns about how the injury happened?
Does my child NOT have any known bone conditions or other limb problems?
Is the break NOT a severe or complex type of fracture?

Answer every question to see your result.

What does participation involve?

If your child joins this study, they will be randomly placed into one of two groups. This is like flipping a coin to make sure the groups are fair. One group will have their leg treated in a cast or a walking boot. The other group will be cared for without a cast or any special support.

You, as the parent, will be asked to fill out some simple questionnaires at three different times: about 72 hours, 3 days, and 28 days after your child starts the study. These questionnaires will ask about your child's pain levels, how happy you are with the treatment, and how quickly your child starts moving around again. You won't need to make extra hospital visits just for the study.

Potential risks and benefits

Taking part in this study could help us learn which treatment works best for toddler's fractures, benefiting many families in the future. For your child, both treatment methods (with or without a cast) are commonly used and have their own pros and cons. A cast might lead to skin problems or stiffness, while no cast could mean a risk of more pain or the bone moving. However, toddler's fractures are usually stable. You are free to withdraw your child from the study at any time without affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Sheffield Childrens Hospital
City only
Sheffield, England

Common questions

What is a 'toddler's fracture'?

It's a common, small break in the shin bone of young children, usually near the ankle, often from a minor fall.

Why is this study being done?

Doctors want to find the best way to treat these fractures, comparing casts to no casts, to reduce pain and make recovery easier for children and families.

Will my child definitely get a cast?

No, your child will be randomly placed into one of two groups: one with a cast or boot, and one without. It's like drawing lots.

How long will the study last for my child?

Your direct participation will involve filling out questionnaires at 72 hours, 3 days, and 28 days after their treatment starts.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR).

How to find out more

Muniba Aslam

muniba.aslam@nhs.net - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.