Major new study launched in Sheffield to find best treatment for ‘toddler’s fractures’ of the leg

A major UK-wide clinical trial led from Sheffield aims to transform the treatment of a common leg injury in young children – known as a toddler’s fracture.

The ToTs Study (Treatment of Toddler’s Fractures), sponsored by Sheffield Children’s NHS Foundation Trust and supported by the Clinical Trials Research Unit (CTRU) at the University of Sheffield, officially launched in October 2025.

The National Institute for Health and Care Research (NIHR) funded study has already recruited its first 30 participants, with 19 hospitals across the UK now involved and up to 25 expected to join.

Toddler’s fractures are small breaks in the shin bone (tibia), usually caused by a minor fall or twist. These injuries generally heal well in young children, but treatments vary widely across hospitals. Some hospitals use casts or walking boots, while others use simple bandages or no immobilisation at all.

Mr Nick Nicolaou, Consultant Orthopaedic Surgeon and Prof Shammi Ramlakhan, Emergency Medicine Consultant, both at Sheffield Children’s are Co-Chief Investigators for the ToTs Study.

Nick explained: “While thought to be safe, not putting the leg in a cast or boot can cause worry for parents and some clinicians about potential pain or worsening of the injury. However, casts and boots can interfere with a child’s daily activities and cause problems such as skin rubbing and muscle weakness.

“We hope the ToTs Study will conclusively determine whether treating these fractures without a cast is a safe, effective, and appropriate alternative.”

For parent Fay, who sits on the study’s management group, the research feels particularly important. Her son Stanley, now six, was treated with a cast after sustaining a toddler’s fracture when he had just turned two.

She is keen for the study to understand whether casts are really needed, as it will make a huge difference for other families like theirs.

Fay said: “Stanley was a confident little walker before the injury, but the cast completely restricted his mobility. Initially, he was very limited in his movement and was often frustrated he couldn’t do things. He struggled to sleep because the cast prevented him moving in bed and woke him throughout the night. He was quite sad.

“Stanley spent a few weeks in a cast and did adjust to it. When it was removed, his leg looked withered and skinny. As soon as he tried to stand on it, he cried – I think he’d become used to the cast. I was reassured his leg had healed well, but it would be weak for several weeks or even months and could hinder his ability to walk until the muscles had strengthened.”

The study will recruit 494 children aged nine months to three years from hospitals across the UK. Participants will be randomly assigned to one of two groups:

• Immobilisation group – treated with a cast or walking boot.
• No immobilisation group – managed without a cast or boot.

Researchers will compare pain levels, recovery, family satisfaction, mobility, and cost between the two approaches – aiming to develop a clear standard of care for the first time.

Katie Ridsdale, Study Manager from the CTRU at the University of Sheffield’s Centre for Health and Related Research (SCHARR), said: “We’ve seen huge enthusiasm from hospitals across the UK. This research will be crucial to creating consistent, evidence-based care for children with these common fractures.”

To find out more, visit www.tots-study.co.uk.