ToTs: Treatment of Toddler's Fractures; Version 1
Research type
Research Study
Full title
Treatment of Toddler's fractures: A multicentre non-inferiority RCT of observation or immobilisation
IRAS ID
353019
Contact name
Nicolas Nicolaou
Contact email
Sponsor organisation
Sheffield Children's Hospital
Duration of Study in the UK
2 years, 9 months, 31 days
Research summary
Toddler's Fractures are breaks in the tibia (shin bone) that often occur as a result of a minor trip, twist or fall. Children present with pain, limping or an inability to put their weight through their leg. The break is in the lower part of the bone towards the ankle, and usually heals well. In younger children the bones have a thick covering that protects the bone and allows quick healing.
Managing toddler’s fractures differs greatly depending on what hospital you go to. Some doctors will treat in a cast and allow the child to walk on the leg. Others use just a walking boot, a bandage or no form of immobilisation.
There are pros and cons to each treatment. A cast can cause problems with weakness, rubbing and can be an inconvenience both to the child and their parents. Treating without any form of cast or boot has been shown to be safe, however this worries some that the child may get pain.
This study will look at whether treating without a cast is an appropriate alternative in terms of pain, convenience for the child and family, and value for money to the NHS.
This trial will include 494 children (aged from 9 months up to their 4th birthday) from approximately 20 hospitals across the UK. The children will be randomly split into 2 groups. One group will be treated with a cast or walking boot for their fracture. One group will be managed without a cast. Parents will be asked to complete questionnaires 3 days, 7 days and 28 days after randomisation, which will include questions on their child's pain, their satisfaction with the treatment, and how quickly they started moving around.
REC name
West of Scotland REC 5
REC reference
25/WS/0066
Date of REC Opinion
5 Jun 2025
REC opinion
Further Information Favourable Opinion