Peer-reviewed article
Treatment of Toddler's Fractures: Study protocol for a multicentre non-inferiority RCT of no-immobilisation or immobilisation.
Ridsdale K, Ramlakhan S, Rombach I, Turtle C, Goodacre S et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a study protocol for a randomised controlled trial comparing immobilisation versus no-immobilisation treatment for toddler's fractures (spiral fractures of the tibia) in children aged 9 months to 4 years. The trial will recruit 494 participants and measure pain as the primary outcome using the FLACC scale at 7 days post-randomisation. Secondary outcomes include mobility recovery, complications, and cost-effectiveness. The study aims to determine whether avoiding immobilisation is safe and non-inferior to standard cast treatment.
Key points
- Toddler's fractures are stable spiral fractures of the lower tibia typically caused by minor falls
- Treatment varies widely, with some clinicians using immobilisation (casts or boots) and others observing without immobilisation
- Immobilisation can cause stiffness, recovery delays and complications, providing rationale for exploring no-immobilisation approaches
- The trial will recruit 494 children aged 9 months to under 4 years from emergency departments and fracture clinics
- Primary outcome is pain at 7 days measured on the FLACC scale; secondary outcomes include mobility recovery, complications and cost-effectiveness
Limitations
This is a study protocol, not a results paper, so it cannot report actual findings or evidence of effectiveness. The document describes the planned methodology rather than providing data on whether the intervention works.
Abstract
Aims Toddler's fractures are non-displaced spiral fractures of the lower third of the tibia which are usually sustained during a minor fall. These fractures are surrounded by a thick outer lining of bone (the periosteum), which typically makes them stable. Treatment approaches vary; most clinicians use casts or boots to immobilise the leg, whereas others observe recovery without immobilisation. Both approaches are thought to be safe. Whilst immobilisation protects the leg, it can cause issues with stiffness, recovery and complications. The aim of the ToTs study is to determine whether no-immobilisation is non-inferior to immobilisation in young children with toddler's fractures. Methods This randomised controlled trial aims to recruit 494 participants aged 9 months up to their 4th birthday, who present with clinically suspected or radiologically confirmed toddler's fractures. Most participants are expected to be recruited from emergency departments or fracture clinics. Patients will be randomly allocated 1:1, to either immobilisation or no-immobilisation. The primary outcome is the FLACC (Face, Legs, Activity, Cry, Consolability) behavioural pain assessment completed by parents/guardians at 7 days post randomisation. The primary comparison will assess non-inferiority using a margin of 1 point on the FLACC scale. Secondary outcomes include pain at 3 and 28 days, hospital attendances, need for treatment of pressure ulcers and fracture displacement after randomisation, recovery of mobility, analgesic use, resource use, and satisfaction, collected either by review of medical notes at 28 days, or parent/guardian questionnaires. The cost-effectiveness of the different treatment strategies will also be assessed. Patient and Public Involvement and Engagement informed the study design and will assist with aspects of trial delivery and dissemination. Discussion The ToTs trial addresses a lack of high-level evidence regarding the management of toddler's fractures. This will generate evidence to guide clinical practice regarding whether these fractures should be immobilised.