Treatment of Toddler’s Fractures: Study protocol for a multicentre non-inferiority RCT of no-immobilisation or immobilisation

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.