Treatment of Toddlers Fractures: Observation Or Immobilisation (TOTs)

Research Question: In children aged 9 months to 3-years diagnosed with a toddler's fracture, is no immobilisation non-inferior to immobilisation with respect to pain scores measured at 1 week by the FLACC score?

Background: Toddler's fractures are common injuries, often treated with immobilisation. Immobilisation can cause complications and affect activities. Some clinicians observe these injuries without immobilisation. There is no universally accepted treatment due to a lack of well-conducted trials. Aims and Objectives:

Objective 1 (Primary): To determine if no immobilisation is non-inferior to current management of immobilisation in this population in relation to pain by undertaking a multi-centre RCT, powered to show a 1-point non-inferiority margin on the FLACC scale at 1 week after injury.

Objective 2: To assess the feasibility of conducting a multi-centre RCT of no immobilisation vs immobilisation for toddler's fractures with an internal pilot RCT. Objective 3: To determine patients' and parents' experience and satisfaction with the two treatments.

Objective 4: To evaluate the relative cost-effectiveness of no immobilisation compared to immobilisation by undertaking a within-trial economic evaluation from both an NHS and a societal perspective. Methods

Design: Multicentre, prospective, parallel group, 1:1 randomised, pragmatic, non-blinded, non-inferiority trial with 6 week follow-up and health economic analysis. Internal pilot to assess feasibility. Setting: 20 Emergency Departments and Fracture clinics in the UK. Participants: Children aged 9 months–3-years with a radiologically confirmed toddler's fracture (<2mm displacement) or a clinically suspected toddler's fracture, presenting within 72 hours of injury. Exclusions: non-accidental injury; multiple injuries; displaced fibula fracture; comminuted, physeal or congenital anomalies; metabolic bone disease.

Interventions: No immobilisation (with optional soft bandage) vs. rigid/semi-rigid immobilisation for 3 weeks.

Outcomes: Primary - pain (FLACC scale) at 1 week. Secondary - pain scores, healthcare resource utilisation, recovery, analgesia use, satisfaction, complications. Sample size: 494 (247 per arm) for 90% power to show non-inferiority (margin 1 point on FLACC). Randomisation: 1:1, using minimisation (site, age, radiological diagnosis), computer-generated, allocated remotely.

Blinding: Participants, parents, clinicians unblinded; analysts blinded.

Analysis: Mixed effects model for FLACC at 1 week, adjusting for baseline, minimisation factors. Intention-to-treat and per-protocol analyses. Subgroup analyses. Parallel economic evaluation will estimate incremental cost-effectiveness ratios.

Timelines for delivery: 34 months. M1-8 set-up; M9-14 pilot (progression criteria); M9-26 main recruitment; M27-28 follow-up; M29-34 analysis/write-up.

Anticipated impact and dissemination: Results will show if immobilisation can be avoided, shaping guidelines and practice to reduce unnecessary treatment. Dissemination through media, organisations, journals, conferences and lay summaries with PPIE input on materials.