Background Management of common childhood spiral tibial fractures, known as toddler’s fractures, has not significantly changed in recent times despite the availability of immobilisation devices known as controlled ankle motion (CAM) boots. We compared standard therapy with these devices on quality-of-life measures.

Methods A prospective randomised controlled trial, comparing immobilisation with an above-knee plaster of Paris cast (AK-POP) with a CAM boot in children aged 1–5 years with proven or suspected toddler’s fractures presenting to a tertiary paediatric ED in Perth, Western Australia, between March 2018 and February 2020. The primary outcome measure was ease of personal care, as assessed by a Care and Comfort Questionnaire (eight questions scored from 0, very easy, to 8, impossible) completed by the caregiver and assessed during three treatment time-points and preintervention and postintervention. Secondary outcome measures included weight-bearing status as well as complications of fracture healing and number of pressure injuries.

Results 87 patients were randomised (44 CAM boot, median age 2 (IQR 1.5–2.3), 71% male; 43 AK-POP, median age 2 (IQR 1.7–2.8), 80% male), a significant difference in the care and comfort score was demonstrated at all treatment time-points; with the AK-POP group reporting greater personal care needs on assessment on day 2, day 7–10 and 4-week review (all p≤0.001). Weight-bearing status was significantly different at day 7–10 (77.5% CAM vs 53.8% AK-POP, p=0.027). There was no difference in fracture healing or pressure areas between the two treatment groups.

Conclusions Immobilisation of toddler’s fractures in a CAM boot allows faster return to activities of daily living and weight-bearing without any effect on fracture healing.

Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12618001311246).