Non-surgical casting versus surgical reduction for children with severely displaced distal radial fractures (the CRAFFT Study): a multicentre, randomised, controlled non-inferiority trial and economic evaluation.

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研究概要

750 children aged 4–10 years with severely displaced distal radial fractures were randomized to receive non-surgical casting or surgical reduction. The primary outcome of interest was upper limb function at 3 months, measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Score for Children. Secondary outcomes included pain, health-related quality of life, cosmetic appearance, complications, unplanned surgery, and health-care costs. Outcomes were assessed at 6 weeks and 3, 6, and 12 months. Overall, the results revealed that surgical reduction provided a small improvement in upper limb function at 3 months, and non-inferiority of casting was not established against the prespecified margin. However, functional differences were no longer evident at 6 or 12 months, while casting was associated with fewer early complications and substantially lower costs. These findings suggested that non-surgical casting could be considered as an initial treatment strategy for most children with severely displaced distal radial fractures.