CRAFFT – Children’s Radius - Acute Fracture Fixation Trial: a multi-centre prospective randomised non-inferiority trial of surgical reduction versus non-surgical casting for displaced distal radius fractures in children

niversity of Oxford0 个研究点目标入组 750 人开始时间: 2020年2月27日最近更新: 2024年7月29日

适应症

试验速览

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•1. Male and female children aged 4 to 10 years inclusive
•2. Parents/guardians willing and able to give informed consent for their child’s participation in the study
•3. There is radiographic evidence of a severely displaced wrist fracture at or adjacent to the physis (Salter-Harris II or a metaphyseal fracture); with or without a corresponding ulna fracture
•4. The treating clinician believes that they may benefit from surgical reduction with or without fixation

•1. The injury is more than 7 days old
•2. The injury is part of a more complex wrist fracture (i.e. open or fracture extending into the joint)
•3. There are other fractured bones elsewhere in the body, in addition to the affected wrist injury
•4. There is evidence that the patient and/or parent would be unable to adhere to trial procedures or complete follow-up, such as insufficient English language comprehension, developmental delay or a developmental abnormality or no access by parents to mobile data/internet

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