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
Radius acute fracture
This trial will compare two approaches to treat displaced distal radius fractures in children aged 4-10 years old inclusive. Participants are randomised to either: Non-surgical casting: This technique involves the application of a plaster cast to hold the bone fragments in the optimal possible position using analgesia, but without giving medication to deliberately alter the conscious level of the child. This may be the initial plaster cast used to stabilise the fracture, or the plaster cast may be changed by the clinician to maximise patient comfort and fracture stability. Although the principles of applying a plaster cast are inherent in the technique, in this pragmatic trial the type of casting material, extent of the cast and the details of the technique will be left to the discretion of the treating clinician as per their usual technique. A record will be made of the cast details and any cast changes. The usual practice is for the plaster cast to be used for 4-6 weeks. A procedure or operation: A procedure or operation will be performed (with or without fixation). The bones will be realigned under general anaesthesia or sedation altering the conscious state of the child. The method used to hold the bones in position will be at the discretion of the clinician; i.e. plaster cast alone, plaster cast and wires, plaster cast and plate. A record will be made of the operative details, the cast details and any cast changes. Following surgery, the usual practice is for the arm to be immobilised in a cast for 4-6 weeks. Specific details on the techniques and materials used in theatre will be collected for each participant.
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