Is casting of displaced paediatric distal forearm fractures non-inferior to reduction under general anaesthesia? Study protocol for a pragmatic, randomized, controlled non-inferiority multicentre trial (the casting trial).

BACKGROUND

Treatment of displaced distal forearm fractures in children has traditionally been closed reduction and pin fixation, although they might heal and remodel without surgery with no functional impairment. No randomized controlled trials have been published comparing the patient-reported functional outcome following non-surgical or surgical treatment of displaced paediatric distal forearm fractures.

METHODS

A multicentre non-inferiority randomized controlled trial. Children aged 4-10 years with a displaced distal forearm fracture will be offered inclusion, if the on-duty orthopaedic surgeon finds indication for surgical intervention. They will be allocated equally to non-surgical treatment (intervention) or surgical treatment of surgeon's choice (comparator). Follow-up will be 4 weeks and 3, 6, and 12 months. The primary outcome is the between-group difference in 12 months QuickDASH score. We will need a sample of 40 patients to show a 15-point difference with 80% power.

DISCUSSION: The results of this trial may change our understanding of the healing potential of paediatric distal forearm fractures. If non-inferiority of non-surgical treatment is shown, the results may contribute to a reduction in future surgeries on children, who in turn can be treated without the risks and psychological burdens associated with surgery.

TRIAL REGISTRATION: www.

CLINICALTRIALS: gov (ID: NCT05736068). Date of registry: 17 February 2023.