CRAFFT – Children’s Radius Acute Fracture Fixation Trial

  • Research type

    Research Study

  • Full title

    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.

  • IRAS ID

    264593

  • Contact name

    Daniel Perry

  • Contact email

    daniel.perry@ndorms.ox.ac.uk

  • Sponsor organisation

    University of Oxford / Clinical Trials and Research Governance

  • ISRCTN Number

    ISRCTN10931294

  • Duration of Study in the UK

    5 years, 8 months, 14 days

  • Research summary

    The most common part of the body for a child to break is their wrist. Most need just a plaster cast, but some have surgery to reset the bones before they go in a plaster cast. These operations are really common but doctors are unsure whether they are really necessary in younger children. In younger children up to 10 years old even when the bones break and move totally out of place, there is evidence to suggest that the wrist will heal well and will grow back to a normal shape over a few months. However, families and some doctors worry that if the bones aren’t reset early, then the wrist might not fully return to normal (may still look bent) and it will take a long time to get back to normal activities. On the other hand, there are risks with resetting bones, including that the child will need an anaesthetic or sedation, they may get scars, and may get an infection. Parents and children want to know if surgery is really necessary to reset the bones, or whether a plaster cast with natural healing will be as good. This study is called a trial, which is the best way to compare treatments to get a proper answer. Half the children and young people will have their broken bones treated with surgery, whilst the other half will have a plaster cast with no surgery. Parents and children won’t be able to choose which treatment they get. To make things fair, this will be decided using the technique of randomisation by a computer.

  • REC name

    West Midlands - Black Country Research Ethics Committee

  • REC reference

    20/WM/0054

  • Date of REC Opinion

    16 Apr 2020

  • REC opinion

    Further Information Favourable Opinion