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

In the UK, the standard treatment for displaced fractures of the distal radius in children is to surgically correct these injuries; with reduction with or without surgical fixation. However, the UK is more interventional than many countries, including the USA, in the treatment of these injuries, with many following a non-operative approach. There is evidence to suggest that these fractures will heal well and completely correct themselves without surgery in children under 11 years old, even if bones are initially displaced, however the quality of evidence is poor. The British Society of Children's Orthopaedic Surgery recently prioritised this as one of their most important research question. There is a clear and pressing need to inform patients about the benefits or otherwise of surgical reduction versus non-operative casting, and a need to inform commissioners regarding the costs of the different treatments to the NHS and society. We propose a multi-centre prospective randomized non-inferiority trial of surgical reduction versus non-surgical casting for severely displaced off-ended distal radius fractures (metaphyseal or Salter Harris) in children aged 4 to 10 years inclusive. We will use well-established networks of children’s orthopaedic and emergency doctors engaged in research. The primary outcome is the Patient Reported Outcomes Measurement Information System Upper Extremity Score for Children (PROMIS UE). The proposed project is a two-phased study. An internal pilot will confirm the expected rate of recruitment to this large trial, and will take place at a minimum of 15 centres over 9 months. The pilot will determine the number of eligible and recruited patients in centres, optimise electronic data collection procedures and enable qualitative work to enhance study procedures. The pilot will seek to recruit 125 patients, and has clear stop/go criteria. The main trial will recruit from at least 35 UK centres. With consent, a research associate will collect baseline demographic data, PROMIS UE, Wong Baker Faces Pain Score, and health-related quality of life using EQ-5DY. Randomisation by minimisation with stratification factors include: centre, fracture type (completely versus incompletely off-ended), fracture location and age group (4-6 years, 7-10 years) will be produced by the trial statistician. Each patient will be randomly allocated (1:1) to interventions. Follow-up will occur at 4-6 weeks during routine follow-up, and thereafter electronically (by email or text message) or by telephone. Outcomes will be collected at 6 weeks, 3 months (Primary outcome time-point), 6 months and 12 months. Electronic follow-up will be administered centrally. Parents will be asked to complete further questionnaires on function, pain, quality of life, cosmesis, satisfaction and resource use at 6 weeks, 3 months, 6 months and 12 months after treatment for the fracture at 3, 6 months and 12 months. Complications will also be collected, including the persistence of deformity identified from routinely collected radiographs. An embedded qualitative study will occur throughout the trial to inform the development of trial materials, to understand the child and parent’s experience of injury, treatment, recovery and reflections on taking part in the trial, and to understand the experience and barriers of the use of interventions amongst staff. Patients will then enter long-term follow-up where a minimal dataset will be requested annually until 3-years post-randomisation, when remodelling of fractures is complete. Complications or further surgery will also be collected throughout.