Title: 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
Funder: Department of Health and Social Care

Abstract: Written by Evan, Philippa and Phoebe_x000D_ The most common bone for a child to break is their wrist. Most need just a plaster cast, but some need 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. Research suggests in children up to 11 years old even when the bones break and then move so they overlap, the wrist will heal well and will grow back to a normal shape over a few months. The risk of not resetting the bones is that they do not fully return to normal (may appear bent) and normal activities will be a bit harder to do, or get better so slowly that it causes the family concern. The risk of resetting the bones with surgery is that the child will need an anaesthetic, may get scars and be at risk of infection. Parents and children want to know if surgery is really necessary, or whether a plaster cast without resetting the bones will be as good by allowing the wrist to heal naturally._x000D_ What is the Research Question?_x000D_ Do broken wrists in children 4-10 years old inclusive need surgery to reset the bones, or will nature naturally reset the bones as they heal without restricting the use of the arm._x000D_ How will the study be done?_x000D_ Children aged 4-10 years old with a broken wrist will be asked to join the study. Only more severe breaks will be included. Families who agree to join the study will be split into two groups at random using a computer:_x000D_ SURGERY - to reset the bones and a plaster cast (and wires, plates or screws if the doctor thinks that they are required)._x000D_ NO SURGERY - a plaster cast will hold the bones in position, though the bones will not be reset._x000D_ The plaster casts will stay on for 4-6 weeks for both treatments._x000D_ All children will be followed-up for 3-years. The study will ask about the use of the arm, pain, how the arm looks, any complications and the number of hospital visits. 750 children are needed to ensure this study is big enough to clearly answer the question._x000D_ How will this research make a difference?_x000D_ At the end of the study, it will allow hospitals to know the best treatment. To make sure people learn about our findings, the doctors who help with this study will talk to other doctors, and other people in the NHS who write national guidelines. Phoebe, Philippa and Evan will help deliver the message to parents and children, and will be invited to share their experience of the trial and the results with medical professionals._x000D_ How have families and the public been involved in this research?_x000D_ This question began at an ‘NIHR Trauma Workshop' in 2017. Evan (12 years old) was the child representative at this event with 100 surgeons. Two years before Evan had a serious bike accident needing surgery, but is now riding his bike again! Evan and his mum Philippa helped develop this question, and are keen to be involved throughout the study._x000D_ This research question has been discussed with the Young Person’s Advisory Group (YPAG), and the Parents Advisory Group (PAG) in Liverpool, and outcomes for the study been determined at an event held with families at Chester Zoo. Parents felt that their initial fears about not having surgery were overcome by showing them pictures of how well the bones heal and straighten over time. In fact, parents identified that they would only want surgery if it is better than not having surgery. An active parent from the PAG, Phoebe Gibson, is also a co-applicant.

Lay abstract: 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._x000D_ 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_x000D_ UE)._x000D_ 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._x000D_ 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._x000D_ 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._x000D_ 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._x000D_ 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.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS