Title: FORCE – The FOrearm fracture Recovery in Children Evaluation. A multi-centre prospective randomized equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilisation for torus fractures of the distal radius in children
Funder: Department of Health and Social Care

Abstract: Background Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. Torus fractures are low risk injuries that universally heal well. The NICE noncomplex fracture guidelines made recommendations on the management of these, concluding that bandaging was probably optimal, though postulated that treatment might not be necessary at all. Despite NICE guidelines, UK treatment varies widely in part due to a lack of evidence underpinning guidelines. Research Question Amongst children with a torus (buckle) fracture of the distal radius, is a soft bandage, simple analgesia and immediate discharge as clinically effective as current treatments with rigid immobilisation? Design and Setting A multicentre prospective, parallel, two-arm randomised controlled equivalence trial. Target Population Children 4-16 years old inclusive, with a torus fracture of the distal radius. Health Technologies Assessed Soft bandage (used at the discretion of the patient and family), simple analgesia and immediate discharge. Rigid splint immobilisation, simple analgesia and usual follow-up. Measurement of Costs and Outcomes The primary outcome is the Wong Baker FACES Pain Scale at 3 days. This is a validated self-reported ordinal assessment of pain, using six facial-expressions for ages 3-16. It is widely used in practice, is part of the Royal College of Emergency Medicine ‘Composite tool for the assessment of pain in children’, is advocated in the NICE major trauma guideline, and has been used by HTA. Measurements will be made up to 6 weeks post randomisation. Secondary Outcomes up to 6 weeks (typically self-reported from 8 years, proxy for younger children): • Functional Recovery using Patient Report Outcomes Measurement System (PROMIS) Upper Extremity Score for Children • Analgesia use, • EQ-5DY: validated, generalised, health related quality of life questionnaire. • School absence. • Complications. • Healthcare Utilisation. Sample Size: The Wong Baker FACES pain scale has an MCID of 1 face (assigned ‘2 points’), which was determined in the setting of the paediatric emergency department. Assuming an equivalence margin of 1 point (half the MCID), 90% power, 1-sided 2.5% significance and a standard deviation of 2.3, which was established from the feasibility study using text messages (detailed above), 278 patients would be required to show equivalence. Allowing for 20% loss to follow-up inflates this to 348 (174 per arm). Consideration is made that the Wong Baker pain tool is an outcome that may behave non-linearly in some instances (i.e. the magnitude of pain within the intervals is not uniform), with non-linearity most likely in younger ages, tending to linearity over 8-years old. Secondary outcomes of functional recovery and EQ5DY, are self-reported from 8 years old, and proxy-reported <8 years old. We have powered the trial to test equivalence separately in the subpopulations of under 8, and 8 years old and above. We plan to recruit a minimum of 696 patients, a minimum of 348 in the 4-7 year age group, and 348 in the 8-16 age group. Project Timetables: The trial will take place over 24-months - 4 months set-up, 6 months internal pilot, followed by a further 6-8 months of recruitment with 6 weeks follow-up respectively, and 5 months for data analysis and reporting. Expertise: The team contains experienced paediatric emergency specialists, paediatric trauma specialists, clinical trialists, statisticians, health economists and trial managers, and strong parent representation.

Lay abstract: Why this study? ‘Torus fractures' (also called buckle fractures) of the wrist are the most common type of broken bone in children. There are 500,000 in the UK per year. They are the mildest form of broken bone, whereby the bone crushes (or buckles) instead of breaking. They heal well, and do not cause long-term problems. Despite being so common there is no ‘standard treatment’. The traditional treatment is to use a plaster cast, and arrange outpatient follow-up. Newer medical research suggests that children may return to normal more quickly if a bandage is used, and are likely to be similarly comfortable in a bandage to a cast. There is also growing research evidence to show that children can be safely discharged from hospital as soon as they are seen in Accident and Emergency. The ‘National Institute of Clinical Excellence’ has recommended that a study is needed to confirm that a bandage and early discharge is as effective as more traditional treatments. This study may be good for children and families by reducing pain and the necessity for outpatient hospital visits, improving arm function, and may be good for the NHS by saving millions of pounds on unnecessary splints, plaster-casts and follow-up appointments. What is the research question? For children with this common type of broken wrist (torus fracture), is a bandage (which is optional to wear) and prompt discharge with no-hospital follow-up, as effective as treatment in a plaster cast or splint and usual follow-up. What type of study? The treatments will be compared in a research study called a trial, which is the ‘gold-standard’ method to compare treatments. The treatment that children receive will be made by a computer at random which ensures that the study is fair. How many children? All children over the age of four will be eligible for the study. Children and their parents will be given information in relation to the study and will be asked for their signed consent to take part. It is hoped that 696 children will participate over a two year period from at least ten hospitals. Initially, the study will begin at a select number of hospitals over four months to ensure that the study process is likely to be successful, before involving more hospitals. What will be recorded? Children and their parents have suggested that pain in the initial days of injury is the factor most important to them. Pain will be measured using a specific ‘pain scale’ which children chose from a variety of different pain measuring scales. The use of their arm, school absences and the financial costs to families and the NHS will be measured. The study will use text messages to collect information rather than paper questionnaires – parents have indicated this to be the preferred way to be included in this study. Text messages (with hyperlinks) will be sent to parents/ children at days 1,3,7,21 and 42, with slightly different information collected at each time point. The final follow-up will be at six weeks. Are families involved? Yes. Parents and children have been involved in shaping the study and will continue to be asked for their input. They will be involved in the creation of study leaflets, participate in the management of the study and help to ensure the results are made available in an accessible format to a variety of people – not just those in medicine! A mum (who is not a medical researcher) will be on the trial group to represent the views of parents and children.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: INJURIES AND ACCIDENTS