Title: SCIENCE - Surgery or Cast for Injuries of the EpicoNdyle in Children’s Elbows. A multi-centre prospective randomized superiority trial of operative fixation versus non-operative treatment for medial epicondyle fractures of the humerus
Funder: Department of Health and Social Care

Abstract: The management of fractures of the medial epicondyle is one of the greatest controversies in paediatric fracture care. The British Society of Children's Orthopaedic Surgery recently prioritised this as the most important research question in paediatric orthopaedic trauma care. The debate for clinicians is whether to realign and hold the fragments of bone with operative fixation, or whether to allow the fragments to heal in their current position without surgery by resting the elbow in a cast. There is a clear and pressing need to inform patients about the benefits or otherwise of operative fixation versus non-operative treatment, and a need to inform commissioners regarding the costs of the different treatment strategies to the NHS and society. We therefore propose: A multi-centre prospective randomized superiority trial of operative fixation versus non-operative treatment for medial epicondyle fractures of the humerus in children, using a well-established network of children’s orthopaedic surgeons engaged in research. The proposed project is a two-phased study. An internal pilot will confirm the expected rate of recruitment in a large-scale multi-centre randomised controlled trial. The main phase will be the proposed randomised controlled trial in a minimum of 35 centres across the UK. The pilot will take place at 20 centres over a period of 12 months. The aim of this initial phase will be to determine the number of eligible and recruited patients in the trauma centres as well as optimise the electronic data collection procedures. The pilot will seek to recruit 80-120 patients from 20 centres over 12 months. If the trial continues into the main phase, patients from the internal pilot will be included in the final analysis. The main trial will recruit from a minimum of 35 centres treating children’s fractures across the UK. All children presenting at the trial centres with a medial epicondyle fracture of the humerus are potentially eligible to take part in the trial. After consent has been gained, a local research associate will collect baseline demographic data, the Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Score for Children Computer Adaptive Test, DASH Sports/Performing Arts Module, Wong Baker Faces Pain Score, and health-related quality of life using the EuroQoL EQ-5DY. A randomisation sequence, stratified by centre, to account for centre-specific effects, and dislocation-status of the elbow (i.e. dislocated or not-dislocated at presentation to the emergency department) will be produced by the trial statistician. Each patient will be randomly allocated (1:1) to either operative fixation, or non-surgical treatment. Follow-up will be at 4 weeks during routine follow-up, and thereafter made electronically (sent by e-mail or text message) for the Patient Reported Outcomes at 6 weeks, 3 months, 6 months and 12 months (Primary outcome time-point). In exceptional circumstances, data can be collected on paper forms or via telephone interview. Electronic patient follow-up will be administered centrally. The parents of participants will also be asked to complete a resource use questionnaire related to their child’s use of healthcare services following treatment for epicondyle fracture at 3, 6 months and 12 months. Patients will then enter a long-term follow-up surveillance phase where a minimal dataset will be requested from them on a yearly basis until 16 years old which for the purposes of this trial has been identified as the point of skeletal maturity. Thereafter the NHS number of participants will be stored to enable future data linkage to sources of routinely collected data (i.e. Hospital Episode Statistics).

Lay abstract: Why this research? Broken bones of the elbow are common in children. One type of elbow break, called a ‘medial epicondyle fracture’, causes particular debate amongst surgeons. Some surgeons argue that these breaks should be treated with surgery to fix the bone with wires or screws, whilst others argue that treating the bone in a cast has just as good results, without the risks and scars associated with surgery. The medical research is of poor quality and has mixed results supporting both arguments. This means that the treatment that children receive is dependent on the beliefs and understanding of the surgeon, rather than proper science. Perhaps unsurprisingly, almost half of children in the UK are treated with surgery, and half with a cast. High-quality research is urgently needed to answer this question for good. What is the question being asked? In children with this elbow injury (medial epicondyle fracture), does treatment with surgery result in better arm function after 1 year than treatment without surgery? What sort of study is it? The study is called a trial, which is the best method to compare treatments and the best study to produce a definite answer. A computer will decide whether a child does or doesn’t get surgery – the decision is made between the treatments at random. How many children will be involved? Children with this injury are usually around 10/11 years old, though anyone over 7 years can participate. It is hoped that 334 children will participate over a two year period from more than 35 hospitals. This number is calculated based on previous scientific research to ensure that the study is large enough to reach a firm conclusion. What will families be asked? Children, parents and doctors all agree that the use of the arm is the most important thing to record. This will be measured using a questionnaire that has specifically been developed to measure arm function in children. In addition to day-to-day function, we will also ask questions about sports, pain, quality of life and the cost of the injury to families and the NHS. These questions will be asked at the time of the broken elbow, and then after 3, 6 and 12 months. The most important follow-up point is at 12-months, which is called the ‘primary outcome’. At the request of parents we will try to avoid paper questionnaires, instead largely using e-mails and text messages to keep in touch with families. Is there involvement from families? A large group of children and parents, who were united at Chester Zoo, have been involved in prioritising ‘which’ outcomes are important, in addition to ‘how’ and ‘when’ to follow-up children. Families have told us that whether they will agree to be randomised will depend a lot on the information provided to them - we therefore have specialists within the team who will explore at an early stage with young people and their families what level of information is needed, and how this should be presented. A dad and daughter team (Tommy & Erin Jess) with direct experience of this injury will be involved in the oversight of the study. Children who advise researchers on projects (called the GenerationR Young Persons Advisory Group) and families of children at the Chester Zoo day have offered to help and advise us with the development of leaflets and online information, such as the development of a 'explainer cartoon', to provide families the information they need to consider joining the research

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