Open Studies

Full title: Development of a core outcome set for childhood lower limb fractures

Summary: It is common for children to sustain fractures (breaks) to their bones, and current estimates are that 1 in 3 children will sustain a break during childhood. Despite the common nature of these injuries, there are few research studies to guide the best way to treat them. We need to establish the validity of outcome tools to measure outcomes following these injuries, as there no previous validation studies.

We will establish the best outcome measures to measure recovery following a lower limb injury. Patients will be recruited in the fracture clinic or emergency department following diagnosis of their injury. These children will complete outcome scores in clinic to provide validation for these measures in the full trial. We will recruit 300 children with face-to-face review at 2 and 6 weeks and postal follow up at 10 and 12 weeks.

Full title: SCIENCE Surgery or Cast for Injuries of the EpicoNdyle in Children’s Elbows:A multi-centre prospective randomised superiority trial of operative fixation versus non-operative treatment for medial epicondyle fractures of the humerus in children.

Summary: Broken bones of the elbow are common in children. Doctors have varying opinions about the best treatment for a medial epicondyle fracture. Some surgeons argue that these breaks should be treated with surgery to fix the bone in place, whilst others argue that treating the bone in a cast will give just as good results, without the risks and scars associated with surgery. The research up to now is of poor quality and has conflicting results. This means that the treatment that children receive is dependent on the beliefs and understanding of the surgeon, rather than based on science. Perhaps unsurprisingly, 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.
It is planned that 334 children will participate over a two year period from more than 35 hospitals.

Children, parents and doctors all agree that how well a child can use their arm is the most important thing to find out. This will be measured using a questionnaire that has been developed to measure arm function in children. In addition, we will also ask questions about sports, pain and quality of life and we will work out the cost of the injury to families and the NHS. Questions will be asked at baseline, 6 weeks, 3, 6 and 12 months. Parents have advised us to avoid lots of paper documents, instead we will use a website and videos/animations to explain the study, and e-mails and text messages will be used to keep in touch with families. With permission, we will also record the child’s NHS number, to look at NHS records in the future to see if they had any future problems with their elbow.