Surgery or Cast for Injuries of the EpicoNdyle in Children’s Elbows
Research type
Research Study
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.
IRAS ID
259931
Contact name
Daniel Perry
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
ISRCTN Number
ISRCTN16619778
Duration of Study in the UK
8 years, 10 months, 31 days
Research 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.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0158
Date of REC Opinion
25 Mar 2019
REC opinion
Favourable Opinion