UNIVERSITY OF OXFORD
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.
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.
Medial epicondyle fractures are common and account for 10% of all elbow fractures in children. They occur between the ages of 7 – 15 years. They are usually a result from an avulsion (pull off) injury caused by a valgus stress at the elbow and contraction of the flexor muscles. The SCIENCE trial will compare the benefits or otherwise of a operative fixation versus non-operative treatment.
We had previously worked with Dan Perry who is a Consultant Children’s Orthopaedic Surgeon based at Alder Hey Children’s hospital on the FORCE study. The FORCE study investigated wrist fractures in children and was one of the trials that we worked on as part of the TRECA project. Dan has helped us to develop the product further with the addition of a Main Trial Website as part of the solution.
The SCIENCE Trial was the first time that we integrated the REDCap system into our solution. REDCap is a secure web application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data (including 21 CFR Part 11, FISMA, and HIPAA-compliant environments), it is specifically geared to support online or offline data capture for research studies and operations. In this case it enables screening and consent to be completed online, with the intention to make the whole process digital. From the Main Trial website we can link to any trial management system or any external system used by the trial team.