Open Studies

CRAFFT – Children’s Radius – Acute Fracture Fixation Trial: A multi-centre prospective randomised non-inferiority trial of surgical reduction versus non-surgical casting for displaced distal radius fractures in children.

The most common part of the body for a child to break is their wrist. Most need just a plaster cast, but some have surgery to reset the bones before they go in a plaster cast. These operations are really common but doctors are unsure whether they are really necessary in younger children. In younger children up to 10 years old even when the bones break and move totally out of place, there is evidence to suggest that the wrist will heal well and will grow back to a normal shape over a few months. However, families and some doctors worry that if the bones aren’t reset early, then the wrist might not fully return to normal (may still look bent) and it will take a long time to get back to normal activities. On the other hand, there are risks with resetting bones, including that the child will need an anaesthetic or sedation, they may get scars, and may get an infection. Parents and children want to know if surgery is really necessary to reset the bones, or whether a plaster cast with natural healing will be as good. This study is called a trial, which is the best way to compare treatments to get a proper answer. Half the children and young people will have their broken bones treated with surgery, whilst the other half will have a plaster cast with no surgery. Parents and children won’t be able to choose which treatment they get. To make things fair, this will be decided using the technique of randomisation by a computer.

For more information please contact the Clinical Research Nurse on clinical.research@ydh.nhs.uk.

 

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.

For more information please contact the Clinical Research Nurse on clinical.research@ydh.nhs.uk.

Our aim is to understand how best to investigate acute severe headaches, which are suggestive of a condition called subarachnoid haemorrhage (SAH). SAH is a potentially severe cause of headache in the UK and requires urgent identification and treatment. It is defined as the presence of blood within one of the layers of the brain. At its most serious, it can cause death and severe disability.

We want to understand the accuracy of CT brain scanning in the Emergency Department (ED) and how this accuracy changes with time.

We will collect data on patients presenting to the Emergency department that have headaches reaching peak intensity within one hour. These are the classic headache patterns that raise concern with clinicians about the possibility of SAH. We will use this data to try and validate recently proposed clinical rules, and CT brain strategies, which suggest they can exclude the possibility of SAH with a high degree of precision.

With this information, we will be able to inform clinicians how accurate CT brain scans are safely excluding SAH. Further to this, we will highlight how this accuracy changes depending on the timing of the scan, using hourly intervals from onset of the headache. We will also evaluate the accuracy of clinical decision rules (without any brain scans) to exclude the condition of SAH.