ODD SOCKS
Research type
Research Study
Full title
ODD SOCKS Study- Outcomes of Displaced Ditsal tibial fractures- Surgery Or Casts in KidS Study
IRAS ID
324571
Contact name
Nicholas D Peterson
Contact email
Sponsor organisation
Alder Hey Children’s NHS Foundation Trust
Duration of Study in the UK
5 years, 3 months, 1 days
Research summary
Broken ankles in children often involve the area from which the bone grows – the growth plate. Following growth plate injuries, the growth of the main shin bone in the lower leg (the tibia) can be altered permanently, which can cause the bone to not grow at all, or to grow wonky. The younger the child at the time of injury (i.e. the more they have to grow) the worse the problem may get once the child has fully grown. Growth plate injuries can cause differences in the length of the legs or can make the leg grow crooked. This altered growth may have an effect on how well the leg works. There are different ways of treating this injury, but at the moment it is not clear whether one type of treatment is better than another.
The first tretament option is Surgical Reduction- – the children in this group will have an anaesthetic or be sedated so their bones can be reset in theatre, and a plaster cast put on their leg. Sometimes, if the doctor thinks it necessary, a small cut will be made and wires, screws or a plate and screws will be inserted to hold the broken bones in position. The second option is Conservative Treatment- the children in this group will not have the bones reset in position, they will receive a plaster cast for support and to allow the bones to heal.It is planned that 192 patients aged between 8 and 15 years old will participate over a three year period from around 30 hospitals. They will be split fairly into the two treatment options.
How well they can function is the most important thing to find out. Therefore, all children and young people will be followed-up for two-years to monitor function. We will also ask about pain, if they needed any more surgery,educational attendance, any complications, the number of hospital visits, their quality of life and satisfaction with care.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
24/EM/0006
Date of REC Opinion
18 Jan 2024
REC opinion
Favourable Opinion