A multi-centre prospective randomised superiority trial of conservative versus surgical treatment for displaced distal tibial fractures in children aged 8-15 years.
Outcomes of Displaced Distal tibial fractures - Surgery Or Casts in KidS (ODD SOCKS)
DEDICATED TRIAL WEBSITE
For more information on this trial including details on taking part, please visit the dedicated ODDSocks trial website by following the link below.
WHY THIS RESEARCH?
Broken ankles in children often involve the area from which the bone grows – the growth plate.
Following growth plate injuries, the growth of the 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. There are different ways to treat this injury, but it is currently unclear whether one type of treatment is better than another.
Some doctors believe that children with growth plate injuries need surgery to reset the bones to ensure that the growth plate is restored into its original position. They believe that this will lower the chance of abnormal growth. However, other doctors believe that attempting to reset the bones to restore the growth plate with surgery could bring about further damage. These doctors recommend the bones to be treated in a plaster cast, without surgery to reset the bones.
WHAT SORT OF STUDY IS THIS?
This is a multi-centre prospective randomised superiority trial of conservative versus surgical treatment for displaced distal tibial fractures in children aged 8-15 years.
This study will aim to recruit a minimum of 192 children with a severe fracture (where the bone ends have moved apart from each other) through the growth plate at the bottom of the tibia bone, over a three-year period from at least 30 hospitals.
After providing consent and baseline data, patients will be randomly allocated (1:1) to either surgical reduction or conservative treatment (non-surgical casting).
All children will be followed-up for two-years to monitor their function, and the length and appearance of the leg. The study will also ask about pain, whether they needed any more surgery, school attendance, complications, the number of hospital visits, their quality of life and satisfaction.
Follow-up will occur at 6 weeks, 3, 6, 12 & 24 months. Participant follow-up will be organised by the University of Oxford – either electronically by email/text message or by telephone.
Recruitment period is approximately 3 years.
Further consent may be sought from participants to allow potential future long term follow-up.
The aim of this pragmatic randomised controlled trial is to evaluate the clinical and cost-effectiveness of surgical reduction, compared to conservative treatment, for the management of displaced Salter Harris-II fractures of the distal tibial physis in children.
The primary objective is to determine whether children treated with surgical correction have improved function compared with children treated with conservative care, as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Mobility Score for Children at two years post-randomisation.
Alder Hey Children’s NHS Foundation Trust
CLINICAL TRIALS UNIT
Oxford Clinical Trials Research Unit, Oxford Trauma & Emergency Care, Kadoorie Centre, NDORMS, University of Oxford