Title: Outcomes of Displaced Distal tibial fractures - Surgery Or Casts in KidS (ODD SOCKS). A multi-centre prospective randomized superiority trial of conservative versus surgical treatment for displaced distal tibial fractures in children
Funder: Department of Health and Social Care

Abstract: This summary has been written by Phoebe Gibson (parent co-investigator) and reviewed by members of the parents advisory group. _x000D_ _x000D_ Families affected by this injury, and the parents advisory group, have been instrumental in the design of the study including determining the key outcome for this study. The group have been involved in deciding the important outcomes to measure in studies of leg-injuries involving children (the ‘Core Outcome Set’), which has been incorporated into this work. The group are keen to be involved in the ongoing management and oversight of this study. In particular, the children and young people are keen to contribute to making the trial ‘cartoon’, and ‘test’ this out in schools and amongst friends to ensure that they can tell the trial ‘story’ in a fair way._x000D_ _x000D_ _x000D_ Background_x000D_ 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 will become once the child has fully grown. These growth plate injuries can cause differences in the length of the legs or can make the affected leg grow crooked. The altered growth may affect function, and may risk problems in the future. Operations may be needed in order to improve the appearance of the leg and ensure that it functions normally. _x000D_ _x000D_ Some surgeons believe that these injuries should have surgery to ensure the growth plate is perfectly realigned. They believe that this will reduce the chance of abnormal growth. Other surgeons believe that this surgery is not necessary, and that surgery may increase the risk of abnormal growth as the growth plate may be ‘scraped’ and damaged by the procedure. Uncertainty exists around which treatment offers the best outcome due to the lack of high-quality evidence. _x000D_ _x000D_ Aims_x000D_ This study will compare surgery to perfectly realign the fracture, to treating the bone in a cast without correcting the fracture position. The important finding will be how well the children and young people can function (i.e. walk/run/play/participate in sport) two years after the condition was first identified, along with the length and appearance of the leg._x000D_ _x000D_ Methods_x000D_ Children aged between 8 and 15 years old 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 will be asked to join the study. _x000D_ _x000D_ Those who agree will be split into two groups, using a computer to fairly select one of the two treatments at random. _x000D_ _x000D_ 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 and the number of hospital visits. The study will need 192 children and young people in total to answer the question._x000D_ _x000D_ On completion of the study we will know the answer to this research question. _x000D_ _x000D_ We will ensure that we are as careful about involving families, children and young people in sharing the research, as we were designing the study. We will change the initial trial cartoon to share the results of the study, and ensure that this and a ‘plain english’ version of the findings appear alongside technical medical reports.

Lay abstract: Fractures in children are complicated by the presence of growth plates (physes). Fractures of the distal tibial growth plate are estimated to account for 40% of growth plate injuries in children. The growth plate at the distal tibia contributes approximately 3-5mm of length to the leg per year, accounting for 45% of tibial growth and 20% of overall leg length. If this growth plate is damaged during a fracture it may heal with a solid block of bone from which no growth can occur. In its simplest form, this can cause a difference in the length of the leg compared to the unaffected side or, if part of the growth plate is damaged, then this can cause progressive angulation (deformity) as the child grows._x000D_ _x000D_ There is uncertainty amongst surgeons as to whether realigning the bone perfectly is beneficial in preventing growth-related complications– with evidence of mixed practice throughout the UK. Realignment typically involves surgery with general anaesthesia to restore the anatomy. This may involve simple manipulation, or may involve open surgery with fixation to hold the bone in position (i.e. metal screws or wires). Surgeons and families are keen to know whether surgery is superior to no surgery, or if the risks associated with surgery are not justified. Current evidence within the literature is contradictory and of poor methodological quality, however evidence suggests that 40% of patients develop problems associated with growth._x000D_ _x000D_ We propose a multi-centre prospective randomised superiority trial of surgery (with or without fixation) versus non-operative care for children with a displaced (Salter Harris II) fracture of the distal tibia, amongst children aged 8 – 15 years old. We will use well- established networks of children’s orthopaedic surgeons engaged in research; many of whom are already contributing to studies in paediatric orthopaedic trauma. _x000D_ _x000D_ The primary outcome is the Patient Reported Outcomes Measurement Information System Mobility Score for Children (PROMIS Mobility). _x000D_ _x000D_ The proposed project is a two-phased study. An internal pilot will confirm the expected rate of recruitment to this trial, and will take place at 30 centres over 9 months. The pilot will determine the number of eligible and recruited patients in centres AND optimise electronic data collection procedures. _x000D_ _x000D_ The pilot will seek to recruit >0.42 patients/ centre month, and has clear stop/go criteria. The main trial will continue to recruit from these centres. A research associate will collect baseline demographic data, PROMIS Mobility, Wong Baker Faces Pain Score, EQ-5DY, leg length, angular deformity, appearance of deformity, need for subsequent surgery, patient satisfaction, educational participation, complications and cost-effectiveness._x000D_ _x000D_ A randomisation sequence, using a minimisation algorithm with stratification factors: centre, age group (8-12 years, 11-15 years) and severity of deformity will be produced by the trial statistician. Patients will be randomly allocated (1:1) to interventions. _x000D_ _x000D_ Follow-up will occur at 6 weeks, 3 months, 6 months, 1 year and 2 years (primary outcome time-point). Electronic follow-up using patient reported outcomes will be administered centrally. _x000D_ _x000D_ Consent will be sought from participants to allow potential future follow-up through efficient means using linkage to routine healthcare databases, such as the hospital episode statistics.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS