Title: Management of ANkle fractures in CHildren: development of a core Outcome set and the feasibility of a Randomised controlled trial (ANCHOR study).
Funder: Department of Health and Social Care

Abstract: Research question Can a randomised trial be delivered to establish the best treatment for stable ankle fractures in children? Background Ankle fractures are common in children, with an annual incidence of 1 in 1,0001. This equates to over 10,000 fractures in school aged children in the U.K. each year. A recent systematic review completed by our group has established that the best treatment for these injuries is unknown2, with a survey of U.K. surgeons demonstrating significant variations in management for these children including treatment with a supportive bandage, ankle brace or below knee cast. Aims and objectives This study will evaluate the feasibility of conducting a trial to compare supportive bandage, ankle brace or below knee cast for the treatment of stable ankle fractures in children, and secondarily deliver a core outcome set for paediatric fractures. The primary objectives are: Patient feasibility Compliance with treatment; Complications with treatment; Outcomes feasibility Determine the ideal outcome measure for this trial; Determine the effect sizes of the interventions; Site and clinician feasibility Numbers of eligible patients; Recruitment and retention rates; Fidelity assessment of inclusion criteria and interventions. In addition, this project will deliver: The identification of the most important outcomes to measure in a core outcome set; Measurement properties of outcome tools for ankle injuries; Qualitative outcomes from trial participants. Establish the potential cost effectiveness of the treatment options Methods Workstream 1: Trial development and core outcome set. The development of a core outcome set for childhood will occur in parallel to trial development. We will build on our completed COMET review, qualitative interviews and expert panel work. This will be condensed into a core outcome set with a Delphi study and consensus meeting. Further PPI work will be undertaken to develop trial materials. Workstream 2: Feasibility trial. A three centre 1:1:1 randomised trial recruiting 126 patients with a minimum of 16 embedded semi-structured interviews will establish the feasibility of conducting a full trial. Timeline for delivery Time period Activity Pre-study work up Team established, long-list of outcomes generated, REC and HRA approvals for consensus methodology, sponsor sign off 0-4 Agreement on core outcomes. Protocol finalisation, REC and HRA approval, patient information drafted and tested with PPI group, local site training 4-7 Initial recruitment period/data collection Additional site training 7-18 Expanded recruitment across all sites/data collection 18-20 Completion of follow up 20-24 Data cleaning, data analysis, write up of report and proposal for full trial (if progress criteria met) Anticipated impact and dissemination This study will deliver several key outputs: An understanding of feasibility of delivering a trial in childhood ankle fractures A core outcome set for use in all future trials of childhood fractures including a lower limb specific module The measurement properties for common outcome instruments in ankle fractures. These may be used in future trials of childhood lower limb fractures This will be disseminated through scientific literature and through our network of patient participants and expert panel.

Lay abstract: It is common for children to sustain fractures (breaks) to their bones, and current estimates are that 1 in 3 children will sustain a break during childhood. Despite the common nature of these injuries, there are few research studies to guide the best way to treat them. One of the most common injuries in children is a broken ankle, and the majority of these do not need an operation. There are a range of different ways to treat these so called 'stable' injuries including the use of a supportive bandage (tubigrip), brace, or plaster cast. Each has its own advantages and disadvantages and a recent survey suggested that there is a range of different treatments offered to the same injury in different hospitals. We have undertaken extensive patient, public and parent (PPI) focus groups to discuss all potential aspects of undertaking a study into this area. We have developed both our research question and proposed answer to this question in conjunction with our PPI groups. A difficulty with undertaking randomised trials in children with musculoskeletal injuries is that it is not clear which are the best questions to ask to assess outcomes. It is also unknown how is best to conduct a study such as this one, as one has never been undertaken before. For this reason, we are planning as part of our trial development to undertake further PPI activities to inform both study design and confirm outcome measures. A feasibility study will then be undertaken to inform a larger definitive study and validate these outcome measures for use in this trial and other trials in this area. We would like to undertake a trial to compare the outcomes of different treatments (supportive bandage, splint or plaster) in children presenting with low risk 'stable' fractures of their ankle. First, we will establish the best outcome measures to measure recovery following a lower limb injury. This will follow a recognised process to develop a 'core outcome set' which is already mostly completed. This will ensure the outcomes measured in trials are relevant to families, clinicians and other stakeholders and ensure the results can be combined with similar trials to maximise research efficiency. Patients will be recruited in the fracture clinic following diagnosis of their injury. Following agreement they will be randomly allocated to either supportive bandage, splint or plaster. We plan to recruit 126 children and treatment will be for 2 weeks followed by face-to-face review at 6 weeks and telephone follow up at 12 weeks. The important outputs from this project will be not only the feasibility data but also a core outcome set which can instantly be applied to future trials and evaluation of children in the clinic.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS