Toddler Fracture Immobilisation Study

Study Procedure and Assessments Demographic and Relevant Clinical Information Emergency department doctors will assess and diagnose the toddler’s fracture during the initial presentation to the ED. Following informed consent, CRF #1 will be completed, containing demographic information for example, participant’s date of birth and gender. In addition, relevant clinical information will be collected including details of the injury, relevant past medical history, and medical evaluations/contacts prior to the ED visit. Patients are then randomised to either CAM boot or AK-POP and the relevant immobilisation device applied prior to discharge from ED. Information regarding care and maintenance of the immobilisation device is given to parents prior to discharge. Prior to discharge from the ED, all patients will receive an appointment and X-ray form for a follow-up review in one week. All patients who are placed in an AK POP will return the following day to the ED for a plaster check as per usual practice (Time Point 2). All parents will be asked to complete a diary on day 2 (CRF 2), recording their child’s pain score on the visual analogue scale (VAS) and an Activities of Daily Living (ADL) questionnaire. The questionnaire used is modified, to be relevant to this study, from the validated Care and Comfort Hypertonicity Questionnaire (CCHQ) and will be known as the Care and Comfort Questionnaire (CCQ). Follow Up Assessment at 7-10 Days (Time Point 3) At Time Point 3 all patients will have a repeat X-ray prior to their ED review clinic and then be seen by an ED consultant or ED nurse practitioner (NP) who will review the X-ray and assess the child clinically. AK POP will be assessed and removed and replaced if there is any concern regarding pressure areas. All POPs will be reinforced with fibreglass wrap and advice given to weight bear as tolerated as per normal practice at this visit. All patients will receive a fracture clinic appointment prior to discharge from the ED review clinic. A CRF # 3 will be completed documenting details of the visit and a pain score from both doctor/NP and parent, as well as completing a CCQ. Weight bearing status of the patient will be clearly documented as full, partial or non-weight bearing. Comparison between the initial x-ray and radiograph at FUA-1 will be formally assessed by the hospital radiology department. Patients will be given a fracture clinic appointment prior to leaving and a CRF will be placed in the notes for completion at the 4 week review. Follow Up Assessment at 4-5 Weeks (Time Point 4) At Time Point 4 post injury, all patients will be reviewed in the orthopaedic fracture clinic and a clinical assessment of fracture healing will be made as well as ability to weight bear. A CRF #4 will be completed documenting a pain score from both the orthopaedic doctor and parent. A CCQ will also be completed by the parent at this appointment. Whether or not the child is weight-bearing, partially weight bearing or not weight bearing will be documented. Any complications encountered during the study period including unscheduled hospital attendances will be documented. Any further investigations or on-going treatment deemed necessary by the orthopaedic surgeon will be documented. Follow Up Assessment At 6 Weeks (Time Point 5) A Time Point 5 a follow-up phone interview will be conducted by the study management team at 6 weeks post study enrolment. A CRF #5 will be completed over the phone documenting pain, ability to weight bearing and any parental concerns. A CCQ will also be completed and the parent will be asked if they would be happy for their child to be immobilised with this technique if required again.