None listed
Conditions
Brief summary
Ankle injuries are very common among children. They include sprains and fractures such as isolated distal fibular fractures, which are the most common fractures of the lower extremity. They are a significant work load on an emergency department. Treatment has historically been based on the principle of treating these fractures by immobilisation; the affected limb being placed in a plaster cast for 3-6 weeks. Plaster cast immobilisation has been considered necessary due to fear of permanent damage, and to control pain. However, it has been shown that fibular fractures of this type are stable and at negligible risk for premature closure of the growth plate. Previous studies have shown that immobilisation of patients with these type of injuries delays the return to normal activity; indeed supporting mobilisation to be beneficial in the healing process for these types of injuries. In the treatment of ankle sprains, mobilisation has likewise been shown to improve outcome and return patients more rapidly to full activity than does plaster cast immobilisation. One study compared the air-stirrup ankle brace with a full plaster, and showed a better functional activity level at 4 weeks post injury with the ankle brace. However, with the current availability of strong fibreglass splints which allow ambulation (unlike plaster), these have become standard treatment of choice in many of these patients. We aim to compare the air-stirrup ankle brace with the fibreglass ‘walking’ backslab splint, with a greater emphasis on mobilisation and physiotherapy. Participants will be randomised to receive either therapy, and be reviewed by a qualified physiotherapist at 2 and 4 weeks post injury. They will be given tailored exercises at 2 weeks. A questionnaire called the Activities Scale for Kids (ASK) is a validated study tool that measures the degree of functional activity performed by a child (performance arm only). This will be filled out by the participating child’s parents at study enrolment, and then again at 4 weeks post injury. The primary outcome of the study is to compare the mean ASK score between both treatments at 4 weeks. Secondary outcomes are to determine which treatment gives the quickest return to the mean baseline ASK score, which treatment is associated with the least pain (measured daily in the clinical diary), and which treatment is most preferred by parents and children.
Interventions
Patients will be randomised to one of 2 groups, receiving either:
1.an Air-Stirrup ankle brace or
2. Control
Regardless of treatment, all participants are requested to wear their device for a period of 2 weeks. Following review at 2 weeks, those unable to weight-bear will be told to retain immobilisation device for a further week.
Sponsors
Emergency Department, Royal Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
5 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Children present to the Emergency Department (ED) at the Royal Children’s Hospital with an acute, symptomatic, isolated low-risk ankle fracture within 72 hours after injury. Definition of low risk fractures includes the following: • undisplaced distal fibular types I & II Salter-Harris fractures • avulsion fractures of the distal fibula, fibular epiphysis, or lateral talusSince undisplaced Salter-Harris type I fractures are not evident on radiographs and the accepted standard for diagnosis of this fracture is based on clinical findings, a presumptive diagnosis of this fracture will be made using the following pre-defined criteria: age < 12 years, an examination consistent with maximal tenderness and swelling over the distal fibular growth plate and a radiograph demonstrating the absence of bony fracture with evidence of soft tissue swelling over the open distal fibular growth plate.
Exclusion criteria
We will exclude from study participation: • children with pre-existing musculoskeletal disease or surgery• children with coagulopathies, or an anti-coagulant therapy• children with gross motor developmental delay• children with previous history of injury of the affected ankle within the three months prior to presentation• children with multi-system or multi-limb trauma, distal tibial, foot and/or open fractures
Outcome results
None listed