Barnett 2012.

Methods	Randomised controlled study (parallel)
Participants	45 children Setting and recruitment period: Royal Children's Hospital (Melbourne, Australia); August 2007 to March 2009 Inclusion criteria: aged 5 to 15 years, inclusive, who attended with a "low‐risk ankle fracture" (avulsion fracture of distal fibula, undisplaced Salter‐Harris I fracture, and type 2 fracture of fibula or avulsion fracture of the lateral talus) Exclusion criteria: Injury older than 72 hours Pre‐existing musculoskeletal disease or surgery to the affected ankle Injury to the same ankle in the previous 3 months Bleeding disorder (e.g. haemophilia) or on anticoagulant therapy Multisystem or multi‐limb trauma Fracture that involved the distal tibia or foot or required manipulation or surgical intervention Gender: 25 females; 20 males Age: mean 10.7 years Fracture type: "A low‐risk ankle fracture was defined as (1) an avulsion fracture of the distal fibula, (2) an undisplaced SHI (defined as isolated tenderness over fibula growth plate and normal x‐radiography) and type II fracture of the fibula, or (3) an avulsion fracture of the lateral talus." SHI stands for Salter‐Harris type I. The majority of fractures (33 of 45) were Salter‐Harris type I fractures
Interventions	Aircast (Vista, CA) Air‐Stirrup Ankle Brace, which was easily removable for bathing Fibreglass posterior splint (backslab) (Dynacast Prelude; Smith & Nephew), which was easily removable for bathing Children were allowed to mobilise using their devices and weight bear as tolerated. Both brace and splint could be removed for bathing. Both brace and splint were removed after 12 to 16 days. Allocation: 22 (brace); 23 (backslab) Analysed: 20 (brace); 20 (backslab)
Outcomes	Follow‐up schedule: At 12 to 16 days post‐injury, the children attended clinic, removed their device, had their ankle radiographed, and were seen by the blinded research physiotherapist, who gave them a second diary. The device may have been removed at this point if clinically appropriate. A second follow‐up appointment was conducted at 4 weeks, at which point the child was assessed, a second ASKp was recorded, and the second diary collected (no second radiograph). Children were given a diary to record the degree of pain and analgesia used and ease of care of the device. Primary outcome: Change in mean functional activity as measured by the ASKp. Secondary outcomes: Physiotherapy assessment at 2 and 4 weeks, degree of pain during the first 2 weeks, amount of analgesia used in the first 2 weeks, ease of caring for the device
Notes	Although separate ASKp data were provided for age subgroups (5 to 10 years and 11 to 15 years), the numbers in each group were not reported, but would in any case have been too small for meaningful subgroup analysis. Requests for raw ASKp data were sent but required ethics committee approval for the author to send these to us (personal communication from Peter Barnett on 29 September 2014)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation stratified by age group (5 to 10 and 11 to 15 years). Random block sizes of 2, 4 and 6 to generate a randomisation schedule.
Allocation concealment (selection bias)	Unclear risk	Study report states that investigators were blinded to the block sizes to ensure allocation concealment, but it was not explained how this was ensured
Blinding of participants and personnel (performance bias) Patient‐rated outcomes	High risk	Blinding children to the allocated intervention was not feasible
Blinding of participants and personnel (performance bias) Clinician‐rated outcomes	High risk	Personnel applying the intervention were not blinded
Blinding of outcome assessment (detection bias) Patient‐rated outcomes	High risk	Patient‐reported outcomes would be at high risk of bias due to the lack of blinding
Blinding of outcome assessment (detection bias) Clinician‐rated outcomes	Low risk	Children removed ankle brace or splint before assessment; this was ensured by the research assistants. Assessors providing physician‐reported outcomes were blinded
Incomplete outcome data (attrition bias) Patient‐rated outcomes	Unclear risk	Participant flow provided: the numbers not included in the analyses (2 versus 3) were comparable in the 2 groups. However, no data were provided regarding the rates of diary completion by children
Incomplete outcome data (attrition bias) Clinician‐rated outcomes	Unclear risk	Participant flow provided: the numbers not included in the analyses (2 versus 3) were comparable in the 2 groups
Selective reporting (reporting bias)	Unclear risk	Protocol not available. Data for daily pain scores, which was a key (secondary) outcome, were not fully presented. Duration of analgesia use rather than amount of analgesia used in the first 2 weeks not provided (key, secondary outcome)
Other bias	Unclear risk	Not enough study participants to satisfy power calculation criteria