Boutis 2010.

Methods	Randomised trial Study period: April 2007 to September 2009
Participants	The Hospital for Sick Children, Toronto, Ontario province, Canada 100 children with a minimally angulated or a minimally displaced acute greenstick or transverse fracture of the metaphyseal portion of the distal radius Inclusion: children between 5 and 12 years of age with open growth plates and presenting to the emergency department with a minimally angulated or a minimally displaced acute greenstick or transverse fracture of the metaphyseal portion of the distal radius. Definition of minimal angulation was a fracture with angulation of 15 ° or less in the sagittal plane of the radiograph. Minimal displacement was defined as translational displacement of 5 mm or less on the frontal plane. Informed consent Exclusion: children whose injuries were older than 5 days and those with a buckle (torus), growth‐plate or open fracture. Children at risk of pathologic fractures, those with congenital anomalies of the wrists, coagulopathies, multisystem trauma or multiple injuries to the same limb, and those with developmental delay Sex: 63 male (66% of 96) Age: mean 9.3 years Fracture type (of 96): minimally displaced acute greenstick (55) or transverse fracture (41) of distal radius; distal radius only (69), associated distal ulna fracture (27 : 22 buckle, 5 ulnar styloid) Assigned: 50 (splint) / 50 (cast) Analysed: 43 / 49 (at 3 months)
Interventions	1. Prefabricated splint (W‐312 Pediatric Thermoplastic Wrist Support, Benik Corporation, Silverdale, USA). Children in the splint group were instructed to always wear the splint except for removal as needed for hygiene reasons 2. Fibreglass short arm cast applied by cast technician Splints and casts were applied by certified cast technicians. Apart from specific instructions about care of the cast or the splint, both study groups received identical instructions. The participants wore the immobilisation device for four weeks and were advised to avoid activities that could re‐injure the wrist for a further 2 weeks. (6 children wore the immobilization device for 6 weeks because their fracture angulation had progressed to 25 ° at the 4‐week visit) All participants attended the fracture clinic at the study hospital at 1 and 4 weeks after the injury. 6 weeks after the injury, participants were visited at home by a research physiotherapist
Outcomes	Length of follow‐up: 3 months, also 1, 4 and 6 weeks Function: modified Activities Scale for Kids‐performance version (ASK‐P) at 6 weeks and status at 3 months (included 8 additional questions related more specifically to activity of the wrist) Complications: extended immobilisation because fracture angulation had progressed to 25 ° at the 4‐week visit; required surgery (3 months); complications resulting in cast or splint change; minor complications recorded by parents (irritation, pain, sores, itching, discomfort) Clinical deformity (4 weeks) Grip strength (6 weeks) Range of motion (6 weeks) Wrist pain (1, 4, 6 weeks) Participant and parent satisfaction and preference Radiological: fracture angulation (1, 4 weeks) Splint use (1, 4 weeks) Cost effectiveness analysis
Funding and declarations of interest	Funding source: "The study was funded by the SickKids Foundation (grant no.XG 07‐001)". Declarations of interest: reported, none
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Concealed allocation of treatment was provided by an online program (www.randomize.net) using block randomisation with random block sizes of three and six.”
Allocation concealment (selection bias)	Low risk	Quote: "Concealed allocation of treatment was provided by an online program (www.randomize.net) using block randomisation with random block sizes of three and six.” Safeguards not mentioned but computer package was independent
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Blinding of participants and treatment providers (cast technicians) not possible
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Blinding of participants and treatment providers (cast technicians) not possible
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Quote: “Because families were aware of treatment allocation, this may have introduced bias in the measurement of our outcomes.” Most outcomes come under the above category Quote: “Three months after the injury, parents were telephoned by a research assistant unaware of treatment allocation to assess recovery and any subsequent complications.”
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Quote: “a radiograph of the wrist was obtained and examined by a staff orthopedic surgeon who was unaware of the treatment allocation.” Quote: “To ensure consistency and accuracy of initial diagnoses, a pediatric musculoskeletal radiologist (P.B.), who was unaware of the treatment allocation, reviewed the radiographs obtained at baseline and at one and four weeks after injury” Quote: “Six weeks after the injury, patients were visited at home by a research physiotherapist unaware of the treatment allocation. To preserve blinding, families were instructed not to reveal which immobilization device had been used, and patients were provided with an opaque stocking that was placed over the affected arm before the physiotherapist’s assessment to hide any indications of which device had been used.” Quote: “for 90 of the 92 patients the physiotherapist could not ascertain which immobilization device had been used.”
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Slight discrepancy with Howard abstract which reports “93 of the 97 completed full clinical, radiographic, and patient determined followup” Quote: “Follow‐up of the primary outcome at six weeks was completed in 92 (96%) of the 96 children.” 4 excluded participants (8%) from splint group incorrectly diagnosed Lost to follow‐up: 3 participants uncontactable from splint group and 1 from cast group
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Slight discrepancy with Howard abstract which reports “93 of the 97 completed full clinical, radiographic, and patient determined followup” Quote: “Follow‐up of the primary outcome at six weeks was completed in 92 (96%) of the 96 children.” 4 excluded participants (8%) from splint group incorrectly diagnosed Lost to follow‐up: 3 participants uncontactable from splint group and 1 from cast group
Selective reporting (reporting bias)	Low risk	Trial registration available. All outcomes reported in full article
Other bias: major imbalance in baseline characteristics	Unclear risk	Baseline characteristics reported and appear comparable. However, those for the 4 children excluded from the splint group are missing
Other bias: performance bias	Low risk	Quote: "A certified research cast technician placed either the fibreglass cast or the splint" Both groups received comparable instructions aside from specific instructions regarding the care of the splint or cast
Other bias	Low risk	None detected