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. 2022 Jun 9;2022(6):CD013609. doi: 10.1002/14651858.CD013609.pub2

Vaidya 2009.

Study characteristics
Methods Design: randomised trial
Study duration: January 2006 to December 2008
Power calculation: no prospective calculation of sample size
Participants Setting: Department of Orthopaedics, Asha Hospital, Bharatpur, Nepal
Sample size: 66 children
Inclusion criteria: children aged 3 to 12 with Gartland 3 supracondylar fracture
Exclusion criteria: delayed presentation > 4 days, previous fracture in the same limb, open fractures, fractures requiring open reduction, floating elbow, and an inability to perform an adequate neurovascular exam
Interventions Group 1 (unclear how many children were initially allocated to this group): manipulation of fracture in theatre with fixation using retrograde wires inserted from the lateral side
Group 2 (unclear how many children were initially allocated to this group): manipulation of fracture in theatre with fixation using retrograde wires inserted from the medial and lateral side. A mini‐open technique was used for the medial wire.
Outcomes 1) Nerve injury
2) Major complications
3) Cosmetic deformity measured as loss of carrying angle at 6‐month follow‐up
4) Return to function at 6‐month follow‐up
5) Radiographic deformity: loss of Baumann's angle and loss of reduction at 3 months
Notes Loss to follow‐up: 6 children lost from randomisation to follow‐up. It is unclear to which groups these children belonged.
Funding source: not stated
Declarations: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomly selected by drawing lots with even number included in group A and odd number in group B"
Allocation concealment (selection bias) Unclear risk Comment: unclear if there was a fixed number of lots that could be drawn that would allow study staff to predict likelihood of next treatment allocation
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "surgery was performed by senior orthopaedic surgeon"
Comment: unclear who provided the treatments and if they were involved as part of the study
Blinding of outcome assessment (detection bias) Unclear risk Quote: "Clinical evaluation was performed by senior orthopaedic surgeon"
Comment: unclear who undertook the outcome assessment and if they were blinded to treatment allocations
Incomplete outcome data (attrition bias)
All outcomes Low risk 6 children lost from randomisation to follow‐up. It is unclear to which groups these children belonged. Final groups appear balanced
Selective reporting (reporting bias) Unclear risk Comment: no published protocol or prospective trial registration was identified.
Other bias Low risk None identified