Vaidya 2009.
Study characteristics | ||
Methods |
Design: randomised trial Study duration: January 2006 to December 2008 Power calculation: no prospective calculation of sample size |
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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 |
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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. |
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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 |
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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 |
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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 |