Dehghan 2012.
Study characteristics | ||
Methods |
Design: randomised trial Study duration: 2010 Power calculation: no prospective calculation of sample size |
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Participants |
Setting: Ayatollah Kashani hospital, Iran Sample size: 90 children Inclusion criteria: children aged 2 to 10 with Gartland 3 supracondylar fractures Exclusion criteria: delayed presentation more than 5 days, previous arm fracture, head injury, underlying disease, unavailability to attend follow‐up, referral to other centres due to complications |
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Interventions |
Group 1 (45 children): closed manipulation of fracture in theatre with fixation using wires Group 2 (45 children): posterior approach open reduction of fracture in theatre with fixation using wires |
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Outcomes | 1) Major complications (pin site infection) | |
Notes |
Loss to follow‐up: no loss to follow‐up reported 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: "through Random Number Table allocated in two groups" |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient detail on allocation concealment to assess |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: it is not clear who performed the interventions and their relationship to the study team. |
Blinding of outcome assessment (detection bias) | Unclear risk | Comment: it is not clear who performed the outcomes assessment and their relationship to the study team. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no reported loss to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Comment: no published protocol or prospective trial registration was identified. The trial was registered after recruitment was complete. |
Other bias | Low risk | None identified |