Altay 2011.
Study characteristics | ||
Methods |
Design: randomised trial Study duration: not stated Power calculation: no prospective calculation of sample size |
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Participants |
Setting: Department of Orthopaedic Surgery, Faculty of Medicine, Harran University, Turkey Sample size: 29 children Inclusion criteria: children (age not specified in inclusion criteria) with Gartland 3 supracondylar fractures Exclusion criteria: associated injuries, nerve lesions, infection, non/malunion, open fractures, bilateral injuries |
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Interventions |
Group 1 (14 children): manipulation of fracture in theatre with fixation using one retrograde wire and one antegrade wire inserted from the lateral side (Dorgan wires) Group 2 (15 children): manipulation of fracture in theatre with fixation using retrograde wires inserted from the medial and lateral side. A percutaneous technique was used for the medial wire. |
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Outcomes | 1) Nerve injury 2) Major complications (pin site infections and compartment syndrome) |
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Notes |
Loss to follow‐up: none reported Cosmesis and range of movement recorded but not presented in sufficient detail to extract Funding source: none Declarations: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: method not stated |
Allocation concealment (selection bias) | Unclear risk | Quote: “Randomization was achieved in a double‐blinded fashion using an envelope containing group assignments.” Comment: unclear if the envelopes were opaque, sealed, or ordered sequentially |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: “Randomization was achieved in a double‐blinded fashion using an envelope containing group assignments.” Comment: no further details regarding blinding of participants or personnel |
Blinding of outcome assessment (detection bias) | Unclear risk | Quote: “Randomization was achieved in a double‐blinded fashion using an envelope containing group assignments” Comment: it is unclear who performed the outcome assessment for clinical nerve dysfunction, cosmesis, and range of motion, and if they were blinded to the treatment provided. |
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. Cosmetic deformity and range of movements not reported in published abstract or full text |
Other bias | Low risk | None identified |