Sadek 2018.
| Study characteristics | ||
| Methods |
Design: prospective randomised study Study duration: June 2015 to January 2016 Power calculation: no prospective calculation of sample size. |
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| Participants |
Setting: Orthopaedic Department, Sohag University Hospital, Egypt Sample size: 40 children Inclusion criteria: children (age not specified in inclusion criteria) with Gartland 2 or 3 supracondylar fracture Exclusion criteria: previous ipsilateral fracture, polytrauma, or neurovascular injury |
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| Interventions |
Group 1 (20 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 (20 children): manipulation of fracture in theatre with fixation using retrograde wires inserted from the lateral side |
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| Outcomes | 1) Nerve injuries 2) Major complications (pin site infections) 3) Cosmetic deformity (loss of carrying angle at 23 to 29 weeks) 4) Range of movement (loss of range of movement at 23 to 29 weeks) 5) Radiographic deformity (absolute Baumann's angle, humeral‐capitellar angle and metaphyseal‐diaphyseal angle at 23 to 29 weeks)* |
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| Notes | *Outcome 5 not reported in sufficient detail to include in analysis Loss to follow‐up: none 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) | Unclear risk | Quote: “40 children were treated for type II and type III supracondylar fracture in humerus. [C]hildren divided randomly into two groups, group A and B” Comment: unclear how randomisation was performed |
| 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 |
| Other bias | Low risk | None identified |