Rizk 2019.
| Study characteristics | ||
| Methods |
Design: randomised trial Study duration: February 2014 to October 2017 Power calculation: no prospective calculation of sample size provided. Sample of 50 children selected but not justified |
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| Participants |
Setting: Department of Orthopaedics and Traumatology, Faculty of Medicine, Benha University, Benha, Egypt Sample size: 50 children Inclusion criteria: children (age not specified in inclusion criteria) with Gartland 3 supracondylar fractures Exclusion criteria: open fractures, patients with associated ipsilateral arm or forearm fractures, patients who required open reduction, and neurovascular injury |
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| Interventions |
Group 1 (25 children): manipulation of fracture in theatre with fixation using two retrograde wires and two antegrade wires inserted from the lateral side Group 2 (25 children): manipulation of fracture in theatre with fixation using two retrograde wires inserted from the medial and lateral side using a percutaneous technique for the medial wire |
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| Outcomes | 1) Nerve injury 2) Major complications 3) Cosmesis (carrying angle at 12 to 40 months) 4) Range of motion at 12 to 40 months' follow‐up 5) Radiographic deformity (loss of Baumann's angle and humeral‐capitellar angle at 12 to 40 months' follow‐up) |
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| Notes |
Loss to follow‐up: none reported 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 | Quote: “This is a prospective randomized control study” Comment: no further information on randomisation technique provided |
| Allocation concealment (selection bias) | Unclear risk | Quote: “This is a prospective randomized control study” Comment: no further information on allocation concealment technique provided |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: unclear who provided the treatments and if they were involved as part of the study |
| Blinding of outcome assessment (detection bias) | Unclear risk | Comment: unclear who assessed the outcomes and if they were blinded to treatment allocation |
| 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 |