Tripuraneni 2009.
| Study characteristics | ||
| Methods |
Design: surgeon randomised study Study duration: March 2004 to August 2006 Power calculation: no prospective calculation of sample size provided |
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| Participants |
Setting: Department of Orthopaedic Surgery, Carrie Tingley Hospital, Albuquerque, New Mexico, USA Sample size: 40 children Inclusion criteria: children (age not specified in inclusion criteria) with a Gartland type 2 or 3 supracondylar fracture Exclusion criteria: revision fixation cases |
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| Interventions |
Group 1 (20 children): manipulation of fracture in theatre with fixation using retrograde wires inserted from the lateral side Group 2 (20 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 | |
| Notes | Radiographic deformity and range of motion assessed at 4 and 8 weeks only (early follow‐up) Loss to follow‐up: 7 (17.5%) children did not attend final follow‐up. It is not specified from which groups these 7 children were lost. 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) | High risk | Quote: "Children were randomized based on which pediatric fellowship‐trained orthopedic surgeon was on trauma call" |
| Allocation concealment (selection bias) | High risk | Comment: day of the week allocation means that study staff could predict allocation |
| 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 | Quote: "All postoperative visits, including radiographic evaluations, were supervised by the attending surgeons" Comment: unclear who undertook the outcome assessment and if they were blinded to treatment allocations |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 7 participants (17.5%) were lost to final follow‐up following pin removal. However, the only extracted outcome was nerve injury, which is unlikely to be impacted by this 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 |