Brodke 2003.
Methods | Method of randomisation: based on the day of admission Assessor blinding: unclear, but probably not Loss to follow‐up or excluded from analysis:
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Participants | Country: USA Period of study recruitment: 01/01/1991 to 31/12/1993 Total number: 52 participants
Age (of 47 followed up)
Gender
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Interventions | Immediate reduction in the Emergency Department. Surgical stabilisation a few days later. 1. Anterior procedure: discectomy or corpectomy + autologous tricortical iliac crest graft harvested for fusion + fixation with an anterior cervical locking plate 2. Posterior procedure: posterior fusion with iliac crest cancellous autograft + fixation with lateral mass screws and plates Postoperative care: Minerva braces or Miami J collars for 8 to 10 weeks. Mobilisation as soon as tolerated and transferred for spinal cord rehabilitation as the patient's other medical conditions allowed |
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Outcomes | Length of follow‐up: minimum six months (anterior: mean 17 months; posterior: mean 14 months) Neurological outcomes: ASIA (American Spinal Injury Association) motor score and Frankel score Radiographical outcomes: fusion and sagittal alignment Clinical outcomes: postoperative pain Complications |
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Notes | The authors of the study did not respond to our questions about missing information on trial methodology The population of the study included the following types of injuries:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Randomisation was based on the day of admission |
Allocation concealment (selection bias) | High risk | Since the allocation sequence was deemed inadequate, it could not be properly concealed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding is not feasible for participants nor treatment providers in this sort of trial |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessors was not mentioned. There was reference to independent review by the lead author |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All participants lost to follow‐up or excluded were reported. However, their data were not presented. Five participants were not included for final pain analysis:
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Selective reporting (reporting bias) | Unclear risk | All the outcomes described in the methods section were presented in the results. However, the scoring system for neurological status was not specified, not fully reported and is inappropriate (it was not used in this review) |
Other bias | High risk |
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