Arm Name | Arm Description |
---|---|
Vertebroplasty | Bone biopsy needles at vertebral body positioned bilaterally, using standard transpedicular placements with local anesthetic (1% lidocaine into each pedicle followed by 0.25% ropivacaine) unless conscious sedation required (50 μg fentanyl in 22% of patients), PMMA injection stopped when cement leakage was noticed via CT (mean PMMA volume 5.1 ml [SD 1.8]). In participants with multiple fractures, all were treated. |
Sham vertebroplasty | Stab incisions at level of the vertebral body, local anesthetic as above, PMMA prepared in close proximity to the participants to duplicate mixing sound and smell; simulated procedure using verbal and physical cues. |
Type | Domain | Specific measurement (i.e., tool/definition/specific outcome) | Populations | Timepoints |
---|---|---|---|---|
Continuous | Pain | Pain intensity (mean [SD], 0 to 10 VAS) |
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Categorical | Harms | Mortality |
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Categorical | Harms | Incident vertebral compression fracture |
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Descriptive Statistics | Between Arm Comparisons | ||||
---|---|---|---|---|---|
Vertebroplasty | Sham vertebroplasty | ||||
1 (year) | |||||
Events | Odds Ratio (OR) | ||||
Percentage | 95% CI low (OR) | ||||
95% CI high (OR) | |||||
p value | |||||
Within Arm Comparisons | Net Comparisons | ||||
Vertebroplasty | Sham vertebroplasty |
Descriptive Statistics | Between Arm Comparisons | ||||
---|---|---|---|---|---|
Vertebroplasty | Sham vertebroplasty | ||||
1 (year) | |||||
Events | Odds Ratio (OR) | ||||
Percentage | 95% CI low (OR) | ||||
95% CI high (OR) | |||||
p value | |||||
Within Arm Comparisons | Net Comparisons | ||||
Vertebroplasty | Sham vertebroplasty |
Descriptive Statistics | Between Arm Comparisons | ||||
---|---|---|---|---|---|
Vertebroplasty | Sham vertebroplasty | ||||
1 (week) | |||||
Mean | Mean Difference (MD) | ||||
SD | 95% CI low (MD) | ||||
95% CI high (MD) | |||||
SD (MD) | |||||
p value (MD) | |||||
1 (month) | |||||
Mean | Mean Difference (MD) | ||||
SD | 95% CI low (MD) | ||||
95% CI high (MD) | |||||
SD (MD) | |||||
p value (MD) | |||||
3 (months) | |||||
Mean | Mean Difference (MD) | ||||
SD | 95% CI low (MD) | ||||
95% CI high (MD) | |||||
SD (MD) | |||||
p value (MD) | |||||
6 (months) | |||||
Mean | Mean Difference (MD) | ||||
SD | 95% CI low (MD) | ||||
95% CI high (MD) | |||||
SD (MD) | |||||
p value (MD) | |||||
1 (year) | |||||
Mean | Mean Difference (MD) | ||||
SD | 95% CI low (MD) | ||||
95% CI high (MD) | |||||
SD (MD) | |||||
p value (MD) | |||||
1 (Day) | |||||
Mean | Mean Difference (MD) | ||||
SD | 95% CI low (MD) | ||||
95% CI high (MD) | |||||
SD (MD) | |||||
p value (MD) | |||||
Within Arm Comparisons | Net Comparisons | ||||
Vertebroplasty | Sham vertebroplasty |