Abstract
ObjectivesTo better understand the choice of the comparator intervention in the design of clinical trials and its impact on the meaning of results we review randomized trials on vertebroplasty. MethodsWe conducted a systematic and narrative review of all randomized trials on vertebroplasty. Trials are categorized according to the comparator intervention (non-surgical management, placebo/sham vertebroplasty, and kyphoplasty). ResultsAll trials were too small to show a difference in objective clinical outcomes, and 20 of 23 RCTs used mean pain scores to compare interventions. Most trials comparing vertebroplasty with non-surgical management concluded that vertebroplasty was superior. Trials comparing kyphoplasty with vertebroplasty showed similar results for both interventions. However, 4 of 5 trials comparing vertebroplasty with placebo surgery failed to show a significant difference between groups. ConclusionThe clinical results of an intervention cannot be interpreted without a comparison that involves a control group. The choice of comparator intervention can change the meaning of the trial. A large pragmatic trial, using hard clinical outcomes such as morbidity and mortality as a primary outcome measure, would be needed to assess the potential clinical benefits of vertebroplasty.
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