Vertebroplasty — 1 Year Later

In two randomized trials published in the August 2009 New England Journal of Medicine , vertebroplasty (injection of a cementing substance into a vertebral fracture) was compared with a sham procedure, in which the blinded control group received preprocedural local anesthesia at the fracture site but no intravertebral injection. In both studies, the vertebroplasty and sham groups improved to a similar extent, with no significant differences between groups (JW Gen Med Aug 5 2009). Because vertebroplasty (and the related procedure, kyphoplasty) still is performed routinely at many medical centers despite these negative results, the topic is worth revisiting. During the past year, investigators from the two sham-controlled trials have engaged in ongoing debate with critics. In perhaps the most-detailed published exchange of views, a group of nine interventional radiologists argued that the two studies were underpowered (one had only 78 patients; the other, 131) and that recruitment difficulties resulted in study populations that did not adequately represent patients who could benefit (Radiology 2010; 255:669). In response, the lead investigators of the two trials provided plausible point-by-point counterarguments; …