Date:1/19/2010

were the first clinical trials to test vertebroplasty against a placebo, and many experts were stunned by the results that suggested that patients got equal amounts of modest pain relief whether they got vertebroplasty, where medical-grade bone cement is injected into broken vertebrae, or a dummy injection. "SIR supports the use of vertebral augmentation (vertebroplasty and kyphoplasty) for patients with painful compression fractures. In addition, SIR supports the important role of research regarding the role of vertebral augmentation, but we should take note that it is increasingly clear that these studies did not tell the whole story," said Stainken. "The groups of patients studied and the analysis raised as many questions as were answered," he said. Based on the NEJM findings, the society recommended that interventional radiologists inform patients of the studies' controversial results during consultation. "The studies demonstrate the importance of debate and rigorous analysis of all data prior to rushing to conclusions. We must closely monitor trends in vertebroplasty research. There will be additional studies at SIR's Annual Scientific Meeting in March that will provide new perspective on the aforementioned studies and reaffirm our perspective that vertebroplasty provides long-term and rapid pain relief for appropriately selected patients," said Stainken.

"We are concerned about the possibility that insurance coverage may be withdrawn for vertebroplasty and possibly kyphoplasty because of the controversy generated by the two NEJM studies," said Stainken. If that occurs, access to these procedures would be limited to patients enrolled in approved trials, leaving many patients in severe pain without a solution. SIR is keeping a watchful eye on this to protect patients' access to medical treatment. SIR will continue to serve as a leader in future trials of vertebroplasty that may confirm or contradict these studies or may identify subsets of patients more
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Contact: Maryann Verrillo mverrillo@sirweb.org 703-460-5572 Society of Interventional Radiology Source:Eurekalert

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