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The ASNR and ASSR are pleased to report breaking news from the Lancet. The Vertebroplasty for Acute Painful Osteoporotic fractURes (VAPOUR) trial has provided compelling evidence in support of the use of vertebroplasty as a treatment for painful acute (less than 6 weeks’ duration) vertebral compression fractures. Our own Drs. Hirsch and Chandra provided an invited commentary dubbed the Resurrection of Evidence for Vertebroplasty?
Vertebroplasty burst onto the American scene in 1997 when NeuroInterventional Radiologists Lee Jensen, Jacques Dion and colleagues published their initial experience with the treatment in the AJNR. That foundational manuscript remains one of the most cited articles in the Journal’s history.
In the decade that followed that initial publication, there was huge enthusiasm for vertebroplasty and a related procedure, kyphoplasty. In 2009, two blinded randomized controlled trials were published simultaneously in the New England Journal of Medicine that raised questions regarding the efficacy of vertebroplasty. These trials were subjected to intense scrutiny and extensive criticism. The challenge facing supporters of augmentation was that the vertebroplasty cohort performed in many ways as one might expect they would. It was the control group performing better than expected that, in large part, led to the question of unproven benefit for vertebroplasty.
VAPOUR randomized 120 patients with acute fractures and intense pain (at least 7 on a 10-point scale) to undergo either vertebroplasty (n=61) or a sham control procedure (n=59). A statistically significant different number of vertebroplasty patients achieved better pain relief (scores of 4 or less) at 14 days, compared with the sham cohort, and these observations were maintained through the 6-month post-treatment observation period.
Given the challenges of conducting randomized controlled trials related to pain, we believe it appropriate to pause and appreciate what Dr. Clark and colleagues have demonstrated. Vertebroplasty, which Neuro- and NeuroInterventional Radiologists have pioneered, developed and championed, has for the first time been shown in a blinded multi-center trial (against sham) to be more effective than placebo in the treatment of acute, painful, osteoporotic vertebral fractures.
Howard Rowley | Joshua A. Hirsch | Jeffrey S. Ross |
President, ASNR | President, ASSR | Editor-in-Chief, AJNR |