medwireNews: Findings from the VERTOS IV trial fail to support the use of vertebroplasty for the treatment of acute osteoporotic vertebral compression fractures.
The randomized controlled trial showed that among patients aged 50 years or older who had one to three vertebral compression fractures and had experienced pain for up to 9 weeks, receiving cementation in addition to subcutaneous lidocaine and bupivacaine did not result in greater pain relief during 12 months of follow-up than a sham procedure.
Clinically and statistically significant reductions in pain, measured on a visual analog scale of 1 (no pain) to 10 (severe pain), were seen over the 12 months in both the 91 patients undergoing vertebroplasty and the 89 receiving sham cementation. Scores fell by an average of 5.00 points (7.72 at baseline to 2.72 points) and 4.75 points (7.92 to 3.17 points), respectively.
But at no time point – 1 day, 1 week, and 1, 3, 6 or 12 months – was there a significant difference in pain scores between the two groups, the researchers report.
“These results suggest that factors aside from instillation of polymethylmethacrylate might have accounted for the observed clinical improvement after vertebroplasty; for example, the effect of local anaesthesia, expectations of pain relief (placebo effect), natural healing of the fracture, and regression to the mean,” they comment in The BMJ.
Significant improvements in quality-of-life and disability were also seen in both groups in the 12 months following treatment, but again there was no additional benefit with vertebroplasty. And the use of analgesics and opioids decreased to a similar extent regardless of vertebroplasty.
There were two adverse reactions, both of which occurred in the vertebroplasty group: a case of respiratory insufficiency in a patient with severe chronic obstructive pulmonary disease and a vasovagal reaction.
“The results suggest that periosteal infiltration alone in the early phase provides enough pain relief with no need for additional cementation,” say Christina Firanescu (Elisabeth TweeSteden Hospital, Tilburg, the Netherlands) and study co-authors.
The only exception may be hospital inpatients with high comorbidity and pain scores, for whom cementation at an early phase could be justified, they suggest.
Nevertheless, the team believes that there is a place for vertebroplasty, “when efficacy outweighs the risks,” for patients who are still experiencing pain after many months and are likely to have unresponsive fractures.
In a linked editorial, Evan Davies, from Southampton General Hospital in the UK, says that the current study gives “reliable information about the place of cement augmentation in the management of acute osteoporotic vertebral fractures.”
But he adds that questions still remain regarding its use in the management of chronic painful fractures, particularly in terms of preventing long-term morbidity and mortality, describing these as “fruitful areas for future research.”
By Lucy Piper
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