New Study Shows Efficacy of Vertebroplasty
BY LAUREN UZDIENSKI, AUGUST 10, 2010
A year after two New England Journal of Medicine studies shook up perspectives on vertebroplasty, new data has been released showing the efficacy and value of the procedure and emphasizing some of the shortcomings of the NEJM papers.
The study, published in the Lancet and conducted in the Netherlands and Belgium, randomized 202 patients diagnosed with a VCF and reporting persistent pain to vertebroplasty or conservative treatment. Patients were 50 years or older with acute pain, defined as being symptomatic for six weeks or less.
At one-month follow-up, patients in the vertebroplasty group experienced greater pain relief than those who received conservative treatment, with average VAS scores declining by 5.2 points from baseline. VAS scores for patients treated medically declined an average of 2.7 points. Results were maintained at one year, with vertebroplasty patients reporting a 5.7-point decline in VAS scores, compared to an average decline of 3.7 points after conservative treatment. The authors note that pain relief was attained at an "acceptable cost."
These results challenge the NEJM results, which showed no statistical benefit to vertebroplasty, as well as align with the broader literature and anecdotal consensus on the efficacy of vertebroplasty. There were several notable differences between the Lancet study and the NEJM studies, the most prominent of which being that patients were not blinded, and a sham procedure was not part of the protocol. In addition to raising ethical concerns, critics of the NEJM study have argued that the sham procedure (an injection of anesthetic to the facet joint) could itself have promoted pain relief. Another difference was the age of the fracture; the Lancet study enrolled only patients with acute fractures, where the NEJM studies enrolled patients with chronic fractures up to a year old.
