Is vertebroplasty better than usual care in decreasing pain in patients with vertebral compression fractures?
In patients with back pain due to acute compression fractures, vertebroplasty reduced pain marginally more than conservative care. These findings are not consistent with data from 2 higher-quality studies with showed no benefit.
Klazen CA, Lohle PN, de Vries J, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet 2010;376(9746):1085-1092.
|Study DesignRandomized controlled trial (nonblinded)||FundingIndustry|
In this industry-sponsored open-label study from the Netherlands and Belgium, patients referred by their primary care physician for radiographs in the evaluation of back pain were eligible if they had vertebral compression fractures, pain for less than 6 weeks, and pain severity of at least 5 of 10 on a visual analog scale (VAS). The authors claim that the masking of patients, physicians, and the outcome assessors was not possible. (Baloney. They didn’t try. For example, 2 well-done, similarly powered, randomized trials compared vertebroplasty with sham vertebroplasty: Buchbinder R, et al. N Engl J Med 2009;36:557-68; and Kallmes DF, et al. N Engl J Med 2009;361:569-79). The researchers in this study used an individualized step-approach to pain management, but everybody received bisphosphonates, calcium, and vitamin D. The researchers evaluated pain and quality o f life at baseline, 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year after enrollment, but they claim to have only been interested in outcomes at 1 month and 1 year. At the end of 1 year, 19% of the patients had dropped out (more than 20% is cause for alarm). Patients in both groups improved after 1 month and 1 year. The degree of improvement achieved at 1 month appeared to determine the ultimate comfort level achieved. The difference between the groups in reduction of the mean VAS score from baseline at 1 month was 2.6 and after 1 year was 2.0. The authors report that a difference of 3 or more points was clinically significant. The authors report that there was no difference in the proportion of patients with at least 1 subsequent fracture (16.5% vs 24.7%; P = .44). In general, open-label studies overestimate the effects of active treatment. In spite of this and the authors’ spin, the differences in reduction in pain scores was not clinically significant. Finally, the American Academy of Orthopedic Surgeons recent guideline (www.aaos.org/research/guidelines/SCFguideline.asp; J Am Acad Orthop Surg 2011;19:176-182.) specifically recommends against vertebroplasty in neurologically intact patients, largely based on the aforementioned higher-quality trials that found no benefit in pain reduction.
(Taken from InfoPOEM)
Robert Moore, MD, MPH