Cement Use in Vertebroplasty May Be Superfluous

A new study has found that relief of pain from vertebral compression fractures, as well as improvement in pain-related dysfunction, were similar in patients treated with vertebroplasty and those treated with simulated vertebroplasty (without cement injections).

Researchers at the Mayo Clinic (Rochester, MD, USA), the University of Washington (Seattle, USA), the University of Edinburgh (United Kingdom), and other institutions conducted a multicenter trial that randomly assigned 131 patients who had one to three painful osteoporotic vertebral compression fractures to undergo either vertebroplasty (68 patients) or a simulated procedure without cement (control group of 63 patients). The baseline characteristics were similar in the two groups. Primary outcomes were scores on the modified Roland-Morris Disability Questionnaire (RDQ) and patients' ratings of average pain intensity during the preceding 24 hours at one month. Patients were allowed to cross over to the other study group after one month.

The results showed that both groups had immediate improvement in disability and pain scores after the intervention, and there was no significant difference between the vertebroplasty group and the control group in either the RDQ score or the pain rating after one month. Although the two groups did not differ significantly on any secondary outcome measure, there was a trend toward a higher rate of clinically meaningful improvement in pain in the vertebroplasty group. At 3 months, there was a higher crossover rate in the control group than in the vertebroplasty group. There was one serious adverse event in each group. The study was published in the August 6, 2009, issue of The New England Journal of Medicine (NEJM).

"Though the medical community has been using vertebroplasty for many years, there were no research results to prove whether the efficacy of the treatment relates to the cement injections, patient expectations, or other factors,” said lead author David Kallmes, M.D., of the department of radiology at the Mayo Clinic. "The cement is a permanent medical implant, and there is some concern that it places patients at future risk for additional spinal fractures.”

Related Links:
Mayo Clinic
University of Washington
University of Edinburgh