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Vertebroplasty for Painful Vertebral Fractures: End of a Treatment Era?

(RCTs) on vertebroplasty published in the New England Journal of Medicine in August offer a fascinating morality play for spine researchers and spine care providers. And the lessons about the virtues of high-quality scientific research couldn’t be clearer. One RCT, by radiologist David Kallmes, MD, of the Mayo Clinic and colleagues, compared vertebroplasty to a sham procedure in 131 patients at 11 centers in the United States, the UK, and Australia. The second RCT, by rheumatologist Rachelle Buchbinder, MBBS, PhD, of Monash University et al., compared vertebroplasty to a sham operation in 78 patients at four centers in Australia. (See Kallmes et al., 2009; Buchbinder et al., 2009.) Neither study found any advantage for vertebroplasty over the dummy treatment. In other words, a procedure performed some 100,000 times per year in the U.S. doesn’t appear to have any specific therapeutic benefit. The studies reiterate the importance of performing rigorous clinical trials— particularly placebo-controlled randomized trials—of even the most promising interventions. For more than a decade, proponents of vertebroplasty had argued that the procedure was so successful in relieving the pain of vertebral fractures that randomized trials were unnecessary. Some even took the more extreme position that randomized trials—which would deny some patients early access to the percutaneous cement procedure—were unethical. (See “When Are Randomized Trials of Treatments for Back Pain Unethical?” on page 110.)