A widely performed procedure faces increased scrutiny
If you’ve ever experienced the pain of an osteoporosis-induced vertebral compression fracture, you know how excruciating and incapacitating it can be. Fortunately, for some people with compression fractures, vertebroplasty has offered pain relief, especially when more conservative approaches like pain medication, bed rest, and back braces fail to provide pain relief.
But two recent studies, published in The New England Journal of Medicine in 2009, reached the controversial conclusion that the operation may be of no more benefit than a placebo. The fallout from these studies has sparked an international debate over the efficacy of the procedure.
Not Reviewed by the FDA
During the vertebroplasty procedure, a medical-grade acrylic cement known as polymethylmethacrylate (PMMA) is injected through a small needle directly into the fractured vertebra. The procedure is performed on an outpatient basis, and the PMMA dries within minutes. Though the procedure is not without its risks—heart and lung damage from leakage of the PMMA and infections—it’s generally regarded as a safe operation. After 24 hours of bed rest, most people can return to normal, non-strenuous activities.
But surgeries like vertebroplasty are not subject to the same rigorous evaluation as prescription drugs and medical devices, which must be approved by the U.S. Food and Drug Administration before they’re made available. In fact, surgical procedures can become the standard of care long before any well-designed, peer-reviewed studies are completed, and government regulatory bodies generally do not get involved.
This makes the two recent studies of vertebroplasty—which was first introduced in the United States in 1997—of particular interest. Today, more than 70,000 vertebroplasty procedures are performed each year.
The Two Trials
In the first randomized, double blind study, Australian researchers followed 71 people with painful, unhealed vertebral compression fractures who either underwent vertebroplasty or had a sham procedure that mimicked the operation in every way except for the injection of PMMA. One week, one month, three months, and six months after the procedure, the participants reported their level of pain.
The participants who under went vertebroplasty had a significant reduction in pain at all of these time points, but the degree of pain relief was no greater than that reported by those who had the sham procedure. Based on these findings, the researchers concluded that vertebroplasty had no beneficial effect.
The second study—another randomized, double-blind trial, conducted largely in the United States and Great Britain—included 131 participants who again were divided into two groups who had either vertebroplasty or a sham procedure. One month later, a similar and significant amount of pain relief occurred in both groups, just like in the first study.
These were not the first studies to cast doubt on the relative benefits of vertebroplasty. In a study published in the journal Spine in 2009 (two months before The New England Journal of Medicine studies were published), researchers found that vertebroplasty offered no real advantage over more conservative medical treatments. In this study, 50 patients were randomized into two groups: vertebroplasty and conservative treatment. Although the group receiving vertebroplasty initially experienced more pain relief, after three months there was no difference in pain scores between the two groups.
Critiquing the Studies
Some experts have criticized the studies from The New England Journal of Medicine because of the relatively small number of patients they enrolled and because they included patients with milder degrees of pain than are usually treated with vertebroplasty. In addition, although vertebroplasty is generally recommended for patients whose compression fractures are less than six months old, the Australian study included some individuals whose fractures were up to 12 months old and may not have responded as well to surgery.
Other researchers have suggested that the local anesthetic used in the sham procedures could have had a genuine effect on pain relief; a study is currently under way to test this hypothesis. It also is possible, some believe, that following the sham procedure some of the patients’ fractures healed on their own, what doctors call the “tincture of time.”
For now, however, based on The New England Journal of Medicine studies, the American Academy of Orthopaedic Surgeons has issued guidelines recommending against the use of this procedure.
The Bottom Line
A range of additional treatments is available for back pain associated with vertebral compression fractures—medication, back braces, kyphoplasty, and spinal fusion—and there is not yet a consensus that one treatment is superior to another. Talk with your doctor(s) about your particular back problem and weigh all the options before deciding which treatment is best for you.