Spine Surgery With Bone Cement No Better Than Placebo

Two emerging studies have just revealed that a common surgical spine treatment involving the use of <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">bone cement provided outcomes no better than a placebo when conducted in osteoporosis patients. WebMD, citing the New England Journal of Medicine, reports that, when comparing results in patients receiving a so-called sham, or placebo, treatment versus those injected with medical-grade bone cement, no increased improvement was seen in the group receiving the bona-fide treatment.

The treatment, called vertebroplasty, is prescribed to stabilize collapsed vertebra, said WebMD, or fill in fractures in the spine. WebMD noted that the treatment is increasing in popularity for osteoporosis-related fractures of the spine, with the number of surgeries doubling in the years between 2001 and 2007. Reuters reported that over 38,000 vertebroplasties are conducted each year.

According to WebMD, the two studies were the most “rigorously designed trials ever” to review the efficacy of vertebroplasty in the treatment of compression fractures in the spine.

One study, conducted in Australia, involved 78 patients who reported severe pain as a result of osteoporosis-related vertebral fractures. The blind study—neither patients nor the research team knew who received what treatment, sham or cement injection—revealed that both groups experienced similar improvement in pain, function, and quality of life improvement, explained Web MD. In both groups, patients received local anesthesia and identical hospital care; those receiving sham treatment experienced cues to allow them to believe they were in the vertebroplasty group, such as being exposed to the scent of bone cement and experiencing pressure on the back.

The other trial, which was similar in nature and conducted by the Mayo Clinic, looked at 131 patients from eight treatment centers in the United States, the United Kingdom, and Australia, said WebMD. And, again, both groups experienced “significant and similar” improvements in all three areas.

“We had hoped this treatment might get the pain better quicker, but we couldn’t demonstrate that,” said Rachelle Buchbinder of Monash University in Malvern, Australia, quoted Reuters. Dr. David Kallmes of the Mayo Clinic in Rochester, Minnesota said, “We aren’t saying the vertebroplasty doesn’t work, because it somehow does,” reported Reuters. “But both sets of patients experienced significant improvements in pain and function a month following the procedure. Improvements may be the result of local anesthesia, sedation, patient expectations, or other factors,” Kallmes added.

But Buchbinder disagreed. “I don’t think there’s any place for vertebroplasty at the moment,” she told Reuters. Compression fractures affect about 1.4 million people worldwide, with over half in the United States, costing as much as $18 billion in this country in 2002.

Back pain researcher Richard Deyo from the Oregon Health and Science University said, “People who got a fake procedure did just as well as people who got the real thing,” quoted Forbes, which noted that Deyo was not on either research team.

“It is absolutely shocking … vertebroplasty as currently practiced in this country and around the world doesn’t seem to work,” said Dr. Kallmes, quoted Forbes.

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