Back Pain

Vertebroplasty Benefits Questioned in Recent Studies

August 13, 2009
by: Sylvia Marten

Recent studies have questioned the minimally-invasive spine surgery vertebroplasty, specifically noting that there was no apparent benefit from the procedure as compared to a simulated treatment that mimicked a vertebroplasty but lacked one key element.

Used to treat vertebral fractures from osteoporosis, vertebroplasty involves a numbing of the back followed by an injection of bone cement into the vertebra to cover the fracture, provide stability to the spine and relieve back pain.

Led by researchers from the Mayo Clinic, one study compared function and pain in patients who had vertebroplasty surgery and a placebo group who had their backs numbed but did not receive an injection of the bone cement.

More specifically:

131 patients were randomly assigned to either a vertebroplasty or the simulated procedure in eight medical centers in the United States, United Kingdom and Australia
68 patients were treated with vertebroplasty
63 patients were given the simulated treatment.

According to the study’s findings as published in the New England Journal of Medicine, there was no difference between the treatments after one month: both groups experienced significant and similar reductions in disability and pain, making it impossible to declare a better treatment, and calling into question, at least according to some, the benefit of vertebroplasty.

While one researcher noted that the study isn’t saying that vertebroplasty is ineffective, it does raise the argument of whether the improvements are actually the result of sedation, local anesthesia or other factors as opposed to the injection of bone cement.

Other Research on Vertebroplasty Supports Mayo Study

The findings of the Mayo-led study coincided with the results of a separate study by the Australian government. In this study that was also recently published in the The New England Journal of Medicine:

78 patients with 1 or 2 unhealed vertebral fractures of less than 12 months in duration participated in the multi-centered study
38 of those patients underwent vertebroplasty
40 patients were placed in the control group.

The primary outcome of overall pain (on a scale of 1-10) was measured at 1 week and 3 and 6 months. According to the findings, both groups of patients experienced significant but similar improvements in pain; in other words, once again there was no major difference establishing one of the two treatments as being more beneficial.

Update: On Thursday, October 16, 2009, the North American Spine Society (NASS) issued a response to these two randomized controlled trials. After reviewing the studies, the NASS noted how it was not looking to discredit these studies or the integrity of their authors, but was rather interested in exploring the disconnect between the findings of these two studies and previous findings on vertebroplasty. Read the NASS response below:

Newly Released Vertebroplasty RCTs: A Tale of Two Trials.

What Do These Findings Reveal about Vertebroplasty?

A lot of opinions have been formed in the week since the release of the results from these first two studies to examine the effect of vertebroplasty. Some doctors have said that these independent studies reveal that vertebroplasty is not beneficial and should be performed only in clinical research trials designed to continue studying its effectiveness.

Other doctors have raised concerns about the vertebroplasty research, including the lack of willing participants, small patient sizes and a flaw in the study that allowed patients to crossover from one treatment to the other. Others have cited the need for more research beyond two trials.

Of course, the issue is an important one for several reasons:

An estimated 100,000 vertebroplasty procedures were performed last year in the United States, according to a Wall Street Journal story. While the risks of vertebroplasty (specifically, leaking bone cement leading to soft tissue damage, nerve pain and compression, pulmonary embolism, respiratory or cardiac failure, and/or even death) are extremely small, it would make no sense to expose patients to such risks if the benefits of the surgery did not outweigh them.
With 250,000 vertebral fractures diagnosed each year, it’s vital that patients are receiving and paying for care that is actually beneficial; the same goes for doctors in terms of performing and paying for vertebroplasty. According to the Wall Street Journal story, vertebroplasty can cost anywhere from $2,000 to $5,000.
Amidst the debate on health care reform, legislators will certainly be interested in the actual benefits of vertebroplasty (which is covered by Medicare) as they go back and forth on legislation. According to a doctor at Dartmouth in a Forbes article, Medicare paid for 40,000 vertebroplasty procedures last year at a price of roughly $3,000 each.

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