How Effective is Vertebroplasty?
A Spine Professional’s Response
A Mayo Clinic study released in an August 2009 issue of the New England Journal of Medicine raised questions about the effectiveness of vertebroplasty, a procedure used to treat spinal compression fractures.
The findings showed that vertebroplasty, which is a common treatment option for people with severe osteoporosis, delivered similar results as a placebo procedure. The study was based on 131 patients who received either actual vertebroplasty treatment or simulated (fake) vertebroplasty.
The study drew mixed responses from the medical community—some believe the results pose significant concerns, while others say that further research is necessary to yield more definitive results.
The Obama Administration praised the research, saying that more of its kind should follow. As part of his plans for health care reform, President Obama hopes to cut medical costs by allocating America's health care funds to the procedures that offer a legitimate benefit to patients.
So a big question remains: is vertebroplasty a truly beneficial surgery—or an unnecessary procedure?
A Spine Professional's Response
Dr. Isador Lieberman is an orthopaedic surgeon with the Cleveland Clinic, and his contributions to the treatment of osteoporotic vertebral compression fractures are nationally and internationally recognized. Dr. Lieberman is a proponent of minimally invasive vertebral augmentation techniques including vertebroplasty and kyphoplasty. Kyphoplasty, is a procedure that is similar to vertebroplasty, but it features inflatable balloon technology. Dr Lieberman maintains that the techniques are not mutually exclusive, each have their own advantages and disadvantages, and are tools to be used at the correct time when treating the spectrum of vertebral compression fractures.
SpineUniverse asked Dr. Lieberman to comment on the published vertebroplasty findings. Below are his thoughts.
"Prior…studies on vertebroplasty showed good pain relief and similar to this study showed that pain relief may not be different at early time points," Dr. Lieberman said.
In analyzing the Mayo Clinic study, Dr. Lieberman also referenced simultaneously published Australian research. He noted that the main drawback of both studies is that they were underpowered—primarily, that they had too few participants.
An issue unique to the Mayo Clinic study was the crossover rate, particularly for the participants who originally received fake vertebroplasty (after one month, patients were able to switch groups).
"The patients crossed over to the vertebroplasty [group] from the sham treatment at a much higher and statistically significant rate, suggesting that there may be subtle benefits from vertebroplasty that these underpowered studies are unable to detect."
Dr. Lieberman also noted that like any surgical technique or intervention, vertebroplasty has certain limitations, which may be responsible for the presumed questionable effectiveness. In addition the patient entry criteria, the overall study time to enroll patients, the number of centers involved and the number of patients from each center, may influence the overall results and must be acknowledged in the interpretation of the results.
The medical community may not agree on the significance of the vertebroplasty study's results, but one thing is certain: it yields more questions than answers. The Mayo Clinic study does not totally discount the effectiveness of vertebroplasty, and there are studies that tout the technique's benefits. Ultimately, more research and a larger participant base are necessary for more definitive results.
"Taken together, these studies do not support robust benefits from performing vertebroplasty," Dr. Lieberman noted. "Yet one must not discount all the previous positive literature."
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