After years of backbiting, practitioners of kyphoplasty and vertebroplasty have finally found an issue upon which they can agree. They need a randomized controlled clinical trial.
Heated exchanges and finger-pointing for alleged clinical flops are the norm between the two camps. However, there is simply no credible evidence to rate one technique above the other for management of osteoporotic vertebral compression fractures, said Dr. Avery J. Evans, an associate professor of radiology and neurosurgery at the University of Virginia, at a special focus session at the RSNA meeting.
Physicians recognize that each technique has shortcomings. For instance, patients undergoing vertebroplasty for fractures caused by tumors seem to have higher complication rates. Some data also suggest that increased vertebral pressure following these interventions can cause new vertebral fractures. Most available references on these procedures, however, come from in vitro biomechanical data, incidental or anecdotal reports, or retrospective, nonrandomized studies.
"Physicians cannot establish the success or complication rate of either technique without a randomized controlled trial," Evans said.
Overall risks seem similar. But the multiple factors influencing the outcome of each procedure have not been properly addressed, said Dr. David F. Kallmes, an interventional neuroradiologist at the Mayo Clinic in Minnesota.
"Until these issues are clearly resolved, we need to have an honest discussion with patients about these procedures," he said. "And we also need to make sure we do our best to manage the disease, not just the symptoms. We definitely need a trial."
Several groups in the U.S. and Canada have set up protocols for prospective studies. The first multicenter randomized controlled trial with a significant patient population is expected to be announced this year.