SIR Supports Vertebroplasty Treatment for Painful Spine Fractures

The Society of Interventional Radiology (SIR, Fairfax, VA, USA) is fighting the negative backlash from two controversial studies that compared vertebroplasty to placebo, possibly placing patients with osteoporosis in jeopardy of losing a beneficial treatment.

In a statement issued by the society, SIR supports the use of vertebral augmentation (vertebroplasty and kyphoplasty) for patients with painful compression fractures. In addition, SIR supports the important role of research regarding the role of vertebral augmentation, but notes that it is increasingly clear that these studies did not tell the whole story. The two studies in question were published in the New England Journal of Medicine (NEJM) in August 2009, and were the first clinical trials to test vertebroplasty against a placebo. Many experts were stunned by the results that suggested that patients got equal amounts of modest pain relief whether they received vertebroplasty (in which medical-grade bone cement is injected into broken vertebrae), or a dummy injection. However, based on the findings of the controversial studies, the society recommends that interventional radiologists inform their patients of these results during consultation.

"The studies demonstrate the importance of debate and rigorous analysis of all data prior to rushing to conclusions. We must closely monitor trends in vertebroplasty research. There will be additional studies at SIR's annual scientific meeting in March [2010] that will provide new perspective on the aforementioned studies and reaffirm our perspective that vertebroplasty provides long-term and rapid pain relief for appropriately selected patients,” stated Brian Stainken, M.D., President of SIR, who represents the U.S. national organization of nearly 4,500 doctors, scientists, and allied health professionals dedicated to improving health care through minimally invasive treatments.

Criticisms of both studies by interventionists include the small numbers of patients treated; the small percentage of eligible patients who were actually enrolled in the trial; inclusion of patients with milder degrees of pain and disability than are usually treated in a typical practice; the small amount of cement injected; treatment of patients with chronic compression fractures; the incomplete use of magnetic resonance imaging (MRI) or computerized tomography (CT) scans to confirm that the fracture was the likely source of pain; and the high rate of crossover from placebo to vertebroplasty in one of the studies.

"Hundreds of thousands of patients have greatly benefited from vertebroplasty with almost complete resolution of their pain; tens of thousands dependent on intravenous narcotics have been discharged from the hospital virtually pain- and drug-free following their treatment,” added Dr. Stainken. "Candidates for the procedure are those who have failed to respond to conventional medical treatment, such as rest, analgesics and narcotic drugs; vertebroplasty can give patients their lives back. Interventional radiologists have the critical skills in imaging and patient care that makes them experts at determining which patients are the most appropriate candidates to receive the treatment.”

Related Links:
Society of Interventional Radiology