SIR vs. NEJM studies on treatment for spine fractures (vertebroplasty)

SIR vs. NEJM studies on treatment for spine fractures
Written by Editorial Staff; January 20, 2010; Last updated on January 21, 2010 at 11:53 am EST. © 2002-2010 TriMed Media Group, Inc.

The Society of Interventional Radiology (SIR) is standing behind vertebroplasty--a minimally invasive treatment for vertebral compression fractures--despite a controversy that arose over two studies that concluded the treatment offered no benefit over a placebo procedure.

Vertebroplasty is a nonsurgical method of repairing spinal compression fractures in individuals who have conditions such as osteoporosis, and is performed by interventional radiologists using x-ray imaging and conscious sedation. The procedure involves the physician injecting medical-grade bone cement into the fractured vertebra, which hardens within 15 minutes and stabilizes the fracture.

In 2009, two studies that were published in the New England Journal of Medicine (NEJM) suggested that patients who were administered vertebroplasty received equal amounts of modest pain relief as those who had received a placebo injection.

Despite the findings, SIR President Brian F. Stainken, MD, of the Roger Williams Medical Center in Providence, R.I., said: “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.”

Stainken noted that the patient-population analyzed in these studies raised as many questions as were answered and expressed concern that insurance coverage for vertebroplasty may be denied to the candidates whom this treatment could help, based on the findings of the NEJM studies.

“SIR supports the important role of research regarding the role of vertebral augmentation, but we should take note that it is increasingly clear that these studies did not tell the whole story," said Stainken.
  • Limitations of the aforementioned studies, as noted by the society included:
  • The small numbers of patients treated;
  • The small percentage of eligible patients who were 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;
  • The incomplete use of MRI or CT 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.
“SIR recognizes the value of randomized controlled trials and evidence-based medicine; however, the weakness in the studies and the degree of discordance between the outcomes of these studies, prior studies and experience, suggest that it is premature—and possibly incorrect—to conclude that vertebroplasty is no better than a control sham procedure,” said J. Kevin McGraw, MD, from Riverside Radiology and Interventional Associates in Columbus, Ohio.

Not every osteoporotic patient is a candidate for the procedure, explained Stainken. Potential candidates can include those in which conventional medical treatment, including analgesics and narcotic drugs, have failed to offer any pain relief. Moreover, most of these patients are not able to perform daily activities and are in constant pain, noted the society.

Due to the recent findings, the society has recommended that further studies be conducted “prior to rushing to conclusions.” At the SIR annual scientific meeting in March 2009, the society said that additional studies regarding vertebroplasty will be presented, as well as more perspectives on the NEJM studies.

“SIR will continue to serve as a leader in future trials of vertebroplasty that may confirm or contradict these studies or may identify subsets of patients more likely to benefit from vertebral augmentation,” concluded Stainken.