Vertebroplasty study adds weight, but not final word

A new study on vertebroplasty adds weight to the argument the procedure is safe and effective for patients with acute osteoporotic vertebral compression fractures. But the trial that researchers hope will dispel all doubts about vertebroplasty’s usefulness starts enrollment in the fall.

A pair of studies in the New England Journal of Medicine a year ago rocked interventional radiology with their conclusions that vertebroplasty is no better than placebo at relieving pain from vertebral fractures.

“For a decade most of us knew verteboplasty was effective in relieving pain and providing symptomatic relief in compression fractures,” said Dr. J. Kevin McGraw, section head of interventional radiology at Riverside Radiology and Interventional Associates in Columbus, OH. “Then the two studies were published in the New England Journal of Medicine and they made us sit back and look more objectively at our results.”

The most recent study, called Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II), found pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment at an acceptable cost.

More than 200 patients from radiology departments in the Netherlands and Belgium who had persistent pain were randomly allocated to either vertebroplasty or conservative care. Vertebroplasty resulted in greater pain relief: the difference in the mean pain score between baseline and one month was -5.2 after vertebroplasty and -2.7 after conservative treatment (Lancet DOI:10.1016/S0140-6736[10]60954-3).

The difference in the mean pain score between baseline and one year was -5.7 after vertebroplasty and -3.7 after conservative treatment. The difference in quality-adjusted life years was 0.010 at one month and 0.108 at one year favoring the vertebroplasty group, and was achieved at an acceptable cost, according to the study authors.

“I think the Vertos II trial reaffirms our initial beliefs prior to a year ago,” McGraw said. “Not only did it show vertebroplasty is effective in pain relief, but [it’s] also cost-effective.”

Another vertebroplasty expert agreed with McGraw and said the Vertos II trial shows vertebroplasty is effective.

“There’s not any lingering doubt in my mind vertebroplasty works,” said Dr. Kieran Murphy, vice chair and chief of medical imaging at the University of Toronto. “But in the minds of the people on the insurance side or the payers’ side, this study is not going to have the impact I hoped for.”

The payers are looking for a certain level of evidence and that’s where research needs to go further, Murphy said.

“We still need to do a prospective, randomized, sham-controlled study to bury the other two papers forever and let people get on with what they need to do,” he said.

One study that could accomplish that is the vertebral augmentation versus local anesthesia infusion trial (VALAIT) being led by Dr. Avery Evans, an associate professor of clinical radiology at the University of Virginia Health System in Charlottesville.

The trial will be a prospective randomized comparison of vertebroplasty versus the injection of a local anesthetic such as bupivacaine. Evans said they’re hoping to enroll about 200 patients in each arm.

It’s not a comparison with placebo because bupivacaine is a pain reliever, but the study will determine whether vertebroplasty is better than local anesthesia, Evans said.

The pilot trial is currently under way at the University of Virginia, and the researchers are almost finished writing the protocol to submit to their institutional review board, he said. Investigators are hoping to have a few early centers enrolling patients this fall.

The VALAIT study is interesting, but ultimately a three-armed study comparing vertebroplasty, local anesthesia, and placebo, including their respective cost-effectiveness, is still needed, according to Murphy.

“That’s the key thing,” he said. “There will be no difference in outcomes in patient benefit but there will be a huge difference in cost. That will be an interesting study to do.”