Angelo Malamis, MD says that 90% of his patients who have undergone a treatment called balloon kyphoplasty for vertebral fractures report significant reductions in pain and disability.
But the number of kyphoplasty referrals Malamis has received from primary care doctors has dropped sharply since two controversial studies were published last year in the New England Journal of Medicine. In findings that have been disputed by two medical societies, researchers reported that a procedure related to kyphoplasty was not significantly better than a placebo-like procedure in reducing pain and disability.
The North American Spine Society and the Society of Interventional Radiology have pointed to flaws in both studies. And earlier studies, published throughout 15 years, found major benefits to kyphoplasty and a related procedure called vertebroplasty.
“We’re missing opportunities for patients to receive a safe and effective treatment that can significantly reduce their pain and disability,” Malamis, an interventional radiologist, said in a news release.
The procedures are used to treat vertebral compression fractures in patients with osteoporosis and other conditions that result in brittle bones. In a vertebroplasty, an acrylic cement is injected into a fractured vertebra. In a kyphoplasty, a balloon-tipped catheter first is inserted into the fracture. The balloon is inflated to restore the height and shape of the vertebra before the cement is injected.
In the controversial studies, patients were randomly assigned to receive a vertebroplasty or a placebo-like “sham” procedure. In the sham procedure, patients received an injection of anesthetic, but no cement.
However, patients in severe pain are reluctant to enroll in a trial where there’s a 50% chance of receiving a sham treatment. In one of the studies, researchers had to screen 1,813 patients to enroll just 131 subjects. In the other study, only 78 of 219 eligible patients were enrolled. This low enrollment rate raises the possibility that the patients who did enroll were not representative.