The North American Spine Society and the Society of Interventional Radiology have pointed to flaws in both studies. And earlier studies, published over 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," said Malamis, an interventional radiologist.
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.
Neva Nelson, 74, of Naperville, Ill., said a kyphoplasty that Malamis performed in October, 2009, has greatly reduced her pain in a vertebra in her lower back that she fractured after falling on ice. Before her kyphoplasty, Nelson had to sit on cushions. Walking, and especially standing, were painful. "I had to do something," she said. "I could not go on like that."
Nelson said that since undergoing her kyphoplasty, "I don't have to worry about my back any more."
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 percent 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.
Patients experience the greatest pain during the first three months after a compression fracture. Thereafter, pain gradually subsides. Thus, a vertebroplasty or kyphoplasty provides the greatest benefit when performed within a week or two of the fracture. But the studies enrolled patients up to 12 months after fractures.
In addition to reducing pain and disability, a kyphoplasty can reduce the risk of subsequent fractures by improving the angle and height of the spine. The studies evaluated vertebroplasty alone, and did not include the more innovative and very different kyphoplasty procedure.
Malamis suggests the medical community wait for the results of additional studies now underway before passing final judgment on vertebroplasty or kyphoplasty. In the mean time, he notes that Medicare still covers the procedures.
thinkahol * on 12 Jun 11What's that word they use for a society where the group of those with money and power are above the law? Oh, that's right: Oligarchy! While this regulatory capture continued, how many of us filled up our homes with these toxic products? Via Think Progress: Large manufacturers and chemical producers have lobbied ferociously to stop the National Institutes of Health from classifying formaldehyde as a carcinogen. A wide body of research has linked the chemical to cancer, but industrial polluters have stymied regulators from action. Last year, the New Yorker's Jane Mayer reported that billionaire David Koch, whose company Georgia Pacific (a subsidiary of Koch Industries) is one of the country's top producers of formaldehyde, was appointed to the NIH cancer board at a time when the NIH delayed action on the chemical. The news was met with protests from environmental groups. Faced with mounting pressure from Greenpeace and the scientific community, Koch offered an early resignation from the board in October. Yesterday, the NIH finally handed down a report officially classifying formaldehyde as a carcinogen: Government scientists listed formaldehyde as a carcinogen, and said it is found in worrisome quantities in plywood, particle board, mortuaries and hair salons. They also said that styrene, which is used in boats, bathtubs and in disposable foam plastic cups and plates, may cause cancer but is generally found in such low levels in consumer products that risks are low. Frequent and intense exposures in manufacturing plants are far more worrisome than the intermittent contact that most consumers have, but government scientists said that consumers should still avoid contact with formaldehyde and styrene along with six other chemicals that were added Friday to the government's official Report on Carcinogens. Its release was delayed for years because of intense lobbying from the chemical industry, which disputed its findings. An investigation by ProPublica found th
