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 18 Jun 11Theodore Berger and his team at the USC Viterbi School of Engineering's Department of Biomedical Engineering have developed a neural prosthesis for rats that is able to restore their ability to form long-term memories after they had been pharmacologically blocked. In a dramatic demonstration, Berger blocked the ability to rats to form long-term memories by using pharmacological agents to disrupt the neural circuitry that communicates between two subregions of the hippocampus, CA1 and CA3, which interact to create long-term memory, prior research has shown. The rats were unable to remember which lever to pull to gain a reward, or could only remember for 5-10 seconds, when previously they could remember for a long period of time. The researchers then developed an artificial hippocampal system that could duplicate the pattern of interaction between CA3-CA1 interactions. Long-term memory capability returned to the pharmacologically blocked rats when the team activated the electronic device programmed to duplicate the memory-encoding function. The researchers went on to show that if a prosthetic device and its associated electrodes were implanted in animals with a normal, functioning hippocampus, the device could actually strengthen the memory being generated internally in the brain and enhance the memory capability of normal rats. "These integrated experimental modeling studies show for the first time that with sufficient information about the neural coding of memories, a neural prosthesis capable of real-time identification and manipulation of the encoding process can restore and even enhance cognitive mnemonic processes," says the paper. Next steps, according to Berger and Deadwyler, will be attempts to duplicate the rat results in primates (monkeys), with the aim of eventually creating prostheses that might help human victims of Alzheimer's disease, stroke, or injury recover function. Ref.: "A Cortical Neural Prosthesis for Restoring and Enhancing
