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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.

 »We’ll just have to wait for the results of the laboratory tests.« These words are familiar to many patients. It then usually takes several days for specimens to be sent to the laboratory and analyzed and for the doctor to receive the results. For many illnesses, however, a speedy diagnosis is crucial if the treatment is to be successful. In future, the patient might only have to sit in the waiting room for a few minutes until the results are ready. In a joint project, researchers from seven Fraunhofer institutes have developed a modular platform for in vitro diagnosis which enables various types of bioanalysis – of blood and saliva for example – to be conducted in the doctor’s surgery. »Thanks to its modular design our IVD platform is so flexible that it can be used for all possible bioanalytical tasks,« states Dr. Eva Ehrentreich-Förster from the Fraunhofer Institute for Biomedical Engineering (IBMT) in Potsdam-Golm.The core element of the mini-laboratory is a disposable cartridge made of plastic which can be fitted with various types of sensor. For an analysis the doctor fills the cartridge with reagents – binding agents which indicate the presence of certain substances such as antigens in the specimen material. Various tests or assays are available for different types of analysis. To perform an assay, the doctor only has to place the relevant substances in the cartridge and the test then takes place automatically. »We have optimized the assays so that up to 500 assay reactions can be conducted in parallel in a single analysis step,« explains Dr. Ehrentreich-Förster. Even in the case of complex analyses the doctor obtains a result within about 30 minutes. A new module on the reverse side of the cartridge also makes it possible to analyze the specimen material at DNA level.Once the cartridge has been prepared, the doctor places it in the measurement system. The results can be read out with either optical or electrochemical biosensors. The researchers have installed a readout window for both methods in the measurement system, which features a bypass through which the specimen is pumped.