The study included 300 patients treated with a new type of vertebral augmentation made of medical polymer. The implant is designed to treat painful and debilitating vertebral compression fractures, which cause the bones in the spine to collapse and, left untreated, can lead to pain and kyphosis.
Recently cleared by the U.S. Food and Drug Administration (FDA), the implant provides a new treatment alternative to vertebroplasty and kyphoplasty, the current standards of care. The implant was shown to meet or exceed the performance of kyphoplasty on every measure studied, according to SIR.
The Kiva System as a Vertebral Augmentation Treatment (KAST) trial was conducted on a group of 153 patients with one or two painful osteoporotic vertebral compression fractures who received the new implant; a control group of 147 had balloon kyphoplasty.
Patients were treated at one of 21 centers in the U.S., Canada, Belgium, France, and Germany and were followed for one year. Results of the study confirmed that the implant provided essentially the same amount of pain relief and improvement in daily function based on accepted measures for pain and function.
The researchers also found that patients who had the implant were more likely to benefit from a reduction in the angle of the kyphosis and less likely to have the bone cement leak. Moreover, the study showed a clinically important trend in that the implant patients were less likely to suffer a fracture in adjacent vertebra, despite the fact that the 153 patients who received the implant had higher risk predictors for future fractures.
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