Results from a randomised controlled trial that used the KIVA System (Benvenue) suggest that the vertebral augmentation device offers a new treatment option for individuals with compression fractures.
The results were reported for the first time at the Society of Interventional Radiology’s 39th Annual Scientific Meeting (22–27 March, San Diego, USA).
KAST (Kiva System as a vertebral augmentation treatment—a safety and effectiveness trial) was a study conducted with USFDA approval in which 153 patients with one or two painful osteoporotic vertebral compression fractures received the new implant and 147 had balloon kyphoplasty (the current standard of care in the treatment of vertebral compression fractures). Patients were treated at one of 21 centres in the USA, Canada, Belgium, France and Germany and were followed for one year. The primary endpoint was non-inferiority on a composite of pain, function, and safety at one year of follow-up on patients treated in the study. The study was designed to evaluate key secondary endpoints including cement volume, extravasation rate, and height restoration as well as other endpoints.
The 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 (visual analogue score; Oswestry Disability Index) and safety. Researchers also found 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. This latter finding is despite the fact that the 153 patients who received the implant had higher risk predictors for future fractures.
“This is the first new method of treating these painful fractures in a decade, which is great news for patients because it not only helps restore quality of life, but it also was shown to outperform our most-used treatment in important ways,” said Sean M Tutton, lead author of the study and professor of Radiology, Medicine and Surgery at Medical College of Wisconsin, Milwaukee, USA. “This level one trial, which provides the highest quality and most reliable data, is one of the largest to date to compare a new treatment for vertebral compression fractures to standard of care—and the results match or exceed those of the current treatment,” said Tutton. “This research also adds to the growing body of evidence supporting the efficacy and safety of these treatments,” he added.
“Interventional radiologists are leading the way in providing minimally invasive treatment innovations for the spine, including developing new technologies that show significant patient benefits,” said SIR president Scott C Goodwin. The Society recently published a multisociety position statement on vertebral augmentation, discussing current and future technologies and noting that augmentation is a safe, effective and durable treatment in appropriate patients, added Goodwin, Hasso Brothers’ Professor and chair of Radiological Services, University of California Irvine (UCI) School of Medicine.
View an animated demonstration of the Kiva System for vertebral compression fractures here.