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Vexim SA Announces Preliminary Results of International Clinical Study on Performance of SpineJack in Treating Vertebral Fractures


Tuesday, 5 Nov 2013 11:45am EST 

Vexim SA announced that the preliminary results of a study on 103 patients confirm the positive performance of SpineJack in treating vertebral fractures. Height restoration and endplates reconstruction with the SpineJack were demonstrated immediately postoperative and at 3 months, even with a high percentage of very complex fractures. In the severe fractures group, the mean of maximum height restoration is 7.62 mm (scanner imaging measurements). The reported rate of adjacent fractures is 2.9% compared with 11% to 21% for vertebroplasty and kyphoplasty techniques1, thus suggesting a direct link between optimal endplate restoration by SpineJack and a reduction of the risk of further fractures. Vertebral pain was assessed using a Visual Analog Scale (VAS), and showed a post op decrease of 79%. A recent publication in the Spine Journal showed a 68% decrease for balloon kyphoplasty and 67% for the KIVA device. In addition, the decrease in pain allowed a reduction in the consumption of analgesics. Three months after the operation, 98% of patients were using mild analgesics or no medication at all. Functional capacity was measured using the Oswestry Disability Index (ODI). Results showed an improvement of 81% at 3 months. A recent publication2 in the Spine Journal reported a score of 58% for balloon kyphoplasty and 50% for the KIVA device respectively at 1 year. 

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21 Nov 2014