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Stryker Announces SAKOS Pivotal Trial Results for SpineJack -

Results from the SAKOS pivotal trial of Stryker's SpineJack® implantable fracture reduction system successfully demonstrated non-inferiority to balloon kyphoplasty (BKP), with an excellent risk/benefit profile for up to 12 months. SAKOS was a prospective, multicenter, randomized study designed to support a non-inferiority finding for use of SpineJack vs. BKP to treat vertebral compression fractures. This trial also provided compelling evidence to establish superiority of SpineJack vs. BKP in the absence of adjacent level fractures and restoration of midline vertebral body height at 12 months. Over 70,000 SpineJack units have been implanted in patients worldwide. (Stryker, 9/25/19)