The Spine Journal published the results of Stryker's SAKOS pivotal trial for the SpineJack implantable fracture reduction system.
Five takeaways:
1. In a prospective, multicenter, randomized study, the SpineJack system demonstrated non-inferiority to balloon kyphoplasty in the treatment of osteoporotic vertebral compression fractures.
2. The SpineJack system had an "excellent" risk/benefit profile for up to 12 months, the trial found.
3. The trial indicated the SpineJack system was superior to BKP for the absence of adjacent-level fractures and midline vertebral body height restoration, at six and 12 months postoperatively.
4. The SpineJack system uses X-ray guidance to insert two expandable implants into the fractured vertebrae via small incisions. Bone cement fills in the area surrounding the implants and forms an internal cast as it hardens, creating stabilization.
5. The SpineJack system, which is part of Stryker's Interventional Spine portfolio, has been commercially available in Europe since 2010. The system received FDA 510(k) clearance in August 2018. More than 70,000 units have been implanted worldwide.
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