The randomized, controlled study included 300 patients with one or two painful osteoporotic vertebral compression fractures at 21 medical centers in a number of countries. Patients were blindly randomized to receive treatment using the Kiva system or receiving balloon kyphoplasty.
The study found that the KIVA system successfully met the primary endpoint of non-inferiority to balloon kyphoplasty in the treatment of osteoporotic vertebral compression fractures based on a composite of pain relief, return to function and safety.
Examination of secondary endpoints showed that the KIVA system showed superiority in cement usage and site-reported cement leakage as well as a positive trend in adjacent level fracture reduction.
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