The KAST study — Kiva Safety and Effectiveness Trial — was a multicenter, randomized controlled trial to evaluate treating osteoporotic vertebral compression fractures with the Kiva system.
One of the studies from the trial was recently published in Spine. The study included 300 patients with one or two painful osteoporotic vertebral compression fractures. The patients were blindly randomized to either the Kiva group or balloon kyphoplasty group. There were 153 patients who received Kiva and 147 who underwent balloon kyphoplasty.
Here are five things to know:
1. The average Kiva patient improved 70.8 points in the visual analogue scale. The average balloon kyphoplasty patient improved 71.8 points on the VAS.
2. Kiva patients reported a 38.1 point improvement for Oswestry Disability Index scores. The average balloon kyphoplasty patient reported a 42.2 point increase in ODI.
3. There weren't any device-related serious adverse events for either group. However, there were significant differences in risk factors for the control group at baseline, the primary endpoint showed non-inferiority of Kiva to balloon kyphoplasty.
4. The analysis of secondary endpoints showed superiority for cement use and site-reported extravasation as well as a positive trend in adjacent level fracture. The authors suggest additional studies in the future.
5. The authors concluded the Kiva system "is non-inferior to BK based on a composite primary endpoint assessment incorporating pain-, function- and device-related serious adverse events for the treatment of VCF."