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Kiva System non-inferior to balloon kyphoplasty for treatment of vertebral compression fractures
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In the results of a recently published study, researchers reported findings that the Kiva System was non-inferior compared with balloon kyphoplasty for the treatment of vertebral compression fractures.
The multicenter, randomized, control KAST study included 300 patients with one or two painful vertebral compression fractures (VCFs) due to osteoporosis who were randomly assigned blindly to one of two treatment groups. The Kiva System (Benvenue Medical) group consisted of 153 patients, whereas the balloon kyphoplasty (BK) group consisted of 147. Patients were followed-up for 12 months, and the study’s primary outcome was a composite of improvements in Oswestry Disability Index (ODI) and VAS scores and the presence of serious adverse events (SAEs).
Patients in the BK group experienced a mean improvement of 42.2 for ODI scores and 71.8 for VAS scores. In the Kiva group, patients experienced mean improvement of 70.8 for VAS and 38.1 for ODI. Additionally, the researchers noted no device-related SAEs were evident in either patient cohort.
The researchers concluded that overall, the Kiva System was not inferior to BK for the treatment of VCFs in terms of reduction of pain, maintaining function or evidence of SAEs, despite early significant differences in risk factors favoring the control (BK) group at baseline. – by Robert Linnehan
Disclosure: The researchers report receipt of funding from Benvenue Medical in support of this work.
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