SAS journal
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The Kineflex lumbar artificial disc replacement device (SpinalMotion, Mountain View, California) is a semiconstrained, posterior center of rotation, metal-on-metal intervertebral disc prosthesis. We performed a prospective, randomized, non-inferiority trial comparing the Kineflex Disc with the Food and Drug Administration (FDA)-approved Charité device (DePuy Spine, Raynham, Massachusetts). Our objective was to evaluate the Kineflex Disc's safety and efficacy using validated outcomes measures-the visual analog scale (VAS) and the Oswestry Disability Index (ODI). ⋯ This level I evidence shows the Kineflex Disc to be non-inferior to the Charité device in terms of pain reduction (VAS score) and FDA-defined clinical success at 24 months' follow-up. Both devices showed a high degree of safety.
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Vertebral compression fractures (VCFs) can cause significant pain and functional impairment, and their cumulative effect can lead to progressive morbidity. This single-arm, prospective feasibility trial, conducted at 4 clinical sites, was undertaken to evaluate the clinical outcomes associated with the use of an innovative vertebral augmentation device, the Kiva VCF Treatment System (Benvenue Medical, Santa Clara, California), in the management of symptomatic VCFs associated with osteoporosis. ⋯ These pilot findings are encouraging, suggesting robust and durable clinical improvement after this novel vertebral augmentation procedure in patients with painful VCFs.
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The utility and cost of minimally invasive surgical (MIS) fusion remain controversial. The primary objective of this study was to compare the direct economic impact of 1- and 2-level fusion for grade I or II degenerative or isthmic spondylolisthesis via an MIS technique compared with conventional open posterior decompression and fusion. ⋯ Level III.