• Z Orthop Unfall · Dec 2012

    Clinical Trial

    [Kiva® VCF Treatment System - clinical study on the efficacy and patient safety of a new system for augmentation of vertebral compression fractures].

    • R Bornemann, L A Otten, E M W Koch, T R Jansen, K Kabir, D C Wirtz, and R Pflugmacher.
    • Klinik und Poliklinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Bonn. rahel.bornemann@googlemail.com
    • Z Orthop Unfall. 2012 Dec 1; 150 (6): 572-8.

    BackgroundAs a further alternative to previously used vertebral augmentation methods, the Kiva VCF Treatment System® was clinically investigated.Material And MethodsThe pilot study included 24 patients (mean age 74 years, 34 vertebrae).ResultsDuring an operation period of 16.6 minutes on average 2.2 ± 1 mL of PMMA cement were injected. 87 % of patients were satisfied or very satisfied with this treatment. In 2 cases leakage of cement has been registered. The pain intensity was already reduced after 7 days to 69.5 mm (VAS scale 0-100). After 30 days, the difference from baseline was 76 mm. Significant improvements have also been shown in the Oswestry Score (functional ability), physical performance and mental well-being.ConclusionOn the basis of these results, the new augmentation can be described as being effective in the treatment of painful vertebral fractures.Georg Thieme Verlag KG Stuttgart · New York.

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