Kiva® VCF Treatment System – klinische Studie zur Wirksamkeit und Patientensicherheit mit einem neuen System zur Augmentation von vertebralen Kompressionsfrakturen

Zusammenfassung

Hintergrund: Als weitere Alternative zu bisher verwendeten Augmentationssystemen wurde das Kiva® VCF Treatment System klinisch geprüft.

Material und Methoden: Die Pilot-Studie wurde an 24 Patienten (Durchschnittsalter 74 Jahre; 34 Wirbelkörper) durchgeführt.

Ergebnisse: Bei einer Operationsdauer von durchschnittlich 16,6 Minuten wurden 2,2 ± 1 ml Zement injiziert. 87 % der Patienten waren mit der Behandlung zufrieden bis sehr zufrieden. In 2 Fällen wurde eine Zementextravasation registriert. Die Schmerzintensität wurde bereits nach 7 Tagen um 69,5 mm (VAS Skala 0–100) reduziert, nach 30 Tagen betrug die Differenz zum Ausgangswert 76 mm. Gesicherte Besserungen wurden auch beim Oswestry Score (Funktionsfähigkeit), bei der körperlichen Leistungsfähigkeit und bei der psychischen Befindlichkeit belegt.

Schlussfolgerung: Das neue Augmentationsverfahren kann nach diesen Resultaten als wirksam zur Behandlung von schmerzhaften Wirbelkörperfrakturen bezeichnet werden.

Abstract

Background: As a further alternative to previously used vertebral augmentation methods, the Kiva VCF Treatment System® was clinically investigated.

Material and Methods: The pilot study included 24 patients (mean age 74 years, 34 vertebrae).

Results: During 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.

Conclusion: On the basis of these results, the new augmentation can be described as being effective in the treatment of painful vertebral fractures.

Schlüsselwörter

Wirbelkörperfrakturen - Kyphoplastie - Osteoporose - Kiva VCF - Wirbelkörperaugmentation

Key words

vertebral fractures - kyphoplasty - osteoporosis - Kiva VCF - vertebral augmentation

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