Clinical Relevance of Cement Leakage after Radiofrequency Kyphoplasty vs. Balloon Kyphoplasty: A Prospective Randomised Study

 

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Abstract

Background: Cement leakage is regarded as a typical complication of cement-based augmentation of vertebral fractures. The gold standard is balloon kyphoplasty (BK). Recent methods, such as radiofrequency kyphoplasty (RFK), must be compared with BK in terms of therapeutic success and complication rates. It is unclear whether the cement leakage rate in RFK is lower than with BK and whether this has any clinical relevance. Therefore, the aim of our prospective clinical study was to compare RFK with BK with respect to cement leakage rates and associated clinical complications. Patients and Methods: After prospective randomisation, 100 patients (76 women and 24 men with an average age of 78.5 years) or 162 vertebral bodies were treated by BK (n = 79) or RFK (n = 83). We evaluated the parameters “localisation of cement leakage” (epidural, intradiscal, extracorporal, intravascular) and “clinical relevance”. Results: More cement is used in BK (5.2 ml) than in RFK (4.0 ml, p = 0.001). Cement leakage was found in 48/79 patients (60.8 %) with BK and 53/83 patients (63.9 %) with RFK (p = 0.420). Even subanalysis by location showed no significant difference between the two methods. Despite the high leakage rates, we experienced only two cases (1× BK, 1× RFK) with intravascular leakage in the inferior vena cava, with interventional endovascular salvage. Conclusion: The two examined kyphoplasty methods (BK vs. RFK) have the same high rates of cement leakage, but are rarely associated with clinically manifest complications. Clinically relevant differences between the two compared kyphoplasty methods could not be found.

Zusammenfassung

Hintergrund: Die Kyphoplastie gilt als Standard in der Behandlung von Wirbelkörperfrakturen. Zementaustritt wird als typische Komplikation zementgestützter Augmentationsverfahren bei Wirbelkörperfrakturen gesehen. Unklar ist, ob neuere Verfahren wie die Radiofrequenzkyphoplastie (RFK) diesbezüglich niedrigere Komplikationsraten haben als die Ballonkyphoplastie (BK). Ziel unserer prospektiven klinischen Studie war es daher, die RFK mit der BK bez. Zementaustrittsraten und assoziierter klinischer Komplikationen zu vergleichen. Patienten und Methoden: Bei 100 Patienten (76 Frauen und 24 Männer mit einem Durchschnittsalter von 78,5 Jahren) bzw. 162 Wirbelkörpern erfolgte nach prospektiver Randomisierung eine Therapie mit 79 Ballonkyphoplastien (BK) und 83 Radiofrequenzkyphoplastien (RFK) und anschließende Auswertung nach den Parametern „Lokalisation des Zementaustritts“ (epidural, intradiskal, extrakorporal, intravasal) und „klinische Relevanz“. Ergebnisse: Bei der BK wird durchschnittlich mehr Zement verwendet (5,2 ml) als bei der RFK mit 4,0 ml (p = 0,001). Bei der BK kam es in 48/79 Fällen (60,8 %) und bei der RFK in 53/83 Fällen (63,9 %) zum Zementaustritt (p = 0,420). Auch bez. der Subanalyse nach Lokalisationen zeigte sich kein signifikanter Unterschied zwischen beiden Methoden. Trotz der hohen Austrittsraten kam es nur in 2 Fällen (1× BK, 1× RFK) zu einem intravasalen Austritt in die V. cava inferior mit interventionell-endovaskulärer Bergung. Schlussfolgerung: Die beiden untersuchten Kyphoplastiesysteme (BK vs. RFK) führen zu gleich hohen Austrittsraten von Zement, gehen jedoch selten mit klinisch manifesten Komplikationen einher. Klinisch relevante Unterschiede zwischen den beiden verglichenen Kyphoplastiesystemen konnten nicht festgestellt werden.

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