H-J Riesner1, K Kiupel1, P Lang1, F Stuby2, B Friemert1, H-G Palm1. 1. Department of Trauma Surgery and Orthopaedics, Ulm Army Hospital. 2. Department of Trauma and Reconstruction Surgery, Tübingen University Hospital.
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. Georg Thieme Verlag KG Stuttgart · New York.
RCT Entities:
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. Georg Thieme Verlag KG Stuttgart · New York.