Korovessis Panagiotis, Vardakastanis Konstantinos, Vitsas Vasilios, Syrimpeis Vasilios
From the Department of Orthopaedic Surgery, General Hospital "Agios Andreas," Patras, Greece.
Spine (Phila Pa 1976). 2014 Feb 15;39(4):E231-9. doi: 10.1097/BRS.0000000000000112.
Prospective, parallel-group, controlled, comparative randomized study.
To compare cement leakage rate and efficacy for vertebral body restoration of balloon kyphoplasty (BK) versus Kiva novel implant with polymethylmethacrylate (PMMA) for treating osteolytic vertebral body metastasis.
Minimally invasively vertebral augmentation techniques with PMMA are mostly performed for treating osteoporotic compression fractures. The Kiva implant with PMMA offers better vertebral body restoration and less PMMA leakage than BK in osteoporotic fractures. No previous study compared leakage rate and efficacy for vertebral body restoration in traditional BK and Kiva with PMMA in osteolytic vertebral body metastases.
This study examined 23 patients (71 ± 13 yr) with 41 osteolytic vertebral bodies, who received Kiva with low viscosity PMMA and 24 patients (70 ± 11 yr) with 43 vertebral body osteolyses, who were reinforced with BK and high viscosity PMMA. All osteolyses were graded as Tomita 1 to 3. Anterior vertebral body height ratio (AVBHr), posterior vertebral body height ratio (PVBHr), and middle vertebral body height ratio (MVBHr), Gardner kyphotic deformity, PMMA leakage and were measured and compared between the groups. Visual analogue scale and Oswestry Disability Index were used for functional outcome evaluation.
No patient survived after 3 months. Asymptomatic PMMA leakage occurred in 4 (9.3%) vertebrae in the BK group solely (2 to the spinal canal, in Tomita grade 3 osteolysis) Anterior, posterior and middle vertebral body height ratio, Gardner angle improved insignificantly in both groups. Visual anlogue scale and Oswestry Disability Index improved postoperatively similarly in both groups (P < 0.001).
BK and Kiva provided equally significant spinal pain relief in patients with cancer with osteolytic metastasis. The absence of cement leakage in the Kiva group and absence of neurological complication in the BK group leakages reflects the safety of both augmentation techniques even in significant osteolysis. The lack of cement leakage in the Kiva cases, although low viscosity PMMA was used, increases this implant safety in augmenting severely destructed thoracolumbar vertebrae and sacrum from osteolytic metastasis.
前瞻性、平行组、对照、比较随机研究。
比较球囊后凸成形术（BK）与含聚甲基丙烯酸甲酯（PMMA）的Kiva新型植入物治疗溶骨性椎体转移瘤时的骨水泥渗漏率及椎体恢复效果。
采用PMMA的微创椎体强化技术主要用于治疗骨质疏松性压缩骨折。在骨质疏松性骨折中，含PMMA的Kiva植入物比BK能更好地恢复椎体形态且减少PMMA渗漏。既往尚无研究比较传统BK和含PMMA的Kiva在溶骨性椎体转移瘤中的渗漏率及椎体恢复效果。
本研究纳入23例（71±13岁）有41个溶骨性椎体的患者，接受含低粘度PMMA的Kiva植入物治疗；以及24例（70±11岁）有43个椎体溶骨的患者，采用BK和高粘度PMMA进行强化。所有溶骨均按Tomita 1至3级分级。测量并比较两组的椎体前缘高度比（AVBHr）、椎体后缘高度比（PVBHr）、椎体中部高度比（MVBHr）、Gardner后凸畸形、PMMA渗漏情况。采用视觉模拟评分法和Oswestry功能障碍指数进行功能结局评估。
3个月后无患者存活。仅BK组有4个椎体（9.3%）发生无症状性PMMA渗漏（2例渗漏至椎管，为Tomita 3级溶骨）。两组的椎体前缘、后缘和中部高度比以及Gardner角改善均不显著。两组术后视觉模拟评分法和Oswestry功能障碍指数均有相似改善（P<0.001）。
BK和Kiva在溶骨性转移瘤癌症患者中缓解脊柱疼痛的效果相当。Kiva组无骨水泥渗漏，BK组无神经并发症，这表明即使在严重溶骨情况下，两种强化技术均安全。Kiva病例中尽管使用了低粘度PMMA仍无骨水泥渗漏，这增加了该植入物在强化因溶骨性转移而严重破坏的胸腰椎和骶骨时的安全性。
1级。
