*Universitaetsklinikum Frankfurt, Frankfurt am Main, Germany †Universitatsmedizin CHARITÉ, Klinik fur Unfall und Wiederherstellungschirurgie, Berlin, Germany ‡Klinikum Ernst-von Bergmann GmbH, Potsdam, Germany §Paracelsus Klinik, Marl, Germany; and ¶University of Massachusetts Medical School, Department of Radiology and Neurological Surgery, Worcester, Massachusetts.
Spine (Phila Pa 1976). 2013 Sep 15;38(20):1730-6. doi: 10.1097/BRS.0b013e3182a14d15.
A novel randomized, controlled, unblinded clinical trial comparing 2 procedural interventions for painful osteoporotic vertebral compression fractures.
The primary study objective was to evaluate cement leakage for a cement directed kyphoplasty system (CDKS) with anteriorly biased cement flow and vertebroplasty. The secondary study objective was to compare adjacent level fracture rates and vertebral body height for these 2 intervention methods.
Cement leakage remains a significant clinical problem associated with vertebroplasty and kyphoplasty procedures. Uncontrolled cement flow in the posterior direction can result in leakage into the vertebral veins or spinal canal, leading to potentially serious clinical complications.
Seventy-seven patients with painful osteoporotic vertebral compression fractures were enrolled. Patients were randomized 2:1 for treatment with CDKS (49 patients, 65 levels) or vertebroplasty (28 patients, 39 levels). Cement leakage was evaluated from radiographs and computed tomographic scans. Three- and 12-month follow-ups included additional radiographs and computed tomographic scans to assess changes in vertebral body height and the incidence of new fractures.
Treatment with CDKS significantly reduced the number of levels with leaks and the total number of leaks per level, as compared with vertebroplasty (P = 0.0132 and P = 0.0012, respectively). Significantly, fewer lateral cortical and spinal canal leaks (posterior leaks) occurred in the CDKS group (P = 0.0050, P = 0.02260, respectively). Three adjacent level fractures occurred in the vertebroplasty group, as compared with 2 in the CDKS group. Vertebral body height maintenance was equivalent.
Cement directed kyphoplasty effectively reduces posterior cement leakage, reducing the risk of leakage related complications.
一项比较两种治疗方法治疗骨质疏松性椎体压缩性骨折的新型随机、对照、非盲临床试验。
主要研究目的是评估一种新型水泥导向后凸成形系统（CDKS）和经皮椎体成形术的水泥渗漏情况。次要研究目的是比较这两种干预方法的相邻节段骨折率和椎体高度。
水泥渗漏仍然是经皮椎体成形术和后凸成形术相关的一个重要临床问题。后向不受控制的水泥流动可能导致水泥渗漏到椎体静脉或椎管内，从而导致潜在的严重临床并发症。
共纳入 77 例患有疼痛性骨质疏松性椎体压缩性骨折的患者。患者按 2:1 的比例随机分为 CDKS 组（49 例，65 个节段）或经皮椎体成形术组（28 例，39 个节段）。通过 X 线和 CT 扫描评估水泥渗漏情况。3 个月和 12 个月的随访包括额外的 X 线和 CT 扫描，以评估椎体高度的变化和新发骨折的发生率。
与经皮椎体成形术组相比，CDKS 组治疗后水泥渗漏的节段数和每个节段的总渗漏数均显著减少（P = 0.0132 和 P = 0.0012）。更重要的是，CDKS 组的外侧皮质和椎管漏（后向漏）较少（P = 0.0050，P = 0.02260）。经皮椎体成形术组发生 3 例相邻节段骨折，而 CDKS 组发生 2 例。椎体高度保持情况相当。
水泥导向后凸成形术能有效减少后向水泥渗漏，降低渗漏相关并发症的风险。
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