Department of Radiology, Mallinckrodt Institute of Radiology, Washington University, Barnes Jewish Hospital, St. Louis, Missouri 63110, USA.
AJNR Am J Neuroradiol. 2013 Jan;34(1):221-7. doi: 10.3174/ajnr.A3156. Epub 2012 Jun 28.
Two injectable materials for the treatment of vertebral compression fractures, Cortoss and PMMA, were compared in a prospective, randomized study. Our purpose was to analyze the incidence and nature of subsequent fractures following treatment, one of the secondary outcomes.
A prospective study was conducted at 21 US sites by 38 investigators by using Cortoss randomized 2:1 to PMMA in 256 patients blinded to treatment assignment. Inclusion criteria were 1-2 osteoporotic fractures causing significant pain or worsening vertebral collapse on radiographs and visual analog scale pain measuring ≥50 mm. Assessments were conducted pretreatment, on treatment day, and at 7 posttreatment intervals. Imaging studies underwent independent blinded review. Internal and independent monitors, including the FDA, verified data.
Of the 256 patients, 45/162 Cortoss-treated (27.8%) and 30/94 PMMA-treated (31.9%) patients experienced new fractures, most within 30-365 days. In patients with 1 acute or subacute fracture and no previous fractures, subsequent fracture incidence was less in patients treated with Cortoss (17.6%) than with PMMA (27.3%). In this subgroup, adjacent fractures occurred in 10.3% of patients treated with Cortoss and 18.2%, with PMMA, a 43.4% lower incidence in the Cortoss group.
Compared with PMMA, Cortoss use resulted in fewer subsequent fractures, especially in patients with first fractures. In patients without previous fractures, the subsequent fracture rate was also lower in Cortoss-treated versus conservatively treated patients in other studies. This reduced subsequent fracture rate may be due to differences in the material and mechanical properties of Cortoss compared with PMMA. As finite-element analysis modeling demonstrated, Cortoss restores a more physiologic load transfer through the treated vertebra. Patients treated with Cortoss were less likely to be hospitalized for new fractures.
两种用于治疗椎体压缩性骨折的可注射材料 Cortoss 和 PMMA 在一项前瞻性、随机研究中进行了比较。我们的目的是分析治疗后继发骨折的发生率和性质，这是次要结局之一。
由 38 位研究者在美国 21 个地点进行了一项前瞻性研究，采用 Cortoss 与 PMMA 2:1 随机分组，256 例患者对治疗分组设盲。纳入标准为：1-2 个骨质疏松性骨折，导致影像学上明显疼痛或椎体塌陷加重，视觉模拟评分≥50mm。评估在治疗前、治疗当天和治疗后 7 个时间点进行。影像学研究进行了独立盲法评估。内部和独立监查员（包括 FDA）对数据进行了核实。
在 256 例患者中，45/162 例 Cortoss 治疗组（27.8%）和 30/94 例 PMMA 治疗组（31.9%）发生了新的骨折，大多数发生在 30-365 天内。在仅有 1 次急性或亚急性骨折且无既往骨折的患者中，Cortoss 治疗组的继发骨折发生率（17.6%）低于 PMMA 治疗组（27.3%）。在该亚组中，Cortoss 治疗组有 10.3%的患者发生相邻骨折，PMMA 治疗组有 18.2%的患者发生相邻骨折，Cortoss 组的发生率降低了 43.4%。
与 PMMA 相比，Cortoss 治疗后发生的继发骨折更少，尤其是在首次发生骨折的患者中。在无既往骨折的患者中，与其他研究中接受保守治疗的患者相比，Cortoss 治疗组的继发骨折发生率也较低。与 PMMA 相比，Cortoss 的继发骨折发生率降低可能与材料和机械性能的差异有关。正如有限元分析模型所示，Cortoss 通过治疗椎体恢复了更符合生理的载荷传递。接受 Cortoss 治疗的患者因新发骨折而住院的可能性较低。
