Clinical Experience Using Cortoss for Treating Vertebral Compression Fractures With Vertebroplasty and Kyphoplasty Twenty Four-Month Follow-up
Clinical Experience Using Cortoss for Treating Vertebral Compression Fractures With Vertebroplasty and Kyphoplasty Twenty Four-Month Follow-up
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DOI：
10.1097/brs.0b013e3181dcda75
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发表时间：
2010-09-15
期刊：
影响因子：
3
通讯作者：
Girardi, Federico
中科院分区：
文献类型：
--
作者：
Bae, Hyun;Shen, Michael;Girardi, Federico
研究设计。40名患者参加了FDA批准的两项试点研究设备豁免(IDE)研究，使用Cortoss治疗椎体压缩骨折(VCF)。20例患者在3个中心行椎体成形术(VP)，20例患者在5个中心行后凸成形术(KP)。目的：评价Cortoss治疗骨质疏松性VCFs的可行性和临床疗效。Cortoss是一种可注射的生物活性、自固化、不透射线的复合材料，被证明可以稳定并立即为骨折的脊椎提供承重支持。Cortoss在欧洲被批准用于螺钉和椎体增大。患者在手术前和手术后24个月使用视觉模拟评分(VAS)、奥斯维斯特残疾指数(ODI)和生活质量评估(SF-12)问卷进行评估。用X线片和CT扫描评估外渗情况。VP患者的疼痛立即得到改善，VAS评分从术前的75.7分下降到72小时的35.9分。从基线到2年持续改善(平均VAS为48.9)。残疾程度有所改善，VP患者的ODI评分从术前的52.2%下降到2年后的38.3%。KP患者的疼痛也立即得到改善，VAS评分从术前的78.1降至72小时的42.7。从基线到2年持续改善(平均VAS为25.4)。KP患者的ODI评分从术前的60.5%提高到2年的34.5%。平均注射量VP组为1.85毫升，KP组为4.13毫升。这两种技术的渗出都很轻微，解剖上接近治疗的椎体，而且没有症状。无心脏异常或肺血栓形成。这些研究表明，Cortoss通过椎体成形术或后凸成形术治疗骨质疏松性VCF是安全有效的。Cortoss的疼痛缓解和功能恢复与文献中发现的聚甲基丙烯酸甲酯的结果相当。
Study Design. Forty patients were enrolled in 2 FDA-approved pilot Investigational Device Exemption (IDE) studies using Cortoss for the treatment of vertebral compression fractures (VCF). Twenty patients were treated at 3 centers, using vertebroplasty (VP) and 20 patients were treated at 5 centers, using kyphoplasty (KP).Objective. To assess the feasibility and clinical outcomes using Cortoss to treat osteoporotic VCF.Summary of Background Data. Cortoss is an injectable bioactive, self-setting, radiopaque composite shown to stabilize and provide immediate weight bearing support to fractured vertebrae. Cortoss is approved for use in Europe for both screw and vertebral augmentation.Methods. Patient assessments were conducted before surgery and after surgery through 24 months using Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and quality-of-life assessment (SF-12) questionnaires. Extravasations were evaluated using radiographs and CT scans.Results. Immediate pain improvement was seen in VP patients with VAS scores decreasing from 75.7 before surgery to 35.9 at 72 hours. Continued improvement from baseline was seen out to 2 years (average VAS of 48.9). Disability improved with average ODI scores decreasing from 52.2% preoperative to 38.3% at 2 years for VP patients. Immediate pain improvement was also seen in KP patients with VAS scores decreasing from 78.1 before surgery to 42.7 at 72 hours. Continued improvement from baseline was seen out to 2 years (average VAS of 25.4). ODI scores improved from 60.5% preoperative to 34.5% at 2 years for KP patients. Average material volumes injected were 1.85 mL for VP and 4.13 mL for KP. Extravasations from both techniques were minor, anatomically close to the treated vertebrae and asymptomatic. No cardiac irregularities or pulmonary emboli were observed.Conclusion. These studies indicate Cortoss is safe and effective in treating osteoporotic VCF using vertebroplasty or kyphoplasty. Pain relief and restoration of function with Cortoss is comparable to results found in the literature for polymethylmethacrylate.