Orthopädische Universitätsklinik Friedrichsheim gGmbH, 60528, Frankfurt/Main, Germany.
Eur Spine J. 2010 Jun;19(6):887-92. doi: 10.1007/s00586-010-1279-z. Epub 2010 Feb 4.
A prospective, non-randomized multicenter study was initiated to study efficacy and safety of a partly resorbable composite of calcium sulphate and hydroxyapatite (Cerament SpineSupport), a novel, injectable bioceramic, in osteoporotic patients with vertebral compression fractures during 18-month follow-up. Fifteen patients with low-energy trauma and 1-2 vertebral compression fractures verified by magnetic resonance imaging were recruited to undergo percutaneous bioceramic vertebral augmentation under fluoroscopy. The patients were treated with a highly flowable bioceramic containing calcium sulphate, hydroxyapatite and the non-ionic radiocontrast agent iohexol, with final setting time within 1 h. After the procedure, the patients were allowed to mobilize after 2 h. Pain (VAS), occurrence of remote and adjacent fractures, and Quality of Life (QoL; SF-36 and EQ-5D) was recorded during 18 months. The injected volume of the composite material ranged from 2.8 to 9 mL (mean 4.2 mL). Pre-operative VAS score was mean 70.3 (CI95% +/-8.7) with an immediate post-operative pain relief, which was maintained at the 4-week visit (mean 26.4 with CI95% +/-16.1) and 8-week visit (mean 18.0 with CI95% +/-13.5 pain relief). Eighty percent of the patients demonstrated a clinical improvement. The pain relief was maintained over 18 months and no adjacent fractures were observed. There was a statistically significant improvement of physical components in the QoL assessment. No extra-vertebral leakage or neurological deficits were reported in this series. This first prospective multicenter study on a partly resorbable bioceramic material indicate that fracture healing can be achieved with sustained pain relief over a follow-up period of 18 months in an osteoporotic patient population with vertebral compression fractures.
一项前瞻性、非随机多中心研究旨在研究硫酸钙和羟基磷灰石（Cerament SpineSupport）部分可吸收复合材料的疗效和安全性，这是一种新型可注射生物陶瓷，用于 18 个月随访期间患有骨质疏松性椎体压缩性骨折的患者。15 例低能量创伤和磁共振成像证实的 1-2 个椎体压缩性骨折患者接受透视引导下经皮生物陶瓷椎体增强术。患者接受了一种高流动性的生物陶瓷，其中含有硫酸钙、羟基磷灰石和非离子型造影剂碘海醇，最终凝固时间在 1 小时内。手术后，患者可在 2 小时后活动。在 18 个月期间记录疼痛（VAS）、远处和相邻骨折的发生以及生活质量（SF-36 和 EQ-5D）。复合材料的注射量为 2.8 至 9 毫升（平均 4.2 毫升）。术前 VAS 评分为 70.3（95%CI95% +/-8.7），术后即刻疼痛缓解，在 4 周（平均 26.4，95%CI95% +/-16.1）和 8 周（平均 18.0，95%CI95% +/-13.5）就诊时疼痛缓解得以维持。80%的患者表现出临床改善。疼痛缓解在 18 个月内持续存在，未观察到相邻骨折。生活质量评估中的身体成分有统计学显著改善。在本系列中未报告额外的椎外渗漏或神经功能缺损。这是第一项关于部分可吸收生物陶瓷材料的前瞻性多中心研究，表明在骨质疏松性椎体压缩性骨折患者人群中，骨折愈合可以通过持续缓解疼痛来实现，随访时间为 18 个月。
