Grafe Ingo A, Baier Martin, Nöldge Gerd, Weiss Christel, Da Fonseca Katharina, Hillmeier Jochen, Libicher Martin, Rudofsky Gottfried, Metzner Cornelia, Nawroth Peter, Meeder Peter-Jürgen, Kasperk Christian
Department of Medicine I, University of Heidelberg, Heidelberg, Germany.
Spine (Phila Pa 1976). 2008 May 15;33(11):1284-90. doi: 10.1097/BRS.0b013e3181714a84.
A comparative prospective trial evaluating 3-year outcome.
To compare clinical and morphologic outcomes as well as follow-up fractures after kyphoplasty of painful osteoporotic vertebral fractures with calcium-phosphate (CaP) cement (group 1) and with polymethylmethacrylate (PMMA)-cement (group 2).
CaP cements seem to be an alternative material for usage in kyphoplasty of vertebral fractures. CaP cements are biodegradable and replaceable by newly formed bone after implantation. Concerns have been raised with regard to the stability of resorbable CaP-cements after implantation into vertebrae post kyphoplasty. Calcibon is a possible CaP cement, which exhibited adequate stability in short-term observations.
Kyphoplasty was performed in 40 consecutive patients with primary osteoporosis and painful vertebral fractures, 20 received CaP-cement, 20 were treated with PMMA-cement. All patients received a pharmacological antiosteoporosis treatment (1000 mg calcium, 1000 IU vitamin D3, and oral aminobisphosphonate), pain medication, and physiotherapy. Pain (visual analog scale [VAS]; range, 0-100), mobility (EVOS-score; range, 0-100) and radiomorphologic measurements were assessed at baseline and after 6, 12, and 36 months.
There were no statistically significant differences between the CaP and PMMA-cement group regarding VAS-scores, EVOS-scores, or height-restoration at any time point. Furthermore, there was no significant difference in the occurrence of vertebral follow-up fractures between both groups during the 3-year follow-up period.
CaP cement, e.g., Calcibon, is as effective and safe as conventional PMMA-cement with regard to immediate and sustained pain reduction and improvement of mobility after kyphoplasty of patients with painful osteoporotic vertebral fractures. CaP cement has the potential of being resorbed and replaced by newly formed bone tissue; thus, it seems to be a promising alternative for PMMA also in younger patients with painful vertebral fractures.
一项评估3年结果的比较性前瞻性试验。
比较使用磷酸钙（CaP）骨水泥（第1组）和聚甲基丙烯酸甲酯（PMMA）骨水泥（第2组）对疼痛性骨质疏松性椎体骨折进行椎体后凸成形术后的临床和形态学结果以及随访期骨折情况。
CaP骨水泥似乎是椎体后凸成形术中使用的一种替代材料。CaP骨水泥可生物降解，植入后可被新形成的骨组织替代。对于可吸收CaP骨水泥在椎体后凸成形术植入椎体后的稳定性存在担忧。Calcibon是一种可能的CaP骨水泥，在短期观察中显示出足够的稳定性。
对40例原发性骨质疏松症伴疼痛性椎体骨折的连续患者进行椎体后凸成形术，20例接受CaP骨水泥治疗，20例接受PMMA骨水泥治疗。所有患者均接受药物抗骨质疏松治疗（1000mg钙、1000IU维生素D3和口服氨基双膦酸盐）、止痛药物治疗和物理治疗。在基线以及6个月、12个月和36个月后评估疼痛（视觉模拟评分[VAS]；范围为0 - 100）、活动能力（EVOS评分；范围为0 - 100）和放射形态学测量结果。
在任何时间点，CaP骨水泥组和PMMA骨水泥组在VAS评分、EVOS评分或高度恢复方面均无统计学显著差异。此外，在3年随访期内，两组椎体随访骨折的发生率也无显著差异。
对于疼痛性骨质疏松性椎体骨折患者，在椎体后凸成形术后立即和持续减轻疼痛以及改善活动能力方面，CaP骨水泥（如Calcibon）与传统PMMA骨水泥一样有效且安全。CaP骨水泥有被新形成的骨组织吸收和替代的潜力；因此，对于疼痛性椎体骨折的年轻患者，它似乎也是PMMA的一种有前景的替代物。
