Department of Orthopaedic Surgery, The First Affiliated Hospital of Ningbo University, Ningbo University, Ningbo 315010, China.
Zhejiang Key Laboratory of Pathophysiology, School of Medicine, Ningbo University, Ningbo 315211, China.
ACS Biomater Sci Eng. 2024 Apr 8;10(4):2398-2413. doi: 10.1021/acsbiomaterials.3c01629. Epub 2024 Mar 13.
In vertebroplasty and kyphoplasty, bioinert poly(methyl methacrylate) (PMMA) bone cement is a conventional filler employed for quick stabilization of osteoporotic vertebral compression fractures (OVCFs). However, because of the poor osteointegration, excessive stiffness, and high curing temperature of PMMA, the implant loosens, the adjacent vertebrae refracture, and thermal necrosis of the surrounding tissue occurs frequently. This investigation addressed these issues by incorporating the small intestinal submucosa (SIS) into PMMA (SIS-PMMA). In vitro analyses revealed that this new SIS-PMMA bone cement had improved porous structure, as well as reduced compressive modulus and polymerization temperature compared with the original PMMA. Furthermore, the handling properties of SIS-PMMA bone cement were not significantly different from PMMA. The in vitro effect of PMMA and SIS-PMMA was investigated on MC3T3-E1 cells via the Transwell insert model to mimic the clinical condition or directly by culturing cells on the bone cement samples. The results indicated that SIS addition substantially enhanced the proliferation and osteogenic differentiation of MC3T3-E1 cells. Additionally, the bone cement's biomechanical properties were also assessed in a decalcified goat vertebrae model with a compression fracture, which indicated the SIS-PMMA had markedly increased compressive strength than PMMA. Furthermore, it was proved that the novel bone cement had good biosafety and efficacy based on the International Standards and guidelines. After 12 weeks of implantation, SIS-PMMA indicated significantly more osteointegration and new bone formation ability than PMMA. In addition, vertebral bodies with cement were also extracted for the uniaxial compression test, and it was revealed that compared with the PMMA-implanted vertebrae, the SIS-PMMA-implanted vertebrae had greatly enhanced maximum strength. Overall, these findings indicate the potential of SIS to induce efficient fixation between the modified cement surface and the host bone, thereby providing evidence that the SIS-PMMA bone cement is a promising filler for clinical vertebral augmentation.
在椎体成形术和后凸成形术中，生物惰性聚甲基丙烯酸甲酯（PMMA）骨水泥是一种传统的填充物，用于快速稳定骨质疏松性椎体压缩性骨折（OVCFs）。然而，由于 PMMA 的骨整合性差、刚度大、固化温度高，导致植入物松动、相邻椎体再骨折和周围组织热坏死频繁发生。本研究通过将小肠黏膜下层（SIS）掺入 PMMA 中（SIS-PMMA）来解决这些问题。体外分析表明，与原始 PMMA 相比，这种新型 SIS-PMMA 骨水泥具有改善的多孔结构，以及降低的压缩模量和聚合温度。此外，SIS-PMMA 骨水泥的操作性能与 PMMA 无显著差异。通过 Transwell 插入模型模拟临床情况或直接在骨水泥样本上培养细胞，研究了 PMMA 和 SIS-PMMA 对 MC3T3-E1 细胞的体外作用。结果表明，SIS 的添加显著增强了 MC3T3-E1 细胞的增殖和成骨分化。此外，还在去钙山羊椎体压缩骨折模型中评估了骨水泥的生物力学性能，结果表明 SIS-PMMA 比 PMMA 具有明显更高的抗压强度。此外，根据国际标准和指南，证明了新型骨水泥具有良好的生物安全性和疗效。植入 12 周后，SIS-PMMA 显示出比 PMMA 更强的骨整合和新骨形成能力。此外，还提取了带有水泥的椎体进行单轴压缩试验，结果表明，与植入 PMMA 的椎体相比，植入 SIS-PMMA 的椎体的最大强度有了显著提高。总体而言，这些发现表明 SIS 具有在改性水泥表面和宿主骨之间诱导有效固定的潜力，从而为 SIS-PMMA 骨水泥是一种有前途的临床椎体增强填充物提供了证据。
