Klinikum rechts der Isar der Technischen Universität München, Klinik und Poliklinik für Unfallchirurgie, München, Germany.
Klinikum rechts der Isar der Technischen Universität München, Klinik für Orthopädie und Sportorthopädie, München, Germany.
J Mater Sci Mater Med. 2018 Jan 9;29(2):17. doi: 10.1007/s10856-017-6017-1.
Calcium sulfate (CS) can be used as an antibiotically impregnated bone substitute in a variety of clinical constellations. Antibiotically loaded bone substitutes find specific application in orthopedic and trauma surgery to prevent or treat bone infections especially in relation to open bone defects. However, its use as a structural bone graft reveals some concerns due to its fast biodegradation. The addition of calcium carbonate and tripalmitin makes CS formulations more resistant to resorption leaving bone time to form during a prolonged degradation process. The aim of the present study was the evaluation of biocompatibility and degradation properties of newly formulated antibiotically impregnated CS preparations. Three different types of CS bone substitute beads were implanted into the tibial metaphysis of rabbits (CS dihydrate with tripalmitin, containing gentamicin (Group A) or vancomycin (Group B); Group C: tobramycin-loaded CS hemihydrate). Examinations were performed by means of x-ray, micro-computed tomography (micro-CT) and histology after 4, 6, 8 and 12 weeks. Regarding biocompatibility of the formulations, no adverse reactions were observed. Histology showed formation of vital bone cells attached directly to the implanted materials, while no cytotoxic effect in the surrounding of the beads was detected. All CS preparations showed osteogenesis associated to implanted material. Osteoblasts attached directly to the implant surface and revealed osteoid production, osteocytes were found in newly mineralized bone. Group C implants (Osteoset) were subject to quick degradation within 4 weeks, after 6-8 weeks there were only minor remnants with little osteogenesis demonstrated by histological investigations. Group A implants (Herafill-G) revealed similar degradation within atleast 12 weeks. In contrast, group B implants (CaSO4-V) were still detectable after 12 weeks with the presence of implant-associated osteogenesis atlatest follow-up. In all of these preparations, giant cells were found during implant degradation on surface and inside of resorption lacunae. None of the analyzed CS preparations triggered contact activation. All implants demonstrated excellent biocompatibility, with implants of Group A and B showing excellent features as osteoconductive and -inductive scaffolds able to improve mechanical stability.
硫酸钙（CS）可作为各种临床情况下的抗生素浸渍骨替代物。抗生素负载的骨替代物在矫形和创伤外科中具有特定的应用，可预防或治疗骨感染，特别是与开放性骨缺损有关。然而，由于其快速生物降解，其作为结构骨移植物的使用存在一些问题。碳酸钙和三棕榈酸甘油酯的添加使 CS 制剂更能抵抗吸收，从而使骨骼在长时间的降解过程中有时间形成。本研究的目的是评估新配方的抗生素浸渍 CS 制剂的生物相容性和降解特性。将三种不同类型的 CS 骨替代珠植入兔胫骨干骺端（含棕榈酸三甘油酯和庆大霉素的 CS 二水合物（A 组）或万古霉素（B 组）；C 组：妥布霉素负载的 CS 半水合物）。分别在 4、6、8 和 12 周后通过 X 射线、微计算机断层扫描（micro-CT）和组织学检查进行评估。关于配方的生物相容性，未观察到不良反应。组织学显示，直接附着在植入材料上的有生命力的骨细胞形成，而在珠的周围未检测到细胞毒性作用。所有 CS 制剂均显示与植入材料相关的成骨作用。成骨细胞直接附着在植入物表面，并显示出类骨质的产生，骨细胞存在于新矿化的骨中。C 组（Osteoset）植入物在 4 周内迅速降解，6-8 周后仅残留少量植入物，组织学研究显示成骨作用较少。A 组（Herafill-G）植入物在至少 12 周内显示出相似的降解。相比之下，B 组（CaSO4-V）植入物在 12 周后仍可检测到，并且在最后一次随访时存在与植入物相关的成骨作用。在所有这些制剂中，在植入物降解时，在吸收陷窝的表面和内部都发现了巨细胞。在分析的 CS 制剂中均未引发接触激活。所有植入物均表现出优异的生物相容性，A 组和 B 组的植入物表现出良好的特性，作为骨传导和诱导支架，能够提高机械稳定性。
