Abstract：
Titanium as the leading implant material in locked plating is challenged by polymers such as carbon fiber-reinforced polyetheretherketone (CFR-PEEK), which became the focus of interest of researchers and manufacturers in recent years. However, data on human tissue response to these new implant materials are rare. Osteosynthesis plates and peri‑implant soft tissue samples of 16 healed proximal humerus fractures were examined (n = 8 CFR-PEEK, n = 8 titanium). Soft tissue was analyzed by immunohistochemistry and µCT. The entrapped foreign bodies were further examined for their material composition by FTIR. To gain insight into their origin and formation mechanism, explanted and new plates were evaluated by SEM, EDX, profilometry and HR-CT. In the peri‑implant soft tissue of the CFR-PEEK plates, an inflammatory tissue reaction was detected. Tissues contained foreign bodies, which could be identified as tantalum wires, carbon fiber fragments and PEEK particles. Titanium particles were also found in the peri‑implant soft tissue of the titanium plates but showed a less intense surrounding tissue inflammation in immunohistochemistry. The surface of explanted CFR-PEEK plates was rougher and showed exposed and broken carbon fibers as well as protruding and deformed tantalum wires, especially in used screw holes, whereas scratches were identified on the titanium plate surfaces. Particles were present in the peri‑implant soft tissue neighboring both implant materials and could be clearly assigned to the plate material. Particles from both plate materials caused detectable tissue inflammation, with more inflammatory cells found in soft tissue over CFR-PEEK plates than over titanium plates. STATEMENT OF SIGNIFICANCE: Osteosynthesis plates are ubiquitously used in various medical specialties for the reconstruction of bone fractures and defects and are therefore indispensable for trauma surgeons, ENT specialists and many others. The leading implant material are metals such as titanium, but recently implants made of polymers such as carbon fiber-reinforced polyetheretherketone (CFR-PEEK) have become increasingly popular. However, little is known about human tissue reaction and particle generation related to these new implant types. To clarify this question, 16 osteosynthesis plates (n = 8 titanium and n = 8 CFR-PEEK) and the overlying soft tissue were analyzed regarding particle occurrence and tissue inflammation. Tissue inflammation is clinically relevant for the development of scar tissue, which is discussed to cause movement restrictions and thus contributes significantly to patient outcome.
摘要：
钛作为锁定电镀中的主要植入材料受到碳纤维增强聚醚醚酮(CFR-PEEK)等聚合物的挑战，近年来成为研究人员和制造商关注的焦点。然而,关于人体组织对这些新植入材料的反应的数据很少。检查了16例已愈合的肱骨近端骨折的接骨板和种植体周围软组织样本（n=8CFR-PEEK，n=8钛)。通过免疫组织化学和µCT分析软组织。通过FTIR进一步检查截留的异物的材料组成。为了深入了解它们的起源和形成机制，通过SEM评估外植和新的平板，EDX,轮廓术和HR-CT。在CFR-PEEK板的种植体周围软组织中，检测到炎症组织反应。组织中有异物，可以识别为钽丝，碳纤维碎片和PEEK颗粒。在钛板的植入物周围软组织中也发现了钛颗粒，但在免疫组织化学中显示出较不强烈的周围组织炎症。外植的CFR-PEEK板的表面更粗糙，显示出暴露和断裂的碳纤维以及突出和变形的钽丝，特别是在使用过的螺丝孔，而在钛板表面上发现划痕。颗粒存在于与两种植入物材料相邻的植入物周围软组织中，并且可以清楚地分配给板材料。来自两种板材料的颗粒引起可检测的组织炎症，在CFR-PEEK板上的软组织中发现的炎症细胞多于钛板。意义声明：接骨板广泛用于各种医学专业，用于重建骨折和缺损，因此对于创伤外科医生来说是必不可少的，ENT专家和其他许多人。主要的植入材料是金属，如钛，但是最近，由碳纤维增强的聚醚醚酮（CFR-PEEK）等聚合物制成的植入物变得越来越流行。然而,关于这些新的植入物类型的人体组织反应和颗粒生成知之甚少。为了澄清这个问题，分析了16个接骨板（n=8钛和n=8CFR-PEEK）和上覆的软组织的颗粒发生和组织炎症。组织炎症在临床上与瘢痕组织的发展有关，这被讨论导致运动限制，从而显著有助于患者的结果。
