A variety of metallic biomaterials is used for fracture fixation. Allergic reactions towards nickel‐containing steels urge the need for alternatives. The present study investigated the suitability of the nickel‐free stainless steel P2000 in comparison to titanium alloy implants for bone surgical applications in a rabbit femora defect model. Thirty‐six rabbits received two different cylindrical implants press‐fit inserted into the distal femoral metaphysis. At day 0, 28, and 56, implant ingrowth was monitored by radiography; implant stability was assessed by pull‐out torque measurements while bone‐to‐implant contact (BIC) was determined histomorphometrically. Radiography revealed comparable implant ingrowth after 1 and 2 months for both implant materials. The pull‐out force of P2000 tended to be higher than that for titanium at day 28 (p = .076) but the values were comparable at day 56 (p = .905). At day 56, implant fixation was significantly increased compared to the day of surgery for both, P2000 (p = .030) and for titanium alloy (p = .026). Microscopic examination revealed that both implant types appeared to be well integrated and firmly anchored in the bone. BIC ratio of titanium alloy tended to be higher at day 28 (p = .079) but they did not differ significantly at day 56 (p = .711). In the present rabbit femora defect model, the nickel‐free stainless steel P2000 provides primary stability and osseointegration comparable to that of titanium alloy implants.

中文翻译：

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兔股骨中无镍钢 X13CrMnMoN18-14-3 和钛合金植入物的体内比较——一种用于骨科手术的有前途的钢

多种金属生物材料用于骨折固定。对含镍钢的过敏反应促使人们需要替代品。本研究调查了无镍不锈钢 P2000 与钛合金植入物在兔股骨缺损模型骨外科应用中的适用性。36 只兔子接受了两种不同的圆柱形植入物，压入配合插入股骨远端干骺端。在第 0 天、第 28 天和第 56 天，通过放射线照相术监测种植体向内生长；通过拔出扭矩测量评估种植体稳定性，同时通过组织形态学测定骨与种植体接触（BIC）。射线照相显示两种种植体材料在 1 个月和 2 个月后种植体长入相当。在第 28 天，P2000 的拔出力往往高于钛（p = .076），但在第 56 天时的值具有可比性（p = .905）。在第 56 天，与手术当天相比，P2000 ( p = .030) 和钛合金 ( p = .026) 的种植体固定显着增加。显微镜检查显示，两种种植体类型似乎都很好地结合并牢固地固定在骨骼中。钛合金的 BIC 比在第 28 天趋于较高（p = .079），但在第 56 天没有显着差异（p = .711）。在目前的兔股骨缺损模型中，无镍不锈钢 P2000 提供了与钛合金植入物相当的初级稳定性和骨整合。