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首页> 外文期刊>Journal of biomedical materials research. Part B, Applied biomaterials. >In vivo biocompatibility testing of peek polymer for a spinal implant system: A study in rabbits
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In vivo biocompatibility testing of peek polymer for a spinal implant system: A study in rabbits

机译：聚醚醚酮聚合物在脊柱植入系统中的体内生物相容性测试：在兔中的研究

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We are developing a new spinal implant system group had the same surgical approach without injection. In (SIS) without fusion (bone graft). This SIS is made from two materials, metal and polyetheretherketone (PEEK) polymer. The Food and Drug Administration recommended testing in vivo, in an animal model, whether the PEEK polymer could be used in a SIS without any harm of wear debris to the nervous tissue (spinal cord and nerve roots). The objective was to evaluate the biological response of the spinal cord and nerve roots (dura mater) to PEEK polymer particles. Twenty-four female New Zealand white rabbits were used. The rabbits were divided into three groups: test (n=12), control (n=9), and sham (n=3). During the surgery, the test group received the PEEK particle injections (5 X 10~7 particles per site, lumbar and thoracic), while the control group received only the vehicle (0.9 percent saline solution). The sham group had the same surgical approach without injection. In each group, the rabbits were euthanized at 1, 4, and 12 weeks postsurgery. The macroscopic and semiquantitative histologic analyses of the spinal cords (dura mater) showed normal vascularization and particle adherence to the connective tissue especially at the injection sites. Neither necrosis nor swelling of the dura mater and nerve roots was observed. The PEEK polymer is harmless to the spinal cord; thus it might be used as component in the spinal implant system.
机译：我们正在开发一个新的脊柱植入物系统组，该组具有相同的手术方法而无需注射。在（SIS）中不融合（骨移植）。该SIS由两种材料制成，金属和聚醚醚酮（PEEK）聚合物。美国食品药品监督管理局建议在动物模型中进行体内测试，以确保PEEK聚合物是否可用于SIS中而不会对神经组织（脊髓和神经根）产生任何磨损。目的是评估脊髓和神经根（硬脑膜）对PEEK聚合物颗粒的生物学反应。使用二十四只雌性新西兰白兔。将兔子分成三组：测试（n ＝ 12），对照（n ＝ 9）和假（n ＝ 3）。在手术过程中，测试组接受了PEEK颗粒注射（每个部位，腰部和胸部5个X 10〜7个颗粒），而对照组仅接受了媒介物（0.9％的盐溶液）。假手术组采用相同的手术方法，无需注射。在每组中，在术后1、4和12周对兔子实施安乐死。脊髓（硬脑膜）的宏观和半定量组织学分析显示正常的血管形成和颗粒对结缔组织的粘附，尤其是在注射部位。未见硬脑膜和神经根坏死或肿胀。 PEEK聚合物对脊髓无害;因此它可以用作脊柱植入系统中的组件。

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