Nieminen Tuomo, Kallela Ilkka, Wuolijoki Erkki, Kainulainen Heikki, Hiidenheimo Ilmari, Rantala Immo
Department of Pharmacological Sciences, Medical School, University of Tampere, Finland.
J Biomed Mater Res A. 2008 Feb;84(2):377-83. doi: 10.1002/jbm.a.31310.
The study was aimed to test the mechanical strength, structural stability, and tissue reactions of optically amorphous and crystalline polyetheretherketone (PEEK) plates during a 3-year follow-up in vivo and in vitro. The injection-moulded PEEK plates were implanted to the dorsal subcutis of 12 sheep, which were sacrificed at 6-156 weeks. Thereafter, the plates were subjected to tensile tests, and levels of crystallinity were assessed by differential scanning calorimetry (DSC). Histological evaluation was carried out using the paraffin technique. In vitro properties were examined with the tensile test and DSC at 0-156 weeks. Tissue reactions were mild and fairly similar for the amorphous and crystalline plates at corresponding points in time. The mechanical characteristics of the plates remained stable over the entire follow-up. The tensile yield load and elongation at the yield load of the crystalline plates were roughly double ( approximately 500 vs. 270 N and 2.4 vs. 1.4 mm, respectively) in comparison to the amorphous plates. The elongation at break load of the crystalline plates was smaller than that of the amorphous ones (6 vs. 10). The level of crystallinity in both the optically amorphous ( approximately 15%) and crystalline (32-34%) plates remained invariable during the follow-up. The in vitro and in vivo data coincided remarkably well. In conclusion, both optically amorphous and crystalline PEEK plates are suitable for the fixation of fractures and osteotomies.
本研究旨在通过3年的体内和体外随访，测试光学非晶态和结晶态聚醚醚酮（PEEK）接骨板的机械强度、结构稳定性和组织反应。将注塑成型的PEEK接骨板植入12只绵羊的背部皮下，在6 - 156周时处死绵羊。此后，对接骨板进行拉伸试验，并通过差示扫描量热法（DSC）评估结晶度水平。使用石蜡技术进行组织学评估。在0 - 156周时通过拉伸试验和DSC检查体外性能。在相应时间点，非晶态和结晶态接骨板的组织反应均较轻且相当相似。在整个随访过程中，接骨板的机械特性保持稳定。与非晶态接骨板相比，结晶态接骨板的拉伸屈服载荷和屈服载荷下的伸长率大致翻倍（分别约为500 N对270 N和2.4 mm对1.4 mm）。结晶态接骨板的断裂载荷伸长率小于非晶态接骨板（6对10）。在随访期间，光学非晶态（约15%）和结晶态（32 - 34%）接骨板的结晶度水平均保持不变。体外和体内数据非常吻合。总之，光学非晶态和结晶态PEEK接骨板均适用于骨折和截骨的固定。
