Du Zhe, Zhu Zhonglin, Yue Bing, Li Zhanchun, Wang You
Department of Bone and Joint Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Jiangsu OKANI Medical Technology Co., Ltd, Soochow, China.
Artif Organs. 2018 Aug;42(8):E204-E214. doi: 10.1111/aor.13101. Epub 2018 Feb 13.
Polyether-ether-ketone (PEEK) is a potential alternative to metal alloys for use in the orthopedic implants; however, an in vivo study in an appropriate animal model is essential and has not yet been initiated. The aim of the present study was to gather some preliminary evidence regarding the performance and safety of a cemented PEEK-based knee replacement device in a goat model. Fifteen adult goats were randomly divided into two groups; the control group (n = 5), which received a sham operation, and the experimental group (n = 10), which received a total knee arthroplasty with a PEEK-based knee replacement device. The animals were sacrificed at 12 (control n = 5; experimental n = 5) or 24 weeks (experimental n = 5). Blood parameter measurements and radiographs of the knee joints were obtained. The synovium and main organs were removed and histologically assessed. The knee joints with the prosthesis were analyzed via micro-computed tomography and laser confocal microscopy. There was no occurrence of implant fracture or prosthesis sinking during the 24 weeks of radiological observations, except for one case of prosthesis dislocation at 4 weeks. There was a 6% decrease in femoral bone density (BD) at 12 weeks, but no further decrease by 24 weeks. No changes in BD were observed in the tibial ends. The bulk implant was biocompatible in terms of histological analysis of the local synovium and organs. There were no optical scratches on the surface of the retrieved components; the femoral component surface was rougher, while the tibial insert was smoother after 24 weeks. The novel PEEK-based knee replacement device in a goat model was feasible and safe; however, prior to use in humans, further studies concerning PEEK high load-bearing implant designs should be carried out to expand on our results.
聚醚醚酮（PEEK）是用于骨科植入物的金属合金的一种潜在替代品；然而，在合适的动物模型中进行体内研究至关重要，且尚未开展。本研究的目的是收集关于一种基于PEEK的骨水泥型膝关节置换装置在山羊模型中的性能和安全性的一些初步证据。15只成年山羊被随机分为两组；对照组（n = 5）接受假手术，实验组（n = 10）接受基于PEEK的膝关节置换装置的全膝关节置换术。在12周（对照组n = 5；实验组n = 5）或24周（实验组n = 5）时处死动物。获取血液参数测量值和膝关节X线片。取出滑膜和主要器官并进行组织学评估。通过微计算机断层扫描和激光共聚焦显微镜对带有假体的膝关节进行分析。在24周的放射学观察期间，除了4周时有1例假体脱位外，未发生植入物骨折或假体下沉。12周时股骨骨密度（BD）下降了6%，但到24周时没有进一步下降。在胫骨末端未观察到BD有变化。就局部滑膜和器官的组织学分析而言，整体植入物具有生物相容性。回收部件表面没有光学划痕；24周后，股骨部件表面更粗糙，而胫骨插入物更光滑。基于PEEK的新型膝关节置换装置在山羊模型中是可行且安全的；然而，在用于人类之前，应开展关于PEEK高承重植入物设计的进一步研究以拓展我们的研究结果。
