[Animal Modeling] - Establishment and Evaluation of a Small Tailed Han Sheep Cervical Anterior Intervertebral Disc Resection and Fusion Model

  Objective: Cervical disc herniation is one of the common orthopedic diseases. With the deepening of research on this disease and the development of cervical implants, establishing an animal model for cervical fusion has become an indispensable part. Currently, there are few research reports on the establishment and evaluation of animal models for cervical fusion in China. This study aims to provide a comprehensive animal model and evaluation plan for the performance of cervical implants for research related to cervical fusion.

  Method: Select small tailed Han sheep and perform anterior cervical discectomy and fusion surgery after improving the surgical method. The polyetheretherketone intervertebral fusion cage control group, 3D printed titanium alloy Cage (experimental group 1), and new method titanium alloy Cage (experimental group 2) were implanted into different cervical segments of each sheep (C2/3-C4/5). Hematology and histopathological analysis were performed after surgery to evaluate the surgical recovery and material biosafety. X-ray, CT, Micro CT, quantitative analysis, hard tissue staining, and biomechanical tests were used to evaluate the bone growth and fusion of the implant.

  The results showed that the sheep modified ACDF model was successfully established, and there was no significant difference in important hematological indicators (P>0.05). Histopathological analysis showed that there were no pathological changes such as inflammatory cell infiltration in both groups, and the implant had good biological safety. X-ray and CT showed good internal fixation position and intervertebral fusion. Micro CT and quantitative analysis at 3 and 6 months after surgery showed that compared with the PEEKCage group, the new method titanium alloy Cage group and 3D printed titanium alloy Cage group had a significant increase in bone volume/total volume, bone trabecular number (P<0.01), and a significant decrease in bone trabecular spacing (P<0.01). In addition, the new method titanium alloy Cage group showed a significant increase in bone volume/total volume, and bone trabecular spacing (P<0.01). The ge group had more bone growth (P<0.01), and hard tissue section staining showed that the new method of titanium alloy Cage group and 3D printed titanium alloy Cage group had significant bone growth in the pores and were relatively dense, slightly better than the PEEKCage group. Biomechanical tests showed that compared with the PEEKCage group, The new method of titanium alloy cage and 3D printed titanium alloy cage to some extent reduced the range of cervical flexion, extension, lateral bending, and torsion movement (P<0.05), while enhancing the stability of the cervical spine. Moreover, the new method of titanium alloy cage has more advantages (P<0.05).

  Conclusion: After establishing the sheep modified surgical ACDF model, the rationality and effectiveness of the model were demonstrated using reasonable and effective evaluation methods. At the same time, it was demonstrated that the Cage of the three materials showed good biological safety. The new method of titanium alloy Cage and 3D printed titanium alloy Cage had stronger bone ingrowth and fusion performance than PEEKCage, which can enhance the stability of the cervical spine. Moreover, the new method of titanium alloy Cage has more advantages.