Effect of surgical factors on the augmentation of cement- injectable cannulated pedicle screw fixation by a novel calcium phosphate-based nanocomposite

Abstract

Bone cement-augmented pedicle screw system demonstrates great efficacy in spinal disease treatments. However, the intrinsic drawbacks associated with clinically used polymethylmethacrylate (PMMA) cement demands for new bone cement formulations. On the basis of our previous studies, a novel injectable and biodegradable calcium phosphate-based nanocomposite (CPN) for the augmentation of pedicle screw fixation was systematically evaluated for its surgical feasibility and biomechanical performance by simulated and animal osteoporotic bone models, and the results were compared with those of clinical PMMA cement. ASTM-standard solid foam and open-cell foam models and decalcified sheep vertebra models were employed to evaluate the augmentation effects of CPN on bone tissue and on the cement-injected cannulated pedicle screws (CICPs) placed in osteoporotic bone. Surgical factors in CICPs application, such as injection force, tapping technique, screw diameter, and pedicle screw loosening scenarios, were studied in comparison with those in PMMA. When directly injected to the solid foam model, CPN revealed an identical augmentation effect to that of PMMA, as shown by the similar compressive strengths (0.73±0.04 MPa for CPN group vs. 0.79±0.02 MPa for PMMA group). The average injection force of CPN at approximately 40–50 N was higher than that of PMMA at approximately 20 N. Although both values are acceptable to surgeons, CPN revealed a more consistent injection force pattern than did PMMA. The dispersing and anti-pullout ability of CPN were not affected by the surgical factors of tapping technique and screw diameter. The axial pullout strength of CPN evaluated by the decalcified sheep vertebra model revealed a similar augmentation level as that of PMMA (1351.6±324.2 N for CPN vs. 1459.7±304.4 N for PMMA). The promising results of CPN clearly suggest its potential for replacing PMMA in CICPs augmentation application and the benefits of further study and development for clinical uses.

Keywords

bone cement / pedicle screw / degenerative spinal diseases / calcium phosphate / injectable

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Acknowledgements

This study was funded by the Youth Clinical Research Project of Peking University First Hospital (No. 2017CR06), the National Natural Science Foundation of China (Nos. 81622032 and 51672184), the Principal Project of Natural Science Research of Jiangsu Higher Education Institutions (No. 17KJA180011), and Jiangsu Innovation and Entrepreneurship Program.

Compliance with ethics guidelines

Haolin Sun, Chun Liu, Shunlun Chen, Yanjie Bai, Huilin Yang, Chunde Li, and Lei Yang declare that they have no conflicts of interest in this study. All institutional and national guidelines for the care and use of laboratory animal were followed. The animal study protocol was approved by the Ethics Committee of Soochow University under case number ECSU-201700031.

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