Safety and effectiveness of a biodegradable magnesium alloy fixation system in animals

doi:10.3969/j.issn.2095-4344.0987

Abstract

Abstract:

BACKGROUND: Biosecurity of new biodegradable magnesium alloys has been confirmed, but there is no report

on the use of magnesium alloy fixation system fixation systems.

OBJECTIVE: To make a preliminary research on the safety and effectiveness of the new biodegradable magnesium alloy fixation system in healthy New Zealand white rabbits in vivo.

METHODS: Thirty healthy New Zealand rabbits were randomized into experimental group in which the biodegradable magnesium alloy fixation system implantation model was established in each animal and control group in which no intervention was performed. Blood routine, hepatic and renal functions, coagulation functions and serum magnesium level were detected at 14, 30, 90, and 180 days after operation. B-ultrasound, CT scanning and operative field exposure were carried out to observe the absorption of fixation system and the impact of gas production at 180 days after operation. Muscle tissues, cranial bones, duramater and brain tissues around the fixation system and the corresponding parts in control group were taken at the same time for pathological observation.

RESULTS AND CONCLUSION: (1) There was no statistical difference between the two groups regarding the number of white blood cells and platelets, and levels of hemoglobin, blood urea nitrogen, alanine aminotransferase and serum magnesium at different time points after operation and all indicators maintained in a relatively stable state. (2) The results of cranial B-ultrasound showed the fixation system degraded gradually and no significant gas accumulated around it. CT scanning and operative field exposure revealed nearly 50% of the fixation system degraded at 180 days after operation, and the man-made cranial suture healed naturally. (3) Histological observation showed the JDBM fixation system did not cause the significant pathological changes and inflammatory reactions of surrounding tissues. These findings suggest that the histocompatibility of JDBM is ideal and the fixation system is safe and effective after implantation.

中国组织工程研究杂志出版内容重点：生物材料；骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性；组织工程

Key words: Alloys, Skull, Histocompatibility, Tissue Engineering

CLC Number:

R318

Liu Tian-jia, Gu Shuo, Zhou Lu, Zhong Jia-fei, Yuan Guang-yin. Safety and effectiveness of a biodegradable magnesium alloy fixation system in animals[J]. Chinese Journal of Tissue Engineering Research, 2018, 22(30): 4876-4881.

Figures/Tables 7

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