Özet:

Issues of safety are very crucial with biomaterials and medical devices. Sixteen male New Zealand White rabbits equally into four groups: Group A, rabbits had part of their radial bone (2 cm, mid shaft) and left empty as a control. Group B, rabbits were implanted with scaffold 5211. Group C, rabbits were implanted with scaffold 5211GTA+Alginate. Group D, rabbits were implanted with 5211PLA. All scaffolds were prepared by freeze-drying method. Blood samples were collected at day 0 and 1st, 2nd, 3rd, 4th and 8th week after implantation. The blood examination included complete hemogram and certain serum biochemical parameters. The results showed that there was no significant difference (P>0.05) among each treatment group in comparison with control group (day 0). However, red blood cells, hemoglobin, packed cell volume, mean corpuscular hemoglobin concentration, monocyte, plasma protein, inorganic phosphate, sodium, chloride and urea were significantly increased (P<0.05) among treatment groups at week 8. An abnormal architecture of viscera was observed in all animals, thus indicating a form of toxicity related to the degrading scaffold materials. The severity of histopathological lesions in viscera was not coated polymers dependent nor development materials. In conclusion, implantation of 5211 scaffold with or without coated framework has a significant impact on histopathological and certain hematological and biochemical parameters.

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