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EN
The aim of this study was to assess tissue reaction to bioabsorbable self-reinforced polyactide/polyglycolide (SR-PLGA) 80/20 miniscrews in rabbit cranial bone. One PLGA screw was implanted on one side and one titanium screw on the other side of the sagittal suture (N=21). Three animals were sacrificed after 2, 4, 8, 16, 24, 54 and 72 weeks. In histological examination the numbers of macrophages, giant cells, active osteoblasts and fibrous tissue layers were assessed and degradation of the bioabsorbable screws was evaluated. After two weeks, macrophages were seen near the heads of both screws. After 4 and 8 weeks, the bioabsrobable screws were surrounded by fibrous tissue. Osteoblastic activity and groups of several giant cells were seen. After 24 weeks, a significant change in the morphology of the PLGA screws has occurred. Osteoblastic activity and the amount of giant cells had decreased. After one year, some PLGA biomaterial was still present. PLGA screws had been replaced by adipose tissue, fibrous tissue and "foamy macrophages" which had PLGA particles inside them. After 11 years, the amount of biomaterial remaining had decreased remarkably. The particles of biomaterial were inside "foamy macrophages". SR-PLGA 80/20 screws are biocompatible and have no clinically manifested complications when used in cranial bone of rabbits. No contraindications as regards their clinical use in craniofacial surgery was found when studied in cranial bone of rabbit.
2
EN
The aim of this study was to compare the pullout forces of recently developed bioabsorbable ciprofloxacin-releasing and plain self-reinforced polylactide/polyglycolide (SR-PLGA) 80/20 tacks in human cadaver parietal bones. Parietal bone pieces (approximately 6 x 20 cm) were collected from five human male cadavers (29-77 years of age). Fifty plain SR-PLGA 80/20 tacks (diameter = 2 mm, length = 6,0 mm) and 50 ciprofloxacin-releasing SR-PLGA 80/20 tacks of similar dimensions were applied to drill holes using a special tack-shooter without tapping the drill holes. The force needed to pull the tacks from human parietal cadaver bones was measured using a universal tensile testing machine. The tack pullout speed was 10 mm/min. Means and standard deviations (SDs) were calculated and analyzed using the Student t test (SPSS version 10.0 for Windows). The pullout forces of the ciprofloxacin-releasing and plain tacks were 147 +/- 10.3 N and 141.4 +/- 12.6 N respectively (insignificant difference, P<0.001). The main cause of failure was the breakage of tack barbs (95% in the both cases). Ciprofloxacin-releasing SR-PLGA tacks have a pullout strength similar to corresponding plain conventional SR-PLGA tacks and they can be applied in cranial bone fixation.
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