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Bioabsorbable Ciprofloxacin-containing and plain self-reinforced polylactide-polyglycolide 80/20 screws: pull-out strength properties in human cadaver parietal bones.

Tiainen J, MD (1), Veiranto M, MSc (Eng.) (2), Suokas E, Dr. Tech. (3), Törmälä P, PhD, Sci.h.c. (2), Waris T, MD, PhD (4), Ninkovic M, MD, PhD (5), and Ashammakhi N, MD, PhD, FRCSEd (1).

1. Department of Surgery, Oulu University Hospital, P.O. Box 20, FIN-90029 Oulu, Finland.
2. Institute of Biomaterials, Tampere University of Technology, P.O. Box 589, FIN-33101 Tampere, Finland.
3. Bionx Implants Ltd., P.O. Box 3, FIN-33721 Tampere, Finland.
4. Department of Surgery, Tampere University Hospital and University of Tampere, Tampere, Finland.
5. Department of Reconstructive Surgery, Innsbruck University Clinic, Anichstraße 35, A-6020 Innsbruck, Austria.

Abstract
The aim of this study was to compare the pull-out forces of recently developed bioabsorbable ciprofloxacin-containing and plain self-reinforced polylactide/polyglycolide (SR-PLGA) miniscrews in human cadaver parietal bones. Parietal bone pieces (c. 6 cm x 20 cm) were collected from five human male cadavers (44 to 75 years old). Fifty plain self-reinforced (SR-PLGA 80/20) miniscrews (diameter 1.5 mm, length 4.0 mm) and fifty ciprofloxacin-containing SR-PLGA (80/20) miniscrews (diameter 1.5 mm, length 4.0 mm) were used in this study. The force needed to pull the screws from human parietal cadaver bones was measured using a tensile strength testing machine. The screw pull-out speed was 10 mm/min. Means and standard deviations (SDs) were calculated and analyzed using Student's t-test (SPSS version 10.0 for Windows). The pull-out forces of the ciprofloxacin-containing and plain miniscrews were 66.8 ± 4.9 and 96.3 ± 9.3 N (significant difference, p<0.001), respectively. The most common cause of failure was screw-shaft breakage (60% in the case of ciprofloxacin-containing screws and 52% in the case of plain SR-PLGA screws). Scanning electron microscopy (SEM) showed that the fibrillar strip-like microstructure of plain SR-PLGA miniscrews turns into a coarse uni-axial platelet-like morphology in antibiotic SR-PLGA miniscrews as a result of the addition of ciprofloxacin. Ciprofloxacin-containing SR-PLGA screws consequently have lower pull-out strength than corresponding plain conventional SR-PLGA screws.

Keywords: Antibiotic, Bioabsorbable, Ciprofloxacin, Miniscrew, SR-PLGA