caa a22 4500 445835095 CHVBK 20180317145328.0 cr unu---uuuuu 170323e20111101xx s 000 0 eng 10.1007/s00586-011-1812-8 doi (NATIONALLICENCE)springer-10.1007/s00586-011-1812-8 In vivo biostability of polymeric spine implants: retrieval analyses from a United States investigational device exemption study [Elektronische Daten] [Ming Shen, Kai Zhang, Petra Koettig, William Welch, John Dawson] The Dynesys System for stabilizing the lumbar spine was first surgically implanted in Europe in 1994. In 2003, a prospective, randomized, investigational device exemption clinical trial of the system for non-fusion dynamic stabilization began. Polycarbonate urethane (PCU) and polyethylene terephthalate (PET) components explanted from four patients who had participated in the study were analyzed for biostability. Components had been implanted 9-19months. The explanted components were visually inspected and digitally photographed. Scanning electron microscopy was used to analyze the surface of the spacers. The chemical and molecular properties of the retrieved spacers and cords were quantitatively compared with lot-matched, shelf-aged, components that had not been implanted using attenuated total reflection Fourier transform infrared (FTIR) and gel permeation chromatography (GPC). FTIR analyses suggested that the explanted spacers exhibited slight surface chemical changes but were chemically unchanged below the surface and in the center. New peaks that could be attributed to biodegradation of PCU were not observed. The spectral analyses for the cords revealed that the PET cords were chemically unchanged at both the surface and the interior. Peaks associated with the PET biodegradation were not detected. GPC results did not identify changes to the distributions of molecular weights that might be attributed to biodegradation of either PCU spacers or PET cords. The explanted condition of the retrieved components demonstrated the biostability of both PCU spacers and PET cords that had been in vivo for up to 19months. Springer-Verlag, 2011 Dynamic stabilization nationallicence Biostability nationallicence Biodegradation nationallicence Polycarbonate urethane nationallicence Polyethylene terephthalate nationallicence Shen Ming Zimmer Inc, 1800 West Center St, 4658, Warsaw, IN, USA aut Zhang Kai Zimmer Spine Inc, 7375 Bush Lake Road, 55439, Minneapolis, MN, USA aut Koettig Petra Zimmer GmbH, Sulzerallee 8, 8404, Winterthur, Switzerland aut Welch William Department of Neurological Surgery, University of Pennsylvania, 330 S. 8th St, 19107, Philadelphia, PA, USA aut Dawson John Zimmer Spine, 7375 Bush Lake Road, 7376 Bush Lake Road, 55439, Minneapolis, MN, USA aut European Spine Journal Springer-Verlag 20/11(2011-11-01), 1837-1849 0940-6719 20:11<1837 2011 20 586 https://doi.org/10.1007/s00586-011-1812-8 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s00586-011-1812-8 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Shen Ming Zimmer Inc, 1800 West Center St, 4658, Warsaw, IN, USA aut NATIONALLICENCE 700 1- Zhang Kai Zimmer Spine Inc, 7375 Bush Lake Road, 55439, Minneapolis, MN, USA aut NATIONALLICENCE 700 1- Koettig Petra Zimmer GmbH, Sulzerallee 8, 8404, Winterthur, Switzerland aut NATIONALLICENCE 700 1- Welch William Department of Neurological Surgery, University of Pennsylvania, 330 S. 8th St, 19107, Philadelphia, PA, USA aut NATIONALLICENCE 700 1- Dawson John Zimmer Spine, 7375 Bush Lake Road, 7376 Bush Lake Road, 55439, Minneapolis, MN, USA aut NATIONALLICENCE 773 0- European Spine Journal Springer-Verlag 20/11(2011-11-01), 1837-1849 0940-6719 20:11<1837 2011 20 586 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer