Abstract
To increase the corrosion prevention of stainless steel implant and fast recovery due to new bone-cell formation at the orthopedic implant site, in the present investigation, a trilayered (with bioceramic interlayer sandwiched between innermost passivated surface and outermost polymer coating) 316L stainless steel (SS) implant was designed and investigated. It was inferred that this new designed implant invokes faster and more bone-cell formation than uncoated commercially available 316L SS implants. Faster bone-cell formation at the coated implant site reduces the initial threat of implant corrosion. The electrochemical corrosion study proved that this model of coated implants is able to prevent corrosion up to 90% better than uncoated commercially available 316L SS. Subsequently, preclinical studies in the rabbit bone defect model (which included histology, radiology, fluorochrome labeling, push-out test, and scanning electron microscopy taken after 45 and 90 days) proved higher rate of new bone tissue formation and better push-out strength between tissue in contact and the coated implant. The toxicological study of vital organs like liver, kidney, and heart also exhibited no abnormality. The outcome of the experimentations indicates suitability of this trilayered 316L SS implant for bone repair and healing.
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B.M. Holzapfel, J.C. Reichert, J-T. Schantz, U. Gbureck, L. Rackwitz, U. Noth, F. Jakob, M. Rudert, J. Groll, and D.W. Hutmacher: How smart do biomaterials need to be? A translational science and clinical point of view. Adv. Drug Delivery Rev. 65, 581 (2013).
T. Thamaraiselvi and S. Rajeswari: Biological evaluation of bioceramic materials—A review. Trends Biomater. Artif. Organs 18, 9 (2004).
M. Vallet-Regi: Ceramics for medical applications. J. Chem. Soc., Dalton Trans., 97 (2001).
W. Rieger, S. Leyen, S. Kobel, and W. Weber: The use of bioceramics in dental and medical applications. Digital Dent. News 3, 6 (2009).
L.L. Hench and J. Wilson: An Introduction to Bioceramics (World Scientific, Singapore, 1993).
X. Lin, K. De Groot, D. Wang, Q. Hu, D. Wismeijer, and Y. Liu: Suppl 1-M4: A review paper on biomimetic calcium phosphate coatings. Open Biomed. Eng. J. 9, 56 (2015).
R.Z. LeGeros: Properties of osteoconductive biomaterials: Calcium phosphates. Clin. Orthop. Relat. Res. 395, 81 (2002).
B.G.X. Zhang, D.E. Myers, G.G. Wallace, M. Brandt, and P.F.M. Choong: Bioactive coatings for orthopaedic implants — Recent trends in development of implant coatings. Int. J. Mol. Sci. 15, 11878 (2014).
N.R. Babu, S. Manwatkar, K.P. Rao, and T.S.S. Kumar: Bioactive coatings on 316L stainless steel implants. Trends Biomater. Artif. Organs 17, 43 (2004).
J. He, T. Huang, L. Gan, Z. Zhou, B. Jiang, Y. Wu, F. Wu, and Z. Gu: Collagen-infiltrated porous hydroxyapatite coating and its osteogenic properties: In vitro and in vivo study. J. Biomed. Mater. Res., Part A 100, 1706 (2012).
N. Saran, R. Zhang, and R.E. Turcotte: Osteogenic protein-1 delivered by hydroxyapatite-coated implants improves bone ingrowth in extracortical bone bridging. Clin. Orthop. Relat. Res. 469, 1470 (2011).
R. Kargupta, S. Bok, C.M. Darr, B.D. Crist, K. Gangopadhyay, S. Gangopadhyay, and S. Sengupta: Coatings and surface modifications imparting antimicrobial activity to orthopedic implants. Wiley Interdiscip. Rev.: Nanomed. Nanobiotechnol. 6, 475 (2014).
J.D. Bumgardner, R. Wiser, P.D. Gerard, P. Bergin, B. Chestnutt, M. Marini, V. Ramsey, S.H. Elder, and J.A. Gilbert: Chitosan: Potential use as a bioactive coating for orthopaedic and craniofacial/dental implants. J. Biomater. Sci., Polym. Ed. 14, 423 (2003).
V.M. Correlo, L.F. Boesel, M. Bhattacharya, J.F. Mano, N.M. Neves, and R.L. Reis: Hydroxyapatite reinforced chitosan and polyester blends for biomedical applications. Macromol. Mater. Eng. 290, 1157 (2005).
S.K. Mishra and S. Kannan: Development, mechanical evaluation and surface characteristics of chitosan/polyvinyl alcohol based polymer composite coatings on titanium metal. J. Mech. Behav. Biomed. Mater. 40, 314 (2014).
S. Zankovych, M. Diefenbeck, J. Bossert, T. Muckley, C. Schrader, J. Schmidt, H. Schubert, S. Bischoff, M. Faucon, and U. Finger: The effect of polyelectrolyte multilayer coated titanium alloy surfaces on implant anchorage in rats. Acta Biomater. 9, 4926 (2013).
J.M. Anderson: Biological responses to materials. Annu. Rev. Mater. Res. 31, 81 (2001).
A.P. Wieslander, M.K. Nordin, B. Hansson, B. Baldetorp, and P.T.T. Kjellstrand: In vitro toxicity of biomaterials determined with cell density, total protein, cell cycle distribution and adenine nucleotides. Biomater. Artif. Cells Immobil. Biotechnol. 21, 63 (1993).
P. Majee and P.K. Mitra: Preventive coating of tri-calcium phosphate (TCP) on implantable 304L SS. Icastor J. Eng. 8, 117 (2015).
T. Kokubo and H. Takadama: How useful is SBF in predicting in vivo bone bioactivity? Biomaterials 27, 2907 (2006).
J.A. Bishop, A.A. Palanca, M.J. Bellino, and D.W. Lowenberg: Assessment of compromised fracture healing. J. Am. Acad. Orthop. Surg. 20, 273 (2012).
K-K. Chew, S.H.S. Zein, and A.L. Ahmad: The corrosion scenario in human body: Stainless steel 316L orthopaedic implants. Nat. Sci. 4, 184 (2012).
U. Kamachimudali, T.M. Sridhar, and B. Raj: Corrosion of bio implants. Sadhana 28, 601 (2003).
J.J. Kim and Y.M. Young: Study on the passive film of type 316 stainless steel. Int. J. Electrochem. Sci. 8, 11847 (2013).
R. Bosco, J. Van Den Beucken, S. Leeuwenburgh, and J. Jansen: Surface engineering for bone implants: A trend from passive to active surfaces. Coatings 2, 95 (2012).
T.V. Thamaraiselvi and S. Rajeswari: Electrochemical behaviour of alkali treated and hydroxyapatite coated 316 LVM. Trends Biomater. Artif. Organs 18, 242 (2005).
S. Dhar and P.K. Mitra: Electrochemical behaviour of hydroxyapatite coatings on phosphate passivated 316L stainless steel in Ringer’s solution. Icastor J. Eng. 5, 155 (2012).
S. Dhar, P.K. Mitra, and B. Duari: Corrosion behaviour of hydroxyapatite coatings on borate and phosphate-passivated 316L stainless steel in Ringer’s solution. Paint India 62, 63 (2012).
T.L. Arinzeh, S.J. Peter, M.P. Archambault, C. Van Den Bos, S. Gordon, K. Kraus, A. Smith, and S. Kadiyala: Allogeneic mesenchymal stem cells regenerate bone in a critical-sized canine segmental defect. J. Bone Jt. Surg. Am. 85, 1927 (2003).
S.M. van Gaalen, M.C. Kruyt, R.E. Geuze, J.D. de Bruijn, J. Alblas, and W.J.A. Dhert: Use of fluorochrome labels in in vivo bone tissue engineering research. Tissue Eng., Part B 16, 209 (2010).
J.L. Kovar, X. Xu, D. Draney, A. Cupp, M.A. Simpson, and D.M. Olive: Near-infrared-labeled tetracycline derivative is an effective marker of bone deposition in mice. Anal. Biochem. 416, 167 (2011).
L.E. Dahners and G.D. Bos: Fluorescent tetracycline labeling as an aid to debridement of necrotic bone in the treatment of chronic osteomyelitis. J. Orthop. Trauma 16, 345 (2002).
C.J. Gibson, V.F. Thornton, and W.A.B. Brown: Incorporation of tetracycline into impeded and unimpeded mandibular incisors of the mouse. Calcif. Tissue Int. 26, 29 (1978).
Z. Shi, K.G. Neoh, E.T. Kang, C. Poh, and W. Wang: Bacterial adhesion and osteoblast function on titanium with surface-grafted chitosan and immobilized RGD peptide. J. Biomed. Mater. Res., Part A 86, 865 (2008).
A. Di Martino, M. Sittinger, and M.V. Risbud: Chitosan: A versatile biopolymer for orthopaedic tissue-engineering. Biomaterials 26, 5983 (2005).
N. Ohara, Y. Hayashi, S. Yamada, S-K. Kim, T. Matsunaga, K. Yanagiguchi, and T. Ikeda: Early gene expression analyzed by cDNA microarray and RT-PCR in osteoblasts cultured with water-soluble and low molecular chitooligosaccharide. Biomaterials 25, 1749 (2004).
J.B. Brunski, D.A. Puleo, and A. Nanci: Biomaterials and biomechanics of oral and maxillofacial implants: Current status and future developments. Int. J. Oral Maxillofac. Implants 15, 15 (1999).
D.H.R. Kempen, L. Lu, A. Heijink, T.E. Hefferan, L.B. Creemers, A. Maran, M.J. Yaszemski, and W.J.A. Dhert: Effect of local sequential VEGF and BMP-2 delivery on ectopic and orthotopic bone regeneration. Biomaterials 30, 2816 (2009).
C.B. Johansson, C.H. Han, A. Wennerberg, and T. Albrektsson: A quantitative comparison of machined commercially pure titanium and titanium–aluminum–vanadium implants in rabbit bone. Int. J. Oral Maxillofac. Implants 13, 315 (1998).
Z. Wang and Q. Hu: Preparation and properties of three-dimensional hydroxyapatite/chitosan nanocomposite rods. Biomed. Mater. 5, 045007 (2010).
ACKNOWLEDGMENTS
The authors would like to thank Technical Education Quality Improvement Program Phase II (TEQIP-II) for financial support. The authors would also like to thank the Director, CSIR-Central Glass and Ceramic Research Institute, Kolkata, India, and Vice Chancellor, West Bengal University of Animal and Fishery Sciences, Kolkata, India, for their generous and kind support to this work. Dr. Howa Begam (School of Bioscience and Engineering, Jadavpur University, Kolkata, India) and all the personnel involved for characterization of materials are sincerely acknowledged.
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Majee, P., Dhar, S., Mitra, P.K. et al. In vivo bone regeneration analysis of trilayer coated 316L stainless steel implant in rabbit model. Journal of Materials Research 33, 2106–2117 (2018). https://doi.org/10.1557/jmr.2018.119
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DOI: https://doi.org/10.1557/jmr.2018.119