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BY-NC-ND 4.0 license Open Access Published by De Gruyter Open Access September 6, 2017

BAG S53P4 putty as bone graft substitute – a rabbit model

Ilkka Saarenpää, Patricia Stoor and Janek Frantzén
From the journal Biomedical Glasses

Abstract

Bioactive glass (BAG) S53P4 granules represent a bone augmentation biomaterial for the surgical treatment of bony defects, even in challenging conditions such as osteomyelitis. The aim of this eight-week rabbit implantation study was to evaluate the biocompatibility and bone regeneration performance of a BAG S53P4 putty formulation following its implantation into the proximal tibia bone of twenty-eight New Zealand white rabbits. BAG S53P4 putty was compared to BAG S53P4 granules (0.5-0.8 mm) to evaluate whether the synthetic putty binder influences the bone regeneration of the osteostimulative granules. The putty formulation facilitates clinical use because of its mouldability, injectability and ease of mixing with autograft. Implantation of putty and granules into proximal tibia defects resulted in good osseointegration of the two groups. Both biomaterials were biocompatible, showed high new bone formation, high vascularization and periosteal growth. No signs of disturbed bone formation were observed due to the PEG-glycerol binder in the BAG S53P4 putty. Instead, intramedullary ossification and stromal cell reaction were more advanced in the putty group compared to the control group (p = 0.001 and p < 0.001). In conclusion, the novel mouldable BAG S53P4 putty showed reliable bone regeneration in bony defects without adverse tissue or cell reactions.

References

[1] El-GhannamA., Bone reconstruction: from bioceramics to tissue engineering, Expert. Rev. Med. Devices, 2005, 2, 87-10110.1586/17434440.2.1.87Search in Google Scholar

[2] Coventry M.B., Tapper E.M., Pelvic instability: a consequence of removing iliac bone for grafting, J. Bone Joint Surg. Am., 1972, 54, 83-10110.2106/00004623-197254010-00008Search in Google Scholar

[3] Younger E.M., Chapman M.W., Morbidity at bone graft donor sites, J. Orthop. Trauma, 1989, 3, 192-19510.1097/00005131-198909000-00002Search in Google Scholar

[4] Goulet J.A., Senunas L.E., DeSilva G.L., Greenfield M.L., Autogenous iliac crest bone graft, complications and functional assessment, Clin. Orthop. Relat. Res., 1997, 339, 76-8110.1097/00003086-199706000-00011Search in Google Scholar

[5] Ubhi C.S., Morris D.L., Fracture and herniation of bowel at bone graft donor site in the iliac crest, Injury, 1984, 16, 202-20310.1016/0020-1383(84)90162-1Search in Google Scholar

[6] Heary R.F., Schlenk R.P., Sacchieri T.A., Barone D., Brotea C., Persistent iliac crest donor site pain: independent outcome assessment, Neurosurgery, 2002, 50, 510-51610.1227/00006123-200203000-00015Search in Google Scholar

[7] Sawin P.D., Traynelis V.C., Menezes A.H., A comparative analysis of fusion rates and donor-site morbidity for autogenic rib and iliac crest bone grafts in posterior cervical fusions, J. Neurosurg., 1998, 88, 255-26510.3171/jns.1998.88.2.0255Search in Google Scholar PubMed

[8] Kurz L.T., Garfin S.R., Booth Jr. R.E., Harvesting autogenous iliac bone grafts - a review of complications and techniques, Spine, 1989, 14, 1324-133110.1097/00007632-198912000-00009Search in Google Scholar PubMed

[9] Giannoudis P.V., Dinopoulos H., Tsiridis E., Bone substitutes: an update, Injury 2005, 36, S20-S2710.1016/j.injury.2005.07.029Search in Google Scholar PubMed

[10] Hench L.L., Xynos I.D., Polak J.M., Bioactive glasses for in situ tissue regeneration, J. Biomater. Sci. Polymer Edn., 2004, 15, 543-56210.1163/156856204323005352Search in Google Scholar PubMed

[11] Hench L.L., The story of Bioglass®, J. Mater. Sci.: Mater. Med., 2006, 17, 967-97810.1007/s10856-006-0432-zSearch in Google Scholar PubMed

[12] Hench L.L., Genetic design of bioactive glass, J . Eur. Ceram. Soc., 2009, 29, 1257-126510.1016/j.jeurceramsoc.2008.08.002Search in Google Scholar

[13] Jones J.R., Review of bioactive glass: from Hench to hybrids, Acta Biomater., 2013, 4457-448610.1016/j.actbio.2012.08.023Search in Google Scholar PubMed

[14] Fagerlund S., Hupa L., Hupa M., Dissolution patterns of biocompatible glasses in 2-amino-2-hydroxymethyl-propane-1,3- diol (Tris) buffer, Acta Biomater., 2013, 9, 5400-541010.1016/j.actbio.2012.08.051Search in Google Scholar PubMed

[15] Moreira-Gonzalez A., Lobocki C., Barakat K., Andrus L., Bradford M., Gilsdorf M., et al., Evaluation of 45S5 bioactive glass combined as a bone substitute in the reconstruction of critical size calvarial defects in rabbits, J. Craniofac. Surg., 2005, 16, 63-7010.1097/00001665-200501000-00013Search in Google Scholar PubMed

[16] Amato M.M„ Blaydon S.M., Scribbick F.W. Jr., Belden C.J., Shore J.W., Neuhaus R.W., et al., Use of bioglass for orbital volume augmentation in enophthalmos: a rabbit model (oryctolagus cuniculus), Ophthal. Plast. Reconstr. Surg., 2003, 19, 455-46510.1097/01.IOP.0000092795.83665.FDSearch in Google Scholar PubMed

[17] Kobayashi H., Turner A.S., Seim H.B., Kawamoto T., Bauer T.W., Evaluation of a silica-containing bone graft substitute in a vertebral defect model, J. Biomed. Mater. Res. Part A, 2010, 92A, 596-60310.1002/jbm.a.32397Search in Google Scholar PubMed

[18] Lin E.C.C., Glycerol utilization and its regulation in mammals, Ann. Rev. Biochem., 1977, 46, 765-79510.1146/annurev.bi.46.070177.004001Search in Google Scholar PubMed

[19] Webster R., Didier E., Harris, P., Siegel N., Stadler J., Tilbury L., et al., PEGylated proteins: evaluation of their safety in the absence of definitive metabolism studies, Drug Metab. Dispos., 2007, 35, 9-1610.1124/dmd.106.012419Search in Google Scholar PubMed

[20] Drago L., Vassena C., Fenu S., De Vecchi E., Signori V., De Francesco R., et al., In vitro antibiofilm activity of bioactive glass S53P4, Future Microbiol., 2014, 9, 593-60110.2217/fmb.14.20Search in Google Scholar PubMed

[21] Drago L., De Vecchi E., Bortolin M., Toscano M., Mattina R., Romano C.L., Antimicrobial activity and resistance selection of different bioglass S53P4 formulations against multidrug resistant strains, Future Microbiol., 2015, 10, 1293-129910.2217/FMB.15.57Search in Google Scholar PubMed

[22] Kankare J., Lindfors N. C., Reconstruction of vertebral bone defects using an expandable replacement device and bioactive glass S53P4 in the treatment of vertebral osteomyelitis: three patients and three pathogens, Scand. J. Surg., 2016, 105, 248- 25310.1177/1457496915626834Search in Google Scholar PubMed

[23] Lindfors N., Romano C., Scarponi S., Lorenzo D., Monica B., Frantzén J., et al., Chapter 14: Bioactive glasses in infection treatment, In: Boccaccini A.R., Brauer D.S., Hupa L. (Eds.), Bioactive glasses: fundamentals, technology and applications, The Royal Society of Chemistry, Croydon, 2017Search in Google Scholar

[24] Wren A.W., Cummins N.M., Towler M.R., Comparison of antibacterial properties of commercial bone cements and fillers with a zinc-based glass polyalkenoate cement, J.Mater. Sci., 2010, 45, 5244-525110.1007/s10853-010-4566-5Search in Google Scholar

[25] Shapiro S.S., Wilk M.B., An analysis of variance test for normality (complete samples), Biometrika, 1965, 52, 591-61110.1093/biomet/52.3-4.591Search in Google Scholar

[26] Mann H.B., Whitney D.R., On a test of whether one of two random variables is stochastically larger than the other, Ann.Math. Statist., 1947, 18, 50-6010.1214/aoms/1177730491Search in Google Scholar

[27] Morton D., Kemp R.K., Francke-Carroll S., Jensen K., McCartney J., Monticello T.M., et al., Best practices for reporting pathology interpretations with GLP toxicology studies, Toxicol. Pathol., 2006, 34, 806-80910.1080/01926230601034624Search in Google Scholar PubMed

[28] The International Organization for Standardization, ISO 10993- 1:2009 Biological evaluation of medical devices - part 1: Evaluation and testing within a risk management process, 2009, https://www.iso.org/obp/ui/#iso:std:iso:10993:-1:ed-4:v1:enSearch in Google Scholar

[29] Wang Z., Lu B., Chen L., Chang J., Evaluation of an osteostimulative putty in the sheep spine, J.Mater. Sci.:Mater. Med., 2011, 22, 185-19110.1007/s10856-010-4175-5Search in Google Scholar PubMed

[30] Schallenberger M.A., Rossmeier K., Lovick H.M., Meyer T.R., Aberman H.M., Juda G.A., Comparison of the osteogenic potential of OsteoSelect demineralized bone matrix putty to NovaBone calcium-phosphosilicate synthetic putty in a cranial defect model, J. Craniofac. Surg., 2014, 25, 657-66110.1097/SCS.0000000000000610Search in Google Scholar PubMed PubMed Central

[31] Fredericks D., Petersen E.B., Watson N., Grosland N., Gibson- Corley K., Smucker J., Comparison of two synthetic bone graft products in a rabbit posterolateral fusion model, Iowa Orthop. J. 2016, 36, 167-173Search in Google Scholar

[32] Wilson J., Low S.B., Bioactive ceramics for periodontal treatment: comparative studies in the patus monkey, J. Appl. Biomater., 1992, 3, 123-12910.1002/jab.770030208Search in Google Scholar PubMed

[33] Wilson J, Pigott G.H., Schoen F.J., Hench L.L., Toxicology and biocompatibility of bioglasses. J. Biomed. Mater. Res. 1981, 15, 805-81710.1002/jbm.820150605Search in Google Scholar PubMed

Received: 2017-3-20
Revised: 2017-6-30
Accepted: 2017-7-23
Published Online: 2017-9-6
Published in Print: 2017-8-28

© 2017

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

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