Radiographic and Histologic Comparison of Two Bioactive Glass Bone Void Fillers in a Rabbit Spinal Fusion Model
International Journal of Biomedical Materials Research
Volume 3, Issue 6, December 2015, Pages: 64-82
Received: Aug. 11, 2015;
Accepted: Aug. 27, 2015;
Published: Sep. 29, 2015
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James F. Kirk, Research and Development Department, Nanotherapeutics Inc., Alachua, FL
Gregg Ritter, Research and Development Department, Nanotherapeutics Inc., Alachua, FL
Michael J. Larson, Ibex Preclinical Research, Logan, UT
Robert C. Waters, Research and Development Department, Nanotherapeutics Inc., Alachua, FL
Isaac Finger, Research and Development Department, Nanotherapeutics Inc., Alachua, FL
John Waters, Research and Development Department, Nanotherapeutics Inc., Alachua, FL
Dhyana Sankar, Research and Development Department, Nanotherapeutics Inc., Alachua, FL
James D. Talton, Research and Development Department, Nanotherapeutics Inc., Alachua, FL
Ronald R. Cobb, Research and Development Department, Nanotherapeutics Inc., Alachua, FL
Bone graft substitutes and bone graft extenders have been routinely used for spine fusions for decades and have become an essential component in a number of orthopedic applications including spinal fusion. Bioactive glass ceramics have the ability to directly bind to bones and have been widely used as bone graft substitutes due to their high osteoconductivity and biocompatibility. The objective of this study was to compare the fusion rates of two bioactive glass containing bone void fillers (Nano FUSE® and Nova Bone Putty) in a posterolateral fusion rabbit model. Nova Bone Putty and Nano FUSE® alone and in combination with autograft were implanted in the posterior lateral intertransverse process region of the rabbit spine. The spines were evaluated for fusion of the L4-L5 transverse processes in skeletally mature rabbits. Radiographical and histological measurements demonstrated the ability of Nano FUSE® to induce new bridging bone across the transverse processes. The material in combination with autograft performed much better than the material alone. In contrast, Nova Bone Putty did not induce bridging bone across the transverse processes at any time point. This in vivo study demonstrates the novel formulation of Nano FUSE®, a bioactive glass combination with porcine gelatin, could be an effective bone graft extender in posterolateral spinal fusions.
James F. Kirk,
Michael J. Larson,
Robert C. Waters,
James D. Talton,
Ronald R. Cobb,
Radiographic and Histologic Comparison of Two Bioactive Glass Bone Void Fillers in a Rabbit Spinal Fusion Model, International Journal of Biomedical Materials Research.
Vol. 3, No. 6,
2015, pp. 64-82.
Goulet, J. A., et al., Autogenous iliac crest bone graft. Complications and functional assessment. Clin Orthop Relat Res, 1997(339): p. 76-81.
Heary, R. F., et al., Persistent iliac crest donor site pain: independent outcome assessment. Neurosurgery, 2002. 50(3): p. 510-6; discussion 516-7.
Ubhi, C. S. and D. L. Morris, Fracture and herniation of bowel at bone graft donor site in the iliac crest. Injury, 1984. 16(3): p. 202-3.
Younger, E. M. and M. W. Chapman, Morbidity at bone graft donor sites. J Orthop Trauma, 1989. 3(3): p. 192-5.
Schnee, C. L., et al., Analysis of harvest morbidity and radiographic outcome using autograft for anterior cervical fusion. Spine (Phila Pa 1976), 1997. 22(19): p. 2222-7.
Silber, J. S., et al., Donor site morbidity after anterior iliac crest bone harvest for single-level anterior cervical discectomy and fusion. Spine (Phila Pa 1976), 2003. 28(2): p. 134-9.
Cook, S. D., et al., In vivo evaluation of demineralized bone matrix as a bone graft substitute for posterior spinal fusion. Spine (Phila Pa 1976), 1995. 20(8): p. 877-86.
Cook, S. D., et al., Evaluation of hydroxylapatite graft materials in canine cervical spine fusions. Spine (Phila Pa 1976), 1986. 11(4): p. 305-9.
Flatley, T. J., K. L. Lynch, and M. Benson, Tissue response to implants of calcium phosphate ceramic in the rabbit spine. Clin Orthop Relat Res, 1983(179): p. 246-52.
Guigui, P., et al., Experimental model of posterolateral spinal arthrodesis in sheep. Part 2. Application of the model: evaluation of vertebral fusion obtained with coral (Porites) or with a biphasic ceramic (Triosite). Spine (Phila Pa 1976), 1994. 19(24): p. 2798-803.
Holmes, R., et al., A coralline hydroxyapatite bone graft substitute. Preliminary report. Clin Orthop Relat Res, 1984(188): p. 252-62.
Holmes, R. E., R. W. Bucholz, and V. Mooney, Porous hydroxyapatite as a bone-graft substitute in metaphyseal defects. A histometric study. J Bone Joint Surg Am, 1986. 68(6): p. 904-11.
Holmes, R. E., R. W. Bucholz, and V. Mooney, Porous hydroxyapatite as a bone graft substitute in diaphyseal defects: a histometric study. J Orthop Res, 1987. 5(1): p. 114-21.
Nasca, R. J., J. E. Lemons, and R. Montgomery, Evaluation of cryopreserved bone and synthetic biomaterials in promoting spinal fusion. Spine (Phila Pa 1976), 1991. 16(8 Suppl): p. S330-3.
Oikarinen, J., Experimental spinal fusion with decalcified bone matrix and deep-frozen allogeneic bone in rabbits. Clin Orthop Relat Res, 1982(162): p. 210-8.
Swetha, M., et al., Biocomposites containing natural polymers and hydroxyapatite for bone tissue engineering. Int J Biol Macromol, 2010. 47(1): p. 1-4.
Chan, C. K., et al., Biomimetic nanocomposites for bone graft applications. Nanomedicine (Lond), 2006. 1(2): p. 177-88.
Shekaran, A. and A. J. Garcia, Nanoscale engineering of extracellular matrix-mimetic bioadhesive surfaces and implants for tissue engineering. Biochim Biophys Acta, 2011. 1810(3): p. 350-60.
Zhou, H. and J. Lee, Nanoscale hydroxyapatite particles for bone tissue engineering. Acta Biomater, 2011. 7(7): p. 2769-81.
Gosain, A. K., Bioactive glass for bone replacement in craniomaxillofacial reconstruction. Plast Reconstr Surg, 2004. 114(2): p. 590-3.
Hattar, S., et al., Behaviour of moderately differentiated osteoblast-like cells cultured in contact with bioactive glasses. Eur Cell Mater, 2002. 4: p. 61-9.
Kokubo, T., et al., Ca, P-rich layer formed on high-strength bioactive glass-ceramic A-W. J Biomed Mater Res, 1990. 24(3): p. 331-43.
Lee, J. H., et al., A 90-day subchronic toxicity study of beta-calcium pyrophosphate in rat. Drug Chem Toxicol, 2009. 32(3): p. 277-82.
Hench, L. L. and H. A. Paschall, Direct chemical bond of bioactive glass-ceramic materials to bone and muscle. J Biomed Mater Res, 1973. 7(3): p. 25-42.
Hench, L. L., I. D. Xynos, and J. M. Polak, Bioactive glasses for in situ tissue regeneration. J Biomater Sci Polym Ed, 2004. 15(4): p. 543-62.
Lindfors, N. C. and A. J. Aho, Tissue response to bioactive glass and autogenous bone in the rabbit spine. Eur Spine J, 2000. 9(1): p. 30-5.
Lee, J. H., et al., Bioactive ceramic coating of cancellous screws improves the osseointegration in the cancellous bone. J Orthop Sci, 2011. 16(3): p. 291-7.
Lee, J. H., et al., Biomechanical and histomorphometric study on the bone-screw interface of bioactive ceramic-coated titanium screws. Biomaterials, 2005. 26(16): p. 3249-57.
Hing, K. A., L. F. Wilson, and T. Buckland, Comparative performance of three ceramic bone graft substitutes. Spine J, 2007. 7(4): p. 475-90.
Lee, J. H., et al., Fabrication and evaluation of osteoblastic differentiation of human mesenchymal stem cells on novel CaO-SiO2-P2O5-B2O3 glass-ceramics. Artif Organs, 2013. 37(7): p. 637-47.
Silver, I. A., J. Deas, and M. Erecinska, Interactions of bioactive glasses with osteoblasts in vitro: effects of 45S5 Bioglass, and 58S and 77S bioactive glasses on metabolism, intracellular ion concentrations and cell viability. Biomaterials, 2001. 22(2): p. 175-85.
Yuan, H., et al., Bone induction by porous glass ceramic made from Bioglass (45S5). J Biomed Mater Res, 2001. 58(3): p. 270-6.
Aitasalo, K., et al., Repair of orbital floor fractures with bioactive glass implants. J Oral Maxillofac Surg, 2001. 59(12): p. 1390-5; discussion 1395-6.
Duskova, M., et al., Bioactive glass-ceramics in facial skeleton contouring. Aesthetic Plast Surg, 2002. 26(4): p. 274-83.
Sculean, A., et al., Four-year results of a prospective-controlled clinical study evaluating healing of intra-bony defects following treatment with an enamel matrix protein derivative alone or combined with a bioactive glass. J Clin Periodontol, 2007. 34(6): p. 507-13.
Oonishi, H., et al., Particulate bioglass compared with hydroxyapatite as a bone graft substitute. Clin Orthop Relat Res, 1997(334): p. 316-25.
Vogel, M., et al., In vivo comparison of bioactive glass particles in rabbits. Biomaterials, 2001. 22(4): p. 357-62.
Wheeler, D. L., et al., Effect of bioactive glass particle size on osseous regeneration of cancellous defects. J Biomed Mater Res, 1998. 41(4): p. 527-33.
Wang, Z., et al., Evaluation of an osteostimulative putty in the sheep spine. J Mater Sci Mater Med, 2011. 22(1): p. 185-91.
Boden, S. D., J. H. Schimandle, and W. C. Hutton, An experimental lumbar intertransverse process spinal fusion model. Radiographic, histologic, and biomechanical healing characteristics. Spine (Phila Pa 1976), 1995. 20(4): p. 412-20.
Bauer, T. W., Bone graft substitutes. Skeletal Radiol, 2007. 36(12): p. 1105-7.
Bauer, T. W. and G. F. Muschler, Bone graft materials. An overview of the basic science. Clin Orthop Relat Res, 2000(371): p. 10-27.
Xynos, I. D., et al., Bioglass 45S5 stimulates osteoblast turnover and enhances bone formation In vitro: implications and applications for bone tissue engineering. Calcif Tissue Int, 2000. 67(4): p. 321-9.
Ohtsuki, C., M. Kamitakahara, and T. Miyazaki, Bioactive ceramic-based materials with designed reactivity for bone tissue regeneration. J R Soc Interface, 2009. 6 Suppl 3: p. S349-60.
Wilson, J., et al., Toxicology and biocompatibility of bioglasses. J Biomed Mater Res, 1981. 15(6): p. 805-17.
Xynos, I. D., et al., Ionic products of bioactive glass dissolution increase proliferation of human osteoblasts and induce insulin-like growth factor II mRNA expression and protein synthesis. Biochem Biophys Res Commun, 2000. 276(2): p. 461-5.
Xynos, I. D., et al., Gene-expression profiling of human osteoblasts following treatment with the ionic products of Bioglass 45S5 dissolution. J Biomed Mater Res, 2001. 55(2): p. 151-7.
Moreira-Gonzalez, A., 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(1): p. 63-70.
Conejero, J. A., J. A. Lee, and J. A. Ascherman, Cranial defect reconstruction in an experimental model using different mixtures of bioglass and autologous bone. J Craniofac Surg, 2007. 18(6): p. 1290-5.
Kobayashi, H., et al., Evaluation of a silica-containing bone graft substitute in a vertebral defect model. J Biomed Mater Res A, 2010. 92(2): p. 596-603.
Wheeler, D. L., et al., Assessment of resorbable bioactive material for grafting of critical-size cancellous defects. J Orthop Res, 2000. 18(1): p. 140-8.
Bozic, K. J., et al., In vivo evaluation of coralline hydroxyapatite and direct current electrical stimulation in lumbar spinal fusion. Spine (Phila Pa 1976), 1999. 24(20): p. 2127-33.
Lehman, R. A., Jr., et al., The effect of alendronate sodium on spinal fusion: a rabbit model. Spine J, 2004. 4(1): p. 36-43.
Liao, S. S., et al., Lumbar spinal fusion with a mineralized collagen matrix and rhBMP-2 in a rabbit model. Spine (Phila Pa 1976), 2003. 28(17): p. 1954-60.
Long, J., et al., The effect of cyclooxygenase-2 inhibitors on spinal fusion. J Bone Joint Surg Am, 2002. 84-A(10): p. 1763-8.
Tay, B. K., et al., Use of a collagen-hydroxyapatite matrix in spinal fusion. A rabbit model. Spine (Phila Pa 1976), 1998. 23(21): p. 2276-81.
Sandhu, H. S. and S. N. Khan, Animal models for preclinical assessment of bone morphogenetic proteins in the spine. Spine (Phila Pa 1976), 2002. 27(16 Suppl 1): p. S32-8.