Complex fractures resulting in bone loss or impaired fracture healing remain problematic in trauma and orthopedic surgeries. Many bone graft substitutes have been developed and are commercially available. These products differ in their osteoconductive and osteoinductive properties. Differential enhancement of these properties may optimize the performance of these products for various orthopedic and craniofacial applications. The use of bone graft substitutes offers the ability to lessen the possible morbidity of the harvest site in autografts. The objective of the present study was to compare the ability of two bone graft substitutes, BioSet® RT, an allograft demineralized bone matrix formulation, and ProOsteon® 500R, a coralline hydroxyapatite, in a rabbit critical tibial defect model. BioSet® RT and ProOsteon® 500R were implanted into a unicortical proximal metaphyseal tibial defect and evaluated for new bone formation. Samples were analyzed radiographically and histologically at 1 day, 6 weeks, 12 weeks, and 24 weeks post surgery. Both materials were biocompatible and demonstrated significant bone growth and remodeling. At 12 weeks, the BioSet ® RT implanted sites demonstrated significantly more defect closure and bone remodeling as determined by radiographic analyses with 10 out of 14 defects being completely healed versus 1 out of 14 being completely healed in the ProOsteon® 500R implanted sites. At 24 weeks, both materials demonstrated complete closure of the defect as determined histologically. There were no statistical differences in radiographic scores between the two implanted materials. However, there was an observable trend that the BioSet® RT material generated higher histological and radiographic scores, although not statistically significant. This study provides evidence that both BioSet® RT and ProOsteon® 500R are biocompatible and able to induce new bone formation as measured in this rabbit model. In addition, this in vivo study demonstrates the ability of BioSet ® RT to induce new bone formation in a shorter timeframe than ProOsteon ® 500R.
Coventry, M.B. and Tapper, E.M. (1972). Pelvic Instability: A Consequence of Removing Iliac Bone for Grafting, J. Bone Joint Surg. Am., 54: 83-101.
2.
Goulet, J.A. , Senunas, L.E., DeSilva, G.L. and Greenfield , M.L. (1997). Autogenous Iliac Crest Bone Graft. Complications and Functional Assessment, Clin. Orthop. Relat. Res., 339: 76-81.
3.
Guha, S.C. and Poole, M.D. ( 1983). Stress Fracture of the Iliac Bone with Subfascial Femoral Neuropathy: Unusual Complications at a Bone Graft Donor Site: Case Report, Br. J. Plast. Surg., 36: 305-306.
4.
Hamad, M.M. and Majeed, S.A. ( 1989). Incisional Hernia Through Iliac Crest Defects. A Report of Three Cases with a Review of the Literature, Arch. Orthop. Trauma Surg., 108: 383-385.
5.
Heary, R.F., Schlenk, R.P., Sacchieri, T.A., Barone, D. and Brotea, C. ( 2002). Persistent Iliac Crest Donor Site Pain: Independent Outcome Assessment, Neurosurgery, 50: 510-516; discussion 516-517.
6.
Kurz, L.T., Garfin, S.R. and Booth Jr, R.E. ( 1989). Harvesting Autogenous Iliac Bone Grafts. A Review of Complications and Techniques, Spine, 14: 1324-1331.
7.
Sawin, P.D., Traynelis, V.C. and Menezes, A.H. ( 1998). A Comparative Analysis of Fusion Rates and Donor-site Morbidity for Autogeneic Rib and Iliac Crest Bone Grafts in Posterior Cervical Fusions, J. Neurosurg., 88: 255-265.
8.
Ubhi, C.S. and Morris, D.L. ( 1984). Fracture and Herniation of Bowel at Bone Graft Donor Site in the Iliac Crest, Injury, 16: 202-203.
9.
Younger, E.M. and Chapman, M.W. (1989). Morbidity at Bone Graft Donor Sites, J. Orthop. Trauma, 3: 192-195.
10.
Cobos, J.A. , Lindsey, R.W. and Gugala, Z. (2000). The Cylindrical Titanium Mesh Cage for Treatment of a Long Bone Segmental Defect: Description of a New Technique and Report of Two Cases, J. Orthop. Trauma, 14: 54-59.
11.
Martin Jr, G.J. , Boden, S.D., Titus, L. and Scarborough , N.L. (1999 ). New Formulations of Demineralized Bone Matrix as a More Effective Graft Alternative in Experimental Posterolateral Lumbar Spine Arthrodesis , Spine, 24: 637-645.
12.
Morone, M.A. and Boden, S.D. ( 1998). Experimental Posterolateral Lumbar Spinal Fusion with a Demineralized Bone Matrix Gel, Spine, 23: 159-167. 13. Chesmel, K.D., Branger, J., Wertheim, H. and Scarborough, N. ( 1998). Healing Response to Various Forms of Human Demineralized Bone Matrix in Athymic Rat Cranial Defects, J. Oral Maxillofac. Surg., 56: 857-863; discussion 864-865.
13.
Edwards, J.T. , Diegmann, M.H. and Scarborough , N.L. (1998 ). Osteoinduction of Human Demineralized Bone: Characterization in a Rat Model, Clin. Orthop. Relat. Res., 357: 219-228.
14.
Kado, K.E., Gambetta, L.A. and Perlman, M.D. ( 1996). Uses of Grafton for Reconstructive Foot and Ankle Surgery , J. Foot Ankle Surg., 35: 59-66. 16. Russell, J., Scarborough, N. and Chesmel, K. ( 1997). Re: Ability of Commercial Demineralized Freeze-dried Bone Allograft to Induce New Bone Formation (1996; 67: 918-926), J. Periodontol., 68: 804-806.
15.
Urist, M.R. and Dowell, T.A. (1968). Inductive Substratum for Osteogenesis in Pellets of Particulate Bone Matrix, Clin. Orthop. Relat. Res., 61: 61-78. 18. Wang, J.C., Alanay, A., Mark, D., Kanim, L.E.A., Campbell, P.A., Dawson, E.G. and Lieberman, J.R. ( 2007). A Comparison of Commercially Available Demineralized Bone Matrix for Spinal Fusion, Eur. Spine. J., 16: 1233-1240.
16.
Adkisson, H.D. , Strauss-Schoenberger , J., Gillis, M., Wilkins, R., Jackson, M. and Hruska, K.A. (2000). Rapid Quantitative Bioassay of Osteoinduction, J. Orthop. Res., 18: 503-511.
17.
Glowacki, J. (2005). A Review of Osteoinductive Testing Methods and Sterilization Processes for Demineralized Bone, Cell Tissue Bank., 6: 3-12.
18.
Han, B. , Tang, B. and Nimni, M.E. (2003). Quantitative and Sensitive In Vitro Assay for Osteoinductive Activity of Demineralized Bone Matrix, J. Orthop. Res., 21: 648-654.
19.
Honsawek, S. , Powers, R.M. and Wolfinbarger , L. (2005). Extractable Bone Morphogenetic Protein and Correlation with Induced New Bone Formation in an In Vivo Assay in the Athymic Mouse Model, Cell Tissue Bank, 6: 13-23.
20.
Wang, J. and Glimcher, M.J. ( 1999). Characterization of Matrix-induced Osteogenesis in Rat Calvarial Bone Defects: I. Differences in the Cellular Response to Demineralized Bone Matrix Implanted in Calvarial Defects and in Subcutaneous Sites, Calcif . Tissue Int., 65: 156-165.
21.
Zhang, M., Powers Jr, R.M. and Wolfinbarger Jr, L. ( 1997). A Quantitative Assessment of Osteoinductivity of Human Demineralized Bone Matrix, J. Periodontol., 68: 1076-1084.
22.
Lee, Y.P. , Jo, M., Luna , M., Chien, B., Lieberman, J.R. and Wang, J.C. ( 2005). The Efficacy of Different Commercially Available Demineralized Bone Matrix Substances in an Athymic Rat Model, J. Spinal Disord. Tech., 18: 439-444.
23.
Damien, C.J. , Parsons, J.R., Benedict, J.J. and Weisman, D.S. ( 1990). Investigation of a Hydroxyapatite and Calcium Sulfate Composite Supplemented with an Osteoinductive Factor, J. Biomed. Mater. Res., 24: 639-654.
24.
Damien, C.J. , Parsons, J.R., Prewett, A.B., Huismans, F., Shors, E.C. and Holmes, R.E. ( 1995). Effect of Demineralized Bone Matrix on Bone Growth Within a Porous HA Material: A Histologic and Histometric Study, J. Biomater. Appl., 9: 275-288.
25.
Elsinger, E.C. and Leal, L. (1996). Coralline Hydroxyapatite Bone Graft Substitutes, J. Foot Ankle Surg. , 35: 396-399.
26.
Holmes, R., Mooney, V., Bucholz, R. and Tencer, A. ( 1984). A Coralline Hydroxyapatite Bone Graft Substitute . Preliminary Report, Clin. Orthop. Relat. Res., 188: 252-262.
27.
Holmes, R.E. , Bucholz, R.W. and Mooney, V. ( 1986). Porous Hydroxyapatite as a Bone-graft Substitute in Metaphyseal Defects. A Histometric Study, J. Bone Joint Surg. Am., 68: 904-911.
28.
Holmes, R.E. , Bucholz, R.W. and Mooney, V. (1987). Porous Hydroxyapatite as a Bone Graft Substitute in Diaphyseal Defects: A Histometric Study, J. Orthop. Res., 5: 114-121.
29.
Light, M. and Kanat, I.O. ( 1991). The Possible Use of Coralline Hydroxyapatite as a Bone Implant, J. Foot Surg., 30: 472-476.
30.
Marchac, D. and Sandor, G. (1994). Use of Coral Granules in the Craniofacial Skeleton, J. Craniofac. Surg. , 5: 213-217.
31.
Mooney, V., Massie, J.B., Lind, B.I., Rah, J.H., Negri, S. and Holmes, R.E. ( 1998). Comparison of Hydroxyapatite Granules to Autogenous Bone Graft in Fusion Cages in a Goat Model, Surg. Neurol. , 49: 628-633; discussion 633-634.
32.
Sartoris, D.J. , Holmes, R.E., Bucholz, R.W., Mooney, V. and Resnick, D. (1986). Coralline Hydroxyapatite Bone-graft Substitutes in a Canine Metaphyseal Defect Model. Radiographic-histometric Correlation, Invest. Radiol. , 21: 851-857.
33.
Sartoris, D.J. , Holmes, R.E., Bucholz, R.W., Mooney, V. and Resnick, D. (1987). Coralline Hydroxyapatite Bone-graft Substitutes in a Canine Diaphyseal Defect Model. Radiographic-histometric Correlation, Invest. Radiol. , 22: 590-596.
34.
Walsh, W.R. , Chapman-Sheath , P.J., Cain, S., Debes, J., Bruce, W.J., Svehla, M.J. and Gillies, R.M. (2003). A Resorbable Porous Ceramic Composite Bone Graft Substitute in a Rabbit Metaphyseal Defect Model , J. Orthop. Res., 21: 655-661.
35.
Eggli, P.S. , Muller, W. and Schenk, R.K. (1988). Porous Hydroxyapatite and Tricalcium Phosphate Cylinders with Two Different Pore Size Ranges Implanted in the Cancellous Bone of Rabbits. A Comparative Histomorphometric and Histologic Study of Bony Ingrowth and Implant Substitution, Clin. Orthop. Relat. Res., 232: 127-138.
36.
Grundel, R.E. , Chapman, M.W., Yee , T. and Moore, D.C. (1991). Autogeneic Bone Marrow and Porous Biphasic Calcium Phosphate Ceramic for Segmental Bone Defects in the Canine Ulna, Clin. Orthop. Relat. Res. , 266: 244-258.
37.
Jensen, S.S. , Aaboe, M., Pinholt, E.M., Hjorting-Hansen , E., Melsen, F. and Ruyter, I.E. ( 1996). Tissue reaction and Material Characteristics of Four Bone Substitutes, Int. J. Oral Maxillofac. Implants, 11: 55-66.
38.
Louisia, S. , Stromboni, M., Meunier, A., Sedel, L. and Petite, H. ( 1999). Coral Grafting Supplemented with Bone Marrow, J. Bone Joint Surg. Br., 81: 719-724.
39.
Moore, D.C. , Chapman, M.W. and Manske, D. ( 1987). The Evaluation of a Biphasic Calcium Phosphate Ceramic for Use in Grafting Long-bone Diaphyseal Defects, J. Orthop. Res., 5: 356-365.
40.
Shimazaki, K. and Mooney, V. (1985). Comparative Study of Porous Hydroxyapatite and Tricalcium Phosphate as Bone Substitute , J. Orthop. Res., 3: 301-310.
41.
Leupold, J.A. , Barfield, W.R., An , Y.H. and Hartsock, L.A. (2006). A Comparison of ProOsteon, DBX, and Collagraft in a Rabbit Model, J. Biomed. Mater. Res., B Appl. Biomater., 79: 292-297.
42.
Stubbs, D., Deakin, M., Chapman-Sheath, P., Bruce, W., Debes, J., Gillies, R.M. and Walsh, W.R. ( 2004). In Vivo Evaluation of Resorbable Bone Graft Substitutes in a Rabbit Tibial Defect Model, Biomaterials, 25: 5037-5044.
43.
Parikh, S.N. (2002). Bone Graft Substitutes in Modern Orthopedics, Orthopedics, 25: 1301-1309; quiz 1310-1311 .
44.
Khan, S.N., Tomin, E. and Lane, J.M. ( 2000). Clinical Applications of Bone Graft Substitutes, Orthop . Clin. North Am., 31: 389-398.
45.
Bomback, D.A. , Grauer, J.N., Lugo, R., Troiano, N., Patel, T. and Friedlaender , G.E. (2004 ). Comparison of Posterolateral Lumbar Fusion Rates of Grafton Putty and OP-1 Putty in an Athymic Rat Model, Spine, 29: 1612-1617.
46.
Frenkel, S.R. , Moskovich, R., Spivak , J., Zhang, Z.H. and Prewett, A.B. (1993). Demineralized Bone Matrix. Enhancement of Spinal Fusion, Spine, 18: 1634-1639.
47.
Burchardt, H. (1983). The Biology of Bone Graft Repair, Clin. Orthop. Relat. Res., 174: 28-42.
48.
Buser, D., Hoffmann, B., Bernard, J.P., Lussi, A., Mettler, D. and Schenk, R.K. ( 1998). Evaluation of Filling Materials in Membrane-protected Bone Defects. A Comparative Histomorphometric Study in the Mandible of Miniature Pigs, Clin. Oral Implants Res., 9: 137-150.
