Intervariability and intravariability of bone morphogenetic proteins in commercially available demineralized bone matrix products

Spine

Volumn 31, Issue 12, 2006, Pages 1299-1306

  Bae, Hyun W ^a   Zhao, Li ^a   Kanim, Linda E A ^a   Wong, Pamela ^a   Delamarter, Rick B ^a   Dawson, Edgar G ^a  

^a SAINT JOHN'S HEALTH CENTER   (United States)

Author keywords

Bone morphogenetic proteins; Demineralized bone matrix; Osteoinductivity; Reliability; Variability

Indexed keywords

BONE MORPHOGENETIC PROTEIN; BONE MORPHOGENETIC PROTEIN 2; BONE MORPHOGENETIC PROTEIN 4; CALCIUM SULFATE; DRUG CARRIER; GLYCEROL; HYALURONIC ACID; LIPID; OSTEOGENIC PROTEIN 1; PHOSPHATIDYLCHOLINE; POLOXAMER; WATER;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BONE DEMINERALIZATION; BONE DEVELOPMENT; BONE GRAFT; BONE MATRIX; CONTROLLED STUDY; DRUG EFFICACY; DRUG FORMULATION; DRUG POTENCY; ENZYME LINKED IMMUNOSORBENT ASSAY; EXTRACTION; MOUSE; NONHUMAN; PRIORITY JOURNAL; PROTEIN ANALYSIS; QUANTITATIVE ANALYSIS; RAT; RELIABILITY; SPINE FUSION;

BIOLOGICAL PRODUCTS; BONE DEMINERALIZATION TECHNIQUE; BONE MATRIX; BONE MORPHOGENETIC PROTEINS; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; OSMOLAR CONCENTRATION; TRANSFORMING GROWTH FACTOR BETA;

EID: 33744816186     PISSN: 03622436     EISSN: 15281159     Source Type: Journal    
DOI: 10.1097/01.brs.0000218581.92992.b7     Document Type: Article

References (62)

1. Urist MR. Bone: Formation by autoinduction. Science 1965;150:893-9.
2. Urist MR, Mikulski A, Lietze A. A solubilized and insolubilized bone morphogenetic protein. Proc Natl Acad Sci U S A 1979;76:1828-32.
3. Hofmann A, Konrad L, Gotzen L, et al. Bioengineered human bone tissue using autogenous osteoblasts cultured on different biomatrices. J Biomed Mater Res A 2003;67:191-9.
4. Kasten P, Luginbuhl R, van Griensven M, et al. Comparison of human bone marrow stromal cells seeded on calcium-deficient hydroxyapatite, beta-tricalcium phosphate and demineralized bone matrix. Biomaterials 2003;24:2593-603.
5. Russell JL. Grafton demineralized bone matrix: Performance consistency, utility, and value. Tissue Eng 2000;6:435-40.
6. Jurisdictional Update: Human demineralized bone matrix. Available at: http://www.fda.gov/cber/tissue/trgfyrpts.htm#04. Accessed February 27, 2005.
7. Allomatrix® C bone graft putty sales sheet. Available at: http://www.wmt.com/Physicians/Products/Biologics/ALLOMATRIXCUSTOMBone Graft Putty.asp. Accessed February 20, 2004.
8. DBX® Demineralized Bone Matrix [package insert]. Edison, NJ: Musculoskeletal Transplant Foundation 2000. DBX® Demineralized Bone Matrix Putty. Jan. 16, 2003. Available at: http://www.creamed.com/DBX/home/htm. Accessed February 19, 2004.
9. DynaGraft® II gel [package insert]. Irvine, CA: GenSci OrthoBiologics, Inc.; July 2002.
10. Dynagraft® II putty [package insert]. Irvine, CA: GenSci OrthoBiologics, Inc.; 2002.
11. Dynagraft II gel and putty. Brochure, technical monograph, in vitro assay. Available at: http://www.citagenix.com/home.html. Accessed February 19, 2004.
12. Grafton® demineralized bone matrix gel [package insert]. Eatontown, NJ: Osteotech, Inc.; October 1999.
13. Grafton® demineralized bone matrix putty [package insert]. Eatontown, NJ: Osteotech, Inc.; October 1999.
14. InterGro® demineralized bone matrix [package insert]. Irvine, CA: Interpore Cross International; February 2003.
15. Osteofil® RT allograft bone paste [package insert]. Alachua, FL: Regeneration Technologies, Inc.; October 23, 1998. Available at: www.rtitechnology.com. Accessed February 20, 2004.
16. Edwards JT, Diegmann MH, Scarborough NL. Osteoinduction of human demineralized bone: Characterization in a rat model. Clin Orthop Relat Res 1998;357:219-28.
17. Boyce T, Edwards J, Scarborough N. Allograft bone. The influence of processing on safety and performance. Orthop Clin North Am 1999;30:571-81.
18. Wolfinbarger L, Burkart M, Croft L, et al. Processing factors contributing to production of maximally osteoinductive demineralized ground bone for use in orthopaedic or periodontal applications. Adv Tissue Banking 1999;3:125-45.
19. Adkisson HD, Strauss-Schoenberger J, Gillis M, et al. Rapid quantitative bioassay of osteoinduction. J Orthop Res 2000;18:503-11.
20. Ferreira SD, Dernell WS, Powers BE, et al. Effect of gas-plasma sterilization on the osteoinductive capacity of demineralized bone matrix. Clin Orthop 2001;388:233-9.
21. Lomas RJ, Gillan HL, Matthews JB, et al. An evaluation of the capacity of differently prepared demineralized bone matrices (DBM) and toxic residuals of ethylene oxide (EtOx) to provoke an inflammatory response in vitro. Biomaterials 2001;22:913-21.
22. Han B, Tang B, Nimni M. Quantitative and sensitive in vitro assay for osteoinductive activity of demineralized bone matrix. J Orthop Res 2003;21:648-54.
23. Blum B, Moseley J, Miller L, et al. Measurement of bone morphogenetic proteins and other growth factors in demineralized bone matrix. Orthopedics 2004;27(suppl 1):s161-5.
24. Sandhu HS, Khan SN, Suh DY, et al. Demineralized bone matrix, bone morphogenetic proteins, and animal models of spine fusion: An overview. Eur Spine J 2001;10(suppl 2):S122-31.
25. Bostrom MP, Yang X, Kennan M, et al. An unexpected outcome during testing of commercially available demineralized bone graft materials: How safe are the nonallograft components? Spine 2001;26:1425-8.
26. Wang JC, Kanim LE, Nagakawa IS, et al. Dose-dependent toxicity of a commercially available demineralized bone matrix material. Spine 2001;26:1429-35.
27. Tsai CH, Chou MY, Jonas M, et al. A composite graft material containing bone particles and collagen in osteoinduction in mouse. Biomed Mater Res B Appl Biomater 2002;63:65-70.
28. Takikawa S, Bauer TW, Kambic H, et al. Comparative evaluation of the osteoinductivity of two formulations of human demineralized bone matrix. J Biomed Mater Res 2003;65A:37-42.
29. Oakes DA, Lee C, Lieberman JR. An evaluation of human demineralized bone matrices in a rat femoral defect model. Clin Orthop 2003;413:281-90.
30. Wang JC, Davies M, Kanim LEA, et al. A comparison of a commercially available demineralized bone matrix for spinal fusion. Paper presented at: Orthopaedic Research Society; November 2001; San Francisco, CA.
31. Lee Y-P, Wang JC, Kanim LEA, et al. The direct comparison of commercially available demineralized bone matrix substances for spinal fusion in an athymic rat model. Paper presented at: Orthopaedic Research Society 2001; San Francisco, CA.
32. Peterson B, Whang PG, Iglesias R, et al. Osteoinductivity of commercially available demineralized bone matrix. Preparations in a spine fusion model. J Bone Joint Surg Am 2004;86-A:2243-50.
33. Bomback DA, Grauer JN, Lugo R, et al. Comparison of posterolateral lumbar fusion rates of Grafton Putty and OP-1 Putty in an athymic rat model. Spine 2004;29:1612-7.
34. An HS, Simpson JM, Glover JM, et al. Comparison between allograft plus demineralized bone matrix versus autograft in anterior cervical fusion. A prospective multicenter study. Spine 1995;20:2211-6.
35. Sassard WR, Eidman DK, Gray PM, et al. Augmenting local bone with Grafton demineralized bone matrix for posterolateral lumbar spine fusion: Avoiding second site autologous bone harvest. Orthopedics 2000;23:1059-65.
36. Thalgott JS, Giuffre JM, Fritts K, et al. Instrumented posterolateral lumbar fusion using coralline hydroxyapatite with or without demineralized bone matrix as an adjunct to autologous bone. Spine J 2001;1:131-7.
37. Cammisa FP Jr, Lowery G, Garfin SR, et al. Two-year fusion rate equivalency between Grafton DBM gel and autograft in posterolateral spine fusion: A prospective controlled trial employing a side-by-side comparison in the same patient. Spine 2004;29:660-6.
38. Cobos JA, Lindsey RW, Gugala Z. 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 2000;14:54-9.
39. Wilkins RM, Kelly CM, Giusti DE. Bioassayed demineralized bone matrix and calcium sulfate: Use in bone grafting procedures. Ann Chir Gynaecol 1999;88:180-5.
40. Neel M. Successful treatment of persistent humeral shaft nonunion using open reduction internal fixation, electrical stimulation, and Allomatrix® custom bone putty. Orthopedics 2004;27(suppl 1):s109-11.
41. Cheung S, Westerheide K, Ziran B. Efficacy of contained metaphyseal and periarticular defects treated with two different demineralized bone matrix allografts. Int Orthop 2003;27:56-9.
42. Fox C, Aufdemorte T, Sandhu HS. Comparative Histologic and Calcium Content Evaluation of Osteofil™, Grafton™ and DynaGraft Putty Bone Inductive Materials in the Nude Rat at 28 Days: Proceedings of North American Spine Society 2000. 15:38-39.
43. Newton PO, Lee SS, Mahar AT, et al. Thoracoscopic multilevel anterior instrumented fusion in a goat model. Spine 2003;28:1614-9.
44. Burg KJL, Porter S, Kellam JF. Biomaterial developments for bone tissue engineering. Biomaterials 2000;21:2347-59.
45. Vaccaro AR, Chiba K, Heller JG, et al. North American Spine Society for Contemporary Concepts in Spine Care. Bone grafting alternatives in spinal surgery. Spine J 2002;2:206-15.
46. Whang PG, Wang JC. Bone graft substitutes for spinal fusion. Spine J 2003;3:155-65.
47. Syftestad GT, Urist MR. Bone aging. Clin Orthop Relat Res 1982;162:288-97.
48. Schwartz Z, Mellonig JT, Carnes DL Jr, et al. Ability of commercial demineralized freeze-dried bone allograft to induce new bone formation. J Periodontol 1996;67:918-26.
49. Schwartz Z, Somers A, Mellonig JT, et al. Ability of commercial demineralized freeze-dried bone allograft to induce new bone formation is dependent on donor age but not gender. J Periodontol 1998;69:470-8.
50. Pinholt EM, Solheim E. Osteoinductive potential of demineralized rat bone increases with increasing donor age from birth to adulthood. J Craniofac Surg 1998;9:142-6.
51. Maddox EWA, Zhan M, Mundy F, et al. Optimizing human demineralized bone matrix for clinical application. Tissue Eng 2000;6:441-8.
52. Lohmann CH, Andreacchio D, Koster G, et al. Tissue response and osteoinduction of human bone grafts in vivo. Arch Orthop Trauma Surg 2001;121:583-90.
53. Traianedes K, Russell JL, Edwards JT, et al. Donor age and gender effects on osteoinductivity of demineralized bone matrix. J Biomed Mater Res 2004;70B:21-9.
54. Zhang M, Powers RM Jr, Wolfinbarger L Jr. Effect(s) of the demineralization process on the osteoinductivity of demineralized bone matrix. J Periodontol 1997;68:1085-92.
55. Lowery OH. Specific procedures: Alkaline phosphatase. In: Pastan IH, ed. Micromethods for the Assay of Enzymes. New York, NY: Academic Press; 1955:265-371.
56. Ballanti P, Coen G, Taggi F, et al. Extent of alkaline phosphatase cytochemistry vs. extent of tetracycline fluorescence in the evaluation of histodynamic variables of bone formation. Bone 1995;16:493-8.
57. Zhang M, Powers RM, Wolfinbarger L Jr. A quantitative assessment of osteoinductivity of human demineralized bone matrix. J Periodontol 1997;68:1076-84.
58. Carnes DL Jr, De La Fontaine J, Cochran DL, et al. Evaluation of 2 novel approaches for assessing the ability of demineralized freeze-dried bone allograft to induce new bone formation. J Periodontol 1999;70:353-63.
59. Mendes SC, Tibbe JM, Veenhof M, et al. Relation between in vitro and in vivo osteogenic potential of cultured human bone marrow stromal cells. J Mater Sci Mater Med 2004;15:1123-8.
60. Li H, Pujic Z, Xiao Y, et al. Identification of bone morphogenetic proteins 2 and 4 in commercial demineralized freeze-dried bone allograft preparations: Pilot study. Clin Implant Dent Relat Res 2000;2:110-7.
61. Sampath TK, Reddi AH. Distribution of bone inductive proteins in mineralized and demineralized extracellular matrix. Biochem Biophys Res Commun 1984;119:949-54.
62. Iwata H, Sakano S, Itoli T, et al. Demineralized bone matrix and native bone morphogenetic protein in orthopaedic surgery. Clin Orthop 2002;2002:99-109.