Recombinant bone morphogenic protein-2 in orthopaedic surgery: A review

Archives of Orthopaedic and Trauma Surgery

Volumn 129, Issue 12, 2009, Pages 1651-1657

  Valdes, Mauricio A ^a   Thakur, Nikhil A ^a   Namdari, Surena ^b   Ciombor, Deborah M ^a   Palumbo, Mark ^a,c  

^a BROWN UNIVERSITY   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c University Orthopedics Incorporated   (United States)

Author keywords

Bone healing; Bone morphogenic protein; Growth factors; Open fractures; Spine fusion

Indexed keywords

BONE MORPHOGENETIC PROTEIN; COLLAGEN; RECOMBINANT BONE MORPHOGENETIC PROTEIN 2;

BIOCOMPATIBILITY; BONE GRAFT; CLINICAL TRIAL; DRUG DELIVERY SYSTEM; DRUG ELIMINATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG RECEPTOR BINDING; DRUG SCREENING; FRACTURE HEALING; HUMAN; LAMINECTOMY; NONHUMAN; ORTHOPEDIC SURGERY; PRIORITY JOURNAL; PROTEIN FUNCTION; PROTEIN SYNTHESIS; REVIEW; SPINE FUSION; TIBIA FRACTURE; TOXICITY TESTING;

ANIMALS; BONE MORPHOGENETIC PROTEIN 2; FRACTURES, MALUNITED; HUMANS; ORTHOPEDIC PROCEDURES; RECOMBINANT PROTEINS; SPINAL FUSION;

EID: 70450255384     PISSN: 09368051     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00402-009-0850-8     Document Type: Review

References (58)

1. EH Riley JM Lane MR Urist, et al. 1996 Bone morphogenetic protein-2: biology and applications Clin Orthop Relat Res 324 39 46 10.1097/00003086- 199603000-00006 10.1097/00003086-199603000-00006 8595775
2. MR Urist 1965 Bone: formation by autoinduction Science 150 893 899 10.1126/science.150.3698.893 10.1126/science.150.3698.893 1:STN:280: DyaF28%2FhvFekuw%3D%3D 5319761
3. MR Urist H Iwata PL Ceccotti, et al. 1973 Bone morphogenesis in implants of insoluble bone gelatin Proc Natl Acad Sci USA 70 3511 3515 10.1073/pnas.70.12.3511 10.1073/pnas.70.12.3511 1:CAS:528:DyaE2cXotVCmtg%3D%3D 4357876
4. D McKay HS Sandhu 2002 Use of recombinant human bone morphogenetic protein-2 in spinal fusion applications Spine 27 16S S66 S85 10.1097/00007632-200208151-00014 10.1097/00007632-200208151-00014 12205423
5. AH Reddi 1998 Initiation of fracture repair by bone morphogenetic proteins Clin Orthop Relat Res 355S s66 s72 10.1097/00003086-199810001-00008 10.1097/00003086-199810001-00008
6. M Lind 1998 Growth factor stimulation of bone healing. Effect on osteoblasts, osteotomies, and implants fixation Acta Orthop Scand 69 Suppl 283
7. SC Ludwig SD Boden 1999 Osteoinductive bone graft substitutes for spinal fusion. A basic science summary Orthop Clin North Am 30 4 635 645 10.1016/S0030-5898(05)70116-4 1:STN:280:DyaK1MvgtlWmtA%3D%3D 10471768 (Pubitemid 29471305)
8. S Ebara K Nakayama 2002 Mechanism for the action of bone morphogenetic proteins and regulation of their activity Spine 27 16S S10 S15 10.1097/00007632-200208151-00004 10.1097/00007632-200208151-00004 12205413
9. G Helm G Anderson GBJ Andersson, et al. 2002 Summary statement: bone morphogenetic proteins Spine 27 16S S9 10.1097/00007632-200208151-00003 10.1097/00007632-200208151-00003
10. JM Wozney 2002 Overview of bone morphogenetic proteins Spine 27 16S S2 S8 10.1097/00007632-200208151-00002 10.1097/00007632-200208151-00002 12205411
11. Schaefer SL, Lu Y, Seeherman H et al (2008) Effect of rhBMP-2 on tibial plateau fractures in a canine model. J Orthop Res
12. SD Glassman JR Dimar LY Carreon, et al. 2005 Initial fusion rates with recombinant human bone morphogenetic protein-2/compression resistant matrix and a hydroxyapatite and tricalcium phosphate/collagen carrier in posterolateral spinal fusion Spine 30 15 1694 1698 10.1097/01.brs.0000172157.39513.80 10.1097/01.brs.0000172157.39513.80 16094268 (Pubitemid 41099480)
13. Yoon ST, Boden SD (2002) Osteoinductive molecules in orthopaedics: basic science and preclinical studies. Clin Orthop Relat Res (395):33-43. doi: 10.1097/00003086-200202000-00005
14. DI Israel J Nove KM Kerns, et al. 1992 Expression and characterization of bone morphogenetic protein-2 in Chinese hamster ovary cells Growth Factors 7 139 150 10.3109/08977199209046403 10.3109/08977199209046403 1:STN:280: DyaK3s%2FktVehsA%3D%3D 1419071
15. McKay W (2001) Medtronic Sofamore Danek. Personal communication. Study on file with FDA, Rockville
16. AR Poynton JM Lane 2002 Safety profile for the clinical use of bone morphogenetic proteins in the spine Spine 27 16S S40 S48 10.1097/00007632- 200208151-00010 10.1097/00007632-200208151-00010 12205419
17. GJ Martin Jr SD Boden MA Morone, et al. 1999 Posterolateral intertransverse process spinal arthrodesis with rhBMP-2 in a nonhuman primate: important lessons learned regarding dose, carrier, and safety J Spinal Disord 12 3 179 186 10382769
18. HS Sandhu LE Kanim JM Kabo, et al. 1995 Evaluation of rhBMP-2 with an OPLA carrier in a canine posterolateral (transverse process) spinal fusion model Spine 20 24 2669 2682 10.1097/00007632-199512150-00008 10.1097/00007632- 199512150-00008 1:STN:280:DyaK28zmtlKnsw%3D%3D 8747245
19. RA Meyer Jr HE Gruber BA Howard, et al. 1999 Safety of recombinant human bone morphogenetic protein-2 after spinal laminectomy in the dog Spine 24 8 747 754 10.1097/00007632-199904150-00004 10.1097/00007632-199904150-00004 10222524 (Pubitemid 29181526)
20. SM David HE Gruber RA Meyer Jr, et al. 1999 Lumbar spinal fusion using recombinant human bone morphogenetic protein in the canine. A comparison of three dosages and two carriers Spine 24 19 1973 1979 10.1097/00007632-199910010- 00002 10.1097/00007632-199910010-00002 1:STN:280:DyaK1MvlslKktQ%3D%3D 10528370 (Pubitemid 29480466)
21. SD Boden GJ Martin Jr MA Morone, et al. 1999 Posterolateral lumbar intertransverse process spine arthrodesis with recombinant human bone morphogenetic protein 2/hydroxyapatite-tricalcium phosphate after laminectomy in the nonhuman primate Spine 24 12 1179 1185 10.1097/00007632-199906150-00002 10.1097/00007632-199906150-00002 1:STN:280:DyaK1MzhtFamsw%3D%3D 10382242 (Pubitemid 29279459)
22. Valentin-Opran A, Wozney J, Csimma C et al (2002) Clinical evaluation of recombinant human bone morphogenetic protein-2. Clin Orthop Relat Res (395):110-120. doi: 10.1097/00003086-200202000-00011
23. EA Wang V Rosen JS D'Alessandro, et al. 1990 Recombinant human bone morphogenetic protein induces bone formation Proc Natl Acad Sci USA 87 2220 2224 10.1073/pnas.87.6.2220 10.1073/pnas.87.6.2220 1:CAS:528:DyaK3cXhslejsrg%3D 2315314
24. W Balemans W Van Hul 2001 Extracellular regulation of BMP signaling in vertebrates: a cocktail of modulators Dev Biol 250 231 250
25. E Canalis AN Economides E Gazzerro 2003 Bone morphogenetic proteins, their antagonists and the skeleton Endocr Rev 24 2 218 235 10.1210/er.2002-0023 10.1210/er.2002-0023 1:CAS:528:DC%2BD3sXjsFyltLo%3D 12700180 (Pubitemid 36515285)
26. HS Sandhu LE Kanim JM Kabo, et al. 1996 Effective doses or recombinant bone morphogenetic protein-2 in experimental spinal fusion Spine 21 18 2115 2122 10.1097/00007632-199609150-00012 10.1097/00007632-199609150-00012 1:STN:280:DyaK2s%2FkvVKjtw%3D%3D 8893436 (Pubitemid 26330597)
27. JH Schimandle SD Boden WC Hutton 1995 Experimental spinal fusion with recombinant human bone morphogenetic protein-2 Spine 20 12 1326 1337 10.1097/00007632-199506000-00002 1:STN:280:DyaK2Mvgs1OksA%3D%3D 7676329
28. SD Boden JH Schimandle WC Hutton, et al. 1995 1995 Volvo Award in basic sciences. The use of an osteoinductive growth factor for lumbar spinal fusion. Part I: Biology of spinal fusion Spine 20 24 2626 2632 1:STN:280: DyaK28zmtlKgtA%3D%3D 8747240
29. SD Boden JH Schimandle WC Hutton 1995 1995 Volvo Award in basic sciences. The use of an osteoinductive growth factor for lumbar spinal fusion. Part II: Study of dose, carrier, and species Spine 20 24 2633 2644 1:STN:280: DyaK28zmtlKgtQ%3D%3D 8747241
30. R Ruppert E Hoffman W Sebald 1996 Human bone morphogenetic protein 2 contains a heparin-binding site which modifies its biological activity Eur J Biochem 237 1 295 302 10.1111/j.1432-1033.1996.0295n.x 10.1111/j.1432-1033.1996. 0295n.x 1:CAS:528:DyaK28Xitlyisrg%3D 8620887
31. HS Sandhu JM Toth AD Diwan, et al. 2002 Histologic evaluation of the efficacy of rhBMP-2 compared with autograft bone in sheep spinal anterior interbody fusion Spine 27 567 10.1097/00007632-200203150-00003 10.1097/00007632-200203150-00003 11884903 (Pubitemid 34226113)
32. TA Zdeblick AJ Ghanayem AJ Rapoff, et al. 1998 Cervical interbody fusion cage: an animal model with and without bone morphogenetic protein Spine 23 758 766 10.1097/00007632-199804010-00002 10.1097/00007632-199804010-00002 1:STN:280:DyaK1c3isVajtA%3D%3D 9563105 (Pubitemid 28169197)
33. N Murakami N Saito H Horiuchi, et al. 2002 Repair of segmental defects in rabbit humeri with titanium fiber mesh cylinders containing recombinant human bone morphogenetic protein-2 (rhBMP-2) and a synthetic polymer J Biomed Mater Res 62 2 169 174 10.1002/jbm.10236 10.1002/jbm.10236 1:CAS:528: DC%2BD38XntFajsbs%3D 12209936 (Pubitemid 34988493)
34. JR Lieberman A Daluiski S Stevenson, et al. 1999 The effect of regional gene therapy with bone morphogenetic protein-2-producing bone-marrow cells on the repair of segmental femoral defects in rats J Bone Joint Surg Am 81 7 905 917 1:STN:280:DyaK1MzlsFSktw%3D%3D 10428121
35. M Szpalski R Gunzburg 2005 Recombinant human bone morphogenetic protein-2: a novel osteoinductive alternative to autogenous bone graft? Acta Orthop Belg 71 2 133 148 16152845
36. Gerhart TN, Kirker-Head CA, Kriz MJ et al (1993) Healing segmental femoral defects in sheep using recombinant human bone morphogenetic protein. Clin Orthop Relat Res (293):317-326
37. K Singh JD Smucker SD Boden 2006 Use of recombinant human bone morphogenetic protein-2 as an adjunct in posterolateral lumbar spine fusion: a prospective CT-scan analysis at one and two years J Spinal Disord Tech 19 6 416 423 10.1097/00024720-200608000-00008 10.1097/00024720-200608000-00008 16891977 (Pubitemid 44197593)
38. JR Dimar SD Glassman KJ Burkus, et al. 2006 Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/compression resistant matrix versus iliac crest bone graft Spine 31 22 2534 2539 10.1097/01.brs.0000240715. 78657.81 10.1097/01.brs.0000240715.78657.81 17047540 discussion 2540 (Pubitemid 44632234)
39. SD Glassman L Carreon M Djurasovic, et al. 2007 Posterolateral lumbar spine fusion with INFUSE bone graft Spine J 7 1 44 49 10.1016/j.spinee.2006.06. 381 10.1016/j.spinee.2006.06.381 17197332 (Pubitemid 46002546)
40. RW Haid Jr CL Branch Jr JT Alexander, et al. 2004 Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages Spine J 4 5 527 538 10.1016/j.spinee.2004.03.025 10.1016/j.spinee.2004.03.025 15363423 discussion 538-539 (Pubitemid 40029169)
41. AT Villavicencio S Burneikiene EL Nelson, et al. 2005 Safety of transforaminal lumbar interbody fusion and intervertebral recombinant human bone morphogenetic protein-2 J Neurosurg Spine 3 6 436 443 10.3171/spi.2005.3.6.0436 16381205
42. TH Lanman TJ Hopkins 2004 Lumbar interbody fusion after treatment with recombinant human bone morphogenetic protein-2 added to poly(L-lactide-co-D, L-lactide) bioresorbable implants Neurosurg Focus 16 3 E9 15198497
43. Mummaneni PV, Pan J, Haid RW, Rodts GE (2004) Contribution of recombinant human bone morphogenetic protein-2 to the rapid creation of interbody fusion when used in transforaminal lumbar interbody fusion: a preliminary report. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004
44. K Lewandrowski C Nanson R Calderon 2007 Vertebral osteolysis after posterior interbody lumbar fusion with recombinant human bone morphogenetic protein 2: a report of five cases Spine J 7 5 609 614 10.1016/j.spinee.2007.01. 011 10.1016/j.spinee.2007.01.011 17526434 (Pubitemid 47471438)
45. JK Burkus MF Gornet C Dickman, et al. 2002 Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages J Spinal Disord 15 337 349
46. JK Burkus SE Heim MF Gornet, et al. 2003 Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device J Spinal Disord Tech 16 2 113 122 12679664
47. JK Burkus JD Dorchak DL Sanders 2003 Radiographic assessment of interbody fusion using recombinant human bone morphogenetic protein type 2 Spine 28 4 372 377 10.1097/00007632-200302150-00012 10.1097/00007632-200302150-00012 12590213 (Pubitemid 36232619)
48. TJ Kleeman UM Ahn A Talbot-Kleeman 2001 Laparoscopic anterior lumbar interbody fusion with rhBMP-2: a prospective study of clinical and radiographic outcomes Spine 26 2751 2756 10.1097/00007632-200112150-00026 10.1097/00007632-200112150-00026 1:STN:280:DC%2BD3Mnptlyjsg%3D%3D 11740368 (Pubitemid 34019769)
49. DS Baskin P Ryan V Sonntag, et al. 2003 A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate Spine 28 12 1219 1224 10.1097/00007632-200306150-00003 10.1097/00007632-200306150-00003 12811263 discussion 1225 (Pubitemid 36734609)
50. Vaidya R, Carp J, Sethi A et al (2007) Complications of anterior cervical discectomy and fusion using recombinant human bone morphogeneticprotein-2. Eur Spine J
51. AL Jones RW Bucholz MJ Bosse, et al. 2006 Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects. A randomized, controlled trial J Bone Joint Surg Am 88 7 1431 1441 10.2106/JBJS.E.00381 10.2106/JBJS.E.00381 16818967
52. L Nordsletten 2006 Recent developments in the use of bone morphogenetic protein in orthopaedic trauma surgery Curr Med Res Opin 22 Suppl 1 S13 S17 10.1185/030079906X80585 1:CAS:528:DC%2BD28XhtVaktrrO 16882365 S23 (Pubitemid 44298364)
53. AH Karladani H Granhed J Karrholm, et al. 2001 The influence of fracture etiology and type on fracture healing: a review of 104 consecutive tibial shaft fractures Arch Orthop Trauma Surg 121 6 325 328 10.1007/s004020000252 10.1007/s004020000252 1:STN:280:DC%2BD38%2FisFSitQ%3D%3D 11482464 (Pubitemid 32591034)
54. M Bhandari P Tornetta 3rd S Sprague, et al. 2003 Predictors of reoperation following operative management of fractures of the tibial shaft J Orthop Trauma 17 5 353 361 10.1097/00005131-200305000-00006 10.1097/00005131- 200305000-00006 12759640 (Pubitemid 36701599)
55. GE Riedel A Valentin-Opran 1999 Clinical evaluation of rhBMP-2/ACS in orthopedic trauma: a progress report Orthopedics 22 7 663 665 1:STN:280:DyaK1MzksFajsw%3D%3D 10418860
56. S Govender C Csimma HK Genant, et al. 2002 Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients J Bone Joint Surg Am 84-A 12 2123 2134 12473698
57. V Alt A Heissel 2006 Economic considerations for the use of recombinant human bone morphogenetic protein-2 in open tibial fractures in Europe: the German model Curr Med Res Opin 22 Suppl 1 S19 S22 10.1185/030079906X80602 10.1185/030079906X80602 16882366 (Pubitemid 44298365)
58. MF Swiontkowski HT Aro S Donell, et al. 2006 Recombinant human bone morphogenetic protein-2 in open tibial fractures. A subgroup analysis of data combined from two prospective randomized studies J Bone Joint Surg Am 88 6 1258 1265 10.2106/JBJS.E.00499 10.2106/JBJS.E.00499 16757759 (Pubitemid 43837120)