Recombinant human bone morphogenetic protein-2 versus autogenous iliac crest bone graft for lumbar fusion: A meta-analysis of ten randomized controlled trials

Archives of Orthopaedic and Trauma Surgery

Volumn 132, Issue 12, 2012, Pages 1725-1740

  Chen, Zhiguang ^a   Ba, Gen ^a   Shen, Tao ^a   Fu, Qin ^a  

^a CHINA MEDICAL UNIVERSITY   (China)

Author keywords

Autogenous iliac crest bone graft; Complication; Lumbar fusion; Meta analysis; Randomized controlled trial; Recombinant human bone morphogenetic protein 2

Indexed keywords

RECOMBINANT BONE MORPHOGENETIC PROTEIN 2;

ARTICLE; AUTOGENOUS ILIAC CREST BONE GRAFT; BONE GRAFT; COMPARATIVE EFFECTIVENESS; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG MEGADOSE; GRAFT FAILURE; HUMAN; INSTRUMENTATION; INTERMETHOD COMPARISON; INTERVERTEBRAL DISK DEGENERATION; LOW DRUG DOSE; META ANALYSIS; OSWESTRY DISABILITY INDEX; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PATIENT SAFETY; PATIENT SATISFACTION; PEDICLE SCREW; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REOPERATION; RETROGRADE EJACULATION; RISK REDUCTION; SHORT FORM 36; SPINE FUSION; SPONDYLOLISTHESIS; SURGICAL TECHNIQUE; SYSTEMATIC REVIEW; UNSPECIFIED SIDE EFFECT;

BONE MORPHOGENETIC PROTEIN 2; HUMANS; ILIUM; LUMBAR VERTEBRAE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECOMBINANT PROTEINS; SPINAL FUSION; TRANSFORMING GROWTH FACTOR BETA;

EID: 84872116582     PISSN: 09368051     EISSN: 14343916     Source Type: Journal    
DOI: 10.1007/s00402-012-1607-3     Document Type: Article

References (61)

1. Kaufman HH, Jones E (1989) The principles of bony spinal fusion. Neurosurgery 24(2):264-270. doi:10.1097/00006123- 198902000-00018
2. Fujiya M, Saita M, Kaneda K, Abumi K (1990) Clinical study on stability of combined distraction and compression rod instrumentation with posterolateral fusion for unstable degenerative spondylolisthesis. Spine 15(11):1216-1222. doi:10.1097/000076 32-199011010-00023
3. Blumenthal SL, Baker J, Dossett A, Selby DK (1988) The role of anterior lumbar fusion for internal disc disruption. Spine 13(5): 566-569. doi:10.1097/00007632-198805000-00023
4. Arrington ED, Smith WJ, Chambers HG, Bucknell AL, Davino NA (1996) Complications of iliac crest bone graft harvesting. Clin Orthop Relat Res 329:300-309. doi:10.1097/00003086-199 608000-00037
5. Younger EM, Chapman MW (1989) Morbidity at bone graft donor sites. J Orthop Trauma 3(3):192-195. doi:10.1097/000051 31-198909000-00002
6. Banwart JC, Asher MA, Hassanein RS (1995) Iliac crest bone graft harvest donor site morbidity. A statistical evaluation. Spine 20(9):1055-1060. doi:10.1097/00007632-199505000-00012
7. Vaccaro AR, Chiba K, Heller JG, Patel T, Thalgott JS, Truumees E, Fischgrund JS, Craig MR, Berta SC, Wang JC (2002) Bone grafting alternatives in spinal surgery. Spine J 2(3):206-215. doi: 10.1016/S1529-9430(02)00180-8
8. Boden SD, Schimandle JH (1995) Biologic enhancement of spinal fusion. Spine 20(24 Suppl):113S-123S. doi:10.1097/00007632-199512151-00008
9. Weiner BK, Walker M (2003) Efficacy of autologous growth factors in lumbar intertransverse fusions. Spine 28(17):1968- 1970. doi:10.1097/01.BRS. 0000083141.02027.48 (discussion 1971)
10. Whang PG, Wang JC (2003) Bone graft substitutes for spinal fusion. Spine J 3(2):155-165. doi:10.1016/S1529-9430(02) 00539-9
11. Urist MR (1965) Bone: formation by autoinduction. Science 150(3698):893-899. doi:10.1126/science.150.3698.893
12. Urist MR, Strates BS (1971) Bone morphogenetic protein. J Dent Res 50(6):1392-1406. doi:10.1177/00220345710500060601
13. Sampath TK, Coughlin JE, Whetstone RM, Banach D, Corbett C, Ridge RJ, Ozkaynak E, Oppermann H, Rueger DC (1990) Bovine osteogenic protein is composed of dimers of OP-1 and BMP-2A, two members of the transforming growth factor-beta superfamily. J Biol Chem 265(22):13198-13205
14. Boden SD, Kang J, Sandhu H, Heller JG (2002) Use of recombinant human bone morphogenetic protein-2 to achieve posterolateral lumbar spine fusion in humans: a prospective, randomized clinical pilot trial: 2002 Volvo Award in clinical studies. Spine 27(23):2662-2673. doi:10.1097/00007632-200212010-00005
15. Dimar JR, Glassman SD, Burkus KJ, Carreon LY (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. doi:10.1097/01. brs.0000240715.78657.81 (discussion 2540)
16. Burkus JK, Gornet MF, Dickman CA, Zdeblick TA (2002) Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. J Spinal Disord Tech 15(5):337-349. doi: 10.1097/00024720-200210000-00001
17. Burkus JK, Sandhu HS, Gornet MF, Longley MC (2005) Use of rhBMP-2 in combination with structural cortical allografts: clinical and radiographic outcomes in anterior lumbar spinal surgery. J Bone Joint Surg Am 87(6):1205-1212. doi:10.2106/JBJS.D.02532
18. Boden SD, Zdeblick TA, Sandhu HS, Heim SE (2000) The use of rhBMP-2 in interbody fusion cages. Definitive evidence of osteoinduction in humans: a preliminary report. Spine 25(3): 376-381. doi:10.1097/00007632-200002010-00020
19. Fairbank JC, Couper J, Davies JB, O'Brien JP (1980) The Oswestry Low Back Pain Disability Questionnaire. Physiotherapy 66(8):271-273
20. Furlan AD, Pennick V, Bombardier C, van Tulder M (2009) 2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine 34(18):1929-1941. doi: 10.1097/BRS.0b013e3181b1c99f
21. DerSimonian R, Laird N (1986) Meta-analysis in clinical trials. Control Clin Trials 7(3):177-188. doi:10.1016/0197-2456(86) 90046-2
22. Higgins JP, Thompson SG, Deeks JJ, Altman DG (2003) Measuring inconsistency in meta-analyses. BMJ 327(7414):557-560. doi:10.1136/bmj.327.7414. 557
23. Egger M, Davey Smith G, Schneider M, Minder C (1997) Bias in meta-analysis detected by a simple, graphical test. BMJ 315(7109):629-634. doi:10.1136/bmj.315.7109.629
24. Begg CB, Mazumdar M (1994) Operating characteristics of a rank correlation test for publication bias. Biometrics 50(4): 1088-1101. doi:10.2307/2533446
25. Egger M, Smith GD (1998) Bias in location and selection of studies. BMJ 316(7124):61-66. doi:10.1136/bmj.316.7124.61
26. Duval S, Tweedie R (2000) Trim and fill: a simple funnel-plotbased method of testing and adjusting for publication bias in meta-analysis. Biometrics 56(2):455-463. doi:10.1111/j.0006-341X. 2000.00455.x
27. Altman DG, Bland JM (2003) Interaction revisited: the difference between two estimates. BMJ 326(7382):219. doi:10.1136/bmj. 326.7382.219
28. Burkus JK, Dorchak JD, Sanders DL (2003) Radiographic assessment of interbody fusion using recombinant human bone morphogenetic protein type 2. Spine 28(4):372-377. doi:10.1097/01.BRS.0000048469.45035.B9
29. Burkus JK, Transfeldt EE, Kitchel SH, Watkins RG, Balderston RA (2002) Clinical and radiographic outcomes of anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2. Spine 27(21):2396-2408. doi:10.1097/00007632-2002 11010-00015
30. Dimar JR 2nd, Glassman SD, Burkus JK, Pryor PW, Hardacker JW, Carreon LY (2009) Two-year fusion and clinical outcomes in 224 patients treated with a single-level instrumented posterolateral fusion with iliac crest bone graft. Spine J 9(11):880-885. doi: 10.1016/j.spinee.2009.03.013
31. Dimar JR 2nd, Glassman SD, Burkus JK, Pryor PW, Hardacker JW, Carreon LY (2009) Clinical and radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral lumbar spine arthrodesis. Journal Bone Joint Surg Am 91(6):1377-1386. doi:10.2106/JBJS.H.00200
32. Glassman SD, Dimar JR, Carreon LY, Campbell MJ, Puno RM, Johnson JR (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. doi:10.1097/01.brs.0000172157.39513.80
33. Dawson E, Bae HW, Burkus JK, Stambough JL, Glassman SD (2009) Recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge with an osteoconductive bulking agent in posterolateral arthrodesis with instrumentation. A prospective randomized trial. J Bone Joint Surg Am 91(7):1604- 1613. doi:10.2106/JBJS.G.01157
34. Glassman SD, Carreon LY, Djurasovic M, Campbell MJ, Puno RM, Johnson JR, Dimar JR (2008) RhBMP-2 versus iliac crest bone graft for lumbar spine fusion: a randomized, controlled trial in patients over 60 years of age. Spine 33(26):2843-2849. doi: 10.1097/BRS.0b013e318190705d
35. Haid RW Jr, Branch CL Jr, Alexander JT, Burkus JK (2004) Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages. Spine J 4(5):527-538. doi:10.1016/j.spinee.2004. 03.025 (discussion 538-529)
36. Meyerding HW (1956) Spondylolisthesis; surgical fusion of lumbosacral portion of spinal column and interarticular facets: use of autogenous bone grafts for relief of disabling backache. Journal Int Coll Surg 26(5 Part 1):566-591
37. McKay B, Sandhu HS (2002) Use of recombinant human bone morphogenetic protein-2 in spinal fusion applications. Spine 27(16 Suppl 1):S66-S85. doi:10.1097/00007632-200208151-00014
38. Boden SD, Martin GJ Jr, Morone MA, Ugbo JL, Moskovitz PA (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. doi:10.1097/00007 632-199906150-00002
39. Martin GJ Jr, Boden SD, Marone MA, Moskovitz PA (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. doi:10.1097/00002517-199906000-00001
40. Boden SD, Schimandle JH, Hutton WC (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. doi:10.1097/00007632-1995 12150-00004
41. Wozney JM (1992) The bone morphogenetic protein family and osteogenesis. Mol Reprod Dev 32(2):160-167. doi:10.1002/mrd. 1080320212
42. Yoon ST, Park JS, Kim KS, Li J, Attallah-Wasif ES, Hutton WC, Boden SD (2004) ISSLS prize winner: lMP-1 upregulates intervertebral disc cell production of proteoglycans and BMPs in vitro and in vivo. Spine 29(23):2603-2611. doi:10.1097/01.brs.00001 46103.94600.85
43. Akamaru T, Suh D, Boden SD, Kim HS, Minamide A, Louis- Ugbo J (2003) Simple carrier matrix modifications can enhance delivery of recombinant human bone morphogenetic protein-2 for posterolateral spine fusion. Spine 28(5):429-434. doi:10.1097/01. BRS.0000048644.91330.14
44. Suh DY, Boden SD, Louis-Ugbo J, Mayr M, Murakami H, Kim HS, Minamide A, Hutton WC (2002) Delivery of recombinant human bone morphogenetic protein-2 using a compressionresistant matrix in posterolateral spine fusion in the rabbit and in the non-human primate. Spine 27(4):353-360. doi:10.1097/00007632- 200202150-00006
45. Barnes B, Boden SD, Louis-Ugbo J, Tomak PR, Park JS, Park MS, Minamide A (2005) Lower dose of rhBMP-2 achieves spine fusion when combined with an osteoconductive bulking agent in non-human primates. Spine 30(10):1127-1133. doi:10.1097/01. brs.0000162623.48058.8c
46. Benglis D, Wang MY, Levi AD (2008) A comprehensive review of the safety profile of bone morphogenetic protein in spine surgery. Neurosurgery 62(5 Suppl 2):ONS423-ONS431. doi: 10.1227/01.neu.0000326030.24220.d8 (discussion ONS431)
47. Wong DA, Kumar A, Jatana S, Ghiselli G, Wong K (2008) Neurologic impairment from ectopic bone in the lumbar canal: a potential complication of off-label PLIF/TLIF use of bone morphogenetic protein-2 (BMP-2). Spine J 8(6):1011-1018. doi: 10.1016/j.spinee.2007.06.014
48. Chen NF, Smith ZA, Stiner E, Armin S, Sheikh H, Khoo LT (2010) Symptomatic ectopic bone formation after off-label use of recombinant human bone morphogenetic protein-2 in transforaminal lumbar interbody fusion. J Neurosurg Spine 12(1):40-46. doi:10.3171/2009.4.SPINE0876
49. Kanatani M, Sugimoto T, Kaji H, Kobayashi T, Nishiyama K, Fukase M, Kumegawa M, Chihara K (1995) Stimulatory effect of bone morphogenetic protein-2 on osteoclast-like cell formation and bone-resorbing activity. J Bone Miner res 10(11):1681-1690. doi:10.1002/jbmr.5650101110
50. Burkus JK, Gornet MF, Schuler TC, Kleeman TJ, Zdeblick TA (2009) Six-year outcomes of anterior lumbar interbody arthrodesis with use of interbody fusion cages and recombinant human bone morphogenetic protein-2. J Bone Joint Surg Am 91(5): 1181-1189. doi:10.2106/JBJS.G.01485
51. Vaidya R, Weir R, Sethi A, Meisterling S, Hakeos W, Wybo CD (2007) Interbody fusion with allograft and rhBMP-2 leads to consistent fusion but early subsidence. J Bone Joint Surg Br 89(3):342-345. doi:10.1302/0301-620X.89B3. 18270
52. Lu S, Xu YQ, Chang S, Zhang YZ, Shi JH, Ding ZH, Li ZH, Zhong SZ (2009) Clinical anatomy study of autonomic nerve with respective to the anterior approach lumbar surgery. Surg Radiol Anat 31(6):425-430. doi:10.1007/s00276-009- 0461-7
53. United States Food and Drug Administration, Department of Health and Human Services, C-enter for Devices and Radiological Health. (2011). InFUSE bone Graft/LT-CAGE Lumbar tapered fusion Devices - P000058. Available at: http://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm num5P000058. Accessed 20 January 2011
54. Smoljanovic T, Siric F, Bojanic I (2010) Six-year outcomes of anterior lumbar interbody arthrodesis with use of interbody fusion cages and recombinant human bone morphogenetic protein-2. J Bone Joint Surg Am 92(15):2614-2615 (author reply 2615-2616)
55. Carragee EJ, Mitsunaga KA, Hurwitz EL, Scuderi GJ (2011) Retrograde ejaculation after anterior lumbar interbody fusion using rhBMP-2: a cohort controlled study. Spine J 11(6):511-516. doi:10.1016/j.spinee.2011.02.013
56. Food and Drug Adminstration. (2011). Food and Drug Administration Executive Summary for P050036 Medtronic's AMPLIFY-rhBMP-2 matrix orthopaedic and rehabilitation devices advisory panel. Available at: http://www.fda.gov/ downloads/Advisory Committees/Committees MeetingMaterials/MedicalDevices/ MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitati-on DevicesPanel/UCM220079.pdf. Accessed July 9, 2011
57. Luhmann SJ, Bridwell KH, Cheng I, Imamura T, Lenke LG, Schootman M (2005) Use of bone morphogenetic protein-2 for adult spinal deformity. Spine 30(17 Suppl):S110-S117. doi: 10.1097/01.brs.0000175184.27407.6a
58. Maeda T, Buchowski JM, Kim YJ, Mishiro T, Bridwell KH (2009) Long adult spinal deformity fusion to the sacrum using rhBMP-2 versus autogenous iliac crest bone graft. Spine 34(20):2205-2212. doi:10.1097/BRS.0b013e3181b0485c
59. Mulconrey DS, Bridwell KH, Flynn J, Cronen GA, Rose PS (2008) Bone morphogenetic protein (RhBMP-2) as a substitute for iliac crest bone graft in multilevel adult spinal deformity surgery: minimum two-year evaluation of fusion. Spine 33(20):2153-2159. doi:10.1097/BRS.0b013e31817bd91e
60. Glassman SD, Howard J, Dimar J, Sweet A, Wilson G, Carreon L (2011) Complications with recombinant human bone morphogenic protein-2 in posterolateral spine fusion: a consecutive series of 1037 cases. Spine 36(22):1849-1854. doi:10.1097/BRS. 0b013e3181d133d0
61. Carragee EJ, Hurwitz EL, Weiner BK (2011) A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Spine J 11(6):471-491. doi:10.1016/j.spinee.2011.04.023