Evidence for Use of Bone Morphogenetic Protein in Lumbar Spine Arthrodesis_Chinese Journal of Evidence-Based Medicine

Authors：

LIU Xi ¹ , SHU Defen ² , LI Tao ¹ ,  LIU Hao ¹

1. Department of Orthopedics, West China Hospital, Sichuan University, Chengdu 610041, China;2. Department of Geriatircs, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

LIU Hao, Email: liuhao6304@163.com

Keywords：

Bone morphogenetic protein; Spine arthrodesis; Lumbar spine; Cost-effective analysis

DOI：

10.7507/1672-2531.20080176

Video：

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Objective　 To evaluate the effectiveness, safety, cost and optimal dosing regimen of bone morphogenetic protein (BMP) used in the lumbar spine arthrodesis.
Methods　 We formulated the clinical questions according to the PICO principle. We searched the ACP Journal Club (1991 to February 2008), The Cochrane Library (Issue 4, 2007) and PubMed (1990 to February 2008) as well as other relevant databases. The evidence retrieved was critically appraised.
Results　 Current evidence showed that BMP was a satisfactory and safe behavior in lumbar arthrodesis. Its cost was equal to that of autogenous iliac bone graft. The types of BMP currently used in clinical practice are BMP-2 and BMP-7. Finished product of fixed composition ratio was recommended in anterior lumbar inter-body fusion, while in posterolateral fusion, 20mg of BMP-2 or 3.5mg of BMP-7 for each side was recommended, with proper carrier according to the place where it was used.
Conclusion　 BMP may be introduced to China for lumbar spine arthrodesis. Before it is applied extensively, further large-scale, high-quality randomized controlled trials are needed. Meanwhile, more research is necessary to determine the proper dosage and preparation form for the dominant Chinese population.

Citation： LIU Xi,SHU Defen,LI Tao,LIU Hao. Evidence for Use of Bone Morphogenetic Protein in Lumbar Spine Arthrodesis. Chinese Journal of Evidence-Based Medicine, 2008, 08(9): 786-790. doi: 10.7507/1672-2531.20080176 Copy

1.	Boden SD. Overview of biology of lumbar spine fusion and principles for selecting a bone graft substitute. Spine, 2002, 27(16 Suppl 1): 26-31.
2.	Helm GA, Dayoub H, Jane JA Jr. Bone graft substitutes for the promotion of spinal arthrodesis. Neurosurg Focus, 2001, 10(4): E4.
3.	Vaccaro AR, Chiba K, Heller JG, et al. Bone grafting alternatives in spinal surgery. Spine J, 2002, 2(3): 206-215.
4.	Guyatt GH, Rennie D. The evidence-based medicine working group. Users’ guides to the medical literature: A manual for evidence-based clinical practice. Chicago: AMA Press, 2002.
5.	Burkus JK, Heim SE, Gornet MF, et al. 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, 2003, 16(2): 113-122.
6.	Garrison KR, Donell S, Ryder J, et al. Clinical effectiveness and cost effectiveness of bone morphogenetic proteins in the non-heal ing of fractures and spinal fusion: a systematic review. Health Technol Assess, 2007, 11(30): 1-150, iii-iv.
7.	Boden SD, Zdebl ick TA, Sandhu HS, et al. The use of rhBMP-2 in interbody fusion cages. Definitive evidence of osteoinduction in humans: a preliminary report. Spine, 2000, 25(3): 376-381.
8.	Dimar JR, Glassman SD, Burkus KJ, et al. 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, 2006, 31(22): 2534-2539; discussion 2540.
9.	Glassman SD, Dimar JR, Carreon LY, et al. 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, 2005, 30(15): 1694-1698.
10.	Vaccaro AR, Patel T, Fischgrund J, et al. A pilot study evaluating the safety and efficacy of OP-1 Putty (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis for degenerative spondylolisthesis. Spine, 2004, 29(17): 1885-1892.
11.	Kanayama M, Hashimoto T, Shigenobu K, et al. A prospective randomized study of posterolateral lumbar fusion using osteogenic protein-1 (OP-1) versus local autograft with ceramic bone substitute: emphasis of surgical exploration and histologic assessment. Spine, 2006, 31(10): 1067-1074.
12.	Johnsson R, Stromqvist B, Aspenberg P. Randomized radiostereometric study comparing osteogenic protein-1 (BMP-7) and autograft bone in human noninstrumented posterolateral lumbar fusion: 2002 Volvo Award in clinical studies. Spine, 2002, 27(23): 2654-2661.
13.	Vaccaro AR, Anderson DG, Patel T, et al. Comparison of OP-1 Putty (rhBMP-7) to iliac crest autograft for posterolateral lumbar arthrodesis: a minimum 2-year follow-up pilot study. Spine, 2005, 30(24): 2709-2716.
14.	Haid RW Jr, Branch CL Jr, Alexander JT, et al. Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages. Spine J, 2004, 4(5): 527-38; discussion 538-539.
15.	Burkus JK, Gornet MF, Dickman CA, et al. Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. J Spinal Disord Tech, 2002, 15(5): 337-349.
16.	Burkus JK, Sandhu HS, Gornet MF. Influence of rhBMP-2 on the heal ing patterns associated with allograft interbody constructs in comparison with autograft. Spine, 2006, 31(7): 775-781.
17.	Burkus JK, Transfeldt EE, Kitchel SH, et al. Clinical and radiographic outcomes of anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2. Spine, 2002, 27(21): 2396-2408.
18.	Burkus JK, Dorchak JD, Sanders DL. Radiographic assessment of interbody fusion using recombinant human bone morphogenetic protein type 2. Spine, 2003, 28(4): 372-377.
19.	Coric D, Fischgrund JS, Patel T, et al. 772 Two-year follow-up on patients in a pilot safety and efficacy study of OP-1 (rhBMP-7) in posterolateral lumbar fusion as a replacement for iliac crest autograft neurological surgeons. Neurosurg, 2004, 55(2): 477.
20.	Ackerman SJ, Mafilios MS, Polly DW. Economic evaluation of bone morphogenetic protein versus autogenous iliac crest bone graft in single-level anterior lumbar fusion: an evidence-based model ing approach. Spine, 2002, 27(16 Suppl 1): S94-99.
21.	Anand N, Hamilton JF, Perri B, et al. Cantilever TLIF with structural allograft and RhBMP2 for correction and maintenance of segmental sagittal lordosis: long-term clinical, radiographic, and functional outcome. Spine, 2006, 31(20): E748-753.
22.	Mummaneni PV, Pan J, Haid RW, et al. 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. J Neurosurg Spine, 2004, 1(1): 19-23.
23.	Joseph V, Rampersaud YR. Heterotopic bone formation with the use of rhBMP2 in posterior minimal access interbody fusion: a CT analysis. Spine, 2007, 32(25): 2885-2890.
24.	Boden SD, Kang J, Sandhu H, et al. 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, 2002, 27(23): 2662-2673.
25.	Sasso RC, LeHuec JC, Shaffrey C. Iliac crest bone graft donor site pain after anterior lumbar interbody fusion: a prospective patient satisfaction outcome assessment. J Spinal Disord Tech, 2005, 18(Suppl): S77-81.

1. Boden SD. Overview of biology of lumbar spine fusion and principles for selecting a bone graft substitute. Spine, 2002, 27(16 Suppl 1): 26-31.
2. Helm GA, Dayoub H, Jane JA Jr. Bone graft substitutes for the promotion of spinal arthrodesis. Neurosurg Focus, 2001, 10(4): E4.
3. Vaccaro AR, Chiba K, Heller JG, et al. Bone grafting alternatives in spinal surgery. Spine J, 2002, 2(3): 206-215.
4. Guyatt GH, Rennie D. The evidence-based medicine working group. Users’ guides to the medical literature: A manual for evidence-based clinical practice. Chicago: AMA Press, 2002.
5. Burkus JK, Heim SE, Gornet MF, et al. 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, 2003, 16(2): 113-122.
6. Garrison KR, Donell S, Ryder J, et al. Clinical effectiveness and cost effectiveness of bone morphogenetic proteins in the non-heal ing of fractures and spinal fusion: a systematic review. Health Technol Assess, 2007, 11(30): 1-150, iii-iv.
7. Boden SD, Zdebl ick TA, Sandhu HS, et al. The use of rhBMP-2 in interbody fusion cages. Definitive evidence of osteoinduction in humans: a preliminary report. Spine, 2000, 25(3): 376-381.
8. Dimar JR, Glassman SD, Burkus KJ, et al. 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, 2006, 31(22): 2534-2539; discussion 2540.
9. Glassman SD, Dimar JR, Carreon LY, et al. 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, 2005, 30(15): 1694-1698.
10. Vaccaro AR, Patel T, Fischgrund J, et al. A pilot study evaluating the safety and efficacy of OP-1 Putty (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis for degenerative spondylolisthesis. Spine, 2004, 29(17): 1885-1892.
11. Kanayama M, Hashimoto T, Shigenobu K, et al. A prospective randomized study of posterolateral lumbar fusion using osteogenic protein-1 (OP-1) versus local autograft with ceramic bone substitute: emphasis of surgical exploration and histologic assessment. Spine, 2006, 31(10): 1067-1074.
12. Johnsson R, Stromqvist B, Aspenberg P. Randomized radiostereometric study comparing osteogenic protein-1 (BMP-7) and autograft bone in human noninstrumented posterolateral lumbar fusion: 2002 Volvo Award in clinical studies. Spine, 2002, 27(23): 2654-2661.
13. Vaccaro AR, Anderson DG, Patel T, et al. Comparison of OP-1 Putty (rhBMP-7) to iliac crest autograft for posterolateral lumbar arthrodesis: a minimum 2-year follow-up pilot study. Spine, 2005, 30(24): 2709-2716.
14. Haid RW Jr, Branch CL Jr, Alexander JT, et al. Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages. Spine J, 2004, 4(5): 527-38; discussion 538-539.
15. Burkus JK, Gornet MF, Dickman CA, et al. Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. J Spinal Disord Tech, 2002, 15(5): 337-349.
16. Burkus JK, Sandhu HS, Gornet MF. Influence of rhBMP-2 on the heal ing patterns associated with allograft interbody constructs in comparison with autograft. Spine, 2006, 31(7): 775-781.
17. Burkus JK, Transfeldt EE, Kitchel SH, et al. Clinical and radiographic outcomes of anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2. Spine, 2002, 27(21): 2396-2408.
18. Burkus JK, Dorchak JD, Sanders DL. Radiographic assessment of interbody fusion using recombinant human bone morphogenetic protein type 2. Spine, 2003, 28(4): 372-377.
19. Coric D, Fischgrund JS, Patel T, et al. 772 Two-year follow-up on patients in a pilot safety and efficacy study of OP-1 (rhBMP-7) in posterolateral lumbar fusion as a replacement for iliac crest autograft neurological surgeons. Neurosurg, 2004, 55(2): 477.
20. Ackerman SJ, Mafilios MS, Polly DW. Economic evaluation of bone morphogenetic protein versus autogenous iliac crest bone graft in single-level anterior lumbar fusion: an evidence-based model ing approach. Spine, 2002, 27(16 Suppl 1): S94-99.
21. Anand N, Hamilton JF, Perri B, et al. Cantilever TLIF with structural allograft and RhBMP2 for correction and maintenance of segmental sagittal lordosis: long-term clinical, radiographic, and functional outcome. Spine, 2006, 31(20): E748-753.
22. Mummaneni PV, Pan J, Haid RW, et al. 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. J Neurosurg Spine, 2004, 1(1): 19-23.
23. Joseph V, Rampersaud YR. Heterotopic bone formation with the use of rhBMP2 in posterior minimal access interbody fusion: a CT analysis. Spine, 2007, 32(25): 2885-2890.
24. Boden SD, Kang J, Sandhu H, et al. 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, 2002, 27(23): 2662-2673.
25. Sasso RC, LeHuec JC, Shaffrey C. Iliac crest bone graft donor site pain after anterior lumbar interbody fusion: a prospective patient satisfaction outcome assessment. J Spinal Disord Tech, 2005, 18(Suppl): S77-81.

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