Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: Bone graft extenders and substitutes as an adjunct for lumbar fusion

Journal of Neurosurgery: Spine

Volumn 21, Issue 1, 2014, Pages 106-132

  Kaiser, Michael G ^a   Groff, Michael W ^b   Watters III, William C ^c   Ghogawala, Zoher ^d,e   Mummaneni, Praveen V ^f   Dailey, Andrew T ^g   Choudhri, Tanvir F ^h   Eck, Jason C ⁱ   Sharan, Alok ^j   Wang, Jeffrey C ^k   Dhall, Sanjay S ^f   Resnick, Daniel K ^l  

^a NEUROLOGICAL INSTITUTE   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c Bone and Joint Clinic of Houston   (United States)

^d LAHEY HOSPITAL AND MEDICAL CENTER   (United States)

^e TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^h MOUNT SINAI SCHOOL OF MEDICINE   (United States)

ⁱ Center for Sports Medicine and Orthopaedics Chattanooga   (United States)

^j ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^k UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^l UNIVERSITY OF WISCONSIN MADISON   (United States)

more..

Author keywords

Bone graft; Bone morphogenetic protein; Bone substitute; Fusion; Lumbar spine; Practice guidelines

Indexed keywords

ABSORBABLE COLLAGEN SPONGE; CALCIUM PHOSPHATE; CALCIUM SULFATE; COLLAGEN SPONGE; HYDROXYAPATITE; RECOMBINANT BONE MORPHOGENETIC PROTEIN 2; UNCLASSIFIED DRUG;

ARTICLE; BONE CONDUCTION; BONE DEVELOPMENT; BONE EXTENDER; BONE GRAFT; BONE MATRIX; DEGENERATIVE DISEASE; DONOR SITE; FOLLOW UP; HUMAN; LUMBAR SPINE; MEDLINE; OPERATION DURATION; OPERATIVE BLOOD LOSS; OSSIFICATION; POSTOPERATIVE PAIN; PRACTICE GUIDELINE; RADICULITIS; SPINE DISEASE; SPINE FUSION;

ACS = ABSORBABLE COLLAGEN SPONGE; AICB = AUTOLOGOUS ILIAC CREST BONE; ALIF = ANTERIOR LUMBAR INTERBODY FUSION; BMA = BONE MARROW ASPIRATE; BONE GRAFT; BONE MORPHOGENETIC PROTEIN; BONE SUBSTITUTE; CHA = CORALLINE HYDROXYAPATITE; CRM = COMPRESSION-RESISTANT MATRIX; DBM = DEMINERALIZED BONE MATRIX; FRA = FEMORAL RING ALLOGRAFT; FUSION; HA = HYDROXYAPATITE; ICBG = ILIAC CREST BONE GRAFT; IDE = INVESTIGATIONAL DEVICE EXEMPTION; LUMBAR SPINE; MJOA = MODIFIED JAPANESE ORTHOPAEDIC ASSOCIATION; NRS = NUMERIC RATING SCALE; ODI = OSWESTRY DISABILITY INDEX; OP-1 = OSTEOGENIC PROTEIN-1; PLIF = POSTERIOR LUMBAR INTERBODY FUSION; PRACTICE GUIDELINES; RCT = RANDOMIZED CONTROLLED TRIAL; RHBMP = RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN; SF-36 = 36-ITEM SHORT FORM HEALTH SURVEY; TLIF = TRANSFORAMINAL LUMBAR INTERBODY FUSION; VAS = VISUAL ANALOG SCALE; Β-TCP = Β-TRICALCIUM PHOSPHATE;

BONE MORPHOGENETIC PROTEINS; BONE SUBSTITUTES; BONE TRANSPLANTATION; EVIDENCE-BASED MEDICINE; HUMANS; LUMBAR VERTEBRAE; PRACTICE GUIDELINES AS TOPIC; SPINAL DISEASES; SPINAL FUSION;

EID: 84903882124     PISSN: 15475654     EISSN: 15475646     Source Type: Journal    
DOI: 10.3171/2014.4.SPINE14325     Document Type: Article

References (67)

1. Acharya NK, Kumar RJ, Varma HK, Menon VK: Hydroxyap-atite- bioactive glass ceramic composite as stand-alone graft substitute for posterolateral fusion of lumbar spine: a prospective, matched, and controlled study. J Spinal Disord Tech 21:106-111, 2008 (Pubitemid 351507599)
2. Agarwal R, Williams K, Umscheid CA, Welch WC: Osteoinductive bone graft substitutes for lumbar fusion: a systematic review. Clinical article. J Neurosurg Spine 11:729-740, 2009
3. Balseiro S, Nottmeier EW: Vertebral osteolysis originating from subchondral cyst end plate defects in transforaminal lumbar interbody fusion using rhBMP-2. Report of two cases. Spine J 10:e6-e10, 2010
4. Banwart JC, Asher MA, Hassanein RS: Iliac crest bone graft harvest donor site morbidity. A statistical evaluation. Spine (Phila Pa 1976) 20:1055-1060, 1995
5. Burkus JK, Dorchak JD, Sanders DL: Radiographic assessment of interbody fusion using recombinant human bone morphogenetic protein type 2. Spine (Phila Pa 1976) 28:372-377, 2003
6. Burkus JK, Gornet MF, Dickman CA, Zdeblick TA: Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. J Spinal Disord Tech 15:337-349, 2002
7. Burkus JK, Gornet MF, Schuler TC, Kleeman TJ, Zdeblick TA: 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 91:1181-1189, 2009
8. Cammisa FP Jr, Lowery G, Garfin SR, Geisler FH, Klara PM, McGuire RA, 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 (Phila Pa 1976) 29:660-666, 2004
9. Carragee EJ, Ghanayem AJ, Weiner BK, Rothman DJ, Bono CM: A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors. Spine J 11:463-468, 2011
10. Carragee EJ, Mitsunaga KA, Hurwitz EL, Scuderi GJ: Retrograde ejaculation after anterior lumbar interbody fusion using rhBMP-2: a cohort controlled study. Spine J 11:511-516, 2011
11. Carter JD, Swearingen AB, Chaput CD, Rahm MD: Clinical and radiographic assessment of transforaminal lumbar interbody fusion using HEALOS collagen-hydroxyapatite sponge with autologous bone marrow aspirate. Spine J 9:434-438, 2009
12. Chang CH, Lin MZ, Chen YJ, Hsu HC, Chen HT: Local autogenous bone mixed with bone expander: an optimal option of bone graft in single-segment posterolateral lumbar fusion. Surg Neurol 70 Suppl 1:S47-S49, 2008
13. Chen CL, Liu CL, Sun SS, Han PY, Lee CS, Lo WH: Posterolateral lumbar spinal fusion with autogenous bone chips from laminectomy extended with OsteoSet. J Chin Med Assoc 69:581-584, 2006
14. Chen NF, Smith ZA, Stiner E, Armin S, Sheikh H, Khoo LT: Symptomatic ectopic bone formation after off-label use of recombinant human bone morphogenetic protein-2 in transforaminal lumbar interbody fusion. Report of 4 cases. J Neurosurg Spine 12:40-46, 2010
15. Chen WJ, Tsai TT, Chen LH, Niu CC, Lai PL, Fu TS, et al: The fusion rate of calcium sulfate with local autograft bone compared with autologous iliac bone graft for instrumented short-segment spinal fusion. Spine (Phila Pa 1976) 30:2293-2297, 2005
16. Dai LY, Jiang LS: Single-level instrumented posterolateral fusion of lumbar spine with beta-tricalcium phosphate versus autograft: a prospective, randomized study with 3-year follow-up. Spine (Phila Pa 1976) 33:1299-1304, 2008
17. Dawson E, Bae HW, Burkus JK, Stambough JL, Glassman SD: 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 91:1604-1613, 2009
18. Delawi D, Dhert WJ, Rillardon L, Gay E, Prestamburgo D, Garcia-Fernandez C, et al: A prospective, randomized, controlled, multicenter study of osteogenic protein-1 in instrumented posterolateral fusions: report on safety and feasibility. Spine (Phila Pa 1976) 35:1185-1191, 2010
19. Dimar JR, Glassman SD, Burkus KJ, Carreon LY: 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 (Phila Pa 1976) 31:2534-2540, 2006
20. Dimar JR II, Glassman SD, Burkus JK, Pryor PW, Hardacker JW, Carreon LY: Clinical and radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral lumbar spine arthrodesis. J Bone Joint Surg Am 91:1377-1386, 2009
21. Epstein NE: Beta tricalcium phosphate: observation of use in 100 posterolateral lumbar instrumented fusions. Spine J 9:630-638, 2009
22. Epstein NE: Efficacy of different bone volume expanders for augmenting lumbar fusions. Surg Neurol 69:16-19, 2008
23. Garrett MP, Kakarla UK, Porter RW, Sonntag VKH: Formation of painful seroma and edema after the use of recombinant human bone morphogenetic protein-2 in posterolateral lumbar spine fusions. Neurosurgery 66:1044-1049, 2010
24. Geibel PT, Boyd DL, Slabisak V: The use of recombinant human bone morphogenic protein in posterior interbody fusions of the lumbar spine: a clinical series. J Spinal Disord Tech 22:315-320, 2009
25. Glassman SD, Carreon L, Djurasovic M, Campbell MJ, Puno RM, Johnson JR, et al: Posterolateral lumbar spine fusion with INFUSE bone graft. Spine J 7:44-49, 2007 (Pubitemid 46002546)
26. Glassman SD, Carreon LY, Djurasovic M, Campbell MJ, Puno RM, Johnson JR, et al: RhBMP-2 versus iliac crest bone graft for lumbar spine fusion: a randomized, controlled trial in patients over sixty years of age. Spine (Phila Pa 1976) 33:2843-2849, 2008
27. Glassman SD, Dimar JR III, Burkus K, Hardacker JW, Pryor PW, Boden SD, et al: The efficacy of rhBMP-2 for posterolateral lumbar fusion in smokers. Spine (Phila Pa 1976) 32:1693-1698, 2007
28. Goldberg VM, Stevenson S: Natural history of autografts and allografts. Clin Orthop Relat Res (225):7-16, 1987 (Pubitemid 18009305)
29. Haid RW Jr, Branch CL Jr, Alexander JT, Burkus JK: Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages. Spine J 4:527-539, 2004
30. Hamilton DK, Jones-Quaidoo SM, Sansur C, Shaffrey CI, Oskouian R, Jane JA Sr: Outcomes of bone morphogenetic pro-tein- 2 in mature adults: posterolateral non-instrument-assisted lumbar decompression and fusion. Surg Neurol 69:457-462, 2008
31. Heary RF, Schlenk RP, Sacchieri TA, Barone D, Brotea C: Persistent iliac crest donor site pain: independent outcome assessment. Neurosurgery 50:510-517, 2002 (Pubitemid 36322833)
32. Hsu CJ, Chou WY, Teng HP, Chang WN, Chou YJ: Coralline hydroxyapatite and laminectomy-derived bone as adjuvant graft material for lumbar posterolateral fusion. J Neurosurg Spine 3:271-275, 2005
33. Jenis LG, Banco RJ: Efficacy of silicate-substituted calcium phosphate ceramic in posterolateral instrumented lumbar fusion. Spine (Phila Pa 1976) 35:E1058-E1063, 2010
34. Joseph V, Rampersaud YR: Heterotopic bone formation with the use of rhBMP2 in posterior minimal access interbody fusion: a CT analysis. Spine (Phila Pa 1976) 32:2885-2890, 2007
35. Kanayama M, Hashimoto T, Shigenobu K, Yamane S, Bauer TW, Togawa D: 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 (Phila Pa 1976) 31:1067-1074, 2006
36. Katayama Y, Matsuyama Y, Yoshihara H, Sakai Y, Nakamura H, Imagama S, et al: Clinical and radiographic outcomes of posterolateral lumbar spine fusion in humans using recombinant human bone morphogenetic protein-2: an average fiveyear follow-up study. Int Orthop 33:1061-1067, 2009
37. Knox JB, Dai JM III, Orchowski J: Osteolysis in transforaminal lumbar interbody fusion with bone morphogenetic protein-2. Spine (Phila Pa 1976) 36:672-676, 2011
38. Korovessis P, Koureas G, Zacharatos S, Papazisis Z, Lambiris E: Correlative radiological, self-assessment and clinical analysis of evolution in instrumented dorsal and lateral fusion for degenerative lumbar spine disease. Autograft versus coralline hydroxyapatite. Eur Spine J 14:630-638, 2005 (Pubitemid 41414079)
39. Kurz LT, Garfin SR, Booth RE Jr: Harvesting autogenous iliac bone grafts. A review of complications and techniques. Spine (Phila Pa 1976) 14:1324-1331, 1989
40. Lanman TH, Hopkins TJ: 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, 2004
41. Lee JH, Hwang CJ, Song BW, Koo KH, Chang BS, Lee CK: A prospective consecutive study of instrumented posterolateral lumbar fusion using synthetic hydroxyapatite (Bongros-HA) as a bone graft extender. J Biomed Mater Res A 90:804-810, 2009
42. Lewandrowski KU, Nanson C, Calderon R: Vertebral osteolysis after posterior interbody lumbar fusion with recombinant human bone morphogenetic protein 2: a report of five cases. Spine J 7:609-614, 2007 (Pubitemid 47471438)
43. Mindea SA, Shih P, Song JK: Recombinant human bone morphogenetic protein-2-induced radiculitis in elective minimally invasive transforaminal lumbar interbody fusions: a series review. Spine (Phila Pa 1976) 34:1480-1485, 2009
44. Mummaneni PV, Pan J, Haid RW, Rodts GE: 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 1:19-23, 2004 (Pubitemid 38812651)
45. Neen D, Noyes D, Shaw M, Gwilym S, Fairlie N, Birch N: Healos and bone marrow aspirate used for lumbar spine fusion: a case controlled study comparing healos with autograft. Spine (Phila Pa 1976) 31:E636-E640, 2006
46. Ong KL, Villarraga ML, Lau E, Carreon LY, Kurtz SM, Glassman SD: Off-label use of bone morphogenetic proteins in the United States using administrative data. Spine (Phila Pa 1976) 35:1794-1800, 2010
47. Pradhan BB, Bae HW, Dawson EG, Patel VV, Delamarter RB: Graft resorption with the use of bone morphogenetic protein: lessons from anterior lumbar interbody fusion using femoral ring allografts and recombinant human bone morphogenetic protein-2. Spine (Phila Pa 1976) 31:E277-E284, 2006
48. Resnick DK, Choudhri TF, Dailey AT, Groff MW, Khoo L, Matz PG, et al: Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: bone graft extenders and substitutes. J Neurosurg Spine 2: 733-736, 2005
49. Rihn JA, Makda J, Hong J, Patel R, Hilibrand AS, Anderson DG, et al: The use of RhBMP-2 in single-level transforaminal lumbar interbody fusion: a clinical and radiographic analysis. Eur Spine J 18:1629-1636, 2009
50. Rihn JA, Patel R, Makda J, Hong J, Anderson DG, Vaccaro AR, et al: Complications associated with single-level transforaminal lumbar interbody fusion. Spine J 9:623-629, 2009
51. Schizas C, Triantafyllopoulos D, Kosmopoulos V, Tzinieris N, Stafylas K: Posterolateral lumbar spine fusion using a novel demineralized bone matrix: a controlled case pilot study. Arch Orthop Trauma Surg 128:621-625, 2008
52. Shah RK, Moncayo VM, Smitson RD, Pierre-Jerome C, Terk MR: Recombinant human bone morphogenetic protein 2-induced heterotopic ossification of the retroperitoneum, psoas muscle, pelvis and abdominal wall following lumbar spinal fusion. Skeletal Radiol 39:501-504, 2010
53. Singh K, Smucker JD, Gill S, Boden SD: 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 19:416-423, 2006 (Erratum in J Spinal Disord Tech 20:185, 2007) (Pubitemid 44197593)
54. Slosar PJ, Josey R, Reynolds J: Accelerating lumbar fusions by combining rhBMP-2 with allograft bone: a prospective analysis of interbody fusion rates and clinical outcomes. Spine J 7: 301-307, 2007 (Pubitemid 46667736)
55. Summers BN, Eisenstein SM: Donor site pain from the ilium. A complication of lumbar spine fusion. J Bone Joint Surg Br 71:677-680, 1989 (Pubitemid 19211233)
56. Taghavi CE, Lee KB, Keorochana G, Tzeng ST, Yoo JH, Wang JC: Bone morphogenetic protein-2 and bone marrow aspirate with allograft as alternatives to autograft in instrumented revision posterolateral lumbar spinal fusion: a minimum two-year follow-up study. Spine (Phila Pa 1976) 35:1144-1150, 2010
57. Urist MR: Bone: formation by autoinduction. Science 150:893-899, 1965
58. US Food and Drug Administration: InFUSE™ Bone Graft/ LT-CAGE™ Lumbar Tapered Fusion Device - P000058. http://www.fda.gov/MedicalDevices/ ProductsandMedical Procedures/DeviceApprovalsandClearances/Recently-Ap provedDevices/ucm083423.htm) [Accessed April 21, 2014]
59. US Food and Drug Administration: Listing of CDRH Humanitarian Device Exemptions. (http://www.fda.gov/Medical Devices/ProductsandMedicalProcedures/ DeviceApprovals andClearances/HDEApprovals/ucm161827.htm) [Accessed April 21, 2014]
60. US Food and Drug Administration: OP-1 Putty - H0200008. (http://www.fda.gov/MedicalDevices/ProductsandMedical rocedures/ DeviceApprovalsandClearances/Recently-App rovedDevices/ucm081181.htm) [Accessed April 21, 2014]
61. Vaccaro AR, Anderson DG, Patel T, Fischgrund J, Truumees E, Herkowitz HN, 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 (Phila Pa 1976) 30:2709-2716, 2005
62. Vaccaro AR, Lawrence JP, Patel T, Katz LD, Anderson DG, Fischgrund JS, et al: The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis: a long-term (>4 years) pivotal study. Spine (Phila Pa 1976) 33:2850-2862, 2008
63. Vaccaro AR, Patel T, Fischgrund J, Anderson DG, Truumees E, Herkowitz H, et al: A pilot safety and efficacy study of OP-1 putty (rhBMP-7) as an adjunct to iliac crest autograft in posterolateral lumbar fusions. Eur Spine J 12:495-500, 2003 (Pubitemid 37409948)
64. Vaccaro AR, Patel T, Fischgrund J, Anderson DG, Truumees E, Herkowitz HN, 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 (Phila Pa 1976) 29:1885-1892, 2004
65. Vaccaro AR, Whang PG, Patel T, Phillips FM, Anderson DG, Albert TJ, et al: The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft for posterolateral lumbar arthrodesis: minimum 4-year follow-up of a pilot study. Spine J 8:457-465, 2008 (Pubitemid 351608966)
66. Vaidya R, Weir R, Sethi A, Meisterling S, Hakeos W, Wybo CD: Interbody fusion with allograft and rhBMP-2 leads to consistent fusion but early subsidence. J Bone Joint Surg Br 89:342-345, 2007 (Pubitemid 46563910)
67. Villavicencio AT, Burneikiene S, Nelson EL, Bulsara KR, Favors M, Thramann J: Safety of transforaminal lumbar interbody fusion and intervertebral recombinant human bone morphogenetic protein-2. J Neurosurg Spine 3:436-443, 2005