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

Volumn 27, Issue 23, 2002, Pages 2662-2673

  Boden, Scott D ^a   Kang, James ^a   Sandhu, Harvinder ^a   Heller, John G ^a  

^a EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Bone morphogenetic protein 2; Calcium phosphate; Clinical trial; Spine fusion

Indexed keywords

CALCIUM PHOSPHATE; HYDROXYAPATITE; RECOMBINANT BONE MORPHOGENETIC PROTEIN 2;

ADULT; ARTHRODESIS; ARTICLE; BONE GRAFT; BONE SCREW; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; DISEASE SEVERITY; FEMALE; FOLLOW UP; HEMATOMA; HUMAN; IMAGE ANALYSIS; INSTRUMENTATION; INTERVERTEBRAL DISK DEGENERATION; LEG PAIN; LOW BACK PAIN; LUMBAR SPINE; MAJOR CLINICAL STUDY; MALE; OSTEOSYNTHESIS; PAIN ASSESSMENT; PARESTHESIA; PATIENT SATISFACTION; PILOT STUDY; POSTOPERATIVE COMPLICATION; POSTOPERATIVE HEMORRHAGE; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; SMOKING; SPINE FUSION; SPINE RADIOGRAPHY; SPONDYLOLISTHESIS; TREATMENT FAILURE; TREATMENT OUTCOME;

AWARDS AND PRIZES; BONE MORPHOGENETIC PROTEINS; BONE SUBSTITUTES; BONE TRANSPLANTATION; CALCIUM PHOSPHATES; DRUG IMPLANTS; FEMALE; FOLLOW-UP STUDIES; HUMANS; ILIUM; INTERNAL FIXATORS; INTERVERTEBRAL DISK DISPLACEMENT; LOW BACK PAIN; LUMBOSACRAL REGION; MALE; MIDDLE AGED; PILOT PROJECTS; PROSPECTIVE STUDIES; RECOMBINANT PROTEINS; REOPERATION; SPINAL FUSION; TRANSFORMING GROWTH FACTOR BETA; TREATMENT OUTCOME;

EID: 0036894554     PISSN: 03622436     EISSN: None     Source Type: Journal    
DOI: 10.1097/00007632-200212010-00005     Document Type: Article

References (58)

1. Arrington ED, Smith WJ, Chambers HG, et al. Complications of iliac crest bone graft harvesting. Clin Orthop 1996;329:300-9.
2. Banwart JC, Asher MA, Hassanein RS. Iliac crest bone graft harvest donor site morbidity: A statistical evaluation. Spine 1995;20:1055-60.
3. Boden SD. Bioactive factors for bone tissue engineering. Clin Orthop 1999; S84-94:
4. Boden SD. Clinical application of the BMPs. J Bone Joint Surg [Am] 2001; 83(Suppl 1):S161.
5. Boden SD, Martin GJ, Horton WC, et al. Laparoscopic anterior spinal arthrodesis with rhBMP-2 in a titanium interbody threaded cage. J Spinal Disord 1998;11:95-101.
6. Boden SD, Martin GJ, Morone MA, et al. Posterolateral lumbar intertransverse process spine arthrodesis with rhBMP-2/hydroxyapatite-tricalcium phosphate (HA-TCP) following laminectomy in the nonhuman primate. Spine 1999;24:1179-85.
7. Boden SD, Martin GJ, Morone MA, et al. The use of coralline hydroxyapatite with bone marrow, autogenous bone graft, or osteoinductive bone protein extract for posterolateral lumbar spine fusion. Spine 1999;24:320-7.
8. Boden SD, Moskovitz PA, Morone MA, et al. Video-assisted lateral intertransverse process arthrodesis: Validation of a new minimally invasive lumbar spinal fusion technique in the rabbit and nonhuman primate (rhesus) models. Spine 1996;21:2689-97.
9. Boden SD, Schimandle JH. Biologic enhancement of spinal fusion. Spine 1995;20:113S-23S.
10. Boden SD, Schimandle JH, Hutton WC. Lumbar intertransverse process spine arthrodesis using a bovine-derived osteoinductive bone protein. J Bone Joint Surg [Am] 1995;77:1404-17.
11. Boden SD, Schimandle JH, Hutton WC. 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 1995;20:2633-44.
12. Boden SD, Schimandle JH, Hutton WC, et al. In vivo evaluation of a resorbable osteoinductive composite as a graft substitute for lumbar spinal fusion. J Spinal Disord 1997;10:1-11.
13. Boden SD, Zdeblick 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;25:376-81.
14. Booth KC, Bridwell KH, Eisenberg BA, et al. Minimum 5-year results of degenerative spondylolisthesis treated with decompression and instrumented posterior fusion. Spine 1999;24:1721-7.
15. Bridwell KH, Sedgewick TA, O'Brien MF, et al. The role of fusion and instrumentation in the treatment of degenerative spondylolisthesis with spinal stenosis. J Spinal Disord 1993;6:461-72.
16. Carragee EJ. Single-level posterolateral arthrodesis, with or without posterior decompression, for the treatment of isthmic spondylolisthesis in adults: A prospective, randomized study. J Bone Joint Surg [Am] 1997;79:1175-80.
17. Cook S. Preclinical and clinical evaluation of osteogenic protein-1 (BMP-7) in bony sites. Orthopaedics 999;22:669-71.
18. Cunningham B, Kanayama M, Parker L, et al. Osteogenic protein versus autologous interbody arthrodesis in the sheep thoracic spine: A comparative endoscopic study using the Bagby and Kuslich interbody fusion device. Spine 1999;24:509-18.
19. Fairbank JCT, Davies JB, Mbaot JC, et al. The Oswestry low back pain disability questionnaire. Physiotherapy 1980;66:271-3.
20. Fischgrund JS, Mackay M, Herkowitz HN, et al. 1997 Volvo award winner in clinical studies. Degenerative lumbar spondylolisthesis with spinal stenosis: A prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation. Spine 1997;22: 2807-12.
21. France JC, Yaszemski MJ, Lauerman WC, et al. A randomized prospective study of posterolateral lumbar fusion: Outcomes with and without pedicle screw instrumentation. Spine 1999;24:553-60.
22. Gartsman GM, Khan M, Hammerman SM. Arthroscopic repair of fullthickness tears of the rotator cuff. J Bone Joint Surg [Am] 1998;80:832-40.
23. Goulet JA, Senunas LE, DeSilva GL, et al. Autogenous iliac crest bone graft. Clin Orthop 1997;339:76-81.
24. Grauer JN, Patel TC, Erulkar JS, et al. 2000 Young investigator research award winner. Evaluation of OP-1 as a graft substitute for intertransverse process lumbar fusion. Spine 2001;26:127-33.
25. Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis: A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg [Am] 1991;73: 802-8.
26. Holliger EH, Trawick RH, Boden SD, et al. Morphology of the lumbar intertransverse process fusion mass in the rabbit model: A comparison between two bone graft materials-rhBMP-2 and autograft. J Spinal Disord 1996;9:125-8.
27. Holm S. A simple sequentially rejective Bonferroni test procedure. Scand J Statistics 1979;6:65-70.
28. Jeppsson C, Saveland H, Rydholm U, et al. OP-1 for cervical spine fusion: Bridging bone in only 1 of 4 rheumatoid patients but prednisolone did not inhibit bone induction in rats. Acta Orthop Scand 1999;70:559-63.
29. Kimura I, Shingu H, Murata M, et al. Lumbar posterolateral fusion alone or with transpedicular instrumentation in L4-L5 degenerative spondylolisthesis. J Spinal Disord 2001;14:301-10.
30. Lansky D, Butler JB, Waller FT. Using health status measures in the hospital setting: From acute care to "outcomes management." Med Care 1992;30: MS57-73.
31. Laursen M, Hoy K, Hansen ES, et al. Recombinant bone morphogenetic protein-7 as an intracorporal bone growth stimulator in unstable thoracolumbar burst fractures in humans: Preliminary results. Eur Spine J 1999;8: 485-90.
32. Magin MN, Delling G. Improved lumbar vertebral interbody fusion using rhOP-1: A comparison of autogenous bone graft, bovine hydroxylapatite (Bio-Oss), and BMP-7 (rhOP-1) in sheep. Spine 2001;26:469-78.
33. Martin G, Boden SD, Titus L. Recombinant human bone morphogenetic protein-2 reverses the inhibitory effect of ketorolac, a nonsteroidal antiinflammatory drug (NSAID) on posterolateral lumbar intertransverse process spine fusion. Spine 1999;24:2188-94.
34. Martin GJ, Boden SD, Morone MA, et al. Posterolateral intertransverse process spinal fusion arthrodesis with rhBMP-2 in a nonhuman primate: Important lessons learned regarding dose, carrier, and safety. J Spinal Disord 1999;12:179-86.
35. McGuigan FX, Hozack WJ, Moriarty L, et al. Predicting quality-of-life outcomes following total joint arthroplasty: Limitations of the SF-36 Health Status Questionnaire. J Arthroplasty 1995;10:742-7.
36. McGuire RA, Amundson GM. The use of primary internal fixation in spondylolisthesis. Spine 1993;18:1662-72.
37. McHorney CA, Ware JE, Lu R, et al. The MOS 36-item short-form health survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse groups. Med Care 1994;32:40-66.
38. Moller H, Hedlund R. Surgery versus conservative management in adult isthmic spondylolisthesis: A prospective randomized study: Part 1. Spine 2000;25:1711-15.
39. Muschler GF, Huber B, Ullman T, et al. Evaluation of bone grafting materials in a new canine segmental spinal fusion model. J Orthop Res 1993;11: 514-24.
40. Nork SE, Hu SS, Workman KL, et al. Patient outcomes after decompression and instrumented posterior spinal fusion for degenerative spondylolisthesis. Spine 1999;24:561-9.
41. Ripamonti U, Duneas N, van den Heever B, et al. Recombinant transforming growth factor beta-1 induces endochondral bone in the baboon and synergizes with recombinant osteogenic protein-1 (bone morphogenetic protein-7) to initiate rapid bone formation. J Bone Miner Res 1997;12:1584-95.
42. Rosen V, Wozney JM, Wang EA, et al. Purification and molecular cloning of a novel group of BMPs and localization of BMP mRNA in developing bone. Connect Tissue Res 1989;20:313-19.
43. Sampath TK, Coughlin JE, Whetstone RM, et al. Bovine osteogenic protein is composed of dimers of OP-1 and BMP-2A, two members of the transforming growth factor-β superfamily. J Biol Chem 1990;265:13198-205.
44. Sandhu HS, Kanim LEA, Toth JM, et al. Experimental spinal fusion with recombinant human bone morphogenetic protein-2 without decortication of osseous elements. Spine 1997;22:1171-80.
45. Schimandle JH, Boden SD, Hutton WC. Experimental spinal fusion with recombinant human bone morphogenetic protein-2 (rhBMP-2). Spine 1995; 20:1326-37.
46. Silcox DH, Boden SD, Schimandle JH, et al. Reversing the inhibitory effect of nicotine on spinal fusion using an osteoinductive protein extract. Spine 1998; 23:291-7.
47. Stewart AL, Hays RD, Ware JE. The MOS short-form general health survey (SF-36). Med Care 1988;26:724-32.
48. Thomsen K, Christensen FB, Eiskjaer SP, et al. The effect of pedicle screw instrumentation on functional outcome and fusion rates in posterolateral lumbar spinal fusion: A prospective, randomized clinical study. Spine 1997; 22:2813-22.
49. Urist MR. Bone: Formation by autoinduction. Science 1965;150:893-9.
50. Urist MR, Jurist JM Jr, Dubuc FL, et al. Quantitation of new bone formation in intramuscular implants of bone matrix in rabbits. Clin Orthop 1970;68: 279-93.
51. Urist MR, Strates BS. Bone formation in implants of partially and wholly demineralized bone matrix: Including observations on acetone-fixed intraand extracellular proteins. Clin Orthop 1970;71:271-8.
52. Urist MR, Strates BS. Bone morphogenetic protein. J Dent Res Suppl 1971; 50:1392-406.
53. Wang EA, Rosen V, Cordes P, et al. Purification and characterization of other distinct bone-inducing factors. Proc Natl Acad Sci 1988;85:9484-8.
54. Wang EA, Rosen V, D'Alessandro JS, et al. Recombinant human bone morphogenetic protein induces bone formation. Proc Natl Acad Sci 1990;87: 2220-4.
55. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992;30:473-83.
56. Wozney JM. Bone morphogenetic proteins and their gene expression. In: Noda M, ed. Cellular and Molecular Biology of Bone. Boston: Academic Press, 1993;131-67.
57. Wozney JM, Rosen V, Celeste AJ, et al. Novel regulators of bone formation: Molecular clones and activities. Science 1988;242:1528-34.
58. Zdeblick TA. A prospective, randomized study of lumbar fusion: Preliminary results. Spine 1993;18:983-91.