A prospective, randomized, controlled, multicenter study of osteogenic protein-1 in instrumented posterolateral fusions: Report on safety and feasibility

Spine

Volumn 35, Issue 12, 2010, Pages 1185-1191

  Delawi, D ^a   Dhert, W J A ^a   Rillardon, L ^b   Gay, E ^c   Prestamburgo, D ^d   Garcia Fernandez, C ^e   Guerado, E ^f   Specchia, N ^g   Van Susante, J L C ^h   Verschoor, N ⁱ   Van Ufford, H M E Quarles ^a   Oner, F C ^a  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^b BEAUJON HOSPITAL   (France)

^c CHU La Tronche and University   (France)

^d OSPEDALE DI CIRCOLO   (Italy)

^e HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^f HOSPITAL COSTA DEL SOL   (Spain)

^g Ospedale Ruiniti di Ancona   (Italy)

^h Department of Orthopaedics ^*  (Netherlands)

ⁱ JEROEN BOSCH HOSPITAL   (Netherlands)

Author keywords

Autograft; BMP 7; Bone morphogenetic proteins; OP 1; Spinal fusion

Indexed keywords

OSTEOGENIC PROTEIN 1;

ADULT; ARTICLE; AUTOGRAFT; BONE GRAFT; BONE RADIOGRAPHY; CARDIOVASCULAR DISEASE; CLINICAL ARTICLE; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; FEASIBILITY STUDY; FEMALE; HEMATOMA; HERNIA; HUMAN; ILIAC CREST; LAMINECTOMY; LEG PAIN; MALE; MALIGNANT NEOPLASTIC DISEASE; MORBIDITY; MULTICENTER STUDY; NERVE INJURY; OSWESTRY DISABILITY INDEX; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SPINE FUSION; SPINE INSTRUMENTED POSTEROLATERAL FUSION; SPONDYLOLISTHESIS; SURGICAL APPROACH; SURGICAL TECHNIQUE;

ADULT; AGED; BONE MORPHOGENETIC PROTEIN 7; BONE TRANSPLANTATION; FEASIBILITY STUDIES; FEMALE; FOLLOW-UP STUDIES; HEMATOMA; HUMANS; ILIUM; LUMBAR VERTEBRAE; MALE; MIDDLE AGED; PILOT PROJECTS; PROSPECTIVE STUDIES; SPINAL FUSION; SPONDYLOLISTHESIS; TRANSPLANTATION, AUTOLOGOUS; TREATMENT OUTCOME;

EID: 77953020026     PISSN: 03622436     EISSN: 15281159     Source Type: Journal    
DOI: 10.1097/BRS.0b013e3181d3cf28     Document Type: Article

References (23)

1. Arrington ED, Smith WJ, Chambers HG, et al. Complications of iliac crest bone graft harvesting. Clin Orthop Relat Res 1996;329:300-9.
2. Younger EM, Chapman MW. Morbidity at bone graft donor sites. J Orthop Trauma 1989;3:192-5.
3. Fernyhough JC, Schimandle JJ, Weigel MC, et al. Chronic donor site pain complicating bone graft harvesting from the posterior iliac crest for spinal fusion. Spine 1992;17:1474-80.
4. Urist MR. Bone: formation by autoinduction. Science 1965;150:893-9.
5. Wozney JM. Overview of bone morphogenetic proteins. Spine 2002; 27 (16 suppl 1) : S2-8.
6. 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;27:2396-408.
7. 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;27:2654-61.
8. 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;31:1067-74.
9. Vaccaro AR, Patel T, Fischgrund J, et al. A 2-year follow-up pilot study evaluating the safety and efficacy of op-1 putty (rhbmp-7) as an adjunct to iliac crest autograft in posterolateral lumbar fusions. Eur Spine J 2005;14:623-9. (Pubitemid 41414078)
10. Vaccaro AR, Lawrence JP, Patel T, 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 2008;33:2850-62.
11. Fairbank JC, Couper J, Davies JB, et al. The Oswestry low back pain disability questionnaire. Physiotherapy 1980;66:271-3.
12. Christensen FB, Laursen M, Gelineck J, et al. Interobserver and intraobserver agreement of radiograph interpretation with and without pedicle screw implants: the need for a detailed classification system in posterolateral spinal fusion. Spine 2001;26:538-44.
13. Anderson DG, Andersson GB, Boden SD, et al. Summary statement: clinical BMP programs. Spine 2002; 27 (16 suppl 1) : S49.
14. Fischgrund JS. The argument for instrumented decompressive posterolateral fusion for patients with degenerative spondylolisthesis and spinal stenosis. Spine 2004;29:173-4.
15. Perri B, Cooper M, Lauryssen C, et al. Adverse swelling associated with use of rh-BMP-2 in anterior cervical discectomy and fusion: a case study. Spine J 2007;7:235-9.
16. Wood GW, Boyd RJ, Carothers TA, et al. The effect of pedicle screw/plate fixation on lumbar/lumbosacral autogenous bone graft fusions in patients with degenerative disc disease. Spine 1995;20:819-30.
17. Zdeblick TA. A prospective, randomized study of lumbar fusion. Preliminary results. Spine 1993;18:983-91.
18. Sengupta DK, Truumees E, Patel CK, et al. Outcome of local bone versus autogenous iliac crest bone graft in the instrumented posterolateral fusion of the lumbar spine. Spine 2006;31:985-91.
19. Initial scientific discussion for the approval of Osigraft. 1 October 2004. 2007. Available at: http://www.ema.europa.eu/humandocs/PDFs/EPAR/osigraft/ 039301en6.pdf.
20. Poynton AR, Lane JM. Safety profile for the clinical use of bone morphogenetic proteins in the spine. Spine 2002; 27 (16 suppl 1) : S40-8.
21. Dirks PB. Brain tumour stem cells: the undercurrents of human brain cancer and their relationship to neural stem cells. Philos Trans R Soc Lond B Biol Sci 2008;363:139-52.
22. Piccirillo SG, Reynolds BA, Zanetti N, et al. Bone morphogenetic proteins inhibit the tumorigenic potential of human brain tumour-initiating cells. Nature 2006;444:761-5.
23. Brodsky AE, Kovalsky ES, Khalil MA. Correlation of radiologic assessment of lumbar spine fusions with surgical exploration. Spine 1991; 16 (6 suppl) : S261-5.