Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages.
In a multicenter, prospective, randomized, nonblinded, 2-year study, 279 patients with degenerative lumbar disc disease were randomly divided into two groups that underwent interbody fusion using two tapered threaded fusion cages. The investigational group (143 patients) received rhBMP-2 on an absorbable collagen sponge, and a control group (136 patients) received autogenous iliac crest bone graft. Plain radiographs and computed tomographic scans were used to evaluate fusion at 6, 12, and 24 months after surgery. Mean operative time (1.6 hours) and blood loss (109.8 mL) were less in the investigational rhBMP-2 group than in the autograft control group (2.0 hours and 153.1 mL). At 24 months the investigational group's fusion rate (94.5%) remained higher than that of the control group (88.7%). New bone formation occurred in all investigational patients. At all intervals, mean postoperative Oswestry, back pain, and leg pain scores and neurologic status improved in both treatment groups with similar outcomes. In the control group, eight adverse events related to the iliac crest graft harvest occurred (5.9%), and at 24 months 32% of patients reported graft site discomfort and 16% were bothered by its appearance. Lumbar fusion using rhBMP-2 and a tapered titanium fusion cage can yield a solid union and eliminate the need for harvesting iliac crest bone graft.
Burkus
J Kenneth
JK
Spine Service, Hughston Clinic, P.C., Columbus, Georgia 31908-9517, USA. jkb66@knology.net
Gornet
Matthew F
MF
Dickman
Curtis A
CA
Zdeblick
Thomas A
TA
D000328:Adult; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins / Q000627:therapeutic use*; D001861:Bone Regeneration; D016025:Bone Transplantation; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000209:etiology; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D013122:Spinal Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery*; D013123:Spinal Fusion / Q000379:methods*; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016212:Transforming Growth Factor beta; D014182:Transplantation, Autologous; D016896:Treatment Outcome
C525718:BMP2 protein, human; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; C499469:recombinant human bone morphogenetic protein-2