Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device.
Multicenter human clinical studies of patients undergoing anterior lumbar fusion have been conducted using recombinant bone morphogenetic protein or rhBMP-2 on an absorbable collagen sponge, marketed as INFUSE Bone Graft, or autograft implanted in the LT-CAGE Lumbar Tapered Fusion device. An integrated analysis of multiple clinical studies was performed using an analysis of covariance to adjust for preoperative variables in a total of 679 patients. Of these patients, 277 had their cages implanted with rhBMP-2 on an absorbable collagen sponge and 402 received autograft transferred from the iliac crest. The patients treated with rhBMP-2 had statistically superior outcomes with regard to length of surgery, blood loss, hospital stay, reoperation rate, median time to return to work, and fusion rates at 6, 12, and 24 months. Oswestry Disability Index scores and the Physical Component Scores and Pain Index of the SF-36 scale at 3, 6, 12, and 24 months showed statistically superior outcomes in the rhBMP-2 group.
Burkus
J Kenneth
JK
Spine Service, The Hughston Clinic, Columbus, Georgia, USA. JKB66@knology.net
Heim
Stephen E
SE
Gornet
Matthew F
MF
Zdeblick
Thomas A
TA
D000704:Analysis of Variance; D018786:Bone Substitutes / Q000627:therapeutic use; D016025:Bone Transplantation / Q000379:methods / Q000706:statistics & numerical data*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D003094:Collagen / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D013122:Spinal Diseases / Q000453:epidemiology* / Q000601:surgery; D013123:Spinal Fusion / Q000295:instrumentation / Q000379:methods / Q000706:statistics & numerical data*; D014182:Transplantation, Autologous / Q000379:methods / Q000706:statistics & numerical data*
D018786:Bone Substitutes; D003094:Collagen