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Is INFUSE Bone Graft Superior to Autograft Bone? An Integrated Analysis of Clinical Trials Using the LT-CAGE Lumbar Tapered Fusion Device

 

作者: J. Burkus,   Stephen Heim,   Matthew Gornet,   Thomas Zdeblick,  

 

期刊: Journal of Spinal Disorders & Techniques  (OVID Available online 2003)
卷期: Volume 16, issue 2  

页码: 113-122

 

ISSN:1536-0652

 

年代: 2003

 

出版商: OVID

 

关键词: Anterior lumbar interbody fusion;INFUSE Bone Graft;Bone morphogenetic protein;Fusion cage;Degenerative disc disease;Lumbar spine;rhBMP-2

 

数据来源: OVID

 

摘要:

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.

 

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