Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device
Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device
复制标题
DOI：
10.1097/00024720-200304000-00001
复制
发表时间：
2003-04-01
影响因子：
--
通讯作者：
Zdeblick, TA
中科院分区：
文献类型：
--
作者：
Burkus, JK;Heim, TE;Zdeblick, TA
对接受前路腰椎融合术的患者进行了多中心人体临床研究，使用重组骨形态发生蛋白或rhBMP-2在可吸收胶原海绵上，作为INFUSE骨移植物销售，或植入LT-CAGE腰椎锥形融合器中的自体移植物。使用协方差分析对多项临床研究进行综合分析，以调整总计679例患者的术前变量。在这些患者中，277例在可吸收胶原海绵上植入了rhBMP-2融合器，402例接受了从髂嵴转移的自体移植物。在手术时间、失血量、住院时间、再手术率、恢复工作的中位时间和6、12和24个月时的融合率方面，接受rhBMP-2治疗的患者具有统计学上更优的上级结局。第3、6、12和24个月时的SF-36量表的奥斯韦斯特里功能障碍指数评分和身体成分评分和疼痛指数显示rhBMP-2组具有统计学上的上级结局。
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.