Burkus J Kenneth, Gornet Matthew F, Dickman Curtis A, Zdeblick Thomas A
Spine Service, Hughston Clinic, P.C., Columbus, Georgia 31908-9517, USA.
J Spinal Disord Tech. 2002 Oct;15(5):337-49. doi: 10.1097/00024720-200210000-00001.
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.
在一项多中心、前瞻性、随机、非盲法的2年研究中,279例退行性腰椎间盘疾病患者被随机分为两组,使用两个锥形螺纹融合器进行椎间融合。研究组(143例患者)在可吸收胶原海绵上接受rhBMP-2,对照组(136例患者)接受自体髂骨移植。在术后6、12和24个月时,使用X线平片和计算机断层扫描评估融合情况。rhBMP-2研究组的平均手术时间(1.6小时)和失血量(109.8 mL)低于自体移植对照组(2.0小时和153.1 mL)。在24个月时,研究组的融合率(94.5%)仍高于对照组(88.7%)。所有研究患者均出现新骨形成。在所有随访期间,两个治疗组的术后Oswestry评分、背痛和腿痛评分以及神经功能状态均有改善,结果相似。在对照组中,发生了8例与髂骨移植采集相关的不良事件(5.9%),在24个月时,32%的患者报告移植部位不适,16%的患者对其外观感到困扰。使用rhBMP-2和锥形钛融合器进行腰椎融合可实现牢固融合,无需采集髂骨移植骨。