Dimar John R, Glassman Steven D, Burkus Kenneth J, Carreon Leah Y
Kenton D. Leatherman Spine Center, Louisville, KY, USA.
Spine (Phila Pa 1976). 2006 Oct 15;31(22):2534-9; discussion 2540. doi: 10.1097/01.brs.0000240715.78657.81.
This is a prospective, randomized study comparing iliac crest bone graft to bone morphogenetic protein (BMP)/compression resistant matrix in instrumented posterolateral fusions for single-level lumbar degenerative disease. A higher recombinant human bone morphogenetic protein (rhBMP)-2 dose and a carrier specific for posterior spine applications were used.
As part of a Food and Drug Administration IDE study, clinical outcomes and fusion rates of single-level instrumented posterolateral fusions using iliac crest bone graft or BMP/compression resistant matrix were evaluated.
Although iliac crest graft is the gold standard for lumbar fusion, alternatives to obviate the morbidity of graft harvest have become available. Randomized clinical trials have demonstrated equivalent fusion rates and clinical outcomes with rhBMP-2 and a collagen sponge versus autograft in anterior lumbar fusions. A human pilot study using rhBMP-2 with biphasic calcium phosphate demonstrated similar results for posterolateral fusions.
Demographic and perioperative data, Short Form 36, Oswestry Low Back Pain Disability Index, and leg and back pain scores were determined before surgery, and 1.5, 3, 6, 12, and 24 months after surgery. Independent neuroradiologists' evaluation of fine-cut computerized tomography scans with reconstructions were obtained at 6, 12, and 24 months.
There were 98 subjects, 45 in the iliac crest bone graft group and 53 in the BMP/compression resistant matrix group. There were no significant differences for age, weight, sex, smoking, or previous surgery between the groups. The average operative time (2.9 hours) and blood loss (465 cc) in the iliac crest bone graft group was greater than in the BMP/compression resistant matrix group (2.4 hours and 273 cc). There were no significant differences in any outcome measure at all time intervals. The fusion rate was lower in the iliac crest bone graft group (73%) than in the BMP/compression resistant matrix group (88%) at P = 0.051.
There was significant improvement of Short Form 36 (physical component score and pain), Oswestry Low Back Pain Disability Index, and leg and back pain scores in both groups over all time intervals. Surgical time and blood loss were significantly less in the BMP/compression resistant matrix group. The fusion rate in the BMP/compression resistant matrix group was significantly higher than the iliac crest bone graft group.
这是一项前瞻性随机研究，比较在单节段腰椎退变性疾病的器械辅助后外侧融合术中，髂嵴骨移植与骨形态发生蛋白（BMP）/抗压基质的效果。使用了更高剂量的重组人骨形态发生蛋白（rhBMP）-2以及一种专门用于脊柱后路手术的载体。
作为美国食品药品监督管理局器械临床试验豁免研究的一部分，评估使用髂嵴骨移植或BMP/抗压基质进行单节段器械辅助后外侧融合术的临床结果和融合率。
尽管髂嵴移植是腰椎融合的金标准，但已有其他方法可避免取骨的并发症。随机临床试验表明，在腰椎前路融合术中，rhBMP-2与胶原海绵联合使用与自体移植相比，融合率和临床结果相当。一项使用rhBMP-2与双相磷酸钙的人体初步研究表明，在后外侧融合术中也有类似结果。
在手术前、术后1.5、3、6、12和24个月，测定人口统计学和围手术期数据、简短健康调查问卷36项（Short Form 36）、Oswestry下腰痛残疾指数以及腿部和背部疼痛评分。在术后6、12和24个月，由独立的神经放射科医生对经重建的薄层计算机断层扫描进行评估。
共有98名受试者，髂嵴骨移植组45名，BMP/抗压基质组53名。两组在年龄、体重、性别、吸烟情况或既往手术史方面无显著差异。髂嵴骨移植组的平均手术时间（2.9小时）和失血量（465毫升）均多于BMP/抗压基质组（2.4小时和273毫升）。在所有时间间隔内，任何一项结果指标均无显著差异。髂嵴骨移植组的融合率（73%）低于BMP/抗压基质组（88%），P = 0.051。
两组在所有时间间隔内，简短健康调查问卷36项（身体成分评分和疼痛）、Oswestry下腰痛残疾指数以及腿部和背部疼痛评分均有显著改善。BMP/抗压基质组的手术时间和失血量明显更少。BMP/抗压基质组的融合率显著高于髂嵴骨移植组。
