*University of Calgary Spine Program and Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta †Division of Orthopedic Surgery, Dalhousie University, Halifax, Nova Scotia, Canada ‡Division of Orthopedic Surgery, University of Western Ontario, London, Ontario, Canada §Division of Orthopedic Surgery, University of Alberta, Edmonton, Alberta, Canada ¶Division of Orthopedic Surgery, Dalhousie University, St. John, New Brunswick, Canada ‖Division of Orthopedic Surgery, Trillium Health Centre, Mississauga, Ontario, Canada; **Division of Orthopedic Surgery, University of Montreal, Montreal, Quebec, Canada; and ††Division of Orthopedic Surgery, University of British Columbia, Vancouver, British Columbia, Canada.
Spine (Phila Pa 1976). 2013 Dec 1;38(25):2139-48. doi: 10.1097/BRS.0000000000000007.
Multicenter randomized controlled trial.
To evaluate the effect of recombinant human bone morphogenetic protein (rhBMP-2) on radiographical fusion rate and clinical outcome for surgical lumbar arthrodesis compared with iliac crest autograft.
In many types of spinal surgery, radiographical fusion is a primary outcome equally important to clinical improvement, ensuring long-term stability and axial support. Biologic induction of bone growth has become a commonly used adjunct in obtaining this objective. We undertook this study to objectify the efficacy of rhBMP-2 compared with traditional iliac crest autograft in instrumented posterolateral lumbar fusion.
Patients undergoing 1- or 2-level instrumented posterolateral lumbar fusion were randomized to receive either autograft or rhBMP-2 for their fusion construct. Clinical and radiographical outcome measures were followed for 2 to 4 years postoperatively.
One hundred ninety seven patients were successfully randomized among the 8 participating institutions. Adverse events attributable to the study drug were not significantly different compared with controls. However, the control group experienced significantly more graft-site complications as might be expected. 36-Item Short Form Health Survey, Oswestry Disability Index, and leg/back pain scores were comparable between the 2 groups. After 4 years of follow-up, radiographical fusion rates remained significantly higher in patients treated with rhBMP-2 (94%) than those who received autograft (69%) (P = 0.007).
The use of rhBMP-2 for instrumented posterolateral lumbar surgery significantly improves the chances of radiographical fusion compared with the use of autograft. However, there is no associated improvement in clinical outcome within a 4-year follow-up period. These results suggest that use of rhBMP-2 should be considered in cases where lumbar arthrodesis is of primary concern.
多中心随机对照试验。
评估与自体髂嵴骨移植物相比，重组人骨形态发生蛋白（rhBMP-2）对手术腰椎融合的影像学融合率和临床结果的影响。
在许多类型的脊柱手术中，影像学融合是与临床改善同样重要的主要结果，它可确保长期稳定性和轴向支撑。生物诱导骨生长已成为获得这一目标的常用辅助手段。我们进行这项研究的目的是客观地评估 rhBMP-2 与传统自体髂嵴骨移植物在器械性后路腰椎融合中的疗效。
接受 1 或 2 节段器械性后路腰椎融合的患者被随机分为接受自体移植物或 rhBMP-2 作为融合构建物。术后 2 至 4 年随访临床和影像学结果。
8 家参与机构共成功随机分配了 197 例患者。与对照组相比，与研究药物相关的不良事件并无显著差异。然而，对照组的植骨部位并发症明显更多，这可能是意料之中的。36 项简短健康调查、Oswestry 残疾指数和腿部/背部疼痛评分在两组之间无显著差异。4 年随访后，rhBMP-2 治疗组（94%）影像学融合率显著高于自体移植物组（69%）（P=0.007）。
与自体移植物相比，rhBMP-2 用于器械性后路腰椎手术可显著提高影像学融合的机会。然而，在 4 年随访期间，临床结果没有改善。这些结果表明，在腰椎融合是主要关注点的情况下，应考虑使用 rhBMP-2。
