The safety of OP-1 for lumbar fusion with decompression - a canine study

The safety of OP-1 for lumbar fusion with decompression - a canine study
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DOI:
10.1097/00006123-199905000-00134
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发表时间:
1999-05-01
期刊:
影响因子:
4.8
通讯作者:
Hadley, MN
Hadley, MN
中科院分区:
医学1区
文献类型:
--
作者:
Paramore, CG;Lauryssen, C;Hadley, MN

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目的:骨形态发生蛋白可作为自体骨的辅助物实现骨融合,重组bmp如成骨蛋白-1 (OP-1)具有完全替代自体骨作为融合底物的潜力。然而,OP-1在脊柱融合术中的安全性知之甚少。本研究考察了鞘囊减压后将OP-1放置于蛛网膜下腔的效果,并将其作为犬腰椎背外侧融合模型的移植物基质。方法:对30只犬进行腰椎减压伴背外侧融合术。打开硬脑膜以模拟术中撕裂,将OP-1放置在蛛网膜下腔和融合床中。16周后处死动物,手工、x线和病理检查脊柱。所有接受OP-1治疗的动物在蛛网膜下腔均出现新骨。该骨压迫脊髓,但未发现神经毒性的临床或病理特征。OP-1治疗的动物在硬脑膜减压部位出现轻度椎管狭窄。触诊结果显示,超过80%接受OP-1治疗的动物发生融合(CT标准为52%),而对照动物只有25%发生融合。结论:重组人OP-1能有效促进犬腰椎背外侧融合模型的融合。然而,骨生长可发生在暴露、减压的硬脑膜上,并可在硬脑膜下和蛛网膜下腔形成。使用OP-1作为脊柱融合术的辅助物似乎有其优点,但必须仔细控制其使用,以避免不必要的骨形成和随后的神经压迫。
OBJECTIVE: Bone morphogenetic proteins can serve as adjuncts to autologous bone to achieve bony fusion, and recombinant BMPs such as osteogenic protein-1 (OP-1) have the potential to replace autologous bone altogether as fusion substrate. However, relatively little is known about the safety of OP-1 for spinal fusion procedures. This study examined the effects of OP-1 intentionally placed in the subarachnoid space following thecal sac decompression, and used as graft substrate in a canine dorsolateral lumbar spine fusion model.METHODS: Lumbar decompression with dorsolateral fusion was performed on 30 canines. The dura was opened to simulate an intraoperative rent and OP-1 was placed in the subarachnoid space and in the fusion bed. Animals were sacrificed after 16 weeks and the spines were examined manually, radiographically and pathologically.RESULTS:. All animals treated with OP-1 developed new bone in the subarachnoid space. This bone compressed the spinal cord, but no clinical or pathological features of neurotoxicity were noted. Mild spinal stenosis was noted at the site of dural decompression in the OP-1 treated animals. Over 80% of animals treated with OP-1 developed fusion as assessed by palpation (52% by CT criteria), while only 25% of control animals fused.CONCLUSIONS: Recombinant human OP-1 is effective at promoting fusion in a canine dorsolateral lumbar spine fusion model. However, bone growth can occur over exposed, decompressed dura, and it can form in the subdural and subarachnoid spaces. The use of OP-1 as an adjunct to spinal fusion appears to have merit, but its use must be carefully controlled to avoid unwanted bone formation and subsequent neural compression.