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羊颈椎融合模型中的生物可吸收椎间融合器

Bioabsorbable interbody cages in a sheep cervical spine fusion model.

作者信息

Kandziora Frank, Pflugmacher Robert, Scholz Matti, Eindorf Tanja, Schnake Klaus J, Haas Norbert P

机构信息

Unfall- und Wiederherstellungschirurgie, Universitätsklinikum Charité der Humboldt-Universität Berlin, Campus Virchow-Klinikum, Germany.

出版信息

Spine (Phila Pa 1976). 2004 Sep 1;29(17):1845-55; discussion 1856. doi: 10.1097/01.brs.0000137060.79732.78.

Abstract

STUDY DESIGN

An experimental study using a sheep cervical spine interbody fusion model.

OBJECTIVES

To compare interbody fusion of an autologous tricortical iliac crest bone graft with two bioabsorbable cages and to determine whether there are differences between the three interbody fusion techniques in 1) the ability to preserve postoperative distraction, 2) the biomechanical stability, and 3) the histologic characteristics of intervertebral bone matrix formation.

SUMMARY AND BACKGROUND DATA

Bioabsorbable cages would be beneficial compared with metallic cages; however, currently no suitable bioabsorbable interbody fusion cage is available.

METHOD

Twenty-four sheep underwent C3/C4 discectomy and fusion. The following stabilization techniques were used: Group 1) autologous tricortical iliac crest bone graft (n = 8); Group 2) bioabsorbable cage made of 70/30 poly(l-lactide-co-d,l-lactide) (experimental) filled with autologous cancellous bone graft (n = 8); Group 3) bioabsorbable cage made of a polymer-calciumphosphate composite (Biomet Europe, Dordrecht, The Netherlands) filled with autologous cancellous bone graft (n = 8). Radiographic scans to determine disc space height were performed before and after surgery and after 1, 2, 4, 8, and 12 weeks, respectively. After 12 weeks, animals were killed, and fusion sites were evaluated using functional radiographic views in flexion and extension. Quantitative computed tomographic scans were used to assess bone mineral density, bone mineral content, and bony callus volume. Biomechanical testing was performed in flexion, extension, axial rotation, and lateral bending to determine stiffness, ROM, and neutral and elastic zone. Histomorphological and histomorphometrical analysis were performed to evaluate fusion and foreign body reactions associated with the bioabsorbable cages.

RESULTS

Over a 12-week period, the polymer-calciumphosphate composite cage showed significantly higher values for disc space height compared with the bone graft and the poly(l-lactide-co-d,l-lactide) cage. Additionally, the polymer-calciumphosphate composite cage demonstrated a significantly higher stiffness and lower ROM, neutral zone, and elastic zone in axial rotation and lateral bending than any other group. However, quantitative computed tomographic scans demonstrated cracks in six of the eight polymer-calciumphosphate composite cages after 12 weeks. Histologically, the highest bone volume/total volume ratio and the highest fusion rate were found in the polymer-calciumphosphate composite cage group. Although the poly(l-lactide-co-d,l-lactide) cage showed grade I through III foreign body reactions in all fusion areas, only two animals developed grade I foreign body reactions with the polymer-calciumphosphate composite cage.

CONCLUSION

After 12 weeks, there was no significant difference between the bioabsorbable poly(l-lactide-co-d,l-lactide) cage and the tricortical bone graft. In comparison to the tricortical bone graft, the bioabsorbable polymer-calciumphosphate composite cage showed significantly better distractive properties, a significantly higher biomechanical stiffness, and an advanced interbody fusion; however, six of eight polymer-calciumphosphate composite cages cracked. Although the fate of the foreign body reactions and the cracks is currently unclear for both bioabsorbable cages, the early appearance of large osteolysis associated with use of the poly(l-lactide-co-d,l-lactide) cage allows skepticism regarding the value of this bioabsorbable implant.

摘要

研究设计

一项使用绵羊颈椎椎间融合模型的实验研究。

目的

比较自体三面皮质髂嵴骨移植与两种可生物吸收椎间融合器的椎间融合情况,并确定这三种椎间融合技术在以下方面是否存在差异:1)术后维持撑开的能力;2)生物力学稳定性;3)椎间骨基质形成的组织学特征。

总结与背景数据

与金属椎间融合器相比,可生物吸收椎间融合器具有优势;然而,目前尚无合适的可生物吸收椎间融合器。

方法

对24只绵羊进行C3/C4椎间盘切除术及融合术。采用以下稳定技术:第1组)自体三面皮质髂嵴骨移植(n = 8);第2组)由70/30聚(L-丙交酯-co-D,L-丙交酯)制成的可生物吸收椎间融合器(实验性)并填充自体松质骨移植(n = 8);第3组)由聚合物-磷酸钙复合材料制成的可生物吸收椎间融合器(荷兰多德雷赫特的Biomet Europe公司)并填充自体松质骨移植(n = 8)。分别在手术前后以及术后1、2、4、8和12周进行X线扫描以确定椎间隙高度。12周后,处死动物,并使用功能位X线片在屈伸位评估融合部位。采用定量计算机断层扫描评估骨密度、骨矿物质含量和骨痂体积。进行屈伸、轴向旋转和侧弯的生物力学测试以确定刚度、活动度以及中性区和弹性区。进行组织形态学和组织形态计量学分析以评估融合情况以及与可生物吸收椎间融合器相关的异物反应。

结果

在12周的观察期内,与骨移植组和聚(L-丙交酯-co-D,L-丙交酯)椎间融合器组相比,聚合物-磷酸钙复合材料椎间融合器组的椎间隙高度值显著更高。此外,聚合物-磷酸钙复合材料椎间融合器组在轴向旋转和侧弯时的刚度显著更高,活动度、中性区和弹性区显著更低。然而,定量计算机断层扫描显示,12周后8个聚合物-磷酸钙复合材料椎间融合器中有6个出现裂缝。组织学检查发现,聚合物-磷酸钙复合材料椎间融合器组的骨体积/总体积比最高,融合率也最高。尽管聚(L-丙交酯-co-D,L-丙交酯)椎间融合器在所有融合区域均显示出I至III级异物反应,但聚合物-磷酸钙复合材料椎间融合器组仅有2只动物出现I级异物反应。

结论

12周后,可生物吸收的聚(L-丙交酯-co-D,L-丙交酯)椎间融合器与三面皮质骨移植之间无显著差异。与三面皮质骨移植相比,可生物吸收的聚合物-磷酸钙复合材料椎间融合器显示出显著更好的撑开性能、显著更高的生物力学刚度以及更先进的椎间融合;然而,8个聚合物-磷酸钙复合材料椎间融合器中有6个出现裂缝。尽管目前尚不清楚两种可生物吸收椎间融合器的异物反应和裂缝的转归情况,但与聚(L-丙交酯-co-D,L-丙交酯)椎间融合器相关的早期大量骨质溶解现象让人对这种可生物吸收植入物的价值产生怀疑。

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