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聚(丙二醇-共-富马酸)增强型可生物降解椎间融合器的生物力学分析

Biomechanical analysis of biodegradable interbody fusion cages augmented With poly(propylene glycol-co-fumaric acid).

作者信息

Kandziora Frank, Pflugmacher R, Kleemann R, Duda Georg, Wise Donald L, Trantolo Debra J, Lewandrowski Kai-Uwe

机构信息

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

出版信息

Spine (Phila Pa 1976). 2002 Aug 1;27(15):1644-51. doi: 10.1097/00007632-200208010-00010.

Abstract

STUDY DESIGN

Three different types of biodegradable poly(L-lactide-co-D,L-lactide) cages with and without augmentation of a biodegradable poly(propylene glycol-cofumaric acid) scaffold were compared with autograft and metallic cages of the same design and size by determining the stiffness and failure load of the L4-L5 motion segment of cadaveric human spines.

OBJECTIVES

To determine how these devices limit the range of motion in the lumbar spine compared with a metallic cage. If biomechanically equivalent, biodegradable spinal fusion systems ultimately could reduce local stress shielding and diminish the incidence of clinical complications, including device-related osteopenia, implant loosening, and breakage.

SUMMARY OF BACKGROUND DATA

Previous studies in dogs and humans have demonstrated vertebral body osteopenia as a result of instrumented spine fusions. To the authors' knowledge, neither an in vitro nor an in vivo biomechanical analysis of a biodegradable interbody fusion system has been performed.

METHODS

Forty-eight L4-L5 motion segments were isolated from 22 male and 26 female human donors with an average age of 49.6 +/- 2.7 years (range 36-55 years). Cages of similar dimensions and design, including a threaded, hollow, porous titanium BAK cage and three different BIO cages (BIO cage 1, pure polymer; BIO cage 2, polymer plus hydroxyapatite buffer; BIO cage 3, polymer plus nano-sized hydroxyapatite), produced from the same poly(L-lactide-co-D,L-lactide) polymer were tested in a comparative analysis to intact motion segment, interbody implantation of autograft, and a BIO cage augmented with an expandable biodegradable foam-scaffold fashioned from poly(propylene glycol-cofumaric acid).

RESULTS

All cages were able to increase stiffness and failure load of the unstable motion segment significantly (P < 0.01). In comparison with the bone graft, the BAK cage (P < 0.01) and BIO cages 1 and 3 (P < 0.05) were able to increase stiffness and failure load. There was no significant difference between BIO cage 2 and the bone graft. Augmentation of BIO cage 1 with the foaming PPF scaffold resulted in higher stiffness and similar failure load as seen with the BAK cage.

CONCLUSION

By comparison, the in vitro lumbar spinal motion segment stiffness and failure load produced by implantation of a biodegradable interbody fusion cage augmented with an expandable PPF scaffold is similar to that of the titanium BAK cage. This suggests that biodegradable anterior interbody fusion systems could be further developed for clinical applications.

摘要

研究设计

通过测定尸体人脊柱L4-L5运动节段的刚度和破坏载荷,比较三种不同类型的可生物降解聚(L-丙交酯-共-D,L-丙交酯)椎间融合器,其中一种带有可生物降解的聚(丙二醇-共富马酸)支架,另一种没有,同时与相同设计和尺寸的自体骨移植和金属椎间融合器进行比较。

目的

确定与金属椎间融合器相比,这些装置如何限制腰椎的活动范围。如果生物力学等效,可生物降解的脊柱融合系统最终可减少局部应力遮挡,并降低临床并发症的发生率,包括与器械相关的骨质减少、植入物松动和断裂。

背景资料总结

先前在犬类和人类中的研究表明,器械辅助的脊柱融合会导致椎体骨质减少。据作者所知,尚未对可生物降解椎间融合系统进行体外或体内生物力学分析。

方法

从22名男性和26名女性供体中分离出48个L4-L5运动节段,供体平均年龄为49.6±2.7岁(范围36-55岁)。在比较分析中,测试了尺寸和设计相似的椎间融合器,包括带螺纹、中空、多孔的钛制BAK椎间融合器和三种不同的BIO椎间融合器(BIO椎间融合器1,纯聚合物;BIO椎间融合器2,聚合物加羟基磷灰石缓冲剂;BIO椎间融合器3,聚合物加纳米级羟基磷灰石),这些椎间融合器均由相同的聚(L-丙交酯-共-D,L-丙交酯)聚合物制成,同时与完整运动节段、自体骨椎间植入以及一种用由聚(丙二醇-共富马酸)制成的可膨胀生物可降解泡沫支架增强的BIO椎间融合器进行比较。

结果

所有椎间融合器均能显著增加不稳定运动节段的刚度和破坏载荷(P<0.01)。与骨移植相比,BAK椎间融合器(P<0.01)以及BIO椎间融合器1和3(P<0.05)能够增加刚度和破坏载荷。BIO椎间融合器2与骨移植之间无显著差异。用发泡PPF支架增强BIO椎间融合器1后,其刚度更高,破坏载荷与BAK椎间融合器相似。

结论

相比之下,植入用可膨胀PPF支架增强的可生物降解椎间融合器所产生的体外腰椎运动节段刚度和破坏载荷与钛制BAK椎间融合器相似。这表明可生物降解前路椎间融合系统可进一步开发用于临床应用。

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