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[一种新型全腕关节融合钢板的生物力学测试]

[Biomechanical testing of a new total wrist arthrodesis plate].

作者信息

Passin Stefan, Pochlatko N, Ebi D, Spiegel A, Sauerbier M

机构信息

Klinik für Plastische, Rekonstruktive und Brustchirurgie, Elblandklinikum Radebeul, Radebeul.

Medartis AG, Basel, Schweiz.

出版信息

Handchir Mikrochir Plast Chir. 2015 Feb;47(1):32-7. doi: 10.1055/s-0034-1398547. Epub 2015 Feb 23.

Abstract

PURPOSE

The aim of this study was to evaluate the biomechanical properties of the APTUS wrist fusion plate in comparison to those of the AO wrist fusion plate.

MATERIAL AND METHOD

6 APTUS wrist fusion plates (APTUS 2.5 TriLock Wrist Fusion Plate Long Bend) from Medartis (Basel, Switzerland) and 6 AO wrist fusion plates (= LCP Wrist Fusion Plate Standard Bend from Dupuy-Synthes, Bettlach, Switzerland) were installed according to the manufacturers' instructions on life-sized, fibre-glass reinforced polyamide models of a healthy human hand. Then fatigue testing with increasing loads on a monoaxial material testing machine was carried out and the force-movement measurements were recorded on a PC. For up to 50,000 cycles, loading was applied in a sinus-wave frequency of 4 Hz and a force ratio (FMin/FMax) of 0.1-70 N. After 50,000 cycles and then at every 10,000 cycles the load was increased by 15% until breakage or a deformation of over 15 mm at the point of force application of the implant occurred. In addition, the tear-out resistance of 5 screws of each type of plate was examined and the system tear-out resistance calculated. The mean values and standard deviations of fatigue strength, torsional moments and fatigue limits (load cycles) were checked for normal distribution and finally the results were compared by means of non-parametric and parametric statistical tests.

RESULTS

Plate breakage occurred with the AO wrist fusion plate on average after 52,596 (SD±12,833) load cycles and with the APTUS wrist fusion plate after an average of 115,428 (SD±12,600) load cycles. For the AO wrist fusion plates, an average load of 6.3 (SD±0.8) Nm and for the APTUS plate one of 10 (SD±1.7) Nm led to failure. For the APTUS plate the screw tear-out resistance was calculated as 2,632 (SD±96) N while that for the AO plate was found to be 1,449 (SD±314) N.

CONCLUSION

In comparison to the AO wrist fusion plate the APTUS wrist fusion plate has significantly higher fatigue resistance and tear-out strength. On the basis of 100,000 load cycles until bone healing in the case a wrist arthrodesis, use of the APTUS plate should enable bone healing to occur before the implant fails.

摘要

目的

本研究旨在评估APTUS腕关节融合钢板与AO腕关节融合钢板相比的生物力学性能。

材料与方法

将来自Medartis(瑞士巴塞尔)的6块APTUS腕关节融合钢板(APTUS 2.5 TriLock腕关节融合长弯钢板)和6块AO腕关节融合钢板(=来自瑞士贝特拉赫的迪普伊-辛迪斯公司的LCP腕关节融合标准弯钢板)按照制造商说明安装在健康人手部的真人大小的玻璃纤维增强聚酰胺模型上。然后在单轴材料试验机上进行递增负荷的疲劳试验,并在电脑上记录力-位移测量结果。在高达50,000次循环中,以4Hz的正弦波频率和0.1 - 70N的力比(FMin/FMax)施加负荷。在50,000次循环后,然后每隔10,000次循环将负荷增加15%,直至植入物施力点出现断裂或超过15mm的变形。此外,检查每种钢板5颗螺钉的抗拔出力并计算系统抗拔出力。检查疲劳强度、扭矩和疲劳极限(负荷循环)的平均值和标准差是否呈正态分布,最后通过非参数和参数统计检验比较结果。

结果

AO腕关节融合钢板平均在52,596(标准差±12,833)次负荷循环后发生钢板断裂,而APTUS腕关节融合钢板平均在115,428(标准差±12,600)次负荷循环后发生断裂。对于AO腕关节融合钢板,平均负荷6.3(标准差±0.8)Nm时导致失效,对于APTUS钢板,平均负荷10(标准差±1.7)Nm时导致失效。对于APTUS钢板,螺钉抗拔出力计算为2,632(标准差±96)N,而AO钢板的抗拔出力为1,449(标准差±314)N。

结论

与AO腕关节融合钢板相比,APTUS腕关节融合钢板具有显著更高的抗疲劳性和抗拔出强度。在腕关节融合术骨愈合需要100,000次负荷循环的情况下,使用APTUS钢板应能使骨愈合在植入物失效前发生。

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