Evaluation of the Fatigue Performance and Degradability of Resorbable PLDLLA-TMC Osteofixations.

Q3 Medicine
Open Biomedical Engineering Journal Pub Date : 2013-11-29 eCollection Date: 2013-01-01 DOI:10.2174/1874120701307010133
Constantin Landes, Alexander Ballon, Shahram Ghanaati, Daniel Ebel, Dieter Ulrich, Uwe Spohn, Ute Heunemann, Robert Sader, Raimund Jaeger
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引用次数: 4

Abstract

The fatigue performance of explanted in-situ degraded osteofixations/osteosyntheses, fabricated from poly (70L-lactide-co-24DL-lactide-6-trimethylane-carbonate or PLDLLA-TMC) copolymer was compared to that of virgin products. The fatigue test was performed on 21 explants retrieved from 12 women and 6 men; 16-46 years by a custom-designed three-point bend apparatus using a staircase method and a specified failure criterion (an increase of the deflection of the specimen > 1 mm) with run-out designated as "no failure" after 150,000 loading cycles. While all the virgin products showed run-out at 38N, all of the specimens fabricated from explants failed at this load level. For the explant specimens, although there was a trend of decreased failure load with increased in-situ time, this decrease was pronounced after 4 months in-situ, however, not yet statistically significant, while a 6-month in-situ explant had significantly less failure load. Three and four month in-situ explants had highly significant differences in failure load between measurements close and distant to the osteotomy line: p=0.0017 (the region of maximum load in-situ). In the virgin products, there were only traces of melt joining and cooling, left from a stage in the manufacturing process. For the implants retrieved after 4.5 months in-situ, the fracture surfaces showed signs of degradation of the implants, possibly caused by hydrolysis, and for those retrieved after 9 months in-situ, there were cracks and pores. Thus, the morphological results are consistent with those obtained in the fatigue test. The present results suggest that resorbable osteofixations fabricated from PLDLLA-TMC are stable enough to allow loading of the healing bone and degrade reliably.

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可吸收pldla - tmc骨固定物疲劳性能及可降解性评价。
研究了由聚(70l -乳酸-co- 24dl -乳酸-6-三甲基丙烷-碳酸酯或pldla - tmc)共聚物制备的外植体原位降解骨固定物/骨合成物的疲劳性能与原始产品的疲劳性能进行了比较。对12名女性和6名男性的21个外植体进行了疲劳试验;16-46年,使用定制设计的三点弯曲装置,采用阶梯法和指定的破坏准则(试样挠度增加> 1mm),在15万次加载循环后,运行指定为“无破坏”。在38N的载荷水平下,外植体制备的样品均失效,而未加工的样品在38N的载荷水平下均失效。对于外植体试样,虽然随着原位时间的增加,破坏载荷有减小的趋势,但在原位放置4个月后,这种减小的趋势较为明显,但还没有统计学意义,而原位放置6个月外植体的破坏载荷明显减小。3个月和4个月的原位植体在离截骨线近和远的测量值之间的失效载荷差异非常显著:p=0.0017(原位最大载荷区域)。在原始产品中,只有熔化连接和冷却的痕迹,这是制造过程中一个阶段留下的。对于放置4.5个月后取出的植入物,骨折面出现降解迹象,可能是由于水解引起的,而对于放置9个月后取出的植入物,则出现裂缝和孔隙。因此,形貌结果与疲劳试验结果一致。目前的结果表明,由pldla - tmc制成的可吸收骨固定物足够稳定,可以承受愈合骨的载荷并可靠地降解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Open Biomedical Engineering Journal
Open Biomedical Engineering Journal Medicine-Medicine (miscellaneous)
CiteScore
1.60
自引率
0.00%
发文量
4
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