Pietrzak William S
Biomet, Inc, Warsaw, Indiana, USA.
J Craniofac Surg. 2012 Sep;23(5):1507-12. doi: 10.1097/SCS.0b013e3182541f0e.
Bioabsorbable fixation device failures occur clinically on occasion, with failures often brittle in nature. However, creep failure may also occur for implants that are subjected to sustained loads whereby the device may slowly deform over time, perhaps leading to fracture. Even without fracture occurring, the device may become too distorted to function. There is little in the literature regarding creep performance of bioabsorbable devices such as plates and screws. This study investigated the creep characteristics of craniofacial plates and screws made of a copolymer of 82% poly-L-lactic acid and 18% polyglycolic acid. Four-hole straight plates were attached to 2 rectangular portions of synthetic bone substrate using 2.0-mm-diameter bioabsorbable screws (2 screws used to attach the plate to each substrate portion). The constructs were submersed in phosphate-buffered saline (pH 7.4, 37°C) and placed in tension with 3 load configurations, that is, 230, 460, and 1140 g, for at least 6 days. Creep rate was constant at a given load and was directly proportional to load (4.7, 14.3, and 33.3 μm/h for 230-, 460-, and 1140-g loads, respectively). The data conformed well to basic creep theory analysis and provided an estimate of the absolute viscosity of the polymer of 8.7 × 10(12) ± 0.81 × 10(12) P (average ± SEM), which is intermediate between that of soft and hard tissue, although closer to the latter. Surgeons and engineers should be aware of the potential for creep to occur when designing bioabsorbable implants and investigating new clinical applications.
生物可吸收固定装置在临床上偶尔会出现故障,这些故障通常具有脆性。然而,对于承受持续载荷的植入物,也可能发生蠕变失效,即装置可能会随着时间的推移而缓慢变形,甚至可能导致骨折。即使没有发生骨折,装置也可能变得过于扭曲而无法正常工作。关于诸如接骨板和螺钉等生物可吸收装置的蠕变性能,文献中报道较少。本研究调查了由82%聚-L-乳酸和18%聚乙醇酸的共聚物制成的颅面接骨板和螺钉的蠕变特性。使用直径2.0毫米的生物可吸收螺钉(每个骨基质部分使用2枚螺钉将接骨板固定)将四孔直板固定在合成骨基质的2个矩形部分上。将构建体浸入磷酸盐缓冲盐水(pH 7.4,37°C)中,并采用3种载荷配置进行拉伸,即230、460和1140克,持续至少6天。在给定载荷下,蠕变率是恒定的,并且与载荷成正比(230克、460克和1140克载荷下的蠕变率分别为4.7、14.3和33.3微米/小时)。数据与基本蠕变理论分析结果吻合良好,并提供了聚合物绝对粘度的估计值为8.7×10(12)±0.81×10(12)泊(平均值±标准误),该值介于软组织和硬组织之间,但更接近后者。外科医生和工程师在设计生物可吸收植入物和研究新的临床应用时,应意识到蠕变发生的可能性。