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Influence of the loading frequency on the wear rate of a polyethylene-on-metal lumbar intervertebral disc replacement.

机译:加载频率对聚乙烯-金属腰椎间盘置换术磨损率的影响。

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摘要

Pre-clinical wear testing of intervertebral disc prostheses is commonly carried out according to ISO 18192-1. Ten million multiaxial loading cycles are applied at a frequency of 1 Hz. At this frequency, testing takes about 4 months. Testing at higher frequencies would therefore be desirable. ISO 18192-1 also offers testing at 2 Hz; however, it says the impact on the implant material behaviour as well as on the accuracy of the test machine shall be investigated by the user. Since such data are not available so far, the aim of this study was to carry out comparative wear tests at 1 and 2 Hz. Seven Prodisc-L lumbar disc prostheses were tested. After a pre-soak period, the implants were placed in specimen cups filled with calf serum, mounted to a Spine Wear Simulator and loaded according to ISO 18192-1. Testing was carried out at a temperature of 37 ± 2 °C. Four million loading cycles were applied at 1 Hz and eight million at 2 Hz in an alternating sequence. Each time after 12 days of testing the implants were removed to measure the weight and the height of the polyethylene cores. Then, the test serum was exchanged and the implants were remounted to the testing machine. The mean wear rate was 5.6 ± 2.3 mg per million cycles at 1 Hz and 7.7 ± 1.6 mg per million cycles at 2 Hz during the first six million loading cycles (p < 0.05) and 2.0 ± 0.6 and 4.1 ± 0.7 mg per million cycles during the second six million cycles (p < 0.05). Similarly, the mean heightloss was also smaller at 1 Hz than at 2 Hz (p < 0.05) with -0.02 ± 0.02 mm versus -0.04 ± 0.02 mm per million cycles during the first half of testing and -0.01 ± 0.01 versus -0.02 ± 0.01 mm per million cycles during the second half. The accuracy of the test machine was within the limits described by ISO 18192-1 at both frequencies. The results showed that the wear rate was higher at the beginning than at the end of testing. Also, the results indicated that testing at 2 Hz increases the wear rate compared with 1 Hz in case of a polyethylene-on-metal implant design. In the absence of retrieval studies it is difficult to decide which rate results in a more physiological wear pattern. However, a loading frequency of 1 Hz is probably closer to physiology than 2 Hz since the loading amplitudes prescribed by ISO 18192-1 are high. They rather represent movements like tying shoes or standing up from a chair than walking or sitting. The authors therefore suggest testing at 1 Hz.
机译:椎间盘假体的临床前磨损测试通常根据ISO 18192-1进行。以1 Hz的频率施加一千万个多轴加载循环。以这种频率,测试大约需要4个月。因此,在较高频率下进行测试将是理想的。 ISO 18192-1还提供2 Hz的测试;但是,它说对植入物材料性能以及测试机精度的影响应由用户调查。由于到目前为止尚无此类数据,因此本研究的目的是在1 Hz和2 Hz下进行比较磨损测试。测试了七个Prodisc-L腰椎间盘假体。经过预浸泡后,将植入物放入装有小牛血清的标本杯中,安装到Spine Wear Simulator上,并根据ISO 18192-1进行装载。测试在37±2°C的温度下进行。以1 Hz的频率施加400万次加载周期,以2 Hz的频率施加800万次加载周期。在测试12天后,每次都将植入物取出以测量聚乙烯芯的重量和高度。然后,更换测试血清并将植入物重新安装到测试机上。在前六百万个加载周期中,平均磨损率为5.6±2.3 mg每百万次循环每百万次循环和7.7±1.6 mg每百万次循环在2 Hz期间(p <0.05)以及2.0±0.6和4.1±0.7 mg每百万次循环在接下来的六百万个周期中(p <0.05)。类似地,在测试的上半年,每百万个周期的-0.02±0.02 mm与-0.04±0.02 mm每百万个周期,在1 Hz时的平均高度损失也小于2 Hz(p <0.05),并且-0.01±0.01对-0.02±下半年每百万个循环0.01毫米。在两种频率下,测试机的精度均在ISO 18192-1规定的范围内。结果表明,测试开始时的磨损率高于测试结束时的磨损率。而且,结果表明,与金属上聚乙烯植入物设计的情况相比,与1 Hz相比,在2 Hz下进行测试会增加磨损率。在缺乏检索研究的情况下,很难确定哪种速率会导致更生理的磨损方式。但是,由于ISO 18192-1规定的加载幅度较高,因此1 Hz的加载频率可能比2 Hz更接近生理。他们宁愿代表绑鞋或从椅子上站起来之类的动作,而不是走路或坐着。因此,作者建议在1 Hz下进行测试。

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