评估髓核置换装置脱出风险的四种体外测试方法比较

IF 3.4 3区 医学 Q1 ORTHOPEDICS
JOR Spine Pub Date : 2024-04-23 DOI:10.1002/jsp2.1332
Tamanna Rahman, Matthew J. Kibble, Gianluca Harbert, Nigel Smith, Erik Brewer, Thomas P. Schaer, Nicolas Newell
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引用次数: 0

摘要

背景 核替代装置(NRD)尚未在临床上常规使用,主要原因是存在装置脱落的风险。严格的体外测试可在临床试验前确定失效机制;然而,目前的测试标准并未规定特定的挤出测试。因此开发了多种方法,使 NRD 设计之间的比较变得复杂。因此,本研究评估了之前报道的四种剥离测试协议的有效性:呼啦圈(协议 1)、改良呼啦圈(协议 2)、偏心循环(协议 3)和斜坡至失效(协议 4),这四种协议适用于两种 NRD,一种是预制的,另一种是原位固化的。 方法 从 40 个牛尾椎间盘中取出髓核材料。将一个 NRD 从后方插入每个椎间盘,然后对椎间盘进行四种驱逐方案中的一种。 结果 NRD 的反应取决于 NRD 的设计和加载方案。与方案 2 相比,方案 1 导致两种 NRD 的移位率更高,失效率更早。当加载方案包含旋转时,预制 NRD 更容易发生迁移。采用单侧弯曲和斜坡测试时,NRD的移位率(60%)和剥离率(60%)相同。综合多项测试结果,可以发现有关 NRD 反应的补充信息。 结论 经改良的呼啦圈测试(方案 2)和斜坡失效测试(方案 4)结合透视分析,揭示了有关移位和失效风险的补充信息。因此,在采用本研究中使用的手术方法和动物模型时,建议同时使用循环加载和斜坡加载方案来评估 NRD 性能。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Comparison of four in vitro test methods to assess nucleus pulposus replacement device expulsion risk

Comparison of four in vitro test methods to assess nucleus pulposus replacement device expulsion risk

Background

Nucleus replacement devices (NRDs) are not routinely used in clinic, predominantly due to the risk of device expulsion. Rigorous in vitro testing may enable failure mechanisms to be identified prior to clinical trials; however, current testing standards do not specify a particular expulsion test. Multiple methods have therefore been developed, complicating comparisons between NRD designs. Thus, this study assessed the effectiveness of four previously reported expulsion testing protocols; hula-hoop (Protocol 1), adapted hula-hoop (Protocol 2), eccentric cycling (Protocol 3), and ramp to failure (Protocol 4), applied to two NRDs, one preformed and one in situ curing.

Methods

Nucleus material was removed from 40 bovine tail intervertebral disks. A NRD was inserted posteriorly into each cavity and the disks were subjected to one of four expulsion protocols.

Results

NRD response was dependent on both the NRD design and the loading protocol. Protocol 1 resulted in higher migration and earlier failure rates compared to Protocol 2 in both NRDs. The preformed NRD was more likely to migrate when protocols incorporated rotation. The NRDs had equal migration (60%) and expulsion (60%) rates when using unilateral bending and ramp testing. Combining the results of multiple tests revealed complimentary information regarding the NRD response.

Conclusions

Adapted hula-hoop (Protocol 2) and ramp to failure (Protocol 4), combined with fluoroscopic analysis, revealed complimentary insights regarding migration and failure risk. Therefore, when adopting the surgical approach and animal model used in this study, it is recommended that NRD performance be assessed using both a cyclic and ramp loading protocol.

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来源期刊
JOR Spine
JOR Spine ORTHOPEDICS-
CiteScore
6.40
自引率
18.90%
发文量
42
审稿时长
10 weeks
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