四种体外试验方法的比较,以评估核脉置换器件驱逐风险的核脉置换器件驱逐风险
Tamanna Rahman1,2, Matthew J Kibble1, Gianluca Harbert1
1Department of Bioengineering Imperial College London London UK.
JOR spine
|April 24, 2024
概括
核替代装置 (NRD) 驱逐测试需要标准化的协议. 结合循环和坡道负载测试,如适应的胡拉胡普和坡道到故障方法,提供了全面的NRD迁移和故障风险的见解.
科学领域:
- 生物医学工程 生物医学工程
- 整形医疗设备 整形医疗设备
- 脊柱外科手术 脊柱外科手术
背景情况:
- 核替代器件 (NRD) 面临临临床限制,因为驱逐的风险.
- 目前的体外试验缺乏标准化的驱逐协议,这阻碍了NRD设计的比较.
- 本研究评估了四种不同的NRD驱逐测试方法.
研究的目的:
- 评估四个之前报告的NRD驱逐测试协议的有效性.
- 在不同的测试条件下,比较预制NRD与现场固化NRD在不同测试条件下的性能.
- 确定最佳的体外测试策略,以预测NRD失败机制.
主要方法:
- 通过去除核物质,制备了40个牛尾椎间盘.
- 核替代器件 (NRD) 在后部植入准备好的磁盘腔.
- 带有NRD的磁盘被 subjected to one of four expulsion testing protocols:胡拉胡普,适应胡拉胡普,古怪的自行车,或坡道到故障. 这四种驱逐测试的协议之一.
主要成果:
- 根据设备设计和应用的加载协议,NRD响应发生了显著的变化.
- 胡拉胡普协议 (协议1) 显示出比适应的胡拉胡普 (协议2) 更高的迁移和更早的失败率.
- 当测试协议包括旋转力时,预制的NRD表现出增加的迁移;然而,在单边曲和坡道测试下,NRD类型之间的迁移和驱逐率相似.
结论:
- 适应的Hula-Hoop (协议2) 和Ramp to Failure (协议4) 协议,特别是光学分析,提供了关于NRD迁移和故障的有价值的,互补的数据.
- 对于手术方法和使用的动物模型,评估NRD性能需要循环和坡道加载协议.
- 标准化测试协议对于可靠评估NRD安全性和有效性至关重要.
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