Study design

Prospective multi-center study.

Objective

The study aimed to evaluate the accuracy of pedicle screw placement using a skin marker-based optical surgical navigation system for minimal invasive thoraco-lumbar-sacral pedicle screw placement.

Methods

The study was performed in a hybrid Operating Room with a video camera-based navigation system integrated in the imaging hardware. The patient was tracked with non-invasive skin markers while the instrument tracking was via an on-shaft optical marker pattern. The screw placement accuracy assessment was performed by three independent reviewers, using the Gertzbein grading. The screw placement time as well as the staff and patient radiation doses was also measured.

Results

In total, 211 screws in 39 patients were analyzed for screw placement accuracy. Of these 32.7% were in the thoracic region, 59.7% were in the lumbar region, and 7.6% were in the sacral region. An overall accuracy of 98.1% was achieved. No screws were deemed severely misplaced (Gertzbein grading 3). The average time for screw placement was 6 min and 25 secs (± 3 min 33 secs). The average operator radiation dose per subject was 40.3 µSv. The mean patient effective dose (ED) was 11.94 mSv.

Conclusion

Skin marker-based ON can be used to achieve very accurate thoracolumbarsacral pedicle screw placements.

中文翻译：

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使用基于皮肤标记的光学导航系统进行的多中心前瞻性临床研究得出经皮胸腰椎椎弓根螺钉置入准确度

学习规划

前瞻性多中心研究。

客观的

该研究旨在评估使用基于皮肤标记的光学手术导航系统进行微创胸腰骶椎弓根螺钉置入的准确性。

方法

该研究是在混合手术室中进行的，该手术室的成像硬件中集成了基于摄像机的导航系统。患者使用非侵入性皮肤标记进行跟踪，而仪器跟踪则通过轴上光学标记模式进行。螺钉放置精度评估由三名独立审查员使用 Gertzbein 分级进行。还测量了螺钉放置时间以及工作人员和患者的辐射剂量。

结果

总共分析了 39 名患者的 211 颗螺钉的螺钉放置准确性。其中 32.7% 位于胸椎，59.7% 位于腰椎，7.6% 位于骶椎。总体准确率为 98.1%。没有螺钉被视为严重错位（Gertzbein 分级 3）。螺钉放置的平均时间为 6 分 25 秒（± 3 分 33 秒）。每个受试者的平均操作员辐射剂量为 40.3 µSv。平均患者有效剂量 (ED) 为 11.94 mSv。

结论

基于皮肤标记的 ON 可用于实现非常准确的胸腰椎椎弓根螺钉放置。