Department of Neurosurgery, Haaglanden Medical Center, PO Box 432, 2501 CK, The Hague, The Netherlands.
Department of Radiology, Haaglanden Medical Center, PO Box 432, 2501 CK, The Hague, The Netherlands.
Spine J. 2024 Sep;24(9):1671-1677. doi: 10.1016/j.spinee.2024.04.033. Epub 2024 May 2.
Accurate pedicle screw placement is a challenge with reported misplacement rates of 10% and higher. A handheld navigation device (HND) may provide accuracy equal to CT-based navigation (CT-Nav) but without the cost and complexity.
To study the accuracy of a handheld navigation device for pedicle screw placement.
This prospective cross-sectional study with consistently applied reference standard enrolled 20 patients undergoing 92 pedicle screw placements.
Patients who underwent pedicle screw placement between May 2022 and September 2022.
Pedicle screw placement accuracy per Gertzbein-Robbins.
Once the screw pilot hole was established, the proposed trajectory of the HND was compared with that proposed by CT-Nav. Postoperatively, screw accuracy was graded according to Gertzbein-Robbins by a blinded radiologist based on CT scans. Accuracy was compared between the two systems and published control for fluoroscopy assisted and CT-Nav placement using Bayesian posterior distribution.
The trajectory proposed by the HND and CT-Nav were in agreement in 98.9% (95% Exact CI; 94.09%-99.97%). The HND accuracy was 98.9% with 91 screws rated "A" and 1 rated "C". Noninferiority to fluoroscopic placement was achieved because the one-sided normal-approximation 95% CI Lower Bound (LB) of 95.3% is greater than the Performance Goal (PG) of 83.4%. Posthoc analysis demonstrated that the probability of superiority of the HND relative to the historical accuracy rate of 91.5% for fluoroscopy assisted procedures is >0.999 and that the HND's accuracy rate is within 4.5% of CT-Nav of 95.5% is >0.999. No adverse events or intra-operative complications associated with HND were observed. There was 1 (1.1%) intra-operative repositioning and no reoperations for any reason.
The accuracy rate of the HND was 98.9%, and the proposed trajectory matched with CT-Nav in 98.9% of the time. This is superior to the historical published accuracy rate for fluoroscopy-assisted procedures and equivalent to the historical published accuracy rate for CT-Nav.
Dutch trial register NL74268.058.20.
准确放置椎弓根螺钉是一项挑战，据报道，其错位率为 10%及以上。手持导航设备（HND）可能提供与基于 CT 的导航（CT-Nav）相当的准确性，但没有成本和复杂性。
研究手持导航设备用于椎弓根螺钉放置的准确性。
本前瞻性横断面研究采用一致的参考标准，共纳入 20 例接受 92 例椎弓根螺钉放置的患者。
2022 年 5 月至 2022 年 9 月接受椎弓根螺钉放置的患者。
基于 Gertzbein-Robbins 的椎弓根螺钉放置准确性。
一旦建立了螺钉导孔，就将 HND 提出的轨迹与 CT-Nav 提出的轨迹进行比较。术后，根据 Gertzbein-Robbins，由一位盲法放射科医生根据 CT 扫描对螺钉准确性进行分级。使用贝叶斯后验分布，将两种系统与发表的用于透视辅助和 CT-Nav 放置的对照进行比较。
HND 和 CT-Nav 提出的轨迹一致的比例为 98.9%（95%精确置信区间；94.09%-99.97%）。HND 的准确性为 98.9%，91 个螺钉评为“A”，1 个评为“C”。非劣效性分析显示，单侧正态逼近 95%置信区间下限（LB）95.3%大于性能目标（PG）83.4%，因此优于透视放置。事后分析表明，HND 相对于透视辅助手术 91.5%的历史准确性的优越性概率>0.999，并且 HND 的准确性与 CT-Nav 的 95.5%相差 4.5%的概率>0.999。未观察到与 HND 相关的不良事件或术中并发症。有 1 例（1.1%）术中重新定位，无因任何原因再次手术。
HND 的准确性为 98.9%，其提出的轨迹在 98.9%的时间内与 CT-Nav 相匹配。这优于透视辅助手术的历史发表准确性，并且与 CT-Nav 的历史发表准确性相当。
荷兰试验登记处 NL74268.058.20。
