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徒手技术与新型激光引导导航系统在股骨颈空心钉固定中的比较:一项随机对照试验。

Comparison of freehand technique and a novel laser-guiding navigation system in femoral neck-cannulated screw fixation: a randomized controlled trial.

机构信息

Department of Orthopaedics, Beijing Friendship Hospital, Capital Medical University, Beijing, China.

出版信息

BMC Surg. 2023 Oct 23;23(1):319. doi: 10.1186/s12893-023-02226-w.

Abstract

Cannulated screw fixation is essential in treating femoral neck fractures, and the widely used freehand technique has several limitations. Therefore, we designed a new laser-positioning and navigation system and compared its efficacy with that of the traditional freehand technique in the cannulated screw fixation of femoral neck fractures. This randomized controlled single-blind trial recruited patients with femoral neck fracture, who were treated using either the newly designed laser-navigation device or the freehand technique. In in-vitro experiments, using the femoral neck model, the laser group was better than the freehand group in terms of operation time (P = 0.0153) and radiation exposure time (P < 0.001). In in-vivo experiments, involving 30 patients (15 in each group), the laser group was better than the freehand group in terms of operation time (P < 0.001), radiation exposure time (P < 0.001), blood loss (P < 0.001) and first success rate (P = 0.03). There was no difference in visual analog scale score, Harris score, and fracture-healing time between the two groups. In conclusion, the novel laser-guiding navigation system resulted in shorter operation time, less radiation exposure, and higher first success rate compared with the freehand technique. Further qualified investigations with a larger number of patients and longer follow-up are required in the future.

摘要

空心螺钉固定是治疗股骨颈骨折的关键,而广泛应用的徒手技术存在一些局限性。因此,我们设计了一种新的激光定位和导航系统,并将其与传统徒手技术在股骨颈骨折空心螺钉固定中的疗效进行了比较。这项随机对照单盲试验招募了股骨颈骨折患者,他们分别接受新设计的激光导航设备或徒手技术治疗。在体外实验中,使用股骨颈模型,激光组在手术时间(P=0.0153)和辐射暴露时间(P<0.001)方面优于徒手组。在体内实验中,涉及 30 名患者(每组 15 名),激光组在手术时间(P<0.001)、辐射暴露时间(P<0.001)、失血量(P<0.001)和首次成功率(P=0.03)方面优于徒手组。两组间视觉模拟评分、Harris 评分和骨折愈合时间无差异。总之,与徒手技术相比,新型激光引导导航系统可缩短手术时间、减少辐射暴露,并提高首次成功率。未来需要进一步开展具有更大患者数量和更长随访时间的合格研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/940f/10594929/df7d03f67434/12893_2023_2226_Fig1_HTML.jpg

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