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单节段腰椎手术中皮质骨轨迹螺钉与传统椎弓根螺钉的疗效比较:一项随机对照试验的系统评价和荟萃分析

Outcomes after Cortical Bone Trajectory Screw versus Traditional Pedicle Screw in Single-Level Lumbar Spine Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

作者信息

Ibrahim Muhammad Talal, Veliky Cole, Yu Elizabeth

机构信息

Division of Spine Surgery, Department of Orthopaedics, College of Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.

College of Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.

出版信息

Spine Surg Relat Res. 2025 Feb 21;9(3):289-299. doi: 10.22603/ssrr.2024-0292. eCollection 2025 May 27.

Abstract

BACKGROUND

Cortical bone trajectory screw (CBTS) is reported to offer increased cortical bone purchase and improved outcomes as compared to the traditional pedicle screw (PS), particularly in osteoporotic patients. The systematic review aims to compare randomized controlled trials comparing CBTS with PS in single-level lumbar spine fusion surgery.

METHODS

A systematic search was conducted on PubMed (MEDLINE), Scopus, Embase, Web of Science, and Cochrane. Moreover, ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), and China National Knowledge Infrastructure (CNKI) were also searched. Outcome measures included fusion rates, complication rates, perioperative parameters, pain scores, and functionality. (PROSPERO: CRD42024523809).

RESULTS

Four manuscripts, reporting on three randomized controlled trials (RCTs) and 416 patients, were included in this review. The follow-up ranged from 24 to 26 months postoperatively. All patients underwent single-level fusion only. There was no significant difference in the fusion rates between CBTS and PS at one-year (risk ratio [RR] 1.05 [0.97, 1.13], p=0.24) or two-year (RR 1.02 [0.96, 1.08], p=0.47) follow-ups. The CBTS group had a lower risk of intraoperative complications (RR 0.44 [0.32, 0.60], p<0.001) but an equal risk of postoperative complications (RR 0.71 [0.42, 1.22], p=0.22). There was no difference in pain, functionality, disability, and quality-of-life scores. CBTS group had better outcomes in incision length (mean difference [MD] -25.44 [-40.76, -10.12], p=0.001), operative time (MD -20.71 [-32.91, -8.51], p=0.009), and blood loss (MD -60.23 [-106.74, -13.72], p=0.01), while there was no difference in length of stay (MD -0.49 [-1.01, 0.04], p=0.07).

CONCLUSIONS

Although slightly favoring CBTS, RCTs were limited in number and had a serious risk of bias. Future RCTs should use superiority trial designs, have minimal bias, and include implant details, incidence of adjacent segment disease, and quality-of-life metrics.

摘要

背景

据报道,与传统椎弓根螺钉(PS)相比,皮质骨轨迹螺钉(CBTS)能增加对皮质骨的把持力并改善治疗效果,尤其是在骨质疏松患者中。本系统评价旨在比较在单节段腰椎融合手术中对比CBTS与PS的随机对照试验。

方法

在PubMed(MEDLINE)、Scopus、Embase、Web of Science和Cochrane上进行了系统检索。此外,还检索了ClinicalTrials.gov、国际临床试验注册平台(ICTRP)和中国知网(CNKI)。结局指标包括融合率、并发症发生率、围手术期参数、疼痛评分和功能。(PROSPERO:CRD42024523809)。

结果

本评价纳入了4篇报告3项随机对照试验(RCT)和416例患者的手稿。随访时间为术后24至26个月。所有患者均仅接受单节段融合。在1年(风险比[RR]1.05[0.97,1.13],p=0.24)或2年(RR 1.02[0.96,1.08],p=0.47)随访时,CBTS和PS之间的融合率无显著差异。CBTS组术中并发症风险较低(RR 0.44[0.32,0.60],p<0.001),但术后并发症风险相同(RR 0.71[0.42,1.22],p=0.22)。在疼痛、功能、残疾和生活质量评分方面没有差异。CBTS组在切口长度(平均差[MD]-25.44[-40.76,-10.12],p=0.001)、手术时间(MD -20.71[-32.91,-8.51],p=0.009)和失血量(MD -60.23[-106.74,-13.72],p=0.01)方面有更好的结果,而住院时间没有差异(MD -0.49[-1.01,0.04],p=0.07)。

结论

尽管对CBTS略有支持,但RCT数量有限且存在严重的偏倚风险。未来的RCT应采用优效性试验设计,尽量减少偏倚,并包括植入物细节、相邻节段疾病发生率和生活质量指标。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f68/12151271/b5ade726c557/2432-261X-9-3-0289-g001.jpg

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