中国修复重建外科杂志

中国修复重建外科杂志

可变向腰椎融合器在腰椎融合治疗中的临床研究

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目的 观察一种改良的可变向腰椎融合器(Cage)在经椎间孔减压腰椎间植骨融合(transforaminal lumbar interbody fusion,TLIF)治疗中的临床疗效。 方法 回顾分析 2013 年 1 月—2015 年 12 月收治的单节段 L4 或 L5 峡部裂性滑脱患者 161 例,根据 Cage 植入情况分为研究组(85 例,TLIF 术中植入改良可变向 Cage)和对照组(76 例,TLIF 术中植入传统非变向 Cage)。两组患者性别、年龄、病程、滑脱节段、滑脱分度等一般资料比较差异无统计学意义(P>0.05),具有可比性。比较两组 Cage 术中植入时间、Cage 位置调整次数、植入 Cage 透视次数、曝光时间、总手术时间;术前及术后 3、6、12 个月分别行疼痛视觉模拟评分(VAS)、Oswestry 功能障碍指数(ODI)评分评价患者临床疗效,记录分析并发症发生情况;分别于术后 6、12 个月行 CT 检查,采用 Bridwell 标准评价腰椎融合情况。 结果 研究组 Cage 术中植入时间、Cage 位置调整次数、植入 Cage 透视次数、曝光时间和总手术时间均显著少于对照组(P<0.05)。161 例患者均获随访,随访时间 12~18 个月,平均 14.3 个月。研究组术中发生 1 例硬膜囊撕裂,对照组发生 1 例切口浅表感染;其余患者均未出现硬膜囊撕裂、切口感染等并发症。术后 6 个月研究组融合率为 76.5%(64/85),显著少于对照组的 57.9%(44/76)(χ2=6.44,P=0.02);术后 12 个月研究组融合率为 96.5%(82/85),对照组为 90.8%(69/76)(其中 Cage 移位 3 例、螺钉断裂 4 例),两组融合率比较差异无统计学意义(χ2=1.54,P=0.26)。两组患者术后 3、6、12 个月 VAS 评分和 ODI 评分逐渐降低,均较术前明显改善(P<0.05);手术前后各时间点两组 VAS 评分和 ODI 评分比较差异均无统计学意义(P>0.05)。 结论 两组 Cage 可获得相同的临床疗效,采用改良可变向 Cage 能有效减少 TLIF 术中的透视次数和辐射剂量,缩短手术时间,有效降低患者和医护人员的受辐射量。

Objective To investigate the effectiveness of modified direction-changeable lumbar Cage in transforaminal lumbar interbody fusion (TLIF). Methods A retrospective analysis was made of 161 patients with single segment L4 or L5 Isthmic spondylolisthesis treated between January 2013 and December 2015. According to the implantation of Cage, they were divided into research group (85 cases, modified direction-changeable lumbar Cage implanted in TLIF) and control group (76 cases, traditional nondirection-changeable Cage implanted in TLIF). There was no significant difference in the general data of gender, age, disease duration, slippage segment, and slippage grade between the two groups (P>0.05). The intraoperative implantation time of Cage, Cage position adjustments times, fluoroscopy during implantation of Cage, fluoroscopy exposure time, and total operation time were compared between the two groups. Visual analogue scale (VAS) and Oswestry disability index (ODI) scores were used to evaluate the effectiveness of the patients before operation, and at 3, 6, and 12 months after operation, and the incidence of complications was recorded and analyzed. CT examinations were performed at 6 and 12 months after operation, and lumbar fusion was evaluated by Bridwell criteria. Results The intraoperative implantation time of Cage, Cage position adjustments times, fluoroscopy during implantation of Cage, fluoroscopy exposure time, and total operation time of research group were significant less than control group (P<0.05). All the 161 patients were followed up 12-18 months (mean, 14.3 months). There was 1 case of dural sac tear in the research group and 1 case of superficial infection in the control group; no complication such as dural tear and infection occurred in other patients. The fusion rate was 76.5% (64/85) in the research group and 57.9% (44/76) in the control group at 6 months after operation, showing significant difference (χ2=6.44, P=0.02); at 12 months after operation, the fusion rate was 96.5% (82/85) in the research group and 90.8% (69/76) in the control group (including 3 cases of Cage displacement and 4 cases of screw breakage), showing no significant difference in the fusion rate between the two groups (χ2=1.54, P=0.26). The VAS and ODI scores of the two groups decreased gradually at 3, 6, and 12 months after operation, and improved significantly when compared with those before operation (P<0.05). There was no significant difference in VAS and ODI scores between the two groups before and after operation (P>0.05). Conclusion Both Cages can obtain the same effectiveness. The modified direction-changeable lumbar Cage can effectively reduce the number of fluoroscopy and radiation dose during TLIF, shorten the operation time, and effectively reduce the radiation exposure of patients and medical staff.

关键词: 腰椎融合器; 经椎间孔减压腰椎间植骨融合术; 腰椎滑脱

Key words: Lumbar Cage; transforaminal lumbar interbody fusion; spondylolisthesis

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