皮质骨轨迹螺钉固定在合并骨质疏松腰椎退行性疾病手术中应用的效果

The efficacy of cortical bone trajectory screw fixation in the treatment of lumbar degenerative disease with osteoporosis

中文关键词:  腰椎退行性疾病  后路腰椎减压融合术  皮质骨轨迹螺钉  骨质疏松  前瞻性随机对照研究

英文关键词:Lumbar degenerative disease  Posterior lumbar interbody fusion  Cortical bone trajectory screw  Osteoporosis  Prospective randomized controlled trail

中文摘要:

  【摘要】 目的：探讨皮质质骨轨迹（cortical bone trajectory，CBT）螺钉与椎弓根螺钉（pedicle screw，PS）固定在腰椎退行性疾病合并骨质疏松手术中应用的效果及并发症发生情况。方法：按照非劣性检验标准估算样本量，经伦理委员会批准，前瞻性纳入2019年3月~2020年6月我院收治的124例腰椎退行性疾病患者，并平均随机分配到CBT组与PS组，分别进行后路腰椎减压单节段CBT螺钉固定与PS固定椎间融合术，经过至少2年随访。主要观测指标为椎间融合率；次要观测指标为术前、术后3个月、术后1年及末次随访时腰背与下肢疼痛视觉模拟评分（visual analogue scale，VAS）、Oswestry残障指数（Oswestry disability index，ODI）和日本骨科协会（Janpanese Orthopedics Association，JOA）评分，手术相关参数（手术时间、切口长度、术中失血量和术后引流量）及术中、术后并发症发生率，对两组数据进行组间与组内对比分析。结果：最终CBT组共有58例、PS组56例完成随访。两组患者在年龄、性别、随访时间、吸烟状况、体重指数、骨密度及手术节段分布方面无显著性差异（P>0.05）。术后1年，CBT组45例（77.59%）、PS组42例（75.00%）患者实现了椎间融合，两组之间无显著性差异（P=0.745）。每组术后3个月、1年及末次随访时的VAS评分、ODI及JOA评分较术前均有明显改善（P<0.05）；术前VAS评分、ODI及JOA评分两组比较均无统计学差异，术后3个月CBT组的ODI及JOA评分均优于PS组（P<0.05），术后3个月、术后1年及末次随访时的VAS评分及术后1年、末次随访时的ODI及JOA评分两组间均无统计学差异（P>0.05）。CBT组的手术时间、术中出血量、切口长度和术后引流量均优于PS组（P<0.05）。两组硬膜撕裂、神经根损伤和手术部位感染发生率相似。术后CT显示螺钉误置，CBT组发生率为2.16%（5/232枚），PS组为1.34%（3/224枚），组间无统计学差异（P=0.724）。CBT组共有2枚螺钉（0.89%）出现松动并在CT扫描图像上出现移位，发生率低于PS组（10/224，4.46%）（P=0.034）。CBT组58例患者中共有3例（5.17%）出现并发症，PS组56例患者中共有9例（16.07%）出现并发症，PS组总体并发症发生率较高（P=0.041）。结论：CBT螺钉固定在合并骨质疏松腰椎退行性疾病患者行单节段固定融合手术时可获得较PS固定更加优秀的短期功能恢复，以及相似的临床效果和椎间融合。CBT螺钉固定用于合并骨质疏松的腰椎疾病人群的手术治疗是较PS内固定有效且更优的替代选择。

英文摘要:

  【Abstract】 Objectives: To investigate the efficacies of cortical bone trajectory(CBT) screw fixation and pedicle screw(PS) fixation in the surgical treatment of lumbar degenerative diseases with osteoporosis and related complications. Methods: The sample size was estimated according to the non-inferiority test criteria. Approved by the ethics committee, we prospectively included 124 patients with lumbar degenerative disease from March 2019 to June 2020 and they were randomly assigned into the CBT group and PS group for single-level CBT screw fixation and PS fixation respectively for posterior lumbar decompression and fusion. The patients were followed up for at least 2 years. The primary endpoint was interbody fusion rate; secondary endpoints were visual analogue scale(VAS) for low back and lower extremity pain, Oswestry disability index (ODI), Janpanese Orthopedics Association(JOA) score at pre-operation, postoperative 3 months and 1-year and final follow up, and surgical parameters (operation duration, incision length, intraoperative blood loss, and postoperative drainage volume), as well as intraoperative and postoperative complications. The data of the two groups were compared between and within groups. Results: A total of 58 patients in the CBT group and 56 in the PS group completed follow-up. No significant differences were found between the two groups in terms of age, gender, follow-up period, smoking history, body mass index(BMI), bone mineral density(BMD) or surgical segment distribution(P>0.05). At 1-year post-operation, 45 patients (77.59%) in the CBT group and 42 (75.00%) in the PS group achieved interbody fusion, and there was no significant difference between the two groups(P=0.745). The VAS, ODI, and JOA score at postoperative 3 months, 1 year, and final follow-up of both groups improved significantly than those before operation(P<0.05); There was no significant difference in preoperative VAS, ODI, and JOA score between the two groups, and the ODI and JOA score of CBT group at postoperative 3 months were better than those of PS group(P<0.05); No statistical difference was found between the two groups in terms of postoperative 3 months, 1 year, and final follow-up VAS and postoperative 1 year and final follow-up ODI and JOA score(P>0.05). The operative time, intraoperative blood loss, incision length, and postoperative drainage volume of CBT group were all superior than those of PS group(P<0.05). The incidences of dural tear, nerve root injury, and surgical site infection were similar in both groups. Postoperative CT images showed screw misplacement rate was 2.16%(5/232) in CBT group and 1.34%(3/224) in PS group, and there was no statistical difference between groups(P=0.724). Two screws in CBT group occurred loosening and showed displacement on CT images, and the incidence rate was lower than that of PS group(10/224, 4.46%)(P=0.034). 3(5.17%) out of 58 patients of CBT group and 9(16.07%) out of 56 of PS group presented with complications, and the incidence rate of complications of PS group was higher(P=0.041). Conclusions: CBT screw fixation can achieve better short-term functional recovery than PS fixation in patients with osteoporotic lumbar degenerative disease undergoing single-level fixation and fusion, as well as similar clinical efficacy and interbody fusion. CBT screw fixation is an effective and superior alternative to PS fixation in the surgical treatment of lumbar degenerative disease patients with osteoporosis.