腰椎间撑开器的研制及其在腰椎滑脱中的应用

Development of lumbar intervertebral spreader and its clinical application in the treatment of spondylolisthesis

目的设计研制具有自主知识产权的腰椎间撑开器,探讨其在腰椎滑脱复位中的应用价值。方法根据国人腰椎解剖特点,在Solidworks软件平台上设计并定制一套厚度递增的腰椎间撑开器。对2013年7月至2014年7月广州医科大学附属第一医院收治的12例腰椎滑脱伴严重椎间狭窄患者,行腰椎间撑开器单侧椎间孔椎间复位、双侧经皮椎弓根钉棒内固定术,回顾性分析其临床资料,观察腰椎间撑开复位和相关并发症发生情况。结果手术时间90~150 min,平均手术时间110 min;术中出血量120~300 m L,平均出血量150 m L。术中未出现神经根、硬脊膜囊损伤。12例患者均获有效随访,随访时间3~15个月（平均7.5个月）。术后1周、3个月、末次随访腰腿痛视觉模拟量表（VAS）评分、腰椎滑脱间隙高度、腰椎滑脱距离均明显优于术前（P〈0.05）;末次随访时腰痛、腿痛VAS评分平均改善率分别为68.9%、68.1%,平均腰椎滑脱改善率为91.8%。完全复位5例,基本复位7例。随访期间未发现断钉断棒及融合器退出、下沉并发症。结论自行研制的腰椎间撑开器安全实用,能有效撑开严重狭窄的腰椎间隙,辅助腰椎滑脱复位。

Objective To design and develop a lumbar intervertebral spreader with independent intellectual property rights for expanding the intervertebral space, and to discuss the application value in the reduction of lumbar spondylolisthesis. Methods According to the anatomic characteristics of Chinese human lumbar spine, a set of intervertebral spreaders with increasing thickness was designed on the Solidworks software platform, and made by a medical apparatus manufacturer. With this self-designed device, 12 patients of lumbar spondylolisthesis with serious intervertebral stenosis underwent unilateral transforaminal interbody spondylolisthesis reduction combined with bilateral percutaneous pedicle screw-rod internal fixation from July 2013 to July 2014 in First Affiliated Hospital of Guangzhou Medical College, and their clinical data were analyzed retrospectively.The interbody traction and reduction during the operation were observed, and the relative complications were recorded. Results The average operative time was 110 min（90-150 min）, the average intraoperative estimate blood loss was 150 m L（120-300 m L）. No nerve root or dural injuries were found during the procedure. The patients were followed up from 3 to 15 months（average, 7.5 months）. At 1 week, 3 months after the surgery, as well as the last follow-up, visual analogue scale（VAS） scoring, intervertebral space height and the distance of lumbar spondylolisthesis were all improved compared with preoperative ones（P〈0.05）; At the last follow-up,the average improvement rate of VAS of back pain and leg pain was 68.9%, 68.1% respectively, and the improvement rate of lumbar spondylolisthesis was 91.8%. There was complete reduction in 5 cases, and nearly complete reduction in 7 cases. No screw-rod breakage or Cage migration, subsidence had happend during the follow-up. Conclusion The self-designed lumbar intervertebral spreader has been proved to be safety and practical which is effective for expanding intervertebral space with severe stenosis, so as to be helpful for the reduction of lumbar spondylolisthesis.