摘要
背景:腰椎动态固定多为早期临床研究,但其中期疗效及力学机制分析研究较少。目的:评价Waveflex内固定系统的临床疗效,分析其生物力学优势,为临床应用及动态固定理论研究奠定基础。方法:回顾性分析2015年9月至2018年10月于山东中医药大学附属医院骨科行髓核摘除Waveflex半刚性内固定治疗并随访的腰椎间盘突出症患者,所有患者对治疗方案均知情同意,且得到医院伦理委员会批准。统计分析患者术前、术后及末次随访的目测类比评分和Oswestry功能障碍指数、腰椎前凸角、椎间隙高度、椎间孔高度和椎间隙退变UCLA分级,评价置入半刚性内固定的临床疗效。构建完整及置入Waveflex半刚性内固定腰椎模型,进行有限元分析,评价Waveflex半刚性内固定模型的生物力学性能,结合临床统计观察验证其安全、有效性。结果与结论:①Waveflex半刚性固定可有效改善患者临床症状,维持腰椎稳定性和活动度,临床疗效肯定;②Waveflex系统可承担较大应力,有效减轻手术节段椎间盘应力,延缓腰椎退变;③总的来说,Waveflex半刚性内固定既可维持固定节段的稳定性,又有一定的活动度,可有效减缓固定节段退变。
BACKGROUND: Lumbar dynamic fixation is mostly studied in early clinical studies, but there are few studies on the efficacy and mechanical mechanism of mid-stage fixation. OBJECTIVE: To evaluate the clinical efficacy of Waveflex internal fixation system and analyze its biomechanical advantages, so as to lay a foundation for clinical application and theory research of dynamic fixation. METHODS: Retrospective analysis was performed in patients who underwent nucleus pulposus excision and semi-rigid internal fixation in the Department of Orthopedics, Affiliated Hospital of Shandong University of Traditional Chinese Medicine from September 2015 to October 2018. All patients signed informed consent. This study was approved by the Ethics Committee of Affiliated Hospital of Shandong University of Traditional Chinese Medicine, China. The corresponding subjective function and objective imaging indexes of the patients in this group before, after and at the last follow-up were statistically analyzed to evaluate the clinical efficacy of implantation of semi-rigid internal fixation. The complete and implanted semi-rigid internal fixation model of the lumbar spine was constructed and finite element analysis was performed to evaluate the biomechanical properties of the Waveflex semi-rigid internal fixation model. The safety and effectiveness were verified by clinical statistical observation. RESULTS AND CONCLUSION:(1) Waveflex semi-rigid fixation can effectively improve the symptoms of patients, maintain lumbar stability and mobility, and the clinical effect is positive.(2) The system can construct the ladder stress distribution, effectively reduce the stress of the surgical segment, and delay lumbar degeneration.(3) In general, the Waveflex semi-rigid internal fixation can maintain the stability of the fixed segment and has a certain range of motion, which can effectively slow down the degeneration of the fixed segment.
作者
甘东浩
乔全来
陈德强
谭国庆
薛海鹏
徐展望
Gan Donghao;Qiao Quanlai;Chen Deqiang;Tan Guoqing;Xue Haipeng;Xu Zhanwang(Shandong University of Traditional Chinese Medicine, Jinan 250355, Shandong Province, China;Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China)
出处
《中国组织工程研究》
CAS
北大核心
2019年第36期5830-5835,共6页
Chinese Journal of Tissue Engineering Research
基金
山东省重点研发计划项目(2015GSF118098)，项目负责人：谭国庆~~
