K-Rod动态稳定系统修复腰椎退行性病变的有效性及安全性:前瞻性、自身对照、临床试验

发布时间：2018-02-24 02:24

本文关键词：组织工程腰椎椎间盘骨科植入物脊椎植入物临床试验 K-Rod动态稳定系统腰椎退行性病变椎间盘间隙椎体高度背部疼痛目测类比评分 Oswestry功能障碍指数 X射线不良反应　出处：《中国组织工程研究》2017年19期 　论文类型：期刊论文

【摘要】：背景:后路内固定融合系统是治疗椎间盘退变导致的慢性背部疼痛的主要方法之一,但固定后不良反应较多。作为一种"动态融合"的替代方法,动态稳定系统可减轻椎间盘/关节面的负荷,保持机械负荷下的运动,并限制脊柱节段的异常运动,理论上可用于修复椎间盘退变损伤。目的:观察K-Rod动态稳定系统修复腰椎退行性病变的有效性及安全性。方法/设计:研究为前瞻性、单中心、自身对照、临床试验。在中国辽宁省,沈阳市骨科医院完成。纳入腰椎退行性病变患者67例,采用K-Rod动态稳定系统进行修复,随访2年。试验的主要观察指标为固定前、固定后3,6,12,24个月的Oswestry功能障碍指数变化。试验的次要观察指标为固定前、固定后3,12,24个月的椎间盘间隙与椎体高度的比值、腰椎前凸角;固定前、固定后3,6,12,24个月的背部疼痛目测类比评分及腰椎X射线形态;固定后3,6,12,24个月不良反应发生率。试验已在北美临床试验注册中心注册(NCT03214042)。试验经中国辽宁省,沈阳市骨科医院伦理委员会批准。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者本人对治疗方案和过程均知情同意,并签署知情同意书。讨论:试验旨在验证K-Rod动态稳定系统修复腰椎退行性损伤安全有效,为临床腰椎退行性病变的治疗提供参考依据。目前部分试验结果显示,患者固定后24个月的Oswestry功能障碍指数及背部疼痛目测类比评分均较固定前相比明显改善(P0.01),但患者术前与固定后各时间点椎间盘间隙与椎体高度的比值及腰椎前凸角差异无显著性意义(P0.05)。结果说明,对腰椎退行性病变患者而言,K-Rod动态稳定系统固定修复后可减轻疼痛并改善腰部功能。
[Abstract]:Background: posterior internal fixation fusion system is one of the main methods for the treatment of chronic back pain caused by disc degeneration, but there are more adverse reactions after fixation. The dynamic stabilization system can reduce the load of intervertebral disc / articular surface, maintain movement under mechanical load, and restrict abnormal movement of spinal segment. Objective: to observe the efficacy and safety of K-Rod dynamic stabilization system in the treatment of lumbar degenerative lesions. Clinical trial. 67 patients with lumbar degenerative diseases were treated with K-Rod dynamic stabilization system in Shenyang Orthopedic Hospital, Liaoning Province, China, and followed up for 2 years. The changes of Oswestry dysfunction index were observed at 12 and 24 months after fixation. The main indexes of the experiment were the ratio of intervertebral disc space to vertebral body height before fixation, 3o 12,24 months after fixation, lumbar kyphosis angle, before fixation, and before fixation. Visual analogue score of back pain and X-ray morphology of lumbar vertebrae, incidence of adverse reactions in 36 cases and 24 months after fixation. NCT03214042 was registered at the North American Clinical trial Registry. The trial was conducted in Liaoning Province, China. Approved by the Ethics Committee of Shenyang Orthopaedics Hospital. The study meets the requirements of the Helsinki Declaration formulated by the World Medical Association. The purpose of the study was to verify the safety and effectiveness of K-Rod dynamic stabilization system in the repair of lumbar degenerative injury, and to provide a reference for the treatment of clinical lumbar degenerative lesions. The Oswestry dysfunction index and visual analogue score of back pain in patients 24 months after fixation were significantly improved compared with those before fixation, but the ratio of intervertebral disc space to vertebral body height and lumbar kyphosis at each time point before and after fixation were significantly improved. There was no significant difference in angle (P 0.05). For patients with lumbar degenerative disease, K-Rod dynamic stabilization system fixation can relieve pain and improve lumbar function.
【作者单位】：沈阳市骨科医院脊柱外科;
【分类号】：R687.3

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