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

doi:10.3969/j.issn.2095-4344.2017.19.005

摘要/Abstract

摘要：

文章快速阅读：

文题释义：

K-Rod动态稳定系统：由钛合金椎弓根螺钉、钛合金线和在椎弓根螺钉头之间的聚醚醚酮(PEEK)壳组成，用于修复退行性损伤。

腰椎前凸角：是通过测量患者侧位X射线从L₁的下终板和S₁的上终板上画的线之间的夹角。

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(P < 0.01)，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(P > 0.05)。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。

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程
ORCID: 0000-0001-7509-749X(王景续)

关键词: 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

Abstract:

BACKGROUND: Posterior internal fixation and fusion system is a main method for chronic back pain caused by intervertebral disc degeneration, but more postoperative adverse reactions occur. Dynamic stabilization system can reduce adjacent-segment degeneration, and theoretically, repair intervertebral disc degeneration.

OBJECTIVE: To investigate the efficacy and safety of K-rod dynamic stabilization system in the repair of lumbar degenerative diseases.

METHODS/DESIGN: We conducted a prospective, single-center, self-controlled, clinical trial at the Orthopedic Hospital of Shenyang, China. Sixty-seven patients with lumbar degenerative diseases were enrolled, and treated with K-rod dynamic stabilization system. All patients were followed for 2 years. The primary outcome was the changes in the Oswestry dysfunction index scores at baseline, 3, 6, 12 and 24 months postoperatively. The secondary outcomes were the ratio of height vertebral space to body and lumbar lordotic angle at baseline, 3, 12 and 24 hours postoperatively; the visual analogue scale scores for back pain and morphological changes in the lumbar vertebrae on x-ray preoperatively and 3, 6, 12 and 24 months after surgery; the incidence of adverse reactions at 3, 6, 12 and 24 months postoperatively. This trial has been registered at ClinicalTrials.gov (identifier: NCT03214042). The study protocol has been approved by the Ethics Committee of Orthopedic Hospital of Shenyang. All protocols will be performed in accordance with the Ethical Principles for Medical Research Involving Human Subjects in the Declaration of Helsinki. Written informed consent was provided by each patient after they indicated that they fully understood the treatment plan.

DISCUSSION: This trial was designed to investigate the efficacy and safety of K-rod dynamic stabilization system for lumbar degenerative diseases, thus providing reference for its clinical application. Partial results demonstrated that the Oswestry Dysfunction Index and Visual Analogue Scale scores at 24 months postoperatively were significantly improved (P < 0.01), but the ratio of height vertebral space to body and lumbar lordotic angle did not differ significantly at different time points (P > 0.01). These results suggest that K-rod dynamic stabilization system can alleviate pain and improve lumbar function in the patients with lumbar degenerative diseases.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Lumbar Vertebrae, Intervertebral Disk

中图分类号:

R318

王景续，宫树一，邬波. 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[J]. 中国组织工程研究, 2017, 21(19): 2980-2985.

Wang Jing-xu, Gong Shu-yi, Wu Bo. Efficacy and safety of K-rod dynamic stabilization system in the repair of lumbar degenerative diseases: study protocol for a prospective, self-controlled, clinical trial[J]. Chinese Journal of Tissue Engineering Research, 2017, 21(19): 2980-2985.

图/表（结果） 2

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引言

材料方法

1.1 试验设计 前瞻性、单中心、自身对照、临床试验。

1.2 试验完成地点 试验在中国辽宁省，沈阳市骨科医院完成。

1.3 试验设计执行流程 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。

试验主要观察腰椎前凸角、椎间盘间隙与椎体高度的比值，背部疼痛目测类比评分，Oswestry功能障碍指数，腰椎X射线形态及不良反应发生率的变化情况。

试验流程图见图1。

1.4 伦理学要求 临床试验方案经沈阳市骨科医院伦理委员会批准。研究的实施符合《赫尔辛基宣言》和医院对人体研究的相关伦理要求。文章的撰写与编辑修改后文章遵守了《临床试验方案规范指南》(SPIRIT指南) ；该临床试验方案已在北美临床试验注册中心注册，注册号为NCT03214042；参与实验的患病个体及其家属应自愿参加，所有供者、受者均应对实验过程完全知情同意，在充分了解本治疗方案的前提下签署“知情同意书”。

1.5 入选标准 符合如下标准者可被纳入研究：

(1)退行性腰椎滑脱(Ⅰ度)；

(2)神经根管或中央椎管狭窄患者；

(3)伴神经根性疼痛和/或慢性背部疼痛者；

(4)年龄32-76岁者；

(5)性别不限；

(6)对试验内容知情，签署知情同意书者。

符合如下条件之一者将被排除研究：

(1)伴有全身感染者；

(2)依从性差，对研究不配合的患者。

1.6 基线分析 基线资料的采集项目见表1。

1.7 样本量 结合课题组以往经验，假设固定前患者Oswestry功能障碍指数为55%，固定后24个月Oswestry功能障碍指数降低至30%，设Power=90%，β=0.1，显著性水准双侧α=0.05，采用PASS 11.0软件(PASS，Keysville，UT，USA)计算后样本量为42例，按20%的脱落率计算，应纳入51例。最终经入选标准和排除标准筛选后，实际共纳入67例患者参加试验。

1.8 招募 采用对沈阳市骨科医院住院发送宣传单的方式招募患者，患者对试验内容感兴趣可直接手机联系研究者，患者及家属亲属知情同意书后，方可纳入试验。

1.9 盲法 本次试验为开放性试验，患者、医生及评估者均对分组及治疗方案非盲。

1.10 干预

K-Rod动态稳定系统：购自Biotech公司，由钛合金椎弓根螺钉，钛合金线和在椎弓根螺钉头之间的聚醚醚酮(PEEK)壳组成(图2)。

弹性固定的腰椎后路K-Rod动态稳定系统内固定：采用全身麻醉，患者俯卧位。根据每个患者固定前计划，在椎弓根螺钉植入前进行一侧椎板切除，全椎板切除和/或椎间盘切除，减压后对患者的位置进行调整，以获得最大的腰椎前凸。然后拧入钛合金椎弓根螺钉。椎弓根螺钉的直径是根据腰椎固定前的X射线片而定的。椎弓根入口点为“人字嵴”顶点，在横突的平面上，保持13°-18°的外翻角。在骶骨位置，螺钉要接近S₁椎体的上终板。动态螺钉在C型臂透视下，放置到尽可能深的位置，以保证螺钉把持力。然后插入钛合金弹性棒和PEEK外壳，再收紧整个系统。

腰椎X射线检测：所有患者在固定前和固定后3，6，12和24个月，要进行腰椎正侧X射线检查。手术水平节段性前凸(或水平)是通过测量椎骨的上下终板所画的线之间的夹角来测量。

1.11 结局指标

1.11.1 主要观察指标固定前、固定后3，6，12，24个月的Oswestry功能障碍指数变化：Oswestry 功能障碍指数问卷表是由10个问题组成^[16]，包括疼痛的强度、生活自理、提物、步行、坐位、站立、干扰睡眠、性生活、社会生活、旅游等10个方面的情况，每个问题的最高得分为5分，记分方法：实际得分/50(最高可能得分)×100%，假如有一个问题未回答，则记分方法是：实际得分/45(最高可能得分)×100%，数值越高表明功能障碍越严重。

1.11.2 次要观察指标

(1)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：椎间盘间隙(IVS)比率=固定前和固定后椎间盘高度/运动节段的椎体高度。

(2)固定前、固定后3，12，24个月腰椎前凸角：腰椎前凸角是通过测量侧位X射线从L₁的下终板和S₁的上终板上画的线之间的夹角。

(3)固定前、固定后3，6，12，24个月背部疼痛目测类比评分：评估腰背部疼痛情况。分值越高表明疼痛越严重。

(4)固定前、固定后3，6，12，24个月腰椎X射线形态：采用X射线检查患者腰椎固定修复后形态。

(5)固定后3，6，12，24个月不良反应发生率：不良反应发生率为发生不良反应的患者数/患者总数×100%。

1.12 试验主要及次要观察指标和观察流程 见表2。

1.13 不良事件 对患者随访时出现的不良反应包括切口疼痛、感染，腰部疼痛、周围神经损伤、固定物松动脱落等，详细记录不良反应发生的时间、类型及当时的处理方法。

1.14 数据收集、管理、分析、开放

数据收集：病例报告表(CRF)由研究者填写，每位入选病例必须完成病例报告表。

数据管理：完成的病例报告表由监查员审查后，第一联移交数据管理员，进行数据录入与管理工作。第一联移交后，病例报告表的内容不再做修改。

数据分析：数据库锁定后提交统计分析人员进行统计分析，并撰写分析报告交给研究者审核。

数据开放：出版数据将公开发布于www.figshare.com。

1.15 统计学分析 采用SPSS 19.0统计软件包进行数据分析，且符合意向分析原则。

计量资料符合正态分布用均值(mean)、标准差(SD)、最小值(min)、最大值(max)表示，非正态分布数据用下四分位数(q1)、中位数(median)和上四分位数(q3)表示。计数资料用百分率表示。

患者固定前与固定后各时间点Oswestry功能障碍指数及背部疼痛目测类比评分的比较采用K-S秩和检验，各时间点组间数据的两两比较采用Mann-Whitney U检验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的比较采用重复测量方差分析和LSD检验。

检验水准α=0.05。

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程