中国组织工程研究

中国组织工程研究 ›› 2019, Vol. 23 ›› Issue (22): 3518-3521.doi: 10.3969/j.issn.2095-4344.1751

• 组织工程骨及软骨材料 tissue-engineered bone and cartilage materials • 上一篇    下一篇

无机诱导因子支架材料和自体骨用于腰椎椎间融合患者远期疗效的差异：非随机对照、2年随访临床试验方案

薛志兴，周建伟，迟  成，王  飞，马玉泉
  

  1. 首都医科大学附属北京同仁医院骨科，北京市  100730
  • 收稿日期:2019-02-22
  • 通讯作者: 薛志兴，主治医师，首都医科大学附属北京同仁医院骨科，北京市 100730
  • 作者简介:薛志兴，首都医科大学附属北京同仁医院骨科，北京市 100730

Long-term effects of inorganic osteogenesis-inducing scaffold versus autologous bone in lumbar interbody fusion: protocol for a non-randomized, controlled trial with 2-year follow-up 

Xue Zhixing, Zhou Jianwei, Chi Cheng, Wang Fei, Ma Yuquan
  

  1. Department of Orthopedics, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
  • Received:2019-02-22
  • Contact: Xue Zhixing, Department of Orthopedics, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
  • About author:Xue Zhixing, Attending physician, Department of Orthopedics, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China

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摘要：

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文题释义：
无机诱导因子支架材料：具有特定化学比例、结晶度的钙、磷等无机元素的化合物，其具有孔率>90%的三维立体结构，颗粒中含有大量纳米级微孔。
植骨术：是用手术将骨组织移植到患者体内骨胳缺损、需要加强或融合的部位。由于骨胳来源不同，分为自体骨移植及同种骨移植。
 
 
背景：课题组前期研究表明，腰椎后路经椎间孔入路椎间融合内固定术中应用无机诱导因子支架材料能够获得与自体骨融合相近的椎间融合效果，近期疗效较好。
目的：观察无机诱导因子支架材料和自体骨用于腰椎椎间融合的远期疗效差异及安全性。
方法：纳入首都医科大学附属北京同仁医院骨科的腰椎退行性疾病住院患者120例，均采用腰椎融合外科修复，按修复材料的不同分为2组，试验组(n=60，50%)和对照组(n=60，50%)分别采用无机诱导因子支架材料及自体骨修复。术后随访1周，1年，2年。试验经首都医科大学附属北京同仁医院医学伦理委员会批准(批准号：TRECKY2017-158，审批时间：2017-09-28)，方案版本号1.0。参与试验的患者及其家属均签署“知情同意书”。试验已在中国临床试验注册中心注册(注册号：ChiCTR1900021333)，注册时间：2019-02-15，方案版本号1.0，注册成功后开始纳入患者，研究成果可在国内外相关会议报告。
结果与结论：试验的主要结局指标为术后2年的Oswestry功能障碍指数问卷表评分；次要结局指标为术前、术后1周、1年的Oswestry功能障碍指数问卷表评分，术前、术后1周、1年、2年的目测类比评分、日本骨科协会评分、腰椎腰椎生理前凸角度，术后1周、1年、2年的不良反应发生率。试验期望验证，无机诱导因子支架材料在腰椎椎间融合可以代替自体骨进行植入修复，并具有相近的远期修复效果。

关键词: 腰椎退行性疾病, 腰椎后路经椎间孔入路椎间融合内固定, 腰椎融合, 无机诱导因子支架材料, 组织工程

Abstract:

BACKGROUND: Preliminary study has shown that inorganic osteogenesis-inducing scaffold material exhibits good biocompatibility and bone-inducing effects in posterior lumbar interbody fusion, with encouraging short-term outcomes.
OBJECTIVE: To investigate the safety and long-term effects of inorganic osteogenesis-inducing scaffold materials versus autologous ilium in lumbar interbody fusion.
METHODS: This prospective, single-center, non-randomized, controlled trial will include 120 patients who receive treatment for lumbar degenerative diseases at the Department of Orthopedics, Beijing Tongren Hospital, Capital Medical University, China. These patients will receive lumbar repair surgery with inorganic osteogenesis-inducing scaffold materials (test group, n=60, 50%) or autologous ilium (control group, n=60, 50%). All patients will be followed up at 1 week, and 1 and 2 years postoperatively. This study was approved by the Medical Ethics Committee, Beijing Tongren Hospital, Capital Medical University, China (approval No. TRECKY2017-158) on September 28, 2017. Study protocol version: 1.0. All participants or their family members must provide written informed consent after fully understanding the study protocol. The study was registered with Chinese Clinical Trial Registry on February 15, 2019 (registration number: ChiCTR1900021333). Study protocol version: 1.0. Patient recruitment bengun and the results will be disseminated through presentations at scientific meetings.
RESULTS AND CONCLUSION: The primary outcome measure of this study is the Oswestry Disability Index at 2 years postoperatively. The secondary outcome measures are the Oswestry Disability Index preoperatively and at 1 week and 1 year postoperatively, the Visual Analog Scale score, Japanese Orthopedic Association score, and lumbosacral angle preoperatively and at 1 week, and 1 and 2 years postoperatively, and the incidence of adverse reactions at 1 week, and 1 and 2 years postoperatively. This study will provide evidence to validate whether inorganic osteogenesis-inducing scaffold material results in similar long-term outcomes to autologous ilium in lumbar interbody fusion.

Key words:  lumbar degenerative diseases, posterior lumbar interbody fusion, lumbar interbody fusion, inorganic osteogenesis-inducing scaffold material, tissue engineering

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