聚甲基丙烯酸甲酯骨水泥和可注射人工骨材料植入修复老年退行性骨质疏松性胸椎压缩骨折:随机对照临床试验方案

Combined use of poly(methyl methacrylate) bone cement and injectable artificial bone implantation for senile degenerative thoracic osteoporotic vertebral compression fractures: study protocol for a randomized controlled trial

背景:经皮椎体后凸成形术是治疗老年退行性骨质疏松性胸椎压缩骨折的有效方法之一,但是国内外学者对其临床远期效果有所争议。在此技术中常用的填充材料聚甲基丙烯酸甲酯(polymethylmethacrylate,PMMA)骨水泥,具有良好的可塑性和椎体成形能力,但生物相容性尚不明确;可注射人工骨是一种新型椎体填充材料,可诱导骨形成,但是远期疗效也有待考证。目的:试验设计对比OSTEOPAL?Plus PMMA和Gene X?可注射人工骨植入修复治疗老年退行性骨质疏松性胸椎压缩骨折,随访观察术后24个月的效果。方法:研究为前瞻性,单中心,开放性,随机对照临床试验。试验将纳入来自青海大学附属医院创伤骨科的老年退行性骨质疏松性胸椎压缩骨折患者378例,随机分为2组,均采用经皮椎体后凸成形术修复,PMMA组采用OSTEOPAL?Plus PMMA骨水泥材料填充修复;人工骨组采用GeneX?可注射人工骨新型椎体材料填充修复,每组189例,术后1周及3,6,12,24个月随访。研究的主要结局指标为术后24个月以患者椎体高度恢复率评估受损胸椎的修复效果;研究的次要结局指标为术后1周,3,6,12个月椎体高度恢复率,术后1周,3,6,12,24个月骨水泥渗漏发生率,术前,术后1周,3,6,12,24个月目测类比评分,Oswestry功能障碍指数问卷评分,椎体前缘压缩比率,胸椎CT检测形态,术后1周,3,6,12,24个月不良反应发生率。讨论:试验数据可否证明,和OSTEOPAL?Plus PMMA骨水泥和GeneX?可注射人工骨植入修复治疗老年退行性骨质疏松性胸椎压缩骨折的近期、2年随访效果及安全性均较好。试验经青海大学附属医院医学伦理委员会批准(审批单位:青海大学附属医院,审批时间:2017年11月,审批号:2017-11)。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者本人对试验方案和过程均知情同意,并签署知情同意书。试验设计时间为2017年12月,试验于2018年7月至开始进行患者招募及数据收集,2020年9月进行结果指标分析,2020年10月试验完成。文章结果将以科学会议报告,或在同行评议的期刊上发表传播。试验已在中国临床试验注册中心注册(注册号:Chi CTR1800015411),注册方案版本号1.0。

BACKGROUND:Percutaneous kyphoplasty is an effective treatment method for senile degenerative thoracic osteoporotic vertebral compression fractures.However,its clinical long-term effect is controversial among scholars both inside and outside China.The poly(methyl methacrylate)(PMMA)bone cement commonly used in percutaneous kyphoplasty has good plasticity and formability,but its biocompatibility is not yet clear.Injectable artificial bone is a novel filling material to induce bone formation,but its long-term efficacy remains to be verified.OBJECTIVE:To compare the efficacy of OSTEOPAL?Plus PMMA bone cement and GeneX?injectable artificial bone graft in the treatment of senile degenerative thoracic osteoporotic vertebral compression fractures at 24 months postoperatively.METHODS:This is a prospective,single-center,open-label,randomized controlled clinical trial.A total of 378 patients with senile degenerative thoracic osteoporotic vertebral compression fractures will be recruited from the Department of Orthopedics,Affiliated Hospital of Qinghai University,China.The patients will be randomized into two groups and undergo percutaneous kyphoplasty.The PMMA group(n=189)will be treated with OSTEOPAL?Plus PMMA bone cement.The artificial bone group(n=189)will be treated with GeneX?injectable artificial bone.Follow-ups will be conducted at 1 week and at 3,6,12,and 24 months.The primary outcome measure will be the vertebral body height restoration rate at 24 months postoperatively to evaluate the repair effect of the damaged thoracic vertebra.The secondary outcome measures will be the vertebral body height restoration rate at 1 week and 3,6,and 12 months postoperatively;the incidence of bone cement leakage at 1 week and 3,6,12,and 24 months postoperatively;the visual analog scale score,Oswestry Disability Index,compression rate of the anterior vertebral height,and thoracic morphology revealed by computed tomography preoperatively and at 1 week and 3,6,12,and 24 months postoperatively;and the incidence of adverse reactions at 1 week and 3,6,12,and 24 months postoperatively.DISCUSSION:Our results will verify whether OSTEOPAL?Plus PMMA bone cement and GeneX?injectable artificial bone graft are effective and safe for treating senile degenerative thoracic osteoporotic vertebral compression fractures in the short-term and at the 2-year follow-up.This study was approved by the Medical Ethics Committee of Affiliated Hospital of Qinghai University of China in November 2017(approval number:2017-11).The study protocol will be conducted in accordance with the Declaration of Helsinki,formulated by the World Medical Association.Written informed consent will be obtained from all participants who will be fully informed of study protocol and process.This trial was designed in December 2017.The recruitment of subjects and data collection will begin in July 2018.Outcome measures will be analyzed in September 2020.This trial will be completed in October 2020.The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal.This trial had been registered in the Chinese Clinical Trial Registry(registration No:ChiCTR1800015411).The version of this study protocol is 1.0.