背景：传统骨水泥材料治疗骨质疏松压缩性椎体骨折时存在易发生散热效应、容易渗漏、力学强度与周围组织差异大等问题，严重影响骨质疏松压缩性椎体骨折的治疗效果。实验拟通过前瞻性自身前后对照开放试验来分析，一种新型高黏度骨水泥治疗骨质疏松压缩性椎体骨折的有效性。 方法/设计：在江苏大学附属宜兴医院进行前瞻性自身前后对照开放试验。对骨质疏松压缩性椎体骨折患者经皮椎体成形植入高黏度骨水泥，即刻结局指标为高黏度骨水泥植入前后改善患者疼痛症状的比较，以目测类比评分进行评价。中远期结局指标为患者脊柱功能的恢复情况以Oswestry功能障碍指数问卷表、椎体高度、骨水泥渗漏率、Barthel指数和SF-36生存质量量表评分评价。 讨论：试验将为高黏度骨水泥治疗骨质疏松压缩性椎体骨折提供临床应用依据。 伦理批准：试验方案已经江苏大学附属宜兴医院医学伦理委员会批准，批件文号：0136。试验获得患者及其家属的书面知情同意。%BACKGROUND:Traditional bone cement in the treatment of osteoporotic vertebral compression fracture easily induces heat dissipation effect, leakage, big difference in mechanical strength with the surrounding tissue, which greatly affects treatment effect of osteoporotic vertebral compression fracture. This prospective self-controled open-label clinical trial is designed to analyze the effectiveness of a novel high viscosity bone cement for osteoporotic vertebral compression fractures. METHODS/DESIGN:This prospective self-controled open-label clinical trial wil be performed in the Yixing Hospital Affiliated to Jiangsu University of China. High viscosity bone cement wil be implanted in patients with osteoporotic vertebral compression fractures by percutaneous vertebroplasty. Immediate outcomes: Pain symptom of patients before and after implantation of high viscosity bone cement, and Visual Analogue Scale score. Middle- and long-term outcomes: The recovery of spinal function, Oswestry dysfunction index questionnaire, vertebral body height, bone cement leakage rate, Barthel index and SF-36 quality of life scale score. DISCUSSION: This trial wil provide a clinical basis for the treatment of osteoporotic vertebral compression fractures with high viscosity bone cement. ETHICS APPROVAL: This trial has been approved by the Medical Ethics Committee, Yixing Hospital Affiliated to Jiangsu University (Approval number 0136). Patients and their family members have signed the informed consent.
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