High viscosity bone cement for osteoporotic vertebral compression fractures: a protocol for prospective self-controlled open-label clinical trial

doi:10.3969/j.issn.2095-4344.2016.17.018

Abstract

Abstract:

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-controlled 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-controlled open-label clinical trial will be performed in the Yixing Hospital Affiliated to Jiangsu University of China. High viscosity bone cement will 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 will 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.
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: Osteoporotic Fractures, Viscosity, Tissue Engineering

Wu Yin-liang, Wang Qiang, Li Fa-nian, Peng Jun, Jiang Long, Chen Liang . High viscosity bone cement for osteoporotic vertebral compression fractures: a protocol for prospective self-controlled open-label clinical trial[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(17): 2562-2568.

Figures/Tables 3

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