High viscosity bone cement for osteoporotic vertebral compression fractures：a protocol for prospective self-controlled open-label clinical trial
10.3969/j.issn.2095-4344.2016.17.018
- VernacularTitle:高黏度骨水泥治疗骨质疏松压缩性椎体骨折：前瞻性自身前后对照开放性临床试验方案
- Author:
Yinliang WU
;
Qiang WANG
;
Fanian LI
;
Jun PENG
;
Long JIANG
;
Liang CHEN
- Publication Type:Journal Article
- From:
Chinese Journal of Tissue Engineering Research
2016;20(17):24522-24528
- CountryChina
- Language:Chinese
-
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-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.
