| Objective Through the prospective,multi-center,single-blind,randomized controlled clinical trial,the safety and effectiveness of the acrylic resin bone cement(type Ⅱ)developed and produced by Shanghai Shangrong Biotechnology Co.,Ltd.for percutaneous vertebroplasty were verified.Provide basis for domestic formal clinical application..Methods This trial is a prospective,multi-center,single-blind,randomized controlled design.In this trial,the clinical use of acrylic resin cement(Type II)was used to evaluate and record the VAS score,ODI score and Vertebral height of the subjects,as well as the adverse events and defects of the test equipment to evaluate the effectiveness and effectiveness of the acrylic resin cement(Type II).It is safe to prove that acrylic resin bone cement(Type II)can effectively relieve and eliminate pain during vertebroplasty and improve the quality of life of the subjects,and it is safe and reliable.Results The safety analysis population of this study was 84 cases,including 42 cases in the test group and 42 cases in the control group.There were 83 cases of FAS,including 41 cases in the test group and 42 cases in the control group.There were 80 cases of PP collection,including 39 cases in the test group and 41 cases in the control group.The baseline situation is balanced between the two groups.There was no statistically significant difference in the proportion of local anesthesia surgery,the ratio of target vertebral thoracolumbar spine,bone cement filling,combined medication ratio,180-day follow-up vertebral body anterior edge height,posterior edge height and preoperative height changes(p> 0.05).The bone cement leakage rate,the incidence of adverse events,postoperative vital signs and postoperative changes of the experimental group and the control group were not statistically significant(p> 0.05).FAS: By 180 days of follow-up,there was no statistically significant difference in VAS scores between the two groups(p> 0.05).The drop points of the experimental group and the control group after 180 days of follow-up relative to before treatment were 6.55 ± 1.47 and 6.12 ± 1.29,the difference between the groups and the 95% confidence interval were 0.430(-0.173 ~ 1.033),and the lower limit of the 95% confidence interval was greater The preset-1 meets the non-inferiority inspection standard.Can be considered non-inferior.After covariance analysis was used to correct the central effect and baseline VAS score,the difference between groups and the 95% confidence interval were 0.244(-0.154 to 0.643),and the lower limit of the 95% confidence interval was greater than the preset-1,reaching the non-inferiority test standard.Can be considered non-inferior.The ODI scores of the two groups were 16.34 ± 12.85 and 24.54 ± 20.46,the difference was statistically significant(p <0.05).The decrease points of the experimental group and the control group after 180 days of follow-up relative to that before treatment were 65.26 ± 15.49 and 53.87 ± 22.14,respectively,and the difference was statistically significant(p <0.05).PP: By 180 days of follow-up,there was no statistically significant difference in VAS scores between the two groups(p> 0.05).The 180-day follow-up period of the experimental group and the control group was 6.55 ± 1.39 and 6.17 ± 1.26 respectively.The difference between the groups was 0.381(-0.210 ~ 0.971),and the lower limit of the 95% confidence interval was greater than the preset-1.Meet the non-inferiority inspection standard.Can be considered non-inferior.After covariance analysis was used to correct the central effect and baseline VAS score,the difference between groups and the 95% confidence interval were 0.292(-0.113 to 0.696),and the lower limit of the 95% confidence interval was greater than the preset-1,reaching the non-inferiority test.Can be considered non-inferior.By 180 days of follow-up,the ODI scores of the two groups were 15.59 ± 12.71 and 24.38 ± 20.68,the difference was statistically significant(p <0.05).The decrease scores of the test group and the control group after 180 days of follow-up relative to before treatment were 65.82 ± 15.64 and 54.16 ± 22.34,respectively,and the difference was statistically significant(p <0.05).Conclusion Acrylic resin bone cement(type Ⅱ)can effectively relieve pain and improve the quality of life of subjects in vertebroplasty,and is safe and reliable.In terms of improving the quality of life of the subjects,acrylic resin bone cement(type II)(high viscosity)is better than low viscosity bone cement,and the two are equivalent in terms of pain relief. |
PDF Full Text Request