【摘要】 目的 通过随机对照临床试验，验证新型国产膝关节假体临床应用的安全性和有效性。方法 本研究采用多中心、随机、单盲、阳性平行对照设计，自2017年3月至2019年3月在全国6家医院共招募72例受试者，试验组和对照组各36例。试验组使用新型国产膝关节假体，对照组使用成熟的膝关节假体。所有受试者在术前和术后3个月、6个月、1年、2年进行随访评估，评价记录术后主要疗效指标HSS评分和不良事件发生率，确认试验产品的临床应用价值。结果 本研究72例受试者均完成了2年的随访。试验组术前和术后3个月、6个月、1年、2年的HSS评分分别为：（56.95±13.07）分、（76.85±9.88）分、（82.80±7.15）分、（88.22±5.95）分、（88.94±4.38）分，对照组HSS评分分别为：（55.25±9.47）分、（77.09±6.41）分、（83.77±6.04）分、（88.96±5.37）分、（89.23±5.06）分。试验组和对照组的HSS评分术后均较术前明显提高，但术后各随访时间点两组HSS评分比较，差异无统计学意义（P>0.05）。试验组和对照组术后不良事件发生率比较，差异无统计学意义（P>0.05）。结论 与对照组相比，试验组新型国产膝关节假体在主要疗效指标HSS评分、安全性评价指标方面均无明显差异。因此，试验组新型国产膝关节假体在术后早期可获得满意效果，远期疗效待进一步观察随访。更多还原

【Abstract】 Objective To evaluate the clinical efficacy and safety of the new domestic knee joint prostheses for total knee arthroplasty via a randomized controlled clinical trial. Methods A multi-center, randomized, single-blind, and positive parallel controlled design was used in this study. From March 2017 to March 2019, 72 subjects were recruited in 6 hospitals across the country, and allocated into experimental group and control group evenly. The new domestic knee joint prostheses were used in the experimental group, while the proven knee joint prostheses were used in the control group. Follow-up evaluations were carried out before the operation, 3 months, 6 months, 1 year, and 2 years after the operation. The HSS score and the incidence of adverse events were evaluated and recorded to confirm the clinical application value of the new domestic knee joint prostheses. Results All 72 subjects in this study had completed the two-year follow-up. The HSS scores of the experimental group before the operation, 3 months, 6 months, 1 year, and 2 years after the operation were(56.95±13.07),(76.85±9.88),(82.80±7.15),(88.22±5.95),(88.94±4.38) points, and the HSS scores of the control group were(55.25±9.47),(77.09±6.41),(83.77±6.04),(88.96±5.37),(89.23±5.06) points, respectively. The HSS scores of the experimental group and the control group after the operation were significantly higher than those before the operation, but there was no statistical difference between the two groups at each follow-up time point(P>0.05).There was no statistical difference in the incidence of adverse events between the two groups(P>0.05).Conclusion There was no significant difference in clinical efficacy and safety between the two groups. Therefore, the effect of the new domestic knee prostheses could be satisfying short term after operation, whereas the long-term effects need to be further followed up.更多还原