新型国产膝关节假体用于全膝关节置换术的临床研究

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...

A clinical trial of the new domestic knee joint prostheses for total knee arthroplasty

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.