国产新型TC-A膝关节假体治疗终末期膝骨关节炎的短期疗效分析

Short-term efficacy of a new domestic TC-A knee prosthesis in the treatment of end-stage knee osteoarthritis

背景:国内全膝关节置换手术量明显增加,但进口假体的设计是基于欧美人种的膝关节解剖结构。亟需开发出适合中国人的膝关节假体,以提高术后满意度。目的:通过前瞻性临床对照研究评估国产新型膝关节假体治疗终末期膝骨关节炎的早期疗效。方法:选取2014年11月至2015年11月因终末期骨关节炎接受初次单侧全膝关节置换术治疗的54例患者,采用随机数字表法将患者分为国产组和进口组,国产组28例,使用国产TC-A型膝关节假体行全膝人工关节置换术;进口组26例,使用进口TC-Plus型膝关节假体行全膝关节置换术,采用美国膝关节协会评分(KSS)、美国西安大略和麦克马斯特大学(WOMAC)骨关节炎指数对手术前后膝关节疼痛和功能进行对比分析。结果:所有患者均获得完整随访,国产组随访12~45个月,平均(13.7±6.8)个月,进口组随访12~40个月,平均(14.0±6.7)个月。术后12个月随访时,两组KSS膝关节评分、KSS功能评分、膝关节活动度、WOMAC骨关节炎指数均较术前改善(P<0.01)。两组术前、术后3个月、术后6个月、术后12个月KSS功能评分、KSS膝关节评分、膝关节活动度、WOMAC骨关节炎指数比较,差异均无统计学意义(P>0.05)。结论:治疗终末期骨关节炎时使用国产TC-A型膝关节假体可获得较好的临床效果,早期疗效与进口假体无明显差异,国产假体治疗终末期骨关节炎的远期疗效有待进一步研究。

Background:The total knee arthroplasty surgery in China has increased significantly,and the imported prosthesesare designed for the knees of European and American people.Thus,the knee prosthesis suitable for Chinese people is requiredwhich will improve patients’postoperative satisfaction.Objective:To evaluate the early efficacy of the new domestic knee pros-thesis in the treatment of end-stage knee osteoarthritis by prospective clinical controlled study.Methods:A total of 54 patientsundergoing primary unilateral total knee arthroplasty for end-stage osteoarthritis from November 2014 to November 2015 were recruited.The patients were randomly divided into two groups:TC-A group(n=28)with domestic prosthesis and TC-Plusgroup(n=26)with imported prosthesis.The pain and function of knees were analyzed by American Knee Society Score(KSS)and Western Ontario and Mc Master University Osteoarthritis Index(WOMAC).Results:All patients were followed up com-pletely.The average follow-up time of TC-A group was(13.7±6.8)months(range,12-45 months)and that of TC-Plus groupwas(14.0±6.7)months(12-40 months).The KSS functional score,KSS knee joint score,knee range of motion and WOMAC in-dex were all improved significantly at 12 months after surgery as compared with that before surgery(P<0.05).No significantdifferences in the KSS functional score,KSS knee joint score,knee range of motion and WOMAC index were found betweenthe two groups(P>0.05).Conclusions:TC-A knee prosthesis made in China can achieve good clinical effect in the treatmentof end-stage osteoarthritis,which is comparable with imported prosthesis for early efficacy.However,the long-term efficacy re-quires further study.