国产膝关节表面假体的临床应用初步报告

Preliminary clinical results of domestic T-free knee prosthesis

目的 比较国产T-free膝关节假体与同类进口假体膝关节置换的早期疗效.方法 2008年7月至2009年12月采用国产T-free膝关节表面假体施行膝关节置换25例35膝,单侧15例、双侧10例；屈曲挛缩19例25膝、内翻畸形11例18膝、外翻畸形4例5膝.膝关节活动度75.11°±27.68°,美国膝关节协会评分系统（Knee Society Score,KSS）膝评分（17.88±14.37）分,KSS功能评分（21.62±21.27）分.同期同一术者施行的同类进口膝关节假体置换27例39膝做为对照进行回顾性研究.两组患者年龄、体重指数、随访时间、术前膝关节活动度的差异无统计学意义；术前KSS膝评分及KSS功能评分的差异有统计学意义.结果 国产假体组24例平均随访（14.92±8.32）个月,与进口假体组26例（15.42±9.87）个月的差异无统计学意义.末次随访时国产假体组的膝关节活动度平均107.53°±18.32°,与进口假体组112.84°±9.76°的差异无统计学意义；KSS膝评分平均（86.71±9.78）分,与进口假体组（86.68±6.01）分的差异无统计学意义；KSS功能评分平均（65.88±25.01）分,与进口假体组（71.35±16.74）分的差异无统计学意义.国产假体组患者的满意率为95.8％（23/24）.结论 国产T-free膝关节表面假体与同类进口产品的近期疗效相当.

Objective To compare domestic T-free knee prosthesis with the similar imported prosthesis in preliminary clinical results for early follow-up.Methods From July 2008 to December 2009,35knees of 25 patients were implanted with domestic T-free knee prosthesis,including unilateral TKA in 15 cases and bilateral TKA in 10.Deformity included flexion contracture in 19 cases with 25 knees,varus deformity in 11 with 18 knees,valgus deformity in 4 with 5 knees.The preoperative average ROM was 75.11°±27.68°,the mean points of Knee Society Score（KSS）were 17.88±14.37,and the average points of KSS function scores were 21.62±21.27.In the same period,all 27 cases with 39 knees operated by the same surgeon were implanted the similar imported prosthesis,and they were set for control group to do the retrospective cohort study.The patients of two groups who completed follow up had no statistical differences in age,BMI and preoperation ROM（P〉0.05）,but they had statistical differences in pre-operation KSS scores and pre-operation KSS function scores（P〈0.05）.Results The domestic prosthesis group＇s average follow-up time were 14.92±8.32 months and had no statistically different with the control group＇s 15.42±9.87 months（P〉0.05）.The mean postoperation knee ROM of domestic knee prosthesis group was 107.53°±18.32° in 14.92±8.32months follow-up,which did not differ with that of the imported group 112.84°±9.76°（P〉0.05）.There was no statistical difference in KSS scores between the domestic 86.71 ±9.78 and the imported group 86.68±6.01,and no difference in KSS functional scores was found between the domestic 65.88±25.01 and the imported knee prosthesis 71.35±16.74（P〉0.05）.The satisfaction rate after TKA was 95.8%（23/24）in domestic knee prosthesis group.Conclusion The domestic T-free knee prosthesis was commensurate with the similar imported knee prosthesis in preliminary clinical results for early follow-up.