Objective: To observe the mid-term clinical outcome of total knee arthroplasty (TKA) with domestic A3 posterior stabilized prosthesis. Methods: The clinical data of 342 patients (438 knees) who underwent primary TKA by the same surgeon from June 2012 to December 2013 in Peking University Third Hospital were retrospectively collected. The patients were divided into 2 groups according to the type of prosthesis: 107 patients (137 knees) with domestic A3 prosthesis, as domestic group; 235 patients (301 knees) with a kind of imported prosthesis, as the control group. In the end, 311 patients (390 knees) received complete follow-up.The postoperative knee maximum flexion angle, postoperative Hospital for Special Surgery Knee Score (HSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), postoperative coronal mechanical axis alignment and hospitalization costs were compared between the groups.Paired t-test was used to compare the preoperative and postoperative data in the same group, and independent sample t-test was used to compare the data between the two groups at the same time points. Results: The average follow-up time of all the patients was (5.6±1.1) years, and it was averaged for 64.8 months in the domestic group and 68.2 months in the control group.There was no significant difference in the HSS score and WOMAC score, the knee maximum flexion angle, and coronal mechanical axis alignment at the 3 months postoperatively and at the end of follow-up between the two groups (t=-0.890, -1.610, 1.740, 0.620, all P>0.05). In 2012, the average hospital cost was (24 879±1 627) yuan/knee in the domestic group and it was (49 611±1 589) yuan/knee in the control group (t=-48.902, P<0.01). In 2013, it was (38 393±2 773) yuan/knee in the domestic group, and was (55 931±3 533) yuan/knee in the control group (t=-14.795, P<0.01). Conclusion: It indicates that the domestic A3 posterior stabilized prosthesis brings comparable mid-term results with the imported prothesis and it reduces medical costs remarkably.
目的： 观察国产A3高屈曲后稳定型假体的中期疗效，并与一款同期的进口人工关节进行对照研究。 方法： 回顾性分析2012年6月至2013年12月在北京大学第三医院骨科初次行全膝关节置换(TKA)治疗的342例(共438膝)终末期膝骨关节炎患者的临床资料。手术均经同一医师完成。将患者按照假体类型分为2组：国产组，采用国产A3假体107例(137膝)；对照组，采用进口Genesis Ⅱ假体235例(301膝)。最终311例(390膝)获得完整随访，对2组患者的术后最大屈曲角度、术后西安大略和麦马斯特大学骨性关节炎指数(WOMAC评分)以及美国特种外科医院膝关节评分(HSS评分)、下肢冠状面力线恢复情况及住院情况进行比较分析。同组患者手术前后计量数据比较采用配对t检验，不同组比较采用独立样本t检验。 结果： 所有患者平均随访时间(5.6±1.1)年，国产组平均64.8个月，对照组68.2个月。两组术后3个月及随访终点的HSS和WOMAC评分、膝关节最大屈曲角度、下肢冠状面力线恢复情况差异均无统计学意义(t＝－0.890、－1.610、1.740、0.620，均P>0.05)。2012年国产组总住院费用(24 879±1 627)元，对照组为(49 611±1 589)元，差异有统计学意义(t＝－48.902，P<0.01)；2013年国产组为(38 393±2 773)元，对照组为(55 931±3 533)元，差异亦有统计学意义(t＝－14.795，P<0.01)。 结论： 国产A3假体全膝关节置换术后中期临床疗效满意，与进口假体相比无显著性差异，能显著降低治疗费用。.
Keywords: Domestic prosthesis; Outcome; Total knee arthroplasty.