Effect ofhigh-flexversusstandardpolyethylene tibial inserts on long-term range of motion after total knee arthroplasty:a randomized controlled study

背景:为提高全膝关节置换(total knee arthroplasty,TKA)术后患者关节活动范围,许多假体推出高屈曲设计.这些高屈曲设计是否为患者带来临床获益,仍需进一步研究.目的:观察高屈曲和标准垫片对患者TKA术后长期关节活动范围以及临床效果的影响.方法:2009年2月至2010年10月入院,并由同一术者使用同一种假体进行单膝TKA患者150例,随机分为观察组和对照组各75例.两组患者术前基线资料无统计学差异(P>0.05).所有患者按照标准术式进行手术,仅在决定安装垫片时根据随机分组信件,观察组使用高屈曲垫片,对照组使用标准垫片.术后使用相同疼痛管理和康复计划.术后对两组患者进行至少5年随访,记录关节活动范围、最大屈曲角度、HSS评分、WOMAC评分及膝前疼痛VAS评分,并进行组间比较.结果:分别有观察组56例和对照组54例患者获得末次随访(平均63.1个月和62.7个月).观察组和对照组在术前和末次随访时的平均活动范围、最大屈曲角度、下肢力线、HSS评分、WOMAC评分及膝前疼痛VAS评分均无统计学差异(P>0.05).所有患者末次随访时均未出现假体松动和翻修.结论:后稳定型假体的高屈曲垫片未能增加TKA术后患者长期膝关节的活动范围及最大屈曲角度.Background: Many implant designs have been modified to a high-flex version for increasing range of motion (ROM) after total knee arthroplasty (TKA). However, its clinical benefits remain unconfirmed. Objective:To investigate the effect of"high-flex"versus"standard"polyethylene tibial inserts on long-term ROM and clinical outcomes after TKA. Meth-ods:A total of 150 patients who underwent TKA by one surgeon from February 2009 to October 2010 were enrolled into a pro-spective, blinded, randomized clinical trial. Of them, 75 patients received a high-flex insert and the other 75 received a stan-dard insert. There were no differences in the baseline information between two groups (P>0.05). All patients received the iden-tical operation, pain management and rehabilitation protocol. With minimum 5-year follow-up, the ROM, maximum flexion angle, and HSS, WOMAC, anterior knee pain VAS scores were recorded and compared between two groups. Results:Eventu-ally, 56 patients in high-flex group and 54 patients in standard group were followed for 63.1 and 62.7 months on average, re-spectively. There was no significant difference in any outcome measures (ROM, maximum flexion angle, HSS, WOMAC, an-terior knee pain VAS scores) before operation or at the last follow-up between the two groups (P>0.05). Conclusions:The high-flex insert can not increase long-term ROM or maximum flexion angle after TKA as compared with a standard insert.118-21,321