【摘要】 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。更多还原

【Abstract】 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. MMeetthh-ods: A total of 150 patients who underwent TKA by one surgeon from February 2009 to October 2010 were enrolled into a prospective, blinded, randomized clinical trial. Of them, 75 patients received a high-flex insert and the other 75 received a standard insert. There were no differences in the baseline information between two groups(P>0.05). All patients received the identical 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: Eventually, 56 patients in high-flex group and 54 patients in standard group were followed for 63.1 and 62.7 months on average, respectively. There was no significant difference in any outcome measures(ROM, maximum flexion angle, HSS, WOMAC, anterior 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.更多还原