INTRODUCTION:Prosthetic and operative modifications in total knee arthroplasty (TKA) have been proposed to maximise post-operative knee flexion as it is essential in routine functional activities. METHODS:We performed a double blind randomised controlled trial to compare clinical outcomes of primary cruciate-retaining TKA for osteoarthritis with the femoral component implanted in either 4° flexion in the sagittal plane (F) or in a neutral position (C). The primary outcome of knee flexion and secondary outcomes knee extension, quadriceps strength, WOMAC, SF-12v2, timed stand test, stair climb test and satisfaction were assessed at 1 year. Knee flexion and extension were also assessed intra-operatively. Implant flexion was measured from true lateral radiographs. RESULTS:Thirty-nine participants (40 knees) were recruited, 20 knees per group. Three subjects from the control group and two from the flexed group were lost to 1 year follow-up but numbers were sufficient to satisfy the sample size calculation. Significant differences were found between the groups in knee flexion (F: 113.6±8.8° pre-operative, 122.4±6.0° intra-operative, 110.2±7.5° 1 year, C: 117.4±11.7°, 117.4±7.6°, 103.5±10.7°. p=0.031) and mental component score of the SF12-v2 (F 53.3±13.2, C 61.1±7.3, p=0.009) but there were no significant differences in other outcomes and patients were equally satisfied. CONCLUSION:Flexing the femoral implant in this cruciate retaining TKA system provided a significant difference in knee flexion compared to a neutral position. The improvement appears to occur predominantly at surgery and was not associated with a clinical or functional benefit at 1 year. (ACTRN12606000325505). LEVEL OF EVIDENCE:Level 1; randomised controlled trial.

译文

简介:已经提出对全膝关节置换术(TKA)进行假体和手术修改,以最大程度地提高术后膝关节屈曲度,因为它是常规功能活动中必不可少的。
方法:我们进行了一项双盲随机对照试验,比较了在骨矢状面(F)或中性位(C)中以4°屈曲度植入股骨组件的原发性保留骨关节炎的TKA的临床结局。在1年时评估膝关节屈曲的主要结果和膝关节伸展,次股四头肌力量,WOMAC,SF-12v2,定时站立测试,爬楼梯测试和满意度的主要结果。术中还评估了膝盖的屈伸性。从真实的侧位X线照片测量植入物的弯曲度。
结果:招募了39名参与者(40膝),每组20膝。对照组的三名受试者和屈肌训练的三名受试者失去了1年的随访,但数量足以满足样本量的计算。两组之间的膝关节屈曲有显着差异(F:术前113.6±8.8°,术中122.4±6.0°,10.2±7.5°1年,C:117.4±11.7°,117.4±7.6°,103.5± SF12-v2的10.7°。p = 0.031)和精神成分评分(F 53.3±13.2,C 61.1±7.3,p = 0.009),但其他结局无显着差异,患者也同样满意。
结论:在这种十字形保持的TKA系统中弯曲股骨植入物与中立位置相比,在膝关节屈曲方面有显着差异。改善似乎主要发生在手术上,并且在1年时与临床或功能获益无关。 (ACTRN12606000325505)。
证据级别:1级;随机对照试验。

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