Murphy Michael, Journeaux Simon, Hides Julie, Russell Trevor
Mater Medical Research Institute, Mater Health Services, Raymond Terrace, South Brisbane, Australia, 4101.
School of Health and Rehabilitation Science, University of Queensland, St Lucia, Australia, 4076.
Knee. 2014 Jan;21(1):257-63. doi: 10.1016/j.knee.2012.10.028. Epub 2012 Nov 24.
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.
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.
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.
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 1; randomised controlled trial.
全膝关节置换术（TKA）中的假体和手术改良已被提出，以最大化术后膝关节屈曲度，因为这在日常功能活动中至关重要。
我们进行了一项双盲随机对照试验，比较将股骨假体在矢状面以4°屈曲位（F组）或中立位（C组）植入的骨关节炎初次保留交叉韧带TKA的临床结果。在1年时评估膝关节屈曲的主要结果以及膝关节伸展、股四头肌力量、WOMAC、SF-12v2、定时起立试验、爬楼梯试验和满意度等次要结果。术中也评估膝关节的屈曲和伸展。通过真正的侧位X线片测量假体的屈曲度。
招募了39名参与者（40个膝关节），每组20个膝关节。对照组3名受试者和屈曲组2名受试者失访至1年，但样本数量足以满足样本量计算要求。两组在膝关节屈曲度（F组：术前113.6±8.8°，术中122.4±6.0°，1年时110.2±7.5°；C组：117.4±11.7°，117.4±7.6°，103.5±10.7°，p = 0.031）和SF12 - v2的心理成分得分（F组53.3±13.2，C组61.1±7.3，p = 0.009）方面存在显著差异，但在其他结果方面无显著差异，且患者满意度相同。
在这种保留交叉韧带的TKA系统中，将股骨假体置于屈曲位与中立位相比，膝关节屈曲度有显著差异。这种改善似乎主要发生在手术时，且在1年时未带来临床或功能益处。（澳大利亚新西兰临床试验注册号：ACTRN12606000325505）。
1级；随机对照试验。
