Hommel Hagen, Kunze Daniel, Hommel Peggy, Fennema Peter
KH-MOL GmBH Sonnenburger Weg 3, 16269 Wriezen, Germany.
Medizinische Hochschule Brandenburg (MHB), Theodor Fontane, Fehrbelliner Straße 38, 16816 Neuruppin, Germany.
Open Orthop J. 2017 Nov 10;11:1236-1244. doi: 10.2174/1874325001711011236. eCollection 2017.
There is ongoing debate about how to obtain correct rotational alignment in total knee arthroplasty (TKA). Two commonly used techniques are the measured resection (MR) and the gap balancing (GB) technique.
The objective of the present study was to analyze which of these two techniques confers a clinical advantage up to 10 years postoperatively.
Two hundred patients were randomized to either MR or GB. The primary outcome was the Knee Society Knee Score (KS) 10 years postoperatively. Secondary outcomes were passive range of motion, the Knee Society Function Score (FS), and the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), along with implant survival. We employed a two one-sided test (TOST) and linear mixed models to assess clinical outcomes.
Mean KS was 82 (95% confidence interval (CI), 80 - 83) and 77 (95% CI, 76 - 79) in the GB and MR group, respectively. The TOST test and linear mixed model both revealed statistical significance (p < 0.001). In addition, GB yielded better postoperative FS and WOMAC. However, between-group differences were consistently small. Implant survival rates at 10 years, with survival for any reason as the endpoint of interest, were 93.7% (95% CI, 86.4% and 97.1%) and 89.8% (95% CI, 81.9% - 94.4%) for the GB group and the MR group, respectively ( = 0.302).
Gap-balancing is a safe and reliable technique. KS for the two study groups at 10 years can be considered equivalent, and the small postoperative advantages may not extend beyond clinical relevance.
关于全膝关节置换术（TKA）中如何获得正确的旋转对线存在持续的争论。两种常用技术是测量截骨（MR）技术和间隙平衡（GB）技术。
本研究的目的是分析这两种技术中的哪一种在术后10年内具有临床优势。
200例患者被随机分为MR组或GB组。主要结局是术后10年的膝关节协会膝关节评分（KS）。次要结局包括被动活动范围、膝关节协会功能评分（FS）、西安大略和麦克马斯特大学骨关节炎指数（WOMAC）以及植入物生存率。我们采用双侧检验（TOST）和线性混合模型来评估临床结局。
GB组和MR组的平均KS分别为82（95%置信区间（CI），80 - 83）和77（95%CI，76 - 79）。TOST检验和线性混合模型均显示具有统计学意义（p < 0.001）。此外，GB组术后FS和WOMAC更好。然而，组间差异始终较小。以任何原因导致的生存为感兴趣的终点，GB组和MR组10年的植入物生存率分别为93.7%（95%CI，86.4%和97.1%）和89.8%（95%CI，81.9% - 94.4%）（p = 0.302）。
间隙平衡是一种安全可靠的技术。两个研究组10年时的KS可认为相当，术后的微小优势可能不具有超出临床意义的影响。
