Anderl Werner, Pauzenberger Leo, Kölblinger Roman, Kiesselbach Gabriele, Brandl Georg, Laky Brenda, Kriegleder Bernhard, Heuberer Philipp, Schwameis Eva
Department of Orthopedics, St. Vincent Hospital, Stumpergasse 13, 1060, Vienna, Austria.
Knee Surg Sports Traumatol Arthrosc. 2016 Jan;24(1):102-11. doi: 10.1007/s00167-014-3345-2. Epub 2014 Oct 19.
The aim of this prospective study was to compare early clinical outcome, radiological limb alignment, and three-dimensional (3D)-component positioning between conventional and computed tomography (CT)-based patient-specific instrumentation (PSI) in primary mobile-bearing total knee arthroplasty (TKA).
Two hundred ninety consecutive patients (300 knees) with severe, debilitating osteoarthritis scheduled for TKA were included in this study using either conventional instrumentation (CVI, n = 150) or PSI (n = 150). Patients were clinically assessed before and 2 years after surgery according to the Knee-Society-Score (KSS) and the visual-analog-scale for pain (VAS). Additionally, the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) and the Oxford-Knee-Score (OKS) were collected at follow-up. To evaluate accuracy of CVI and PSI, hip-knee-ankle angle (HKA) and 3D-component positioning were assessed on postoperative radiographs and CT.
Data of 222 knees (CVI: n = 108, PSI: n = 114) were available for analysis after a mean follow-up of 28.6 ± 5.2 months. At the early follow-up, clinical outcome (KSS, VAS, WOMAC, OKS) was comparable between the two groups. Mean HKA-deviation from the targeted neutral mechanical axis (CVI: 2.2° ± 1.7°; PSI: 1.5° ± 1.4°; p < 0.001), rates of outliers (CVI: 22.2%; PSI: 9.6%; p = 0.016), and 3D-component positioning outliers were significantly lower in the PSI group. Non-outliers (HKA: 180° ± 3°) showed better clinical results than outliers at the 2-year follow-up.
CT-based PSI compared with CVI improves accuracy of mechanical alignment restoration and 3D-component positioning in primary TKA. While clinical outcome was comparable between the two instrumentation groups at early follow-up, significantly inferior outcome was detected in the subgroup of HKA-outliers.
Prospective comparative study, Level II.
本前瞻性研究旨在比较初次活动平台全膝关节置换术（TKA）中传统器械与基于计算机断层扫描（CT）的患者特异性器械（PSI）在早期临床结果、影像学下肢对线以及三维（3D）组件定位方面的差异。
本研究纳入了290例连续的计划行TKA的重度、致残性骨关节炎患者（300膝），其中150例使用传统器械（CVI），150例使用PSI。在手术前及术后2年，根据膝关节协会评分（KSS）和疼痛视觉模拟量表（VAS）对患者进行临床评估。此外，在随访时收集西安大略和麦克马斯特大学骨关节炎指数（WOMAC）和牛津膝关节评分（OKS）。为评估CVI和PSI的准确性，在术后X线片和CT上评估髋-膝-踝角（HKA）和3D组件定位。
平均随访28.6±5.2个月后，有222膝（CVI：108膝，PSI：114膝）的数据可用于分析。在早期随访时，两组的临床结果（KSS、VAS、WOMAC、OKS）相当。PSI组偏离目标中立机械轴的平均HKA（CVI：2.2°±1.7°；PSI：1.5°±1.4°；p<0.001）、异常值发生率（CVI：22.2%；PSI：9.6%；p=0.016）和3D组件定位异常值均显著更低。在2年随访时，非异常值（HKA：180°±3°）的临床结果优于异常值。
与CVI相比，基于CT的PSI提高了初次TKA中机械对线恢复和3D组件定位的准确性。虽然在早期随访时两组器械的临床结果相当，但在HKA异常值亚组中检测到明显较差的结果。
前瞻性比较研究，二级。
