Department of Orthopaedics, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands.
Department of Orthopaedics, VieCuri Medical Centre, Tegelseweg 210, 5912 BL, Venlo, The Netherlands.
Knee Surg Sports Traumatol Arthrosc. 2022 Mar;30(3):918-927. doi: 10.1007/s00167-021-06471-5. Epub 2021 Feb 11.
The aim of this two-centre RCT was to compare pre- and post-operative radiological, clinical and functional outcomes between patient-specific instrumentation (PSI) and conventional instrumented (CI) unicompartmental knee arthroplasty (UKA). It was hypothesised that both alignment methods would have comparable post-operative radiological, clinical and functional outcomes.
One hundred and twenty patients were included, and randomly allocated to the PSI or the CI group. Outcome measures were peri-operative outcomes (operation time, length of hospital stay and intra-operative changes of implant size) and post-operative radiological outcomes including the alignment of the tibial and femoral component in the sagittal and frontal plane and the hip-knee-ankle-axis (HKA-axis), rate of adverse events (AEs) and patient-reported outcome measures (PROMs) pre-operatively and at 3, 12 and 24 months post-operatively.
There was a statistically significant difference (p < 0.05) in alignment of the femoral component in the frontal plane in favour of the CI method. No statistically significant differences were found for the peri-operative data or in the functional outcome at 2-year follow-up. In the PSI group, the approved implant size of the femoral component was correct in 98.2% of the cases and the tibial component was correct in 60.7% of the cases. There was a comparable rate of AEs: 5.1% in the CI and 5.4% in the PSI group.
The PSI method did not show an advantage over CI in regard of positioning of the components, nor did it show an improvement in clinical or functional outcome. We conclude that the possible advantages of PSI do not outweigh the costs of the MRI scan and the manufacturing of the PSI.
Randomised controlled trial, level I.
本项双中心 RCT 的目的在于比较个体化截骨模板（PSI）与传统截骨（CI）单髁膝关节置换术（UKA）在术前、术后影像学、临床和功能结果方面的差异。研究假设两种截骨方法在术后影像学、临床和功能结果方面具有可比性。
本研究共纳入 120 例患者，并随机分为 PSI 组或 CI 组。评估指标包括围手术期结果（手术时间、住院时间和术中植入物尺寸的变化）和术后影像学结果（包括胫骨和股骨组件在矢状面和额状面的对线情况以及髋膝踝轴（HKA 轴），以及术前和术后 3、12 和 24 个月时的不良事件（AE）发生率和患者报告的结局测量（PROM）。
在额状面股骨组件对线方面，CI 方法具有显著的统计学优势（p<0.05）。但在围手术期数据或 2 年随访时的功能结果方面，未发现具有统计学意义的差异。在 PSI 组中，股骨组件的批准植入物尺寸在 98.2%的病例中是正确的，胫骨组件在 60.7%的病例中是正确的。AE 发生率相当：CI 组为 5.1%，PSI 组为 5.4%。
PSI 方法在组件定位方面并未优于 CI，也未在临床或功能结果方面显示出改善。我们得出结论，PSI 的可能优势并不超过 MRI 扫描和 PSI 制造的成本。
随机对照试验，一级。
