Viecuri Medical Centre, Tegelseweg 210, 5912 BL, Venlo, The Netherlands,
Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2206-12. doi: 10.1007/s00167-013-2620-y. Epub 2013 Aug 9.
This prospective, double-blind, randomised controlled trial was designed to address the following research questions: firstly, is there a significant difference in outliers in alignment in the frontal and sagittal plane between PSG TKA and conventional TKA. Secondly, is there a significant difference in operation time, blood loss and length of hospital stay between the two techniques. We hypothesise that there will be fewer outliers with PSG TKA and that operation time, blood loss and length of hospital stay can be significantly reduced with PSG.
A total of 180 patients were randomised for PSG TKA (group 1) or conventional TKA (group 2) in two centres. Patients were stratified per hospital. Alignment of the mechanical axis of the leg and flexion/extension and varus/valgus of the individual prosthesis components were measured on digital, standing, long-leg and standard lateral radiographs by two independent outcome assessors in both centres. Percentages of outliers (>3°) were determined. We compared blood loss, operation time and length of hospital stay.
There was no statistically significant difference in mean mechanical axis or outliers in mechanical axis between groups. No statistically significant difference was found for the alignment of the individual components in the frontal plane nor for the percentages of outliers. There was a statistically significant difference in outliers for the femoral component in the sagittal plane, with a higher percentage of outliers in the group 1 (p = 0.017). No such significant result was found for the tibial component in that plane. All interclass correlation coefficients were good. Blood loss was 100 mL less in group 1 (p < 0.001). Operation time was 5 min shorter in group 1 (p < 0.001). Length of hospital stay was identical with a mean of 3.6 days (p = 0.657).
The results in terms of obtaining a neutral mechanical axis and a correct position of the prosthesis components did not differ between groups. A small reduction in operation time and blood loss was found with the PSG system. Future research should especially focus on cost-effectiveness analysis and functional outcome of PSG TKA.
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本前瞻性、双盲、随机对照试验旨在解决以下研究问题：首先，在额状面和矢状面的对线中，PSG TKA 与传统 TKA 是否存在明显的偏倚差异。其次，两种技术在手术时间、失血量和住院时间方面是否存在显著差异。我们假设 PSG TKA 的偏倚更少，并且 PSG 可以显著减少手术时间、失血量和住院时间。
在两个中心，共 180 例患者被随机分为 PSG TKA（组 1）或传统 TKA（组 2）。按医院分层。在两个中心的站立位、全长位和标准侧位 X 线片上，由两位独立的结果评估者测量机械轴的对线以及单个假体组件的屈伸和内翻/外翻情况。确定偏倚大于 3°的百分比。我们比较了失血量、手术时间和住院时间。
两组之间的机械轴平均值或机械轴偏倚无统计学差异。在额状面单个组件的对线以及偏倚百分比方面也没有发现统计学差异。在矢状面股骨组件的偏倚方面存在统计学差异，组 1 的偏倚百分比更高（p = 0.017）。在该平面的胫骨组件中未发现显著结果。所有组内相关系数均良好。组 1 的失血量减少 100ml（p < 0.001）。组 1 的手术时间缩短 5 分钟（p < 0.001）。住院时间相同，平均为 3.6 天（p = 0.657）。
两组在获得中立机械轴和假体组件正确位置方面的结果无差异。PSG 系统可减少手术时间和失血量。未来的研究应特别关注 PSG TKA 的成本效益分析和功能结果。
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