Sydney Knee Specialists, Sydney, Australia.
Faculty of Medicine, University of New South Wales, Sydney, Australia.
Bone Joint J. 2022 May;104-B(5):604-612. doi: 10.1302/0301-620X.104B5.BJJ-2021-1299.R2.
Intraoperative pressure sensors allow surgeons to quantify soft-tissue balance during total knee arthroplasty (TKA). The aim of this study was to determine whether using sensors to achieve soft-tissue balance was more effective than manual balancing in improving outcomes in TKA.
A multicentre randomized trial compared the outcomes of sensor balancing (SB) with manual balancing (MB) in 250 patients (285 TKAs). The primary outcome measure was the mean difference in the four Knee injury and Osteoarthritis Outcome Score subscales (ΔKOOS) in the two groups, comparing the preoperative and two-year scores. Secondary outcomes included intraoperative balance data, additional patient-reported outcome measures (PROMs), and functional measures.
There was no significant difference in ΔKOOS between the two groups at two years (mean difference 0.4 points (95% confidence interval (CI) -4.6 to 5.4); p = 0.869), and multiple regression found that SB was not associated with a significant ΔKOOS (0.2-point increase (95% CI -5.1 to 4.6); p = 0.924). There were no significant differences between groups in other PROMs. Six-minute walking distance was significantly increased in the SB group (mean difference 29 metres; p = 0.015). Four-times as many TKAs were unbalanced in the MB group (36.8% MB vs 9.4% SB; p < 0.001). Irrespective of group assignment, no differences were found in any PROM when increasing ICPD thresholds defined balance.
Despite improved quantitative soft-tissue balance, the use of sensors intraoperatively did not differentially improve the clinical or functional outcomes two years after TKA. These results question whether a more precisely balanced TKA that is guided by sensor data, and often achieved by more balancing interventions, will ultimately have a significant effect on clinical outcomes. Cite this article: 2022;104-B(5):604-612.
术中压力传感器可让外科医生在全膝关节置换术（TKA）期间量化软组织平衡。本研究旨在确定使用传感器实现软组织平衡是否比手动平衡更能改善 TKA 的结果。
一项多中心随机试验比较了 250 例患者（285 例 TKA）中传感器平衡（SB）与手动平衡（MB）的结果。主要观察指标是两组之间四个膝关节损伤和骨关节炎结果评分（KOOS）亚量表的平均差值（ΔKOOS），比较术前和两年的评分。次要结果包括术中平衡数据、其他患者报告的结果测量（PROM）和功能测量。
两组在两年时的ΔKOOS 无显著差异（平均差异 0.4 分（95%置信区间（CI）-4.6 至 5.4）；p = 0.869），多元回归发现 SB 与 ΔKOOS 无显著相关性（0.2 分增加（95% CI -5.1 至 4.6）；p = 0.924）。两组在其他 PROM 方面无显著差异。SB 组的 6 分钟步行距离显著增加（平均差异 29 米；p = 0.015）。MB 组的 TKA 不平衡率是 SB 组的四倍（36.8% MB 与 9.4% SB；p < 0.001）。无论分组如何，当增加 ICPD 阈值定义平衡时，任何 PROM 均未发现差异。
尽管软组织平衡的定量改善，但术中使用传感器并不能在 TKA 两年后对临床或功能结果产生差异。这些结果质疑是否更精确的平衡 TKA 会受到传感器数据的指导，并经常通过更多的平衡干预来实现，最终会对临床结果产生重大影响。
