Risk of Revision and Patient-Reported Outcomes Following Primary UKR Performed Using Computer Navigation or Patient-Specific Instrumentation: An Analysis of National Joint Registry Data.

M M Farhan-Alanie,D Gallacher,P Craig,J Griffin,J Kozdryk,J Mason,P D H Wall,J M Wilkinson,A Metcalfe,P Foguet
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Abstract

BACKGROUND Computer navigation and patient-specific instrumentation in unicompartmental knee replacement (UKR) improve the precision of implant positioning, but there is limited information regarding their impact on implant survival and patient-reported outcomes. We aimed to compare postoperative implant survival, Oxford Knee Score (OKS) values, health-related quality of life (measured using the EuroQol-5 Dimension 3-level version [EQ-5D-3L]), and intraoperative complications between UKRs performed using computer navigation or patient-specific instrumentation versus conventional instrumentation. METHODS Using National Joint Registry data, an observational study of patients who underwent primary UKR for osteoarthritis between 2003 and 2020 was performed. The primary analyses focused on all-cause revision, and the secondary analyses focused on differences in the OKS and EQ-5D-3L at 6 to 12 months postoperatively. To account for several covariates, weights based on propensity scores were generated. Cox proportional hazards models and generalized linear models were used to assess for differences in revision risk, and OKS and EQ-5D-3L change scores, respectively, between patient groups. Sensitivity analyses accounting for body mass index were performed. Effective sample sizes (ESSs) were computed, representing the statistical power comparable with that of an unweighted sample. RESULTS Compared with conventional instrumentation, the hazard ratio (HR) for all-cause revision was 1.126 (95% confidence interval [CI], 0.909 to 1.395; p = 0.277; ESS, 4,273) with computer navigation and 0.805 (95% CI, 0.442 to 1.467; p = 0.478; ESS, 1,199) with patient-specific instrumentation. No difference was found in the change in OKS between the groups (-1.287; 95% CI, -2.851 to 0.278; p = 0.107; ESS, 470), although improvement in the EQ-5D-3L scores was relatively lower for computer-navigated UKR compared with conventional instrumentation (-0.049, 95% CI, -0.093 to -0.005; p = 0.028; ESS, 455). However, sensitivity analyses demonstrated that computer navigation was associated with an increased risk of all-cause revision (HR, 1.446; 95% CI, 1.102 to 1.898; p = 0.008; ESS, 3,011) and relatively smaller improvements in the OKS (-2.845; 95% CI, -5.006 to -0.684; p = 0.010; ESS, 272) and EQ-5D-3L scores (-0.087; 95% CI, -0.145 to -0.030; p = 0.003; ESS, 286). There were no differences in intraoperative complications (p = 0.073). CONCLUSIONS This study found no clinically meaningful differences in patient-reported outcomes following computer-navigated UKR. Although likely underpowered, the primary analyses showed no difference in implant survival. While a sensitivity analysis suggested that computer navigation could worsen implant survival, this analysis had a smaller sample size. These findings highlight potential signals that warrant further investigation. LEVEL OF EVIDENCE Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
使用计算机导航或患者专用仪器进行原发性UKR后的修订风险和患者报告的结果:国家联合注册数据分析
背景:在单室膝关节置换术(UKR)中,计算机导航和患者特定的器械可提高植入物定位的精度,但关于它们对植入物存活和患者报告的结果的影响的信息有限。我们的目的是比较术后植入物存活、牛津膝关节评分(OKS)值、健康相关生活质量(使用EuroQol-5维度3级版本[EQ-5D-3L]测量)以及使用计算机导航或患者特定器械与传统器械进行UKRs的术中并发症。方法使用国家联合登记处的数据,对2003年至2020年间因骨关节炎接受原发性UKR的患者进行了一项观察性研究。主要分析集中于全因修正,次要分析集中于术后6至12个月OKS和EQ-5D-3L的差异。为了解释几个协变量,基于倾向得分生成了权重。采用Cox比例风险模型和广义线性模型分别评估患者组间修订风险、OKS和EQ-5D-3L改变评分的差异。对体重指数进行敏感性分析。计算有效样本量(ESSs),表示与未加权样本相当的统计能力。结果与常规仪器相比,全因修正的风险比(HR)为1.126(95%可信区间[CI], 0.909 ~ 1.395;P = 0.277;ESS, 4273)和0.805 (95% CI, 0.442至1.467;P = 0.478;ESS, 1199),配备患者专用仪器。两组间OKS变化无差异(-1.287;95% CI, -2.851 ~ 0.278;P = 0.107;ESS, 470),尽管与传统仪器相比,计算机导航UKR的EQ-5D-3L评分的改善相对较低(-0.049,95% CI, -0.093至-0.005;P = 0.028;ESS, 455)。然而,敏感性分析表明,计算机导航与全因修正风险增加相关(HR, 1.446;95% CI, 1.102 ~ 1.898;P = 0.008;ESS, 3,011),而OKS的改善相对较小(-2.845;95% CI, -5.006 ~ -0.684;P = 0.010;ESS, 272)和EQ-5D-3L评分(-0.087;95% CI, -0.145 ~ -0.030;P = 0.003;ESS, 286)。术中并发症发生率差异无统计学意义(p = 0.073)。结论:本研究发现计算机导航UKR后患者报告的结果没有临床意义的差异。虽然可能功效不足,但初步分析显示种植体存活率没有差异。虽然敏感性分析表明,计算机导航可能会降低植入物的存活率,但该分析的样本量较小。这些发现突出了值得进一步研究的潜在信号。证据水平:治疗性三级。有关证据水平的完整描述,请参见作者说明。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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