BACKGROUND Radiostereometric analysis (RSA) provides highly accurate data about the migration of a total knee arthroplasty (TKA) component. However, patient-reported outcome measures (PROMs) reflect the patients' perspective of their functional status, pain, and overall health after TKA. The aim of this study was to evaluate the association between tibial implant migration and change in postoperative PROMs and clinical scores, using data pooled from long-term follow-up RSA studies. METHODS Individual implant migration data were collected from 5 randomized RSA studies, including a total of 300 patients with 6 distinct TKA implant designs (all Stryker). Tibial implant migration (maximum total point motion [MTPM]) was evaluated with RSA at 3 months, 1 year, and 2, 5, 7, and 10 years postoperatively. The Knee Society Score (KSS)-Knee and KSS-Function and Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales were collected in all studies at the same follow-up times. Linear mixed-effects models, with adjustment for TKA implant design and patient characteristics, were used to analyze the data. The 3-month follow-up visit was used as the baseline to assess the association between implant migration and PROMs across the 10-year follow-up. RESULTS No association between tibial implant migration and change in KSS-Knee (p = 0.384), KSS-Function (p = 0.737), KOOS-Symptoms (p = 0.398), KOOS-Pain (p = 0.699), KOOS-Activities of Daily Living (p = 0.205), KOOS-Sport and Recreation (p = 0.702), or KOOS-Quality of Life (p = 0.368) was found across the entire follow-up. Similar results were found when using the 2-year follow-up as the baseline, after which both cemented and uncemented implants are expected to have stabilized. CONCLUSIONS Tibial baseplate migration was not associated with postoperative worsening in PROMs or clinical scores in patients who underwent TKA. These findings suggest that implant migration, as measured with RSA, measures a different parameter (i.e., implant-bone fixation) than PROMs (i.e., patient perception) and clinical scores. Therefore, to assess the performance and safety of TKA implant designs, RSA and PROMs cannot be used interchangeably during the postoperative follow-up of patients and evaluation of the fixation of knee implants. LEVEL OF EVIDENCE Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.

中文翻译：

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胫骨底板迁移与 TKA 后患者报告的结果测量和临床评分的变化无关：5 项放射立体测量分析研究的二次分析，随访 10 年。


背景 放射立体测量分析 （RSA） 提供有关全膝关节置换术 （TKA） 组件迁移的高精度数据。然而，患者报告的结果测量 （PROM） 反映了患者对 TKA 后功能状态、疼痛和整体健康状况的看法。本研究的目的是使用从长期随访 RSA 研究中汇总的数据，评估胫骨植入物迁移与术后 PROM 和临床评分变化之间的关联。方法 从 5 项随机 RSA 研究中收集个体植入物迁移数据，包括总共 300 名具有 6 种不同 TKA 植入物设计的患者 （均为 Stryker）。在术后 3 个月、 1 年和 2 、 5 、 7 和 10 年用 RSA 评估胫骨植入物迁移 （最大总点运动 [MTPM]）。在相同的随访时间，所有研究均收集膝关节协会评分 （KSS） - 膝关节和 KSS 功能以及膝关节损伤和骨关节炎结果评分 （KOOS） 分量表。使用线性混合效应模型分析数据，并调整 TKA 植入物设计和患者特征。以 3 个月的随访为基线，评估 10 年随访中植入物迁移与 PROM 之间的关联。结果胫骨植入物迁移与 KSS-膝关节 （p = 0.384）、KSS 功能 （p = 0.737）、KOOS 症状 （p = 0.398）、KOOS-疼痛 （p = 0.699）、KOOS 日常生活活动 （p = 0.205）、KOOS-运动和娱乐 （p = 0.702） 或 KOOS 生活质量 （p = 0.368） 的变化之间没有关联在整个随访中被发现。当使用 2 年随访作为基线时，发现了类似的结果，之后骨水泥和非骨水泥植入物预计都已稳定。 结论 胫骨底板移位与接受 TKA 的患者术后 PROM 恶化或临床评分无关。这些发现表明，用 RSA 测量的种植体迁移测量的参数（即种植体-骨固定）与 PROM （即患者感知）和临床评分不同。因此，为了评估 TKA 植入物设计的性能和安全性，RSA 和 PROM 在患者术后随访和膝关节植入物固定评估期间不能互换使用。证据级别 预后 III 级 .有关证据级别的完整描述，请参阅作者说明。