Background: Patients undergo total knee arthroplasty (TKA) at widely disparate stages of osteoarthritis, raising the possibility of high heterogeneity among patients enrolled in TKA research studies. Obscuration of treatment effectiveness and other problems that may stem from cohort heterogeneity can be controlled in clinical studies by rigorously defining target patients. The purpose of this review was to determine the extent to which randomized controlled trials (RCTs) on TKA use osteoarthritis severity, as defined by radiographic grade or patient-reported outcome measures (PROMs), in their inclusion criteria, and to investigate potential impact on outcome. Methods: A search of PubMed, Embase, Scopus, Web of Science, and Cochrane databases used a combination of terms involving TKA, PROMs, and radiographic scoring. A total of 1,227 studies were independently reviewed by 2 screeners for the above terms. RCTs with ≥100 patients (236) and with <100 patients (325) undergoing TKA were analyzed with regard to the specific inclusion criteria and recruitment process. Results: Among the identified RCTs with ≥100 patients, 18 (<8%, with a total of 2,952 randomized patients) used specific radiographic scoring or PROM thresholds in their inclusion criteria. Eleven of the 18 studies used specific radiographic scoring, such as the Kellgren-Lawrence or Ahlbäck classifications. Three studies used preoperative PROM thresholds: Knee Society Knee Score of <60, Knee Society Function Score of <60, Oxford Knee Score of <20, and Hospital for Special Surgery Score of <60. Among studies with <100 patients, 48 (<15%) used specific inclusion criteria. Conclusions: The vast majority of RCTs (>85%) did not enroll patients based on disease severity, as measured by PROM score thresholds or radiographic classifications, in their inclusion criteria. The lack of consistent inclusion criteria likely results in heterogeneous cohorts, potentially undermining the validity of RCTs on TKA. Level of Evidence: Prognostic Level I. See Instructions for Authors for a complete description of levels of evidence.

中文翻译：

---

全膝关节置换术随机对照试验中的患者选择

背景：患者在骨关节炎的不同阶段接受全膝关节置换术 (TKA)，这增加了参与 TKA 研究的患者之间存在高度异质性的可能性。在临床研究中，可以通过严格定义目标患者来控制治疗效果的模糊性和可能源于队列异质性的其他问题。本次综述的目的是确定 TKA 随机对照试验 (RCT) 在纳入标准中使用骨关节炎严重程度（根据放射学分级或患者报告的结果指标 (PROM) 定义）的程度，并调查对骨关节炎的潜在影响。结果。 方法：对 PubMed、Embase、Scopus、Web of Science 和 Cochrane 数据库的检索使用了涉及 TKA、PROM 和放射学评分的术语组合。总共 1,227 项研究由 2 名筛选者针对上述术语进行了独立审查。针对具体纳入标准和招募过程，对≥100例患者（236例）和<100例患者（325例）接受TKA的随机对照试验进行了分析。 结果：在已确定的≥100名患者的随机对照试验中，18项（<8%，总共2,952名随机患者）在其纳入标准中使用了特定的放射学评分或PROM阈值。18 项研究中有 11 项使用了特定的放射学评分，例如 Kellgren-Lawrence 或 Ahlbäck 分类。三项研究使用术前 PROM 阈值：膝关节协会膝关节评分 <60、膝关节协会功能评分 <60、牛津膝关节评分 <20、特种外科医院评分 <60。在少于 100 名患者的研究中，48 项 (<15%) 使用了特定的纳入标准。 结论：绝大多数随机对照试验（>85%）在纳入标准中并未根据疾病严重程度（通过 PROM 评分阈值或放射学分类来衡量）来招募患者。缺乏一致的纳入标准可能会导致异质队列，从而可能破坏 TKA 随机对照试验的有效性。 证据级别：预后一级。有关证据级别的完整描述，请参阅作者须知。