Patient Selection in Randomized Controlled Trials of Total Knee Arthroplasty: A Systematic Review Assessing Inclusion Criteria

• Published in: Journal of bone and joint surgery. American volume 2024-03, Vol.106 (6), p.553-563
• Main Authors: Beiene, Zodina A, Tanghe, Kira K, Neitzke, Colin C, Hidaka, Chisa, Lyman, Stephen, Gausden, Elizabeth B, McLawhorn, Alexander S
• Format: Article
• Language: English
• ISSN: 0021-9355; 1535-1386; 1535-1386
• DOI: 10.2106/JBJS.23.00629

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. 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