Assessing the Clinical Usefulness and Transparency of Knee Arthroplasty Randomized Controlled Trials (2020-2024): A Systematic Review Using the van't Hooft Framework.

Abstract

Osteoarthritis is the most common joint disorder in the United States, and total knee arthroplasty (TKA) is among the most frequently performed surgeries. Although randomized controlled trials (RCTs) are essential for guiding treatment, their clinical usefulness remains uncertain. This study assessed the utility of TKA RCTs published between 2020 and 2024 using the van't Hooft usefulness framework. We systematically reviewed RCTs of knee arthroplasty published between 2020 and 2024, identified through MEDLINE and Embase (April 2, 2025). Utility was assessed using the 13-item van't Hooft framework. Linear regression analyzed associations between utility scores and study characteristics, including funding, sample size, and journal impact factor. Of 184 studies, 29.3% met the problem-base criterion. Although 86.4% included patient-centered outcomes, most were secondary. Pragmatism was rare (1.1%). 23.9% were prospectively registered, and 4.9% provided raw data. Transparency and clinical utility were moderately correlated (r = 0.28, p < 0.001). Most RCTs showed internal validity but limited real-world relevance. Narrow eligibility, short follow-up, and poor transparency limit clinical impact. These findings should not be interpreted as a dismissal. Rather, they highlight opportunities to strengthen future trials so that they remain a cornerstone of evidence-based orthopaedics. Level II. See Instructions for Authors for a complete description of levels of evidence.