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Review
. 2025 Oct 14;10(4):e25.00218.
doi: 10.2106/JBJS.OA.25.00218. eCollection 2025 Oct-Dec.

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

Tanner Livsey  1 , Samuel Lassiter  1 , Alec Young  1 , Taylor Gardner  1 , Chance Bratten  1 , Adam Khan  1 , Eli Paul  1 , J Michael Anderson  2 , Amar Patel  2 , Alicia Ito Ford  1   3 , Matt Vassar  1   3
Affiliations
Review

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

Tanner Livsey et al. JB JS Open Access. .

Abstract

Background: 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.

Methods: 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.

Results: 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).

Conclusion: 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 of evidence: Level II. See Instructions for Authors for a complete description of levels of evidence.

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Conflict of interest statement

M. Vassar reports receipts of funding from the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the U.S. Office of Research Integrity, Oklahoma Center for Advancement of Science and Technology, and internal grants from Oklahoma State University Center for Health Sciences—all outside of the present work. A.I. Ford reports funding from the Center for Integrative Research on Childhood Adversity, Oklahoma Shared Clinical and Translational Resources, and internal Oklahoma State University Center for Health Sciences grants, all outside this work. All other authors have nothing to report. Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJSOA/A962).

Figures

Fig. 1
Fig. 1
Trends in clinical utility, transparency, and overall usefulness (2020-2024). Scatter plots with linear regression lines showing the sum of clinical utility scores. Fig. 1-A Sum of transparency criteria (Fig. 1-B) and sum of total usefulness criteria (Fig. 1-C) across publication years 2020 to 2024. Overall, trends remained relatively stable with slight increases over time.
See this image and copyright information in PMC

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