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Assessing the Clinical Usefulness and Transparency of Knee Arthroplasty Randomized Controlled Trials (2020-2024): A
Tanner Livsey1, Samuel Lassiter1, Alec Young1
1Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma.
Most total knee arthroplasty randomized controlled trials (RCTs) lack real-world relevance due to limited transparency and narrow criteria. Future RCTs need improvement to enhance clinical impact in orthopaedics.
Area of Science:
- Orthopaedics
- Clinical Trials
- Health Services Research
Background:
- Osteoarthritis is a prevalent joint disorder in the US.
- Total knee arthroplasty (TKA) is a common surgical procedure.
- The clinical usefulness of TKA randomized controlled trials (RCTs) requires evaluation.
Purpose of the Study:
- To assess the clinical utility of TKA RCTs published between 2020 and 2024.
- To evaluate TKA RCTs using the van't Hooft usefulness framework.
- To identify factors influencing the utility of TKA RCTs.
Main Methods:
- Systematic review of TKA RCTs from 2020-2024.
- Assessment of study utility using the 13-item van't Hooft framework.
- Linear regression to analyze associations between utility scores and study characteristics (funding, sample size, impact factor).
Main Results:
- Only 29.3% of studies met the problem-base criterion.
- 86.4% included patient-centered outcomes, but mostly as secondary endpoints.
- Pragmatism was observed in only 1.1% of trials, with low rates of prospective registration (23.9%) and raw data availability (4.9%).
- Transparency and clinical utility showed a moderate positive correlation (r = 0.28, p < 0.001).
Conclusions:
- Most TKA RCTs possess internal validity but lack external relevance.
- Limited clinical impact stems from narrow eligibility criteria, short follow-up periods, and poor transparency.
- Enhancing future TKA trials is crucial for maintaining their role in evidence-based orthopaedics.
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