Usefulness of orthopaedic shoulder surgery trials: Are they meeting key criteria?

Background: Shoulder surgery is a significant subset of orthopaedic interventions, and randomized controlled trials (RCTs) are critical for advancing surgical techniques and informing clinical guidelines. However, poorly designed or inadequately reported RCTs make applying findings to clinical practice more difficult. This study applies a usefulness assessment tool developed by van’t Hooft et al. to evaluate the utility of shoulder surgery RCTs published in the past five years, aiming to identify trends and gaps to improve trial design and reporting.

Methods: This study evaluated RCTs on orthopaedic shoulder surgery published between January 1, 2019, and October 28, 2024. Using Medline and Embase, articles were screened for inclusion based on predefined criteria. Data extraction focused on general trial characteristics and fulfillment of 13 items within the usefulness criteria. Each criterion was scored from 0–2, with a maximum total score of 26. Statistical analysis included descriptive statistics for trial characteristics, linear regression models for scores and time, and a correlation analysis between core usefulness and transparency scores.

Results: The mean usefulness score was 13.0/26, with scores ranging from 6 to 23. Core usefulness scores showed a slight decline over time, while transparency scores exhibited an upward trend, leading to a modest overall increase in combined scores. Transparency items, such as conflict of interest and funding disclosures, were well-reported, while public availability of raw data and trial protocols scored poorly. Core usefulness items like problem base and feasibility were widely achieved, but pragmatism and value for money were frequently unmet. A moderate positive correlation (r = 0.29, p = 0.0037) was observed between transparency and core usefulness scores.

Conclusions: While transparency improvements have driven slight overall progress in trial quality, substantial gaps remain in key criteria like raw data availability and value for money. The findings highlight the need for journals and researchers to adopt comprehensive strategies to enhance the clinical impact of RCTs. This study underscores the value of structured assessment tools in identifying opportunities to optimize trial design and reporting, ultimately improving evidence-based care in orthopaedic shoulder surgery. The application of the usefulness tool reveals opportunities to strengthen RCT design and reporting, paving the way for more impactful orthopaedic research and better patient outcomes.