Do Published Orthopaedic RCTs Match Their Registered Protocols? A 6-year Analysis of Leading Orthopaedic Journals

Area of Science:

• Orthopaedic Surgery
• Clinical Trial Methodology
• Evidence-Based Medicine

Background:

• Prospective registration of randomized controlled trials (RCTs) is crucial for reducing publication bias and selective reporting.
• Adherence to prespecified protocols ensures the integrity of research findings.
• The extent of compliance with registration standards in leading orthopaedic surgery journals remains unevaluated.

Purpose of the Study:

• To assess compliance with prospective registration best practices for RCTs in top orthopaedic surgery journals.
• To identify major discrepancies between registered protocols and published RCTs.
• To determine if specific study types are associated with a higher likelihood of reporting discrepancies.

Main Methods:

• A review of RCTs published in the top five general-interest orthopaedic surgery journals was conducted.
• Nine essential elements from the WHO minimum data set were extracted and compared between registry entries and published articles.
• Chi-square tests were used to analyze associations between study characteristics and reporting discrepancies.

Main Results:

• 95% of RCTs had identifiable registry entries, but 2% lacked identifiers and 2% were long-term follow-ups without unique entries.
• Major discrepancies were frequent: sample size (33%), primary outcome (25%), secondary outcomes (60%), inclusion criteria (33%), and exclusion criteria (53%).
• Trials from the US or international collaborations were more likely to have updated registry results (37% vs. 10%).

Conclusions:

• Prospective registration is standard in high-impact orthopaedic journals, but a gap exists between registration and data accuracy.
• Registration is often treated as a procedural step rather than a commitment to a fixed protocol.
• Stricter standards for trial registration, reporting, and verification are needed to enhance confidence in published orthopaedic evidence.