Characteristics and Discrepancies in Publication of Clinical Trials Related to Foot and Ankle Surgery

Abstract

Category: Other Introduction/Purpose: The significance of trial registration has grown rapidly as an increasing number of journals require NCT IDs prior to publication. Although various reports have been published in different medical fields, including several orthopaedic subspecialties, no study has examined the discrepancies between trial registries and publications in the area of foot and ankle surgery. Therefore, this study aimed to investigate (1) the characteristics of foot and ankle surgery-related clinical trials registered in the widely used Clinicaltrials.gov (CTG) clinical trials database, (2) the publication rates, (3) inconsistencies between the original trial plans and final publications, and (4) possible risk factors that could contribute to discrepancies. The hypothesis was that foot and ankle surgery-related trials would have a low publication rate, and discrepancies would exist between trial registries and final published results. Methods: The study used the CTG database to identify eligible trials based on the following inclusion criteria: (1) related to foot and ankle surgery, (2) interventional study, (3) randomized controlled, and (4) anticipated completion date before the end of 2018. Exclusion criteria consisted of (1) ongoing trials, (2) trials assessing vascular surgeries or anesthetic procedures, and (3) trials examining conservative treatment methods without any surgical intervention. The search was performed on January 1, 2021, allowing the authors at least 24 months from trial completion to publication. The corresponding publications of the included trials were searched using various databases, including Medline, Web of Science, Scopus, and Google Scholar. NCT ID, title, keywords, and the name of the principal investigator provided in CTG were used for literature search, and the title and abstract of the publications were reviewed to confirm the match with the trial. Results: Out of all the trials analyzed, 67.5% were registered either during the trial period or after completion. Industry funded 46.5% of trials. A reported 54.8% of trials were completed, and only 42% (66 trials) were published in a journal. Among the analyzed trials, 57.6% had a sample size discrepancy, 28.8% had a follow-up time discrepancy, 45.5% had a primary outcome discrepancy, and 89.4% had an inclusion/exclusion criteria discrepancy. Trials funded by industry exhibited significantly more sample size and inclusion/exclusion criteria discrepancies (p=0.024, 0.001, 0.037, respectively). Furthermore, industry-funded studies had a higher frequency of positive results (p=0.011). Conclusion: The findings of this study draw attention to the existing issues in clinical trials related to foot and ankle surgery. The results not only serve as a warning to researchers regarding potential inconsistencies but also support the need for stricter trial registry regulations. Registering a trial does not guarantee its publication or ensure that there will be no modifications to the methodology during the trial period. Therefore, it is crucial to register trials before enrolling the first patient to minimize the risk of bias.