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

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

Validation of the Angle Bisector Method for Precise Tibiofibular Syndesmosis Fixation Angle Using Computed Tomography and 3D-Printed Models

Category: Ankle; Trauma Introduction/Purpose: The proposed ideal alignment for the syndesmosis involves a line connecting the centroids of the fibula and tibia, but there is uncertainty about the optimal intraoperative method for determining the appropriate fixation angle. This is due to the fact that the AO guidelines do not account for patient or level-specific factors, and the determination of the angle relative to the coronal plane relies on the surgeon's judgment. Inexperienced trauma surgeons may encounter significant problems with syndesmotic malalignment as a result. The goal of this study was to validate the effectiveness of the angle bisector method using computed tomography and 3D-printed ankle models, in order to determine whether it can assist in achieving proper screw trajectory for syndesmotic fixation. Methods: The angle bisector method was utilized to identify a precise trajectory for the true syndesmotic axis, using the bisector of the angle formed by two lines tangential to the anterior and posterior fibula and tibia. CT validation was made on CT angiography of 50 consecutive patients. DICOM data from 16 ankles were used to create 3D anatomical models which were printed using a desktop FDM printer. Two trauma surgeons performed syndesmotic fixations using the angle bisector method at 2 cm and 3.5 cm proximal to the joint space, after identifying the bisector of the angle formed by two K-wires tangential to the anterior and posterior fibula and tibia. The axial sections of CTs and printed 3D-models were analyzed using software to determine the relationship between centroidal axis and the inserted screws. The measurements were made twice by two blinded observers, with a two-week interval. Results: The results of the study show that the angle bisector method provides a reliable direction with minimal differences at both the 2 cm and 3.5 cm levels. The average angle between the centroidal axis and screw trajectory was 2.4° ± 2° at the 2 cm level and 1.3° ± 1.5° at the 3.5 cm level. Furthermore, the average distance between the fibular entry points of the centroidal axis and screw trajectory was less than 1 mm at both levels, indicating that the angle bisector method can serve as an excellent entry point for syndesmotic fixation on the fibula. The inter- and intra-surgeon analyses showed excellent consistency, with all ICC values above 0.90. Similarly, inter- and intra-observer consistencies regarding the measurements were also excellent. Conclusion: The study demonstrated that the angle bisector method was successful in identifying the original syndesmotic axis and aided in the precise placement of implants in the desired direction. The method has the potential to be replicated intraoperatively and could serve as a basis for the development of a novel surgical guide for determining the correct syndesmotic axis. However, safety analysis using cadavers should be conducted prior to clinical implementation