Statistical Fragility Analysis of Open Reduction Internal Fixation vs Primary Arthrodesis to Treat Lisfranc Injuries: A Systematic Review

Abstract

Background: There is a lack of consensus in the use of open reduction internal fixation (ORIF) vs primary arthrodesis (PA) in the management of Lisfranc injuries. Statistical fragility represents the number of events needed to flip statistical significance and provides context to interpret P values of outcomes from conflicting studies. The current study evaluates the statistical fragility of existing research with an outcome-specific approach to provide statistical clarity to the ORIF vs PA discussion. We hypothesized that statistical fragility analysis would offer clinically relevant insight when interpreting conflicting outcomes regarding ORIF vs PA management of Lisfranc injuries. Methods: All comparative studies, RCTs, and case-series investigating ORIF vs PA management of Lisfranc injuries published through October 5, 2023, were identified. Descriptive characteristics, dichotomous outcomes, and continuous outcomes were extracted. Fragility index and continuous fragility index were calculated by the number of event reversals needed to alter significance. Outcomes were categorized by clinical relevance, and median FI and CFI were reported. Results: A total of 244 studies were screened. Ten studies and 67 outcomes (44 dichotomous, 23 continuous) were included in the fragility analysis. Of the 10 studies, 4 studies claimed PA to correlate with superior outcomes compared to ORIF with regard to functional scores and return to function outcomes. Of these 4 studies, 3 were statistically robust. Six studies claimed PA and ORIF to have no differences in outcomes, in which only 2 studies were statistically robust. Conclusion: The overall research regarding ORIF vs PA is relatively robust compared with other orthopaedic areas of controversy. Although the full statistical context of each article must be considered, studies supporting PA superiority with regard to functional scores and return to function metrics were found to be statistically robust. Outcome-specific analysis revealed moderate fragility in several clinically relevant outcomes such as functional score, return to function, and wound complications.