The Statistical Fragility of Foot and Ankle Surgery Randomized Controlled Trials

Abstract

Fragility index (FI) is a metric used to interpret the results of randomized controlled trials (RCTs), and describes the number of subjects that would need to be switched from event to non-event for a result to no longer be significant. Studies that analyze FI of RCTs in various orthopedic subspecialties have shown the RCTs to be largely underpowered and highly fragile. However, FI has not been assessed in foot and ankle RCTs. The MEDLINE and Embase online databases were searched from 1/1/2011 through 11/19/2021 for RCTs involving foot and ankle conditions. FI, fragility quotient (FQ), and difference between the FI and number of subjects lost to follow-up was calculated. Spearman correlation was performed to determine the relationship between sample size and FI. Overall, 1262 studies were identified of which 18 were included in the final analysis. The median sample size was 65 (interquartile range [IQR] 57-95.5), the median FI was 2 (IQR 1-2.5), and the median FQ was 0.026 (IQR 0.012-0.033). Ten of 15 (67%) studies with non-zero FI values had FI values less than the number of subjects lost to follow-up. There was linear association between FI and sample size (R² = 0.495, p-value: .031). This study demonstrates that RCTs in the field of foot and ankle surgery are highly fragile, similar to other orthopedic subspecialties.

Keywords: fragility index; randomized controlled trials; statistical analysis: data interpretation.