The Reverse Fragility Index: Interpreting the Current Literature on Long-Term Survivorship of Computer-Navigated Versus Conventional TKA: A Systematic Review and Cross-Sectional Study of Randomized Controlled Trials

Abstract

Background: Despite the most recent American Academy of Orthopaedic Surgeons clinical practice guideline making a "strong" recommendation against the use of intraoperative navigation in total knee arthroplasty (TKA), its use is increasing. We utilized the concept of the reverse fragility index (RFI) to assess the strength of neutrality of the randomized controlled trials (RCTs) comparing the long-term survivorship of computer-navigated and conventional TKA.

Methods: A systematic review was performed including all RCTs through August 3, 2021, comparing the long-term outcomes of computer-navigated and conventional TKA. Randomized trials with mean follow-up of >8 years and survivorship with revision as the end point were included. The RFI quantifies the strength of a study's neutrality by calculating the minimum number of events necessary to flip the result from nonsignificant to significant. The RFI at a threshold of p < 0.05 was calculated for each study reporting nonsignificant results. The reverse fragility quotient (RFQ) was calculated by dividing the RFI by the study sample size.

Results: Ten clinical trials with 2,518 patients and 38 all-cause revisions were analyzed. All 10 studies reported nonsignificant results. The median RFI at the p < 0.05 threshold was 4, meaning that a median of 4 events would be needed to change the results from nonsignificant to significant. The median RFQ was 0.029, indicating that the nonsignificance of the results was contingent on only 2.9 events per 100 participants. The median loss to follow-up was 27 patients. In all studies, the number of patients lost to follow-up was greater than the RFI.

Conclusions: The equipoise in long-term survivorship between computer-navigated and conventional TKA rests on fragile studies, as their statistical nonsignificance could be reversed by changing the outcome status of only a handful of patients--a number that was always smaller than the number lost to follow-up. Routine reporting of the RFI in trials with nonsignificant findings may provide readers with a measure of confidence in the neutrality of the results.

Level of evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.