Document Type

Article

Publication Date

8-6-2024

Comments

This article is the author's final published version in Journal of Experimental Orthopaedics, Volume 11, Issue 3, August 2024, Article number e12113.

The published version is available at https://doi.org/10.1002/jeo2.12113

Copyright © 2024 The Authors.

Abstract

INTRODUCTION: Fragility analysis is a method of further characterising the robustness of statistical outcomes. This study evaluates the statistical fragility of randomised controlled trials (RCTs) comparing patellar resurfacing versus non-patellar surfacing in total knee arthroplasty (TKA).

METHODS: PubMed, MEDLINE and EMBASE were searched for RCTs comparing outcomes in TKA based on patellar resurfacing. Fragility index (FI) and reverse FI (collectively, "FI") were calculated for dichotomous outcomes as the number of outcome reversals needed to change statistical significance. Fragility quotient (FQ) was calculated by dividing the FI by the sample size for that outcome. Median FI and FQ were calculated for each individual outcome and for the overall study. Subanalyses were performed to assess FI and FQ based on outcome type, statistical significance and loss to follow-up.

RESULTS: Twenty-one RCTs were included in the analysis, capturing 3910 subjects. The overall median FI was 5.0 (interquartile range, [IQR] 4.0-6.0), and the overall median FQ was 0.048 (IQR 0.022-0.065). The outcome of anterior knee pain has a median FI of 6.0 (IQR 4.0-6.0) and a median FQ of 0.057 (IQR 0.025-0.065). Only five (7%) outcomes were significant. The loss to follow-up was greater than the FI in 12 of 19 studies (63%) with available data.

CONCLUSION: RCTs comparing patellar resurfacing in TKAs show significant statistical fragility; a few outcome reversals can alter findings. The majority of outcomes were nonsignificant, indicating that the choice to resurface the patella may not affect most clinical outcomes; however, clinical conclusions are limited by the statistical fragility of the analysed outcomes. Larger RCTs for this comparison are necessary, and we suggest adding FI and FQ to RCT reports with

LEVEL OF EVIDENCE: Level II.

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Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.

Language

English

Included in

Orthopedics Commons

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