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The Fragility Of Statistical Significance In Cartilage Restoration Of The Knee: A Systematic Review Of Randomized Controlled Trials

Robert L Parisien, MD, UNITED STATES Michael Constant, BA, UNITED STATES Bryan M Saltzman, MD, UNITED STATES Charles A. Popkin, MD, UNITED STATES Christopher S. Ahmad, MD, UNITED STATES Xinning Li, MD, UNITED STATES David P Trofa, MD, UNITED STATES

Columbia University Medical Center Department of Orthopaedics, New York, New York, UNITED STATES

2021 Congress ePoster Presentation Not yet rated

Anatomic Location

Knee

Anatomic Structure

Cartilage

Diagnosis / Condition

Trauma Tears

Treatment / Technique

Allograft Arthroscopy Autograft Biologics Osteotomy Repair / Reconstruction Transplantation

Cartilage

Osteochondritis Cartilage Treatment Cartilage Injuries

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Summary: The orthopaedic literature evaluating articular cartilage defects of the knee is fragile as the reversal of relatively few outcome events may alter the significance of statistical findings.

Objective

A growing body of evidence demonstrates instability of reported outcomes within the orthopaedic literature. The purpose of this study was to utilize fragility analysis to assess the robustness of randomized controlled trials evaluating the management of articular cartilage defects of the knee. We hypothesize the cartilage restorative literature will be fragile with the reversal of only a few outcome events required to change statistical significance.

Design: Randomized controlled trials (RCTs) from prominent orthopaedic journals indexed on PubMed from 2000-2020 that reported dichotomous outcome measures relating to the management of articular cartilage defects of the knee were included. The Fragility Index (FI) for each outcome was calculated through the iterative reversal of a single outcome event until significance was reversed. The Fragility Quotient (FQ) was calculated by dividing each FI by study sample size. Additional statistical analysis was performed to provide median FI and FQ across subgroups.

Results

Nineteen RCTs containing 60 dichotomous outcomes were included for analysis. The FI and FQ of all outcomes was 4 (IQR 2-7) and 0.067 (IQR 0.034-0.096), respectively. The average number of patients lost to follow up (LTF) was 3.9 patients with 15.8% of the included studies reporting LTF greater than or equal to 4, the FI of all included outcomes.

Conclusions

The orthopaedic literature evaluating articular cartilage defects of the knee is fragile as the reversal of relatively few outcome events may alter the significance of statistical findings. We therefore recommend comprehensive fragility analysis and triple reporting of the P value, FI and FQ to aid in the interpretation and contextualization of clinical findings reported in the cartilage restoration literature.

Keywords: articular cartilage; knee; fragility index; fragility quotient; P value; cartilage restoration; statistical significance

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The Fragility Of Statistical Significance In Cartilage Restoration Of The Knee: A Systematic Review Of Randomized Controlled Trials

The Fragility Of Statistical Significance In Cartilage Restoration Of The Knee: A Systematic Review Of Randomized Controlled Trials

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The Fragility Of Statistical Significance In Cartilage Restoration Of The Knee: A Systematic Review Of Randomized Controlled Trials

The Fragility Of Statistical Significance In Cartilage Restoration Of The Knee: A Systematic Review Of Randomized Controlled Trials

Objective

Results

Conclusions