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Updated: Jun 22, 2026
06:40
Screening of Axonal Degeneration in Carpal Tunnel Syndrome Using Ultrasonography and Nerve Conduction Studies
Published on: January 11, 2019
11.8K
Randomized Controlled Trials Evaluating Carpal Tunnel Release Are Statistically Fragile: A Systematic Review
Julian V Javier1, Michaela Corvi2, Graham Sabo1
1Department of Orthopedic Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Hand (New York, N.Y.)
|June 27, 2025
Summary
Statistical outcomes in randomized controlled trials (RCTs) for carpal tunnel release (CTR) are often fragile. A median of just 5 patients could reverse study findings, urging cautious interpretation and reporting of statistical stability metrics.
Area of Science:
- Orthopedic Surgery
- Biostatistics
- Clinical Trial Methodology
Background:
- Randomized controlled trials (RCTs) for carpal tunnel release (CTR) frequently report P-values without assessing statistical stability.
- This limits the reliability of findings influencing surgical decision-making.
Purpose of the Study:
- To evaluate the statistical stability of RCTs assessing CTR approaches using fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ).
Main Methods:
- A systematic literature search of PubMed, Embase, and Medline was conducted for RCTs on CTR published between January 1, 2000, and January 31, 2024.
- Fragility metrics (FI, rFI, FQ) were calculated for study outcomes to quantify statistical robustness.
Main Results:
- Twelve RCTs with 43 outcomes were included.
- The pooled median fragility index (FI) was 5 (interquartile range 4-6.5), indicating that a median of 5 patients could alter statistical significance.
- This suggests that the statistical significance of outcomes in CTR RCTs is potentially fragile.
Conclusions:
- Statistical outcomes in RCTs analyzing CTR approaches demonstrate fragility and require cautious interpretation.
- Co-reporting FI, rFI, and FQ alongside P-values is recommended for comprehensive reliability assessment to aid surgeon decision-making.
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