Statistical Robustness of Randomized Controlled Trials Comparing Biceps Tenotomy Versus Tenodesis: A Reverse...

Area of Science:

• Orthopedic Surgery
• Biostatistics
• Clinical Trial Analysis

Background:

• The reverse continuous fragility index (rCFI) assesses the statistical robustness of non-significant findings in randomized controlled trials (RCTs).
• Studies comparing biceps tenotomy and tenodesis for shoulder arthroscopy typically report similar clinical and functional outcomes.

Purpose of the Study:

• To evaluate the statistical robustness and fragility of non-significant outcomes from high-quality RCTs.
• To compare clinical outcomes between biceps tenotomy and tenodesis procedures during shoulder arthroscopy using rCFI.

Main Methods:

• A systematic review and meta-analysis (Level of evidence, 1) searched PubMed, Embase, and Cochrane Library (2004-2025).
• Included RCTs compared clinical outcomes of biceps tenodesis versus tenotomy in shoulder arthroscopy.
• Calculated mean rCFI for primary non-significant outcomes, recorded loss to follow-up, and computed the reverse fragility quotient.

Main Results:

• Seven studies with 622 patients were analyzed; the mean rCFI was 17.7 (SD, 8.6).
• Applying rCFI revealed statistically significant outcomes in 57.14% of studies, favoring tenodesis.
• Loss to follow-up (mean 7.8) did not exceed the calculated rCFI in any study; mean reverse fragility quotient was 0.227.

Conclusions:

• High-quality RCTs indicate statistical noninferiority of clinical outcomes between biceps tenotomy and tenodesis.
• The rCFI analysis supports the moderate robustness of these conclusions regarding non-significant findings.