Statistical Robustness of Randomized Controlled Trials Comparing Biceps Tenotomy Versus Tenodesis: A Reverse Continuous Fragility Index Analysis

Abstract

Background:

The reverse continuous fragility index (rCFI) is a statistical measure utilized to evaluate the relative robustness or fragility of nonstatistically significant findings of randomized controlled trials. Such studies comparing biceps tenotomy versus tenodesis during shoulder arthroscopy have generally shown similar clinical and functional outcomes between the treatments.

Purpose:

To evaluate the statistical robustness or fragility of nonsignificant outcomes of high-quality randomized controlled studies comparing clinical outcomes of biceps tenotomy versus tenodesis during shoulder arthroscopy.

Study Design:

Systematic review and meta-analysis; Level of evidence, 1.

Methods:

The PubMed, Embase, and Cochrane Library databases were searched according to the PRISMA guidelines from 2004 to September 2025 with the following search strategy: “(‘biceps’ OR ‘biceps brachii’ OR ‘long head biceps’) AND (‘tenodesis’ OR ‘tenotomy’) AND (‘Randomized controlled trial’ OR ‘RCT’).” Studies were included if they were randomized controlled trials that compared clinical outcomes of biceps tenodesis versus biceps tenotomy during shoulder arthroscopy. rCFI was calculated on the primary nonsignificant outcomes of all studies and averaged to obtain the mean rCFI. Loss to follow-up was recorded for each study. The reverse continuous fragility quotient was calculated to account for the study sample size.

Results:

Seven studies with 622 patients were included in the final analysis. The mean rCFI of primary study outcomes of all included studies was 17.7 (SD, 8.6; range, 4-26). When rCFI was calculated, 4 (57.14%) of the 7 studies reported a now-significant outcome, with the tenodesis group having greater outcome scores as compared with the tenotomy group. The total loss to follow-up was 55, with a mean 7.8 across all studies. No studies reported a loss to follow-up that was greater than the calculated rCFI. The mean reverse fragility quotient was 0.227 (SD, 0.104). For studies comparing tenotomy versus tenodesis with concomitant rotator cuff repair, the mean rCFI and reverse fragility quotient were 18.25 and 0.163, respectively.

Conclusion:

High-quality randomized controlled trials comparing biceps tenotomy versus tenodesis during shoulder arthroscopy have largely demonstrated statistical noninferiority of clinical outcomes. The evaluation of rCFI of these nonstatistically significant results supports the moderate robustness of these conclusions.