AJSM - 2026-09-01 - Journal Article; Systematic Review; Meta-Analysis; Comparative Study
Statistical Robustness of Randomized Controlled Trials Comparing Biceps Tenotomy Versus Tenodesis: A Reverse Continuous Fragility Index Analysis.
Hu EY, Althoff AD, Cervantes JE, Dave U, Kessler KG, Moran TE
Topics
Key Takeaway
Seven RCTs comparing biceps tenotomy versus tenodesis yielded a mean reverse continuous fragility index of 17.7, indicating moderate robustness of nonsignificant findings, though 57% of studies would flip to tenodesis superiority if rCFI threshold were crossed.
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Summary
This systematic review applied the reverse continuous fragility index (rCFI) to evaluate the statistical robustness of nonsignificant primary outcomes in 7 RCTs comparing biceps tenotomy versus tenodesis during shoulder arthroscopy. Mean rCFI was 17.7 (SD 8.6; range 4–26), and no study had a loss to follow-up exceeding its rCFI, supporting moderate conclusion robustness. However, 4 of 7 studies (57%) would yield a statistically significant tenodesis advantage if the rCFI threshold were reached, and the mean reverse fragility quotient was 0.227.
Key Limitation
Only 7 eligible RCTs with heterogeneous concomitant procedures (rotator cuff repair vs. isolated biceps surgery) were available, preventing subgroup rCFI analysis with adequate power to detect differential robustness by procedure context.
Original 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.