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Examining the Statistical Fragility of Randomized Trials on Operative Versus Nonoperative Treatment of
Alyssa D Althoff1, Udit Dave2, Jesus E Cervantes3
1Prisma Health, Greenville, South Carolina.
Orthopedics
|July 7, 2026
Summary
The reverse continuous fragility index (rCFI) reveals that conclusions favoring nonoperative treatment for acromioclavicular (AC) joint separations may be unreliable due to patient loss to follow-up. This highlights the fragility of nonoperative management outcomes.
Area of Science:
- Orthopedic Surgery
- Clinical Trials Methodology
Background:
- Acromioclavicular (AC) joint separations are common injuries.
- Treatment decisions involve operative versus nonoperative approaches.
- The reliability of nonsignificant outcomes in randomized controlled trials (RCTs) needs evaluation.
Purpose of the Study:
- To analyze nonsignificant, continuous outcomes in RCTs comparing operative and nonoperative treatment for AC joint separations.
- To establish the reverse continuous fragility index (rCFI) for these RCTs.
Main Methods:
- Searched databases for RCTs comparing operative vs. nonoperative AC joint treatment published after 2004.
- Calculated rCFI for primary nonsignificant outcomes.
- Derived rCFI quotient by dividing rCFI by sample size.
Main Results:
- Analyzed 7 RCTs with 362 patients (Rockwood types III-V).
- Mean rCFI was 14.9 ± 6.5; mean rCFI quotient was 0.21 ± 0.06.
- Patient loss to follow-up exceeded rCFI in 3 of 7 studies.
Conclusions:
- The rCFI indicates fragility in conclusions favoring nonoperative management for AC joint injuries.
- Nonoperative management outcomes may be less robust than previously suggested.
- Further investigation into treatment efficacy and trial methodology is warranted.