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Statistical Fragility of Studies Comparing Revision Rates After Manual Versus Robotic-Assisted or Computer-Navigated
Daniel C Gabriel1, Marcos R Gonzalez2, Sang W Lee1
1Harvard Medical School, Boston, Massachusetts.
The Journal of Arthroplasty
|May 8, 2025
Summary
Studies comparing robotic-assisted hip replacement to manual methods show statistically fragile results. This fragility suggests that outcomes may not be as robust as initially reported, impacting the reliability of current evidence.
Area of Science:
- Orthopedic Surgery
- Medical Technology Evaluation
- Biostatistics
Background:
- Computer-navigated and robotic-assisted total hip arthroplasty (THA) are increasingly used, but their comparative outcomes to manual THA remain uncertain.
- Assessing the statistical robustness of randomized controlled trials (RCTs) comparing revision rates is crucial.
Purpose of the Study:
- To evaluate the statistical robustness of RCTs comparing revision rates between manual and technology-assisted total hip arthroplasty (THA).
- To implement the reverse fragility index (RFI) and reverse fragility quotient (RFQ) to assess study reliability.
Main Methods:
- A systematic review of RCTs reporting revision rates for manual versus robotic-assisted/computer-navigated THA was conducted.
- The reverse fragility index (RFI) and reverse fragility quotient (RFQ) were calculated for each study.
- Nine RCTs involving 894 patients were analyzed, with data collected up to February 2, 2025.
Main Results:
- The median RFI was five for both computer-navigated and robotic-assisted THA subgroups, indicating a small number of event reversals could alter significance.
- The median RFQ was 0.045, suggesting that a 4.5% change in outcomes could shift results from nonsignificant to significant.
- Seven out of nine studies (78%) had a loss to follow-up greater than or equal to their RFI, raising concerns about data integrity.
Conclusions:
- All included RCTs demonstrated significant statistical fragility when comparing revision rates of manual versus technology-assisted THA.
- Routine reporting of RFI and RFQ metrics is recommended for future RCTs, especially those with nonsignificant findings.
- Careful interpretation of P values is advised given the observed statistical fragility in current evidence.
