scholarly journals The Statistical Fragility of Single-Bundle vs Double-Bundle Autografts for ACL Reconstruction: A Systematic Review of Comparative Studies

2021 ◽  
Vol 9 (12) ◽  
pp. 232596712110646
Author(s):  
Cooper B. Ehlers ◽  
Andrew J. Curley ◽  
Nathan P. Fackler ◽  
Arjun Minhas ◽  
Ariel N. Rodriguez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Comparative Studies ◽  
Statistical Significance ◽  
Double Bundle ◽  
Single Bundle ◽  
Bundle Versus ◽  
P Values ◽  
Number Of Patients ◽  
Lost To Follow Up

Background: The statistical significance of a given study outcome can be liable to small changes in findings. P values are common, but imperfect statistical methods to convey significance, and inclusion of the fragility index (FI) and fragility quotient (FQ) may provide a clearer perception of statistical strength. Purpose/Hypothesis: The purpose was to examine the statistical stability of studies comparing primary single-bundle to double-bundle anterior cruciate ligament reconstruction (ACLR) utilizing autograft and independent tunnel drilling. It was hypothesized that the study findings would be vulnerable to a small number of outcome event reversals, often less than the number of patients lost to follow-up. Study Design: Systematic review; Level of evidence, 2. Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, the authors searched PubMed for comparative studies and randomized controlled trials (RCTs) published in select journals, based on impact factor, between 2005 and 2020. Risk-of-bias assessment and methodology scoring were conducted for the included studies. A total of 48 dichotomous outcome measures were examined for possible event reversals. The FI for each outcome was determined by the number of event reversals necessary to alter significance. The FQ was calculated by dividing the FI by the respective sample size. Results: Of the 1794 studies screened, 15 comparative studies were included for analysis; 13 studies were RCTs. Overall, the mean FI and FQ were 3.14 (IQR, 2-4) and 0.050 (IQR, 0.032-0.062), respectively. For 72.9% of outcomes, the FI was less than the number of patients lost to follow-up. Conclusion: Studies comparing single-bundle versus double-bundle ACLR may not be as statistically stable as previously thought. Comparative studies and RCTs are at substantial risk for statistical fragility, with few event reversals required to alter significance. The reversal of fewer than 4 outcome events in a treatment group can alter the statistical significance of a given result; this is commonly less than the number of patients lost to follow-up. Future comparative study analyses might consider including FI and FQ with P values in their statistical analysis.

The Statistical Fragility of Hamstring Versus Patellar Tendon Autografts for Anterior Cruciate Ligament Reconstruction: A Systematic Review of Comparative Studies

2020 ◽  
pp. 036354652096997
Author(s):  
Cooper B. Ehlers ◽  
Andrew J. Curley ◽  
Nathan P. Fackler ◽  
Arjun Minhas ◽  
Edward S. Chang
Keyword(s):  
Anterior Cruciate Ligament ◽  
Anterior Cruciate Ligament Reconstruction ◽  
Comparative Studies ◽  
Ligament Reconstruction ◽  
Cruciate Ligament ◽  
Statistical Significance ◽  
Number Of Patients ◽  
Anterior Cruciate ◽  
Lost To Follow Up

Background: Evidence-based medicine utilizes data to inform clinical decision making, despite the ability of a small number of outcome reversals to change statistical significance. P values are common measurements of statistical significance that possess inherent flaws. The inclusion of the fragility index (FI) and fragility quotient (FQ) may provide a clearer conveyance of statistical strength. Purpose/Hypothesis: The purpose was to examine the statistical stability of studies comparing hamstring tendon and bone–patellar tendon–bone autografts in primary single-bundle anterior cruciate ligament reconstruction with independent tunnel drilling. We hypothesized that the findings of these studies are vulnerable to a small number of outcome event reversals, often fewer than the number of patients lost to follow-up. Study Design: Systematic review. Methods: Comparative studies and randomized controlled trials (RCTs) published in 10 leading orthopaedic journals between 2000 and 2020 were analyzed. Statistical significance was defined as a P value ≤.05. FI for each outcome was determined by the number of event reversals necessary to alter significance. FQ was calculated by dividing the FI by the respective sample size. Results: Of the 1803 studies screened, 643 met initial search criteria, with 18 comparative studies ultimately included for analysis, 8 of which were RCTs. A total of 114 outcomes were examined. Overall, the mean (interquartile range) FI and FQ were 3.77 (2-4) and 0.040 (0.016-0.055), respectively. The FI was less than the number of patients lost to follow-up for 76.3% of outcomes. Conclusion: Studies examining graft choice for anterior cruciate ligament reconstruction may not be as statistically stable as previously thought. Comparative studies and RCTs are at substantial risk for statistical fragility, with few event reversals required to alter significance. The reversal of <4 outcome events in a treatment group can alter the statistical significance of a given result; this is commonly fewer than the number of patients lost to follow-up. Future comparative study analyses might consider including FI and FQ with P values in their statistical analysis.

scholarly journals Evaluation of Single-Bundle versus Double-Bundle PCL Reconstructions with More Than 10-Year Follow-Up

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Masataka Deie ◽  
Nobuo Adachi ◽  
Atsuo Nakamae ◽  
Kobun Takazawa ◽  
Mitsuo Ochi
Keyword(s):  
Evaluation Method ◽  
Cruciate Ligament ◽  
Knee Injuries ◽  
Surgical Techniques ◽  
Double Bundle ◽  
Single Bundle ◽  
Bundle Versus ◽  
Significant Difference ◽  
The Mean

Background. Posterior cruciate ligament (PCL) injuries are not rare in acute knee injuries, and several recent anatomical studies of the PCL and reconstructive surgical techniques have generated improved patient results. Now, we have evaluated PCL reconstructions performed by either the single-bundle or double-bundle technique in a patient group followed up retrospectively for more than 10 years.Methods. PCL reconstructions were conducted using the single-bundle (27 cases) or double-bundle (13 cases) method from 1999 to 2002. The mean age at surgery was 34 years in the single-bundle group and 32 years in the double-bundle group. The mean follow-up period was 12.5 years. Patients were evaluated by Lysholm scoring, the gravity sag view, and knee arthrometry.Results. The Lysholm score after surgery was89.1±5.6points for the single-bundle group and91.9±4.5points for the double-bundle group. There was no significant difference between the methods in the side-to-side differences by gravity sag view or knee arthrometer evaluation, although several cases in both groups showed a side-to-side difference exceeding 5 mm by the latter evaluation method.Conclusions. We found no significant difference between single- and double-bundle PCL reconstructions during more than 10 years of follow-up.

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