The statistical fragility of intramedullary reaming in tibial nail fixation: a systematic review

Minhas, Arjun; Berkay, Fehmi; Ehlers, Cooper B; Froehle, Andrew W.; Krishnamurthy, Anil

doi:10.1007/s00068-023-02254-4

Cited by 3 publications

(5 citation statements)

References 38 publications

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“…Recently, it had been shown that the robustness of such trials in orthopaedic trauma is not that stable as we thought before where a limited number of event reversals might alter the trial’s significance [ 7 ]. Now, Minhas and coworkers [ 8 ] have analyzed in a systematic review that with respect to the non-union rate with and without reaming of the intramedullary canal in tibial nail fixation 87.5% of the studies did not find significant differences which is line with concurrent publications [ 9 ], but more than 78% of the findings were statistically fragile. This means that on average 2 event reversals for statistical findings and 4 event reversals for insignificant findings will suffice to alter statistical significance.…”

mentioning

confidence: 59%

Editorial—Focus on tibia shaft fractures

Mittlmeier

2023

Eur J Trauma Emerg Surg

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mentioning

confidence: 59%

Editorial—Focus on tibia shaft fractures

Mittlmeier

2023

Eur J Trauma Emerg Surg

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Section: Corrective Techniques and Advancesmentioning

confidence: 99%

“…Intramedullary reaming represents a key step in exchange nailing, and it is often incorporated into original IMN surgical fixation as well [ 94 ]. However, the balance between the benefits and risks incurred by intramedullary reaming remains debated today [ 94 ]. Intramedullary reaming disrupts the endosteal blood supply to the bone in question through direct vascular damage and penetration of the central venous sinus within the medullary cavity [ 95 ].…”

Section: Corrective Techniques and Advancesmentioning

confidence: 99%

“…However, the value of intramedullary reaming to optimize bone–nail congruence and maximize fixation stability cannot be understated [ 95 , 96 ]. At this time, consensus regarding the use of intramedullary reaming in initial IMN fixation has not been reached, and the majority of clinical studies display marked statistical fragility, with merely one or two event reversals necessary to reverse a binary conclusion [ 94 ]. On the other hand, intramedullary reaming during exchange nailing has been refined and augmented over time, serving as a valuable debridement tool for septic nonunion and a delivery method for intramedullary lavage and antibiotic therapy [ 98 ].…”

Section: Corrective Techniques and Advancesmentioning

confidence: 99%

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Delayed Union and Nonunion: Current Concepts, Prevention, and Correction: A Review

Bowers,

Anderson

2024

Bioengineering

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Surgical management of fractures has advanced with the incorporation of advanced technology, surgical techniques, and regenerative therapies, but delayed bone healing remains a clinical challenge and the prevalence of long bone nonunion ranges from 10 to 15% of surgically managed fractures. Delayed bone healing arises from a combination of mechanical, biological, and systemic factors acting on the site of tissue remodeling, and careful consideration of each case’s injury-related, patient-dependent, surgical, and mechanical risk factors is key to successful bone union. In this review, we describe the biology and biomechanics of delayed bone healing, outline the known risk factors for nonunion development, and introduce modern preventative and corrective therapies targeting fracture nonunion.

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“…6 The FI has since been used widely in the orthopaedic literature to assess the stability across study findings. [7][8][9][10][11][12][13][14][15][16] The reverse fragility index (rFI) is a similar metric that evaluates the number of outcome event reversals needed to alter nonsignificant findings that has also been used widely. [17][18][19] A smaller FI or rFI value indicates that fewer outcome event reversals are needed to alter outcome significance and thus statistical fragility is appreciated.…”

Section: Introductionmentioning

confidence: 99%

The Fragility of Statistical Findings in the Femoral Neck Fracture Literature: A Systematic Review of Randomized Controlled Trials

Yendluri,

Megafu,

Wang

et al. 2024

Journal of Orthopaedic Trauma

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Objectives: Randomized controlled trials (RCTs) in the femoral neck fracture literature frequently report p-values for outcomes which have substantial implications in guiding surgical management. This study utilized the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to assess the statistical stability of outcomes reported in RCTs evaluating the management and treatment of femoral neck fractures. Methods: Data Sources: Pubmed, Emabse, and MEDLINE were queried for RCTs (January 1, 2010 to February 28th, 2023) that evaluated surgical management/treatment of femoral neck fractures. Study Selection: RCTs with two treatment arms reporting categorical dichotomous outcomes were included. Non-RCT studies, RCTs with greater than 2 treatment arms, and RCTs without a femoral neck fracture cohort were excluded. Data Extraction and Synthesis: The FI and rFI were calculated as the number of outcome event reversals required to alter statistical significance for significant (p<0.05) and non-significant (p≥0.05) outcomes, respectively. The FQ was calculated by dividing the FI by the sample size for the study. Results: 985 articles were screened with 71 studies included for analysis. The median FI across a total of 197 outcomes was 4 (IQR 2-5) with an associated FQ of 0.033 (IQR 0.017-0.060). 47 outcomes were statistically significant with a median FI of 2 (IQR 1-4) and associated FQ of 0.02 (IQR 0.014-0.043). 150 outcomes were statistically non-significant with a median rFI of 4 (IQR 3-5) and associated FQ of 0.037 (IQR 0.019-0.065). Conclusion: Statistical findings in femoral neck fracture RCTs are fragile with reversal of a median 4 outcomes altering significance of study findings. The authors thus recommend standardized reporting of p-values with FI and FQ metrics to aid in interpreting the robustness of outcomes in femoral neck fracture RCTs. Level of evidence: Level I. See Instructions for Authors for a complete description of levels of evidence.

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The statistical fragility of intramedullary reaming in tibial nail fixation: a systematic review

Cited by 3 publications

References 38 publications

Editorial—Focus on tibia shaft fractures

Editorial—Focus on tibia shaft fractures

Delayed Union and Nonunion: Current Concepts, Prevention, and Correction: A Review

The Fragility of Statistical Findings in the Femoral Neck Fracture Literature: A Systematic Review of Randomized Controlled Trials

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