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65 (); 329-335
doi:
10.1016/j.jor.2025.06.011

Pediatric lower extremity fracture treatments: a statistical review of randomized controlled trials

, , , , , ,
a Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, USA
b Columbia University Irving Medical Center, New York, NY, USA

⁎Corresponding author: Matthew D. Ramey. matthewramey@berkeley.edu

Received: , Accepted: ,
Professor P K Surendran Memorial Education Foundation
Disclaimer:
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.

Abstract

Abstract

Pediatric lower extremity fractures present with significant clinical challenges and largely rely on randomized controlled trials (RCTs) for intervention evaluation. The statistical robustness of these trials is seldom evaluated, but when examined reveals issues such as small sample sizes and underpowered results. Therefore, this study aimed to test the statistical robustness of RCTs evaluating pediatric lower extremity fracture interventions using fragility statistics.

PubMed, Embase, and MEDLINE were systematically searched for recent RCTs (2000–2023) assessing outcomes for pediatric patients with lower extremity fractures. The fragility index (FI), or number of event reversals required to alter statistical significance, was calculated for all dichotomous outcomes. The fragility quotient (FQ) was then determined by dividing the FI by the study sample size.

After screening, 14 studies were included for analysis. Across 83 total dichotomous outcomes, the median FI was 5 (IQR 3–6) with an associated median FQ of 0.070 (IQR 0.033–0.107), suggesting that just event reversal in 5 patients, or 7.0 % of the study population, would alter significance for 50 % of outcomes. 15 outcomes were statistically significant (FQ = 0.029), and 68 outcomes were non-significant (FQ = 0.083). Outcomes were grouped into three categories, including fracture reduction or union (28 outcomes), functional improvement and patient satisfaction (26 outcomes), and adverse events (29 outcomes). Category FQs were 0.061, 0.069, and 0.076, respectively. 47 outcomes were extracted from studies published prior to 2018 (FQ = 0.086), while the 36 outcomes published in 2018 or later resulted in a median FQ of 0.048. Three fracture types were assessed, including tibia (37 outcomes), femur (39 outcomes), and ankle (7 outcomes) fractures, with FQs of 0.075, 0.060, and 0.050, respectively. Across the 59 outcomes from studies with operative interventions, the FQ was 0.075, whereas the 24 outcomes from studies with non-operative interventions reported a FQ of 0.060.

The efficacy of treatments in pediatric lower extremity fractures from RCTs are slightly fragile, particularly among significant outcomes. Over time, these studies have become less robust. Larger RCTs that combine the reporting of p-values with FI and FQ metrics may provide more robust evidence for guiding effective treatment strategies in pediatric lower extremity fractures.

Keywords

Pediatrics
Lower extremity
Statistical fragility
Fragility index
Fragility quotient
Systematic review
1

1 Introduction

Pediatric lower extremity fractures present unique challenges in both diagnosis and treatment, given the rapid growth and developmental changes occurring during childhood and adolescence.1 These fractures also account for a significant portion of pediatric injuries, with studies indicating the rate of childhood fractures being between 12.0 to 36.1 per 1000 children per year.2 Treatment strategies range from conservative management, such as casting and immobilization, to surgical interventions, depending on the type and severity of the fracture.3 With the unique characteristics of developing bones, it is essential to identify effective treatment strategies that minimize complications and optimize recovery outcomes.4

While randomized controlled trials (RCTs) are considered the ‘gold standard’ for assessing the efficacy of treatments in orthopaedics, limitations due to study design can hinder the strength of results presented.5 Reliance on the p-value as the sole measure of treatment efficacy has faced scrutiny, given its dependence on arbitrary significance thresholds and inability to account for variability across studies, including loss to follow-up and different distributions of outcomes.6,7 To address these limitations, the concept of fragility has emerged as a valuable metric in orthopaedic literature.8–10 The fragility index (FI) and reverse fragility index (rFI) provide insights into the robustness of RCT outcomes by quantifying the number of outcome reversals required to change the statistical significance of results.11 The FI specifically represents the number of outcome modifications required to turn statistically significant outcomes into non-significant, whereas the rFI indicates the number of outcome modifications required to turn statistically non-significant outcomes significant.12 Additionally, the fragility quotient (FQ) accounts sample size calculating the proportion of patients that would necessitate an outcome change to affect significance, with lower values indicating increased fragility. 13,14

The primary objective of this study was to evaluate the statistical fragility of RCT outcomes related to pediatric lower extremity fractures using FI, rFI, and FQ metrics. We hypothesized that outcomes for pediatric lower extremity fractures would demonstrate statistical fragility and outcomes reported as significant would reflect the least robustness.15

2

2 Methods

2.1

2.1 Literature review

This systematic review was performed in alignment with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA).16 Pubmed, Embase, and Medline databases were queried to identify RCTs published between January 1, 2000 and August 1, 2024 pertaining to pediatric fracture treatments. The search keywords used across all databases were (“fracture”) AND (“treatment”) AND (“pediatric” OR “child” OR “youth”) AND (“knee” OR “elbow” OR “wrist” OR “humerus” OR “radius” OR “tibia” OR “fibula” OR “carpal” OR “acetabular”). Injury sites chosen for this study were based upon commonly cited injuries in pediatric orthopaedic studies.17,18 Included studies were RCTs published in English reporting dichotomous, categorical outcomes on pediatric fracture management. Meta-analyses, papers without full text availability, protocol proposals, case reports, papers not available in English, in vitro studies, and animal studies were excluded. Abstract screening and full text review were performed by two authors and subsequent conflicts were verified by a third author for inclusion. Bias assessment was conducted using the revised Cochrane Risk of Bias tool for evaluating bias in randomized trials.

2.2

2.2 Included studies

425 RCTs were identified, where 118 met the full text screening criteria, and 82 studies were included for analysis (Fig. 1). Given the volume of studies specifically investigating lower extremity fracture treatments, this study was able to conduct a site-specific analysis of lower extremity fracture treatment fragility, including 14 total studies (Table 1, Fig. 1). Studies were obtained from 13 different journals (Table 1).

PRISMA flow diagram showing identification, screening, and inclusion of eligible PubMed, Embase, and MEDLINE articles.
Fig. 1 PRISMA flow diagram showing identification, screening, and inclusion of eligible PubMed, Embase, and MEDLINE articles.
Table 1 Characteristics of included studies: year, journal of publication, and total sample size.41–54.
First Author Year Journal Sample Size
Boutis et al. 2006 Pediatrics 104
Willie-Ledon et al. 2011 Acta Pediatrica 58
Barnett et al. 2012 Pediatric Emergency Care 40
Silva et al. 2012 The Journal of Bone and Joint Surgery 81
Bradman et al. 2021 Journal of Emergency Medicine 304
Fox et al. 2022 Journal of Pediatric Orthopaedics 44
Larsen et al. 2004 Journal of Orthopaedic Trauma 45
Shemshaki et al. 2011 Journal of Orthopaedics and Traumatology 46
Kumar et al. 2014 Journal of Clinical and Diagnostic Research 52
Gyaneshwar et al. 2016 Chinese Journal of Traumatology 34
Zheng et al. 2018 International Journal of Surgery 80
Wang et al. 2019 Pakistan Journal of Medical and Health Sciences 120
James et al. 2021 Journal of Pediatric Orthopaedics 40
Zhang et al. 2023 European Review of Medical and Pharmacological Sciences 100
2.3

2.3 Data extraction

Author name, publication year, sample size, and journal of publication were extracted and included in Table 1. Study intervention, outcomes measured, number of patients per intervention with each outcome, number lost to follow-up, and reported p-values were also extracted from each article. Outcomes were assigned to and analyzed in the following subgroups: significant outcomes, non-significant outcomes, operative intervention, non-operative intervention, published before 2018, published 2018 or later, fracture reduction/union outcomes, functional improvement/patient satisfaction outcomes, and adverse event outcomes. A site specific analysis was conducted for outcomes related to the tibia, femur, and ankle. Finally, given the potential bias that can result from loss to follow-up, a secondary analysis was conducted excluding studies in which loss to follow-up was greater or equal to the respective FI or rFI of the outcome.

2.4

2.4 Fragility analysis

With a 2 × 2 contingency table, the amount of patients with each outcome for each intervention arm was reversed until the statistical significance of an outcome was altered, and vice versa for non-significant outcomes. This methodology is depicted in Fig. 2. FI and rFI values were defined as the amount of patient reversals needed to alter statistical significance or non-significance, respectively. The FQ metric was determined by dividing the FI or rFI by total sample size. Median FI and FQ values were utilized for subgroup analysis. The p-value for each outcome was calculated using the two-tailed Fisher exact test, with values less than 0.05 considered significant. Fragility metrics were reported as medians with corresponding interquartile ranges (IQRs).

Demonstration of statistical significance reversal using a 2 × 2 contingency table with a resulting fragility index (FI) = 1 (Zhang et al., 2023). Femoral fracture union rate of locking plate fixation vs. K wire internal fixation was being examined.
Fig. 2 Demonstration of statistical significance reversal using a 2 × 2 contingency table with a resulting fragility index (FI) = 1 (Zhang et al., 2023). Femoral fracture union rate of locking plate fixation vs. K wire internal fixation was being examined.
3

3 Results

From the 14 RCTs ultimately included in the review (Table 1), there were 83 reported outcomes with a median FI of 5 (IQR 3–6), indicating a minimum of 5 patient outcome reversals would be needed to shift significance (Table 2). Accounting for sample size, the median FQ for all outcomes was found to be 0.070 (IQR 0.033–0.107), suggesting 7 patients per 100 would require outcome reversals for a shift in significance. Of the 83 reported outcomes, 68 were found to be nonsignificant but had similar median rFI of 5 (IQR 3.75–6) but a higher median FQ of 0.083 (IQR 0.050–0.116). Outcomes reported as significant had a median FI of 2 (IQR 2–3.5) and FQ of 0.029 (IQR 0.020–0.043). In nine outcomes, loss to follow-up exceeded the respective FI or rFI. Upon exclusion of these outcomes, the median FI remained 5 (IQR 3–6) while the median FQ decreased to 0.069 (IQR 0.033–0.1).

Table 2 Fragility data based on outcome characteristics.
Number of Outcomes FI, Median (IQR) FQ, Median (IQR)
All RCT Outcomes 83 5 (3–6) 0.07 (0.033–0.107)
Significant Outcomes (P < 0.05) 15 2 (2–3.5) 0.029 (0.020–0.043)
Nonsignificant Outcomes (P ≥ 0.05) 68 5 (3.75–6) 0.083 (0.05–0.116)

When stratified by date of publication (pre- and post-2018), the median FI for studies published prior to 2018 was recorded as 5 (IQR 3–6) while that of studies published after 2018 was calculated to be 4 (IQR 2–2.5) (Table 3). This similarity between pre and post-2018 was also observed in FQ, with the median value for pre-2018 studies being 0.086 (IQR 0.056–0.118) and post-2018 studies being 0.048 (IQR 0.022–0.093). Meanwhile, outcomes from operative (n = 59) versus non-operative interventions (n = 24) had a median FI of 5 (IQR 3–6) and 4 (IQR 2–6), and FQ of 0.075 (IQR 0.033–0.117) and 0.050 (0.060–0.088), respectively (Table 4).

Table 3 Fragility data separated by year published.
Number of Outcomes FI, Median (IQR) FQ, Median (IQR)
Published Before 2018 47 5 (3–6) 0.086 (0.056–0.118)
Published in 2018 or Later 36 4 (2–2.5) 0.048 (0.022–0.093)
Table 4 Fragility data from operative versus non-operative interventions.
Number of Outcomes FI, Median (IQR) FQ, Median (IQR)
Operative Interventions 59 5 (3–6) 0.075 (0.033–0.117)
Non-operative Interventions 24 4 (2–6) 0.060 (0.033–0.088)

The most fragile outcome category, among fracture reduction/union, functional improvement/patient satisfaction, adverse events, was adverse events with a median FI of 4 (IQR 3–6) and FQ of 0.076 (IQR 0.050–0.103) (Table 5). The least fragile category by FI was functional fracture reduction or union with a median FI of 5 (IQR 2–6). All outcome categories had a similar number of outcomes: 28 in fracture reduction/union, 26 in functional improvement/patient satisfaction, and adverse events (n = 29), with similar median FIs and FQs. When stratified by fracture type (femoral, tibial, and ankle), femoral fractures were the most fragile (FI = 4), followed by ankle (FI = 5) and tibial (FI = 5) fractures (Table 6).

Table 5 Subgroup analysis based on outcome category.
Number of Outcomes FI, Median (IQR) FQ, Median (IQR)
Fracture Reduction/Union 28 5 (2–6) 0.061 (0.024–0.096)
Functional Improvement/Patient Satisfaction 26 4.5 (3–6) 0.069 (0.029–0.117)
Adverse Events 29 4 (3–6) 0.076 (0.05–0.103)
Table 6 Fragility data based on fracture site.
Number of Outcomes FI, Median (IQR) FQ, Median (IQR)
Tibia 37 5 (3–6) 0.075 (0.052–0.091)
Femur 39 4 (2.5–6) 0.060 (0.030–0.118)
Ankle 7 5 (3–5.5) 0.050 (0.038–0.091)

A risk of bias assessment was evaluated utilizing the Revised Cochrane Risk-of-Bias tool for randomized trials, yielding one study of high concern for bias and ten (71.4 %) studies as low risk for bias (Table 7).

Table 7 Risk of bias assessment for included studies evaluated using Revised Cochrane Risk-of-Bias Tool for randomized trials. Green shading indicates “low risk” of bias, yellow shading indicates “some concern” for bias, red shading indicates “high concern.”
4

4 Discussion

The goal of this study was to examine the statistical fragility of outcomes observed in RCTs assessing pediatric lower extremity fracture management. There were 83 outcomes of interest included in this study, yielding a median FI of 5 and median FQ of 0.07. Several studies that reported higher fragility values than those in the present study considered their observations particularly fragile.19–21 Currently, there are no standard thresholds for what constitutes a “fragile” and a “robust” outcome, which is a limitation of fragility analyses that has been previously discussed by Oeding et al. 22 However, there have been attempts to propose thresholds for the FI, rFI, and FQ, most notably an empirical assessment by Xin and Lin which grouped scores on a scale from “extremely fragile” to “extremely robust; ” given the lack of other scales, this served as the primary reference for values found in this study. 23 The overall fragility values presented in this study would therefore be considered “slightly robust.” 23

Among the 83 outcomes included in this study, 15 were statistically significant. A fragility analysis of these outcomes resulted in a median FI of 2 and a median FQ of 0.029; conversely, the median rFI and FQ among non-significant outcomes were 5 and 0.083, respectively. This suggests that statistically significant outcomes are “moderately” to “slightly” fragile, while non-significant outcomes are between “slightly” fragile and robust. The low fragility metrics associated with significant outcomes are notable, and indicate that outcomes may be due to chance despite the p-value indicating significance. Additionally, statistically significant outcomes have been previously demonstrated to carry substantial influence in interpreting clinical relevance, specifically among orthopaedic physicians.24 This stresses the importance of previous claims raised about the p-value and its inability to account for sample size, study design, or loss to follow-up.6,25,26 With regards to the effects of loss to follow-up, the fragility of the outcomes in this study were minimally impacted; during a secondary analysis excluding outcomes in which the loss to follow-up exceeded or equaled the respective FI or rFI, the median FI and FQ remained essentially unchanged. Additionally, there were very few outcomes in which the amount of patients lost to follow-up exceeded or equaled the respective FI or rFI (10.8 %) compared to the amount observed in previous fragility studies. 10,19,27 However, it remains important to consider the impact that these factors can have on statistical significance.

A secondary analysis based on RCT design revealed that there was a slight difference in fragility between studies assessing operative interventions versus those assessing non-operative interventions. While both categories were found to be “slightly” fragile, operative outcomes were slightly more robust than non-operative outcomes. Additionally, more outcomes from this study were associated with operative outcomes compared to non-operative outcomes – 59 and 24, respectively. Previous studies have observed an increase in operative treatments for both femoral and tibial fractures among pediatric populations, but positive outcomes are contingent on a number of factors including fracture type and patient characteristics.28,29 These findings may explain the prevalence of operative outcomes included in this study. One reason for the popularity and support of operative interventions is the adoption of new technological advances – such as flexible nailing techniques – which have been found to work particularly well in treating these injuries.28 The higher fragility metrics observed among operative interventions across a larger sample of studies supports the continued adoption of these techniques in both clinical and research settings. Further analysis by outcome category (fracture reduction/union, functional improvement/patient satisfaction, and adverse events) revealed minimal differences between fragility metrics as well. Each outcome category yielded values which indicate “slightly” fragile outcomes. These findings are of potential concern, as interventions praised for their low likelihood of adverse events, for example, may not be as superior to other interventions despite outcomes presented in RCTs. Notably, outcomes pertaining to fracture reduction/union were the least fragile, suggesting that clinical decision making may be best rooted in this outcome category. Finally, an assessment of temporal trends revealed that studies published prior to 2018 were less fragile than those published 2018 and onward. This finding is notable given it reflects a decreasing strength of orthopaedic RCTs over time. Numerous efforts have been made to improve RCT design, such as CONSORT 2010, and observations such as those in the present study indicate a lack of success of these implementations. 30

When examining the fragility of outcomes by fracture type (tibial, femoral, ankle), minimal differences in fragility were observed. These categories ranged from “slightly” fragile to “slightly” robust, with femoral fracture outcomes being the most fragile of the three. In a recent review from Rickert et al., the current state of pediatric lower extremity fracture management research was discussed. 31 With regards to femoral fractures, results of previous studies suggest more rigid fixation methods promote earlier union and return to activity, although future studies on long term outcomes are needed. 31 Given the robustness of operative interventions over non-operative, this study supports the continued use of operative treatments for the management of pediatric femoral fractures. Rickert et al., found that treatments for tibial fractures seem to vary, although most injuries can be managed conservatively; notably, they reported that indications which necessitate operative intervention are inconsistent in prior literature. Nevertheless, the current study found that tibial fracture outcomes were the least fragile. Fractures to the ankle were “slightly” robust in the current study, with only non-operative interventions being included in this category. This aligns with previous literature, which typically suggest closed reduction. 31

Previous orthopaedic fragility studies examining lower extremity fracture RCTs have observed similar trends to those in this study. Mian et al. observed a median FI of 5 and a median FQ of 0.089 in a fragility analysis of distal fibula fractures. 32 Similar results were also demonstrated in a study of distal femur fractures by Megafu et al., with a median FI of 5 across 98 outcomes. 20 Yendluri et al. also observed a median FI of 2 among significant outcomes pertaining to femoral neck fracture management. 33 Given the fragility of outcomes reported in studies of lower extremity fracture treatment typically range from “moderately” to “slightly” fragile, it should be advised to interpret the literature with some degree of caution. Furthermore, researchers should be advised to supplement the p-value with other reliable indicators of statistical strength, such as the FI.

Support for supplemental metrics to aid interpretation of statistical significance has been voiced by many researchers. Parisien et al. has advocated for triple reporting p-values and using fragility metrics when presenting outcomes.34 Beyond the FI and FQ, there are a host of other reliable metrics. Ostojic et al. have voiced extensive support for the use of minimally clinically important difference (MCID) to connect statistical significance and clinical relevance. 35 Other valuable measures of clinical significance include substantial clinical benefit (SCB) and patient acceptable symptom state (PASS) thresholds. 36 While MCID, SCB, and PASS metrics have become increasingly utilized in orthopaedic research, some authors warn that there is sizeable variability in the reporting of these thresholds. Previous literature has found that MCID, SCB, and PASS thresholds are inconsistently used for outcomes following a range of treatments, including, but not limited to: rotator cuff repair, shoulder and knee arthroplasty, anterior cruciate ligament repair, and spine surgery. 37–40 To our knowledge, no study has examined these thresholds in the context of lower extremity fracture treatment. With standardization, these metrics can serve as reliable tools for interpreting the results of RCTs. Given treatments practiced by orthopaedic specialists rely on RCTs for validation, it is important to concomitantly present the statistical robustness of reported outcomes. The ability of fragility metrics to measure the strength of RCT outcomes makes them an especially useful tool in guiding clinical decision making.

4.1

4.1 Limitations

Only categorical, dichotomous outcomes can be used to calculate the FI and FQ. Thus, many RCTs were excluded during the screening process due to our specific inclusion criteria. This could potentially bias the observations reported in this study, as continuous outcomes may provide more or less robust results. Through a Cochrane Risk of Bias assessment, three studies were flagged for “some concern” and one study was flagged for “high concern.” Though not likely, these studies may have presented sources of bias, which could influence the results of the present study. Finally, there are no established thresholds for the FI, rFI, and FQ that indicate fragility or a lack thereof. Consensus over these thresholds will help researchers better interpret the results of fragility studies.

5

5 Conclusion

The efficacy of treatments in pediatric lower extremity fractures from RCTs are slightly fragile, with notable fragility among significant outcomes. Over time, these studies have become less robust, despite efforts to improve RCT designs and increasing awareness of fragility statistics. Larger RCTs that combine the reporting of p-values with FI and FQ metrics may provide more robust evidence for guiding effective treatment strategies in pediatric lower extremity fractures.

CRediT authorship contribution statement

Matthew D. Ramey: Conceptualization, Data curation, Formal analysis, Writing – original draft, Writing – review & editing, Project administration. Niklas H. Koehne: Data curation, Formal analysis, Project administration. Auston R. Locke: Data curation, Formal analysis. Jonathan J. Huang: Writing – original draft, Writing – review & editing. Laurel Wong: Writing – original draft, Writing – review & editing. Nikan Namiri: Writing – review & editing. Robert L. Parisien: Conceptualization, Supervision.

Ethical statement

N/A.

Funding Statement

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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