The Journal of Foot & Ankle Surgery 60 (2021) 109−113

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The Journal of Foot & Ankle Surgery

journal homepage: www.jfas.org

Concomitant Distal Tibia-Fibula Fractures Treated with Intramedullary

Nailing, With or Without Fibular Fixation: A Meta-Analysis
Jing Peng, MD, Xiaotao Long, MD, Jun Fan, MD, Shiyang Chen, MD, Yang Li, MD, Wei Wang, MD
Surgeon, Department of Orthopedics, Chongqing General Hospital, University of Chinese Academy of Science, Chongqing, China

A R T I C L E I N F O A B S T R A C T

Level of Clinical Evidence: 3 There is no consensus on whether a fibular fracture should be fixed when a concurrent extra-articular distal tibia
Keywords: fracture is managed with intramedullary nails. We evaluated the use of fibular fixation in a meta-analysis of ran-
distal tibia fracture domized trials and observational studies. Two researchers independently assessed the quality of eligible studies
fibular fracture and extracted the data. We analyzed 4 trials with a pooled sample of 283 patients (mean age, 24 to 43 years; 141
fracture fixation men), 94 who had undergone fibular fixation and 189 who had not. Two randomized trials assessed on the
intramedullary nail Cochrane risk-assessment criteria were determined to have a moderate risk of bias, and 2 retrospective cohort
studies evaluated with the Newcastle-Ottawa Scale were considered to be high quality. Tibia malalignment at fol-
low-up times ranging from 12 to 72 weeks was reported in 20% (19/94) of patients in the fibular-fixation group
and 67% (126/189) of patients in the nonfixation group, indicating that fibular fixation was significantly associated
with a lower risk of malalignment (risk ratio, 0.34; 95% confidence interval [CI] 0.13 to 0.92; p = .03). The groups
did not differ in the proportion of patients with malalignment immediately after surgery, delayed union, non-
union, or infection. When distal extra-articular tibia-fibular fractures are treated with intramedullary nails, fibular
fixation may decrease the risk of late malalignment. Further randomized controlled trials with higher quality are
required to verify the result.
© 2020 by the American College of Foot and Ankle Surgeons. All rights reserved.

Distal fibula-tibia fracture is a common orthopedic injury. Although
intramedullary nailing is popular for treating extra-articular fractures of
the distal tibia, concurrent fibula fracture fixation is still controversial.
The theoretical benefits of concurrent fibular fixation may be improved
stability and anatomic alignment. An early study showed that fibula plat-
ing can increase stability (1). Other studies found that intramedullary
tibia nailing can also provide sufficient stability and maintain alignment
when augmented with more distal multidirectional locking screws, sug-
gesting that fibular fixation does not substantially improve stability and
is unnecessary (2,3).
In the distal fragment of the tibia, the medullary canal becomes funnel-
shaped. Thus, a mismatch between the canal and the intramedullary nail
can reduce fixation stability, which may increase postoperative malalign-
ment. What is more, some authors believe that fibula fixation may inter-
fere with tibial union because it can inhibit the cyclic stress on the tibia
fracture (4,5). Clinical studies have reported contradictory results about
the effect of fibula fixation on healing and alignment (6−9).
Because there is no consensus on whether fibula fractures should be
fixed when combined with distal tibia fracturs managed with intrame-
dullary nailing, we systematically reviewed the literature to determine
the effect of fibula fixation when a concurrent extra-articular distal tibia
fracture was treated with intramedullary nailing.
Methods
Systematic Literature Search
We searched PubMed, EMBASE, and the Cochrane Library for studies of any research
design published in English between 1990 and 2019 with the keywords “tibia fractures,”
“fibular fracture,” and “fracture fixation.” We did not look for unpublished studies. Two
researchers (J.P. and S.C.) independently evaluated the titles and abstracts to select articles
addressing fibula fixation in the setting of concurrent distal tibia fractures. The full texts of
all selected studies were obtained and screened for eligibility. The references of included
articles were also carefully reviewed to identify relevant studies that may have been missed
in the literature research.

Financial Disclosure: None reported.

Conflict of Interest: None reported.
Address correspondence to: Fan Jun, Department of Orthopedics, Chongqing General
Hospital, University of Chinese Academy of Science, Chongqing, People’s Republic of
China 400000.
E-mail address: fengyurenpingshen@qq.com (J. Fan).
J. Peng and X. Long contributed equally to this research and should be considered co-
first authors.
Inclusion and Exclusion Criteria
We accepted randomized control trials (RCTs) and observational studies of patients
with acute combined distal tibia and fibula fractures. Studies of articular fractures and
syndesmosis were excluded. Only trials comparing fibula fixation with no fibula fixation
when the distal fracture was treated with intramedullary nailing were included. Studies
using tibia plating were excluded.

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https://doi.org/10.1053/j.jfas.2020.05.006

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Data Extraction and Quality Assessment

Two investigators (J.P. and X.L.) independently extracted data from the included
articles, and another 2 (J.F. and Y.L.) assessed the methodological quality of each included
study. Disagreement was resolved by consensus and discussion with a third assessor
(W.W.). If 2 or more studies reported the same data, only that with the most definitive
data was included.
The following data were extracted from included studies: study design; characteris-
tics of participants; the percentage of open fractures; how patients with and without
fibula fixation were treated; the definitions and frequencies of malalignment, nonunion,
and wound infection; and the length of follow-up.
The quality of RCTs was assessed with the Cochrane risk bias tool (10), which com-
prises 6 domains: random sequence generation, allocation concealment, blinding
(which groups were blinded and from what information), incomplete outcome data,
evidence of selective reporting, and evidence of other biases. Each domain was scored
as low, high, or unclear. The overall risk-of-bias judgment was adapted from the work
of Pas et al (11). Studies were considered as having a low risk of bias if all domains
were assessed as low risk of bias or if 1 item was scored as high risk or unclear. If
2 domains were scored as high or unclear, the study was considered at moderate risk.
When more than 2 domains were scored as high risk, the study was regard as high risk
of bias. Nonrandomized trials were assessed with the Newcastle-Ottawa Scale, in
which a score of 5 or higher indicates high quality (12).

Statistical Methods

Data were analyzed with Review Manager 5.3 software. Relative risks (RRs) were cal-
culated for dichotomous outcomes. Alpha was set at 0.05, and all tests were 2-tailed. Het-
erogeneity among studies was assessed with I-squared (I2) and chi-squared tests. Effects
with no statistical heterogeneity (I2 < 50% or chi-squared p ≥ .1) were analyzed with a
fixed-effects model. Effects with statistical heterogeneity were analyzed with a random-
effects model. Because only 4 trials were included, funnel plots were not created to assess Fig. 1. Article selection process in a meta-analysis of studies comparing concomitant dis-
publication bias. tal tibia-fibula fractures treated with intramedullary nailing, with or without fibular fixa-
tion. Abbreviation: RCT, randomized controlled trial.

Results of Tibia Malalignment

Results
Only 3 trials reported immediate postoperative malalignment; that is,
Characteristics of Studies
for 8 of the 64 available patients (13%) in the fibular fixation group and
41 of the 159 available patients (25%) in the nonfixation group. In this
Of 684 unique studies retrieved from the database, 4 (2 RCTs and 2
analysis, there was no statistical heterogeneity (x2 = 2.60; p = 0.27,
retrospective cohort studies) were included in the analysis (Fig. 1;
I2 = 23%), so the data were analyzed with a fixed-effect model. The results
Tables 1 and 2). The pooled sample consisted of 94 patients treated
showed no significant difference in immediate malalignment between
with fibular fixation and 189 treated without fixation.
groups (risk ratio 0.73; 95% confidence interval [CI] 0.39 to 1.35; Fig. 3).
In 1 RCT, the fibula fracture was fixed with a 3.5-mm, dynamic
Late malalignment may occur secondary to loss of reduction, so all
compression plate or a one-third tubular plate, and tibia intramedul-
data on malalignment at the most recent follow-up appointment were
lary nails were usually locked with 2 medial-to-lateral bolts, although
also analyzed. Data were available for 19 of 94 patients (20%) in the
3 distal bolts were inserted in 2 patients (1 in each group) to increase
fibular fixation group and 126 of 189 patients (67%) in the nonfixation
stability (13). In the other RCT, the fibula was fixed with a 3.5-mm
group. The data showed significant heterogeneity (x2 = 15.16,
dynamic compression plate, and all tibia fractures were fixed with
p = 0.002; I2 ==0%) and so were analyzed with a random-effects model.
intramedullary nails with 2 distal locking screws (14). In 1 retrospec-
Malalignment was significantly lower in the fixation group (RR 0.34;
tive cohort study, distal fractures were more common in the fixation
95% CI 0.13 to 0.92; Fig. 4).
group than in the nonfixation group (15). In this study, tibia intrame-
dullary nailing was applied with 1 or 2 medial-to-lateral distal locking
bolts. In the other retrospective cohort study, the tibia intramedullary Other Complications
nail was inserted with 2 or 3 distal locking bolts, and blocking screws
were inserted in some patients (16). Other complications consisted of delayed union, nonunion, and infec-
tion. Two studies reported cases of delayed union. Analysis with a ran-
dom-effects model found no significant difference between groups (RR
1.06; 95% CI 0.86 to 1.31). Three studies reported nonunion in several
Quality Assessment
patients. Analysis with a random-effects model again found no significant
difference between groups (RR 1.02; 95% CI 0.96 to 1.08). In the 2 trials
The 2 RCTs did not blind either the patients or surgeons, so perfor-
reporting cases of infection, patients treated with fixation did not differ
mance bias cannot be ruled out. Whether outcome evaluators were
significantly from those who were not (RR 0.92; 95% CI 0.70 to 1.19; Fig. 5).
blinded, which could have biased measurements of malalignment, is
unclear. Unclear allocation concealment might have resulted in selec-
tion bias in one of the RCTs. In short, the types of bias were assessed as Discussion
moderate (Fig. 2). The 2 retrospective cohort studies were assessed
with the Newcastle-Ottawa Scale and found to be of high quality This meta-analysis supports a conclusion that fibular fixation is
(Table 3). associated with lower rates of late tibia malalignment, although not in

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 J. Peng et al. / The Journal of Foot & Ankle Surgery 60 (2021) 109−113 111

Table 1
Characteristics of 4 Studies Included in a Meta-Analysis Comparing Fibula Fixation With Nonfixation in Concomitant Distal Tibia-Fibula Fractures Treated With Intramedullary Nails

Studies Included in the Meta-Analysis

Characteristic Egol et al (15) Rouhani et al (13) Prasad et al (14) Taylor et al (16) Total

Design Retrospective cohort RCT RCT Retrospective cohort

Sample size (n) 72 53 60 98 283
Fixation 25 24 30 15 94
Nonfixation 47 29 30 83 189
Men/women, n 141/67
Fixation 19/6 22/2 NA 12/3 53/11
Nonfixation 31/16 23/6 NA 49/34 88/56
Mean age (y)
Fixation 41.6 24.2 NA 42.8
Nonfixation 43.1 28.6 NA 40.3
Open fracture (n) 114
Fixation 10 11 14 1 36
Nonfixation 19 17 12 30 78
Follow-up (wk) 12 24 72 47
Abbreviation: NA, not available; RCT, randomized controlled trial.

Table 2
Outcomes of 4 Studies Included in the Meta-Analysis.

Studies included in the meta-analysis

Outcome Egol et al (15) Rouhani et al (13) Prasad et al (14) Taylor et al (16)

Immediate postop malalignment (n)

Fixation 1 1 NA 6
Nonfixation 3 6 NA 32
Late malalignment
Fixation 2 1 6 10
Nonfixation 9 10 30 45
Delayed union (n)
Fixation NA 1 0 NA
Nonfixation NA 5 0 NA
Nonunion
Fixation NA 0 0 2
Nonfixation NA 3 0 11
Infection
Fixation NA 1 6 NA
Nonfixation NA 2 0 NA
Abbreviation: NA, not available.

malalignment immediately after surgery. The incidence of delayed
union, nonunion, and infection did not differ between groups.
Although the 2 RCTs were subject to detection bias and perfor-
mance bias, the nonrandomized controlled trials were assessed as
high quality. Thus, the evidence for the primary outcome can be
Fig. 2. Risk of bias in 2 randomized controlled trials comparing concomitant distal tibia-
fibula fractures treated with intramedullary nailing with or without fibular fixation.
described as medium grade, according to the GRADE standard.
Although the data for malalignment showed significant heterogene-
ity, the 2 groups were similar in terms of age, sex, and fracture classi-
fication. The heterogeneity may result from differences among
surgeons, because surgical technique may cause malalignment. In
addition, the number of distal locking screws and the use of blocking
screws can also affect alignment: both clinical and biomechanical
studies show that more distal bolts tend to increase stability and
help maintain the reduction (1,3,15).
Intramedullary nails must be placed in the center of the distal frag-
ment to maintain reduction and avoid malalignment. Blocking screws
are also essential in some cases. In a study by De Giacomo et al (17) of
distal tibia fractures treated with intramedullary nails without fibula
fixation, the overall rate of malalignment was 2%, and the rate of mal-
union was 3%. The authors believed that the most important factor in
preventing malalignment was maintaining the reduction until the
intramedullary nails were locked (intraoperatively with distal screws
or blocking screws/bolts) (17). However, the trials included in our
meta-analysis had few cases treated with intramedullary nailing with
>2 distal screws or blocking screws, and we could not determine
whether the reduction techniques used to maintain alignment with
intramedullary nailing of the tibia were appropriate. Hence, we recom-
mend that our results be applied only to the common intramedullary
nail with 2 distal locking screws.

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Table 3 found a higher non-union rate for fractures at the same level when the
Quality assessment of the 2 retrospective cohort trials with the Newcastle-Ottawa Scale fibula was left untreated and hence recommended fibular fixation for
Criterion Study these fractures. A retrospective matched cohort study of nonunion and
malalignment in tibia fractures (OTA/AO 41, 42, or 43 tibia fracture)
Egol et al (15) Taylor et al (16)
after concurrent tibia intramedullary nailing and fibular fixation found
Selection *** *** no significant difference between groups treated with and without fib-
Comparability * * ular fixation (19). Pogliacomi et al. (20) documented a higher incidence
Outcome ** **
of valgus deformity in patients with concurrent distal tibia-fibular frac-
Total ****** ******
Study quality 6 stars, high 6 star, high ture treated without fibula fixation, but some tibia fractures had been
treated with plate and screws, and the authors indicated that the
Scale, The Newcastle-Ottawa scale uses 0 to 9 stars; 5 or more stars indicates a higher-
quality study. results could have been influenced by the experience and personal bias
of the surgeons.
In a randomized, parallel-group trial investigating the effectiveness
Several studies have considered the use of fibular fixation in treating of fibular fixation in combined distal tibia and fibula fractures with the
combined distal tibia-fibula fractures. Berlusconi et al. (18) investigated tibia fracture fixed with intramedullary nails or by plates (21), the rate
the effectiveness of stabilizing the fibula in distal 42 AO fractures. They of varus-valgus angulation and union were similar between groups.

Fig. 3. Effect on fibula alignment immediately after surgery to treat concomitant distal tibia-fibula fractures treated with intramedullary nailing, with or without fibular fixation. Abbrevi-
ation: M-H, Mantel-Haenszel fixed effects.

Fig. 4. Fibula alignment at follow-up after surgery to treat concomitant distal tibia-fibula fractures treated with intramedullary nailing, with or without fibular fixation. Abbreviation:
M-H, Mantel-Haenszel random effects.

Fig. 5. Complications after surgery to treat concomitant distal tibia-fibula fractures treated with intramedullary nailing, with or without fibular fixation. Abbreviation: M-H, Mantel-
Haenszel random effects.

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 J. Peng et al. / The Journal of Foot & Ankle Surgery 60 (2021) 109−113
However, differences between surgeons, small number of samples, and
the selection bias may have affected the outcomes. Finally, a review of
the literature on distal tibia fractures fixed with plate or intramedullary
nails found no consensus on the value of adjunctive fibular fixation in
cases of distal metaphysical fractures (22). In our research, analysis of
the pooled data showed that the benefit of fibula fixation was limited
to improving alignment and had no effect on delayed union, nonunion,
or postoperative infection. Improved alignment was ascribed to fibula
fixation, which contributed to reducing the tibia fracture when insert-
ing the intramedullary nails, and to increases in stability when multi-
plane distal locking screws or blocking screws were not applied.
Our study has some limitations. The quality of the eligible trials was
not high. The ideal evidence for a systematic review comes from random-
ized controlled trials that adequately implemented allocation concealment
and blinding of those delivering the intervention and outcome assessors.
However, blinding is difficult in surgical trials; thus, the eligible trials were
assessed as having a moderate risk of bias. Only 2 RCTs were included, and
although the baseline characteristics in the 2 historical cohort studies
were similar, selection bias could not be ruled out. The outcomes did not
include function scores, which are important measures of clinical effect.
We believe the results support the conclusion that, in distal tibia frac-
tures treated with intramedullary nailing, concurrent fibular fixation is
likely associated with a lower rate of malalignment than is nonfixation.
This conclusion is related only to cases treated with intramedullary nails
with 2 distal locking screws, because modern intramedullary nails with
>2 distal screws or with blocking screws may increase the tibia stability,
and further research is required to determine whether the conclusion
can be applied to those conditions.
Acknowledgments
This research was supported by the Health Commission of Chongq-
ing [2016MSXM064], Science and Technology Innovation Fund of
Chongqing General Hospital [Y2017MSXM05].
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