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BUCKLEY MALEOLO MEDIAL

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ORIGINAL ARTICLE
Single-Screw Fixation Compared With Double Screw
Fixation for Treatment of Medial Malleolar Fractures:
A Prospective Randomized Trial
Richard Buckley, MD, FRCSC,* Ernest Kwek, MBBS, FRCS, FAMS,† Paul Duffy, MD, FRCSC,*
Robert Korley, MD, FRCSC,* Shannon Puloski, MD, FRCSC,* Andrew Buckley, BSc,*
Ryan Martin, MD, FRCSC,* Emilia Rydberg Moller, MD,‡ and Prism Schneider, MD, FRCSC, PhD*
Objectives: To determine whether single or double screw (DS)
Downloaded from http://journals.lww.com/jorthotrauma by BhDMf5ePHKbH4TTImqenVBhf5K8zlU/3e4mQYkz4H4uvGcPZI6MefqDnks9SF51J on 11/05/2018
fixation of medial malleolar fractures results in better long-term
health outcomes.
Key Words: ankle, fracture, trauma, randomized controlled trial,
medial malleolus, fixation
Level of Evidence: Therapeutic Level I. See Instructions for
Authors for a complete description of levels of evidence.
Design: Randomized clinical trial; sealed envelope technique.
Setting: Level 1 Trauma Hospital at University of Calgary, Canada.
Patients: One hundred forty patients were randomized to receive
(J Orthop Trauma 2018;32:548–553)
INTRODUCTION
Accepted for publication July 17, 2018.
From the *Section of Orthopedics, Department of Surgery, University of Calgary, Calgary, AB, Canada; †Department of Orthopedic Surgery, Tan Tock
Seng Hospital, Singapore; and ‡Department of Orthopedics and Trauma,
Sahlgrenska University Hospital, Gothenberg, Sweden.
The authors report no conflict of interest.
Presented at the Annual Meeting of the Orthopaedic Trauma Association,
October 13, 2017, Vancouver, Canada.
Supplemental digital content is available for this article. Direct URL citations
appear in the printed text and are provided in the HTML and PDF versions
of this article on the journal’s Web site (www.jorthotrauma.com).
Reprints: Richard Buckley, MD, FRCSC, 3134 Hospital Dr NW, 0490
McCaig Tower, Calgary, AB, Canada T2N 5A1 (e-mail: buckclin@
ucalgary.ca).
Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
DOI: 10.1097/BOT.0000000000001311
Ankle fractures are among the most common skeletal
injuries treated by orthopaedic surgeons, with an annual
incidence of 187 per 100,000 in the general population.1 The
mechanism of injury for malleolar fractures in young patients
is typically high-energy trauma such as motor vehicle collisions or falls from height, whereas elderly patients suffer
similar injuries, often with comorbidities, from low-energy
trauma.2 Open reduction and internal fixation is recommended for unstable bimalleolar and trimalleolar fractures.3 Isolated medial malleolar fractures are less common, but surgery
is also indicated in significantly displaced fractures with joint
incongruence.4 Several techniques have been described for
surgical fixation of medial malleolar fractures, including lag
screws, tension band wiring, K-wiring, bioabsorbable implants,
and buttress plating.1,5,6 Recent research has shown the effectiveness of tension band/k-wire fixation,7 however, screw fixation remains the most popular and reliable fixation method. A
common technique uses 4.0-mm partially threaded cancellous
lag screws placed perpendicular to the fracture line,8 whereas
a recent research study indicates that 30-mm partially threaded
screws or 45-mm fully threaded screws may provide more optimal fracture compression when placed at the physeal scar.9
Traditional teaching is to use two 4.0-mm screws instead of 1
for medial malleolar fixation to ensure rotational control. However, the medial malleolus usually fails in tension or compression, and it is questionable if significant torsional forces exist,
which might require 2 screws for stable fixation.5,9
Although the results of operative stabilization of ankle
fractures are generally good, patient dissatisfaction can result
from implant-related pain.10 On the medial aspect of the
ankle, malleolar screws can cause irritation of the posterior
tibialis tendon or other soft-tissue irritation or bony impingement. A previous study has suggested that screws placed
posterior to the anterior colliculus have the potential to cause
posterior tibialis tendon irritation.11 Two previous studies
have evaluated this subject with inconclusive results.12,13
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J Orthop Trauma Volume 32, Number 11, November 2018
either 1 or 2 screws to reduce a medial malleolar fracture. Thirteen
patients were excluded because of loss to follow-up (n = 127).
Intervention: Surgical fixation of the medial malleolar fracture
was performed using 1 or 2 stainless steel screws.
Main Outcome Measurements: Primary outcome was comparison of physical functioning summary score on Short Form 36
questionnaires between patients in the 2 groups. Secondary objectives were to compare the Ankle Hindfoot Scale and operating room
time. Clinical and radiographic assessment occurred at the time of
injury and 2, 6 weeks, 3, 6, 12, and 24 months postoperatively.
Results: Fourteen patients crossed over from the DS group to the
single screw (SS) group based on intraoperative decisions by the
surgeon (fragment too small for 2 screws), leaving the SS (n = 75) and
DS groups (n = 52). There was no difference in the operating room
time, SF36, or Ankle Hindfoot Scale at all follow-up time points.
Conclusions: SS medial malleolar fixation provides an equally
safe and effective method of fracture care as compared to DS
fixation. Twenty percent of patients receiving 2 screws can be
expected to crossover to receive SS fixation as a safer alternative.
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J Orthop Trauma Volume 32, Number 11, November 2018
Single Screw Fixation
The incidence of implant-related complications may potentially be reduced by single-screw (SS) fixation without sacrificing joint stability.
The primary goal of this study was to compare the longterm functional outcomes in 2 randomized groups after either
single- or double-screw (DS) fixation of medial malleolar
fractures. Secondary objectives were to compare re-operation
rates between groups, rates of malunion and non-union, and
time to union and complications such as implant-related pain
and loss of fixation.
classification method found that medial malleolus fractures
could be classified with moderate interobserver reliability.16
The soft-tissue damage was described using the Tscherne
classification.14 No Herscovici Type-A fractures were
included in this study, and all medial malleolar fractures were
randomized even if they were an anterior collicular fracture.
Preoperative antibiotics were administered before skin
incision (cefazolin 1 gm IV or equivalent). Operative
intervention included open reduction and internal fixation of
the lateral and posterior malleolar fractures as deemed
necessary, with or without syndesmotic screw fixation. For
the medial malleolus, a medial incision was performed. Direct
visualization and reduction of the fracture fragments was
achieved before the insertion of the lag screws. One or two
4.0-mm partially threaded cancellous screws were placed
perpendicular to the fracture line. If an SS was used, it was
placed in the center of the fragment or slightly more anterior
(without the use of an antirotation wire). If 2 screws were
used, an attempt was made to place them parallelly and
equally spaced along the width of the fragment. The length of
the unicortical screws (25–50 mm) and the use of a washer for
the screws were at the discretion of the operating surgeon.
After surgical intervention, application of a splint was
performed, followed by a removable cast for the period of 2–6
weeks to allow early mobilization and protected weightbearing. Rehabilitation instructions and ankle mobilization
exercises were provided to ensure standardized treatment.
Weight-bearing was permitted based on the stability of the
fracture and fixation. Patients in the 2 groups were monitored
in an equivalent fashion. Critical aspects of postfracture care
and rehabilitation were controlled. Clinical and radiographic
assessments were performed at surgical consultation at the
time of fracture, at 2, 6 weeks, 3, 6, 12, and 24 months
posttreatment. We followed functional outcome results at
enrollment, 6, 12, and 24 months after enrollment using outcome questionnaire Short Form 36 (SF-36) and ankle visual
analog score. The SF-36 is a widely used generic measure
assessing both the mental and physical aspect of a person’s
well-being; 36 questions divided into 8 categories are
answered.17 For this study, we focused on comparing the
category of general health. Results for a joint specific outcome measure were similarly compared. The Ankle and
Hindfoot Scale (AHS) produced by the American Orthopaedic Foot and Ankle Society (AOFAS) was used. The AHS is
a 100-point physician administered score that evaluates different aspects of the ankle by assessing the 3 categories of
pain (/40 points), function (/50 points), and ankle alignment
(/10 points). In general, a higher score of 100 indicates better
overall ankle health based on these categories.18
Complete surgical report forms were reviewed for
accuracy and adherence to protocol by the research coordinator. Protocol deviations were reviewed to correct any
problems. Any patient treated with SS fixation who demonstrated loss of reduction that required placement of an
additional screw intraoperatively or on follow-up examinations was analyzed according to the “intention to treat” principle; analysis were performed in the group to which the
patients were initially randomized to. This also applied to
any fracture in the DS group that was not amenable to such
PATIENTS AND METHODS
This prospective randomized single-center trial was
conducted at a level 1 trauma center. All 4 surgeons who
participated were experienced trauma surgeons with previous
experience in randomized control trials. Ethical and research
approval was granted at the local conjoint University Ethics
Board. This study was not funded.
After giving informed consent to participate in the
study, patients were randomized into 1 of 2 groups, either
single or double lag screw fixation of the medial malleolus as
a treatment method for their fracture.
All patients with closed or open ankle fractures
involving the medial malleolus requiring surgery presenting to the hospital were identified through direct contact.
Potentially eligible patients were assessed by an orthopaedic surgeon, a trauma fellow, or an orthopaedic resident. A
physical examination and complete checklist based on
study parameters were performed for eligibility. The
surgeon, resident, fellow, or research coordinator conducted the informed consent discussion with the patient
and obtained consent. The inclusion and exclusion criteria
are shown in Supplemental Digital Content 1 (see Table,
http://links.lww.com/JOT/A454) (inclusion and exclusion
criteria). All skeletally mature patients who met the eligibility criteria and signed the informed consent were randomized to a fracture management strategy using the
computer-generated sealed envelope technique. Independent study personnel were in charge of running the study.
All participants had the option to withdraw from the trial at
any point without repercussion. Neither the surgeons nor
the patients were blinded to the randomization.
Ankle fractures were broadly classified as isolated
medial malleolar fractures, bimalleolar fractures, or trimalleolar fractures based on radiographic assessment. Both
OTA/AO14 and Danis–Weber classifications15 were used.
All medial malleolar fractures were included in the study
except if they could not be fixed with compression lag
screws [see Table, Supplemental Digital Content 1, http://
links.lww.com/JOT/A454 (inclusion and exclusion criteria)].
More specifically, medial malleolar fractures were also
classified according to the Herscovici classification.4 Type-A
fractures are avulsions of the tip of the malleolus, type-B
occur between the tip and the level of the plafond, type-C
are located at the level of the plafond [see Figure, Supplemental Digital Content 2, http://links.lww.com/JOT/A455
(typical bi-malleolar fracture)], and type-D extends vertically
above this level. An evaluation of the Herscovici fracture
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Buckley et al
J Orthop Trauma Volume 32, Number 11, November 2018
fixation after review intraoperatively (eg, fragment too small
or comminuted) and could only be fixed with an SS. This
kind of crossover between groups was considered a secondary
study event and included in the secondary analyses because
surgical or medical intervention may contaminate results.
Complications that did not require re-operation were also
documented as part of the follow-up report forms. These
include superficial wound infection, skin ulceration or breakdown, complex regional pain syndromes, loss of reduction
not believed to require operative intervention, delayed union
(failure of progression of the fracture to heal at 3 months),
prominent implant not requiring removal, and ankle stiffness.
Use of medications that affect bone healing and associated
additional procedures were documented as part of the study.
Because of the randomization process, we anticipated cointerventions to be evenly distributed between groups.
Follow-up for the study continued for 24 months to
allow for the secondary objectives of studying the incidence
of implant-related pain and rate of implant removal, performed 6–24 months after surgery. Syndesmosis screws were
removed after 6 months only if the patient demonstrated
marked pain in the local area. The primary outcome measure
for this study was the SF-36. The SF-36 standard deviation
for patients with acute tibial fractures has been calculated to
range from 8.6–11.4. The minimum clinical important difference has been identified for the SF-36 to be a 5-point difference that is roughly equal to half an SD.19
The following assumptions were used: a student t test
was used to compare the mean SF-36 scores, the 2 study
groups were independent, there were an equal number of
patients in each group, SF-36 SD for patients with acute
fractures of the ankle estimated as 10 (based on SF-36 SD
for a similar group outlined above), b = 0.2 (giving each
group 80% power to detect a difference of 5%, type II error
= 20%), and an alpha level of 0.05 (type I error = 5%). Using
these assumptions, a power calculation was performed giving
a sample size of 63 patients per group. Given the loss to
follow-up rate of 10% in similar trauma patient groups, the
minimum sample size for this study was determined to be 70
patients per group. Statistical tests were performed using
SPSS statistical software package on a personal computer
(Version 11.0; SPSS, Inc, Chicago, IL).
respectively. The SS group comprised 26 men and 35 women,
and the DS group had 29 men and 37 women. There were
also no differences between the groups as far as additional
medical complications. In the SS group, 17 patients were
smokers, 14 were previous smokers, and 30 were nonsmokers. Of the patients randomized to receive DSs, 13 were
smokers, 12 were previous smokers, and there were 38 nonsmokers. The 2 groups also provided similar medical histories. There were 4 patients with osteoporosis, 1 patient with
diabetes, and 9 patients with cardiovascular disease in the SS
group compared with 2 patients with osteoporosis and 8 with
cardiovascular disease in the DS group.
The most common mechanism of injury for both groups
was a low-energy fall, and they presented with similar
patterns of injury, including 1 open fracture in each group.
The fracture patterns were identified using clinical assessment
and plain radiography. There was no difference between
groups regarding their injury pattern (Table 2).
Between the single and DS groups, there was no
significant difference in the fracture pattern using either the
Herscovici or Weber classification. (see Table, Supplemental Digital Content 3, http://links.lww.com/JOT/A456 [fracture classification characteristics between groups]).
All patients in this study were surgically treated within
14 days of their initial injury. There was no difference in the
operating room (OR) time, time in hospital postsurgery, or
need for syndesmotic fixation whether the patient received 1
or 2 screws to repair their medial malleolus (see Table,
Supplemental Digital Content 4, http://links.lww.com/
JOT/A457 [Patient hospital data]) (see Figure, Supplemental Digital Content 5, http://links.lww.com/JOT/A458
[examples of fractures fixed with 1 or 2 medial malleolar
screws]). Ten cases had washers used for the medial malleolar screws—7 cases in the 1 screw group and 3 cases in
the 2 screw group.
Using the AHS as a measure of patient well-being after
surgery, there was no difference in baseline, 3-, or 24-month
scores between the single and DS groups (Table 3).
Similar results were found for baseline, 3-, and 24month follow-up time points for the SF-36. In the 8
measures used for this study, physical function, role
physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health, there was no
difference in patients’ self-reported scores whether they
were treated with single or DS fixation. In addition, despite
the number of patients involved, there was no indication of
a difference when it came to implant pain or need for
removal (see Table, Supplemental Digital Content 6,
http://links.lww.com/JOT/A459 [Patient complications until
24 months]).
RESULTS
Between August 2010 and June 2014, 140 patients with
ankle fractures involving the medial malleolus requiring
surgery were identified. Initially, there were 140 patients
enrolled in this study, but 13 were excluded because of early
loss to follow-up or withdrawal. Of the 127 remaining
patients, 61 had been randomized to receive 1 screw and 66
were randomized to receive 2 screws. Intraoperative decisions
by the surgeon at the time of fixation resulted in 14 patients
crossing over from the DS group to the SS group [fragment
too small for 2 screws (“intention to treat” still followed)],
leaving SS (n = 75) and DS (n = 52) (Fig. 1). There were no
significant differences between the groups as far as demographic data (Table 1). The mean age of the SS and DS
groups was 44.1 (616.3) years and 45.3 (615.1) years,
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DISCUSSION
A large randomized study was necessary to determine
whether DS fixation had any clinical advantage over SS
fixation for medial malleolar fractures. To the best of our
knowledge, this study is only the second randomized
controlled trial to specifically examine the medium-term
health outcomes of single versus DS fixation for medial
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Copyright Ó 2018 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
J Orthop Trauma Volume 32, Number 11, November 2018
Single Screw Fixation
FIGURE 1. Consort statement study schematic
and design.
malleolar fixation. Jones conducted a prospective randomized clinical trial with the main purpose to investigate
whether single versus DS fixation could provide similar
outcomes while reducing adverse results.12 Sixty consecutive patients eligible for medial malleolar surgery were randomized, of which 47 were available for follow-up at an
average of 2.5 years. Their conclusion stated that medial
malleolar ankle fractures can be safely and efficiently internally stabilized with SS fixation. The second study conducted by Shah et al13 was a retrospective analysis of case
notes and x-rays from 76 patients having medial malleolar
fracture fixation. The outcome measures were postoperative
fracture displacement, bony and clinical union, and patient
self-assessment of return to their preinjury level of activity.
Shah et al concluded that medial malleolar fractures fixed
with 1 screw did not increase the risk of postoperative
displacement.
It has been discussed for decades in the OR worldwide
that a medial malleolar fracture probably needs 2 points of
fixation to minimize malrotation and failure of fixation. Our
Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
primary outcome, the SF-36, and the secondary outcome,
AHS, at baseline, 3, and 24 months did not show a single
point of statistical difference in any of the 8 categories
between groups. This lack of difference points to SS fixation
being an equivalent fracture care method in terms of the 8
general health categories of the SF-36. Our secondary
objectives showed that there was no difference in the OR
time, days in hospital postsurgery, or need for syndesmotic
fixation between groups. Importantly, the fracture classification or complexity did not influence the overall trends in
functional assessment or secondary objectives.
Perhaps the most notable and important finding from
the study was the patient crossover. Fourteen patients, almost
25% of those randomized to receive 2 screws, received only 1
screw. The treating surgeon had been uncomfortable with
placing 2 screws in a small medial malleolar fracture fragment
for fear of comminuting this small piece of bone and opted for
1 screw only. However, 2-year follow-up proved that clinical
and functional outcome was no different regardless of the
number of screws used.
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J Orthop Trauma Volume 32, Number 11, November 2018
Buckley et al
TABLE 1. Demographic Data
TABLE 3. Ankle Hindfoot Scores (AHS) with P , 0.05
Mean (6SD) or Count
Age
SS
DS
Sex
SS
Men
Women
DS
Men
Women
Smoking status
SS
Smoker
Previous smoker
Nonsmoker
DS
Smoker
Previous smoker
Nonsmoker
Medical history
SS
Osteoporosis
Diabetes (type 2)
Cardiovascular disease
DS
Osteoporosis
Diabetes (type 2)
Cardiovascular disease
P
0.66
44.1 (616.3) y
45.3 (615.1) y
0.88
26
35
29
37
n = 17
n = 14
n = 30
n = 13
n = 12
n = 38
.0.05
n=4
n=1
n=9
n=2
n=0
n=8
TABLE 2. Medial Malleolar Injury Patterns
Mean (6SD) or Count
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0.88
98.5 (66.5)
98.6 (64.4)
0.74
81.1 (611.5)
81.7 (610.5)
0.30
92.3 (68.4)
94.1 (65.6)
0.22
Anterior collicular fractures are small, and treatment
with 1 screw in our study proved to be satisfactory. When this
study was initiated, all medial malleolar fractures were
included. It is important to note, however, that the anterior
colliculus represents the attachment of the superficial deltoid
ligament. Because the deep deltoid is responsible for medial
stability and is attached to the posterior colliculus, fixation of
the anterior colliculus may in fact not be needed.20
Interestingly, there were no nonunions in either arm of
our study, again suggesting that there was no advantage to
using more than 1 screw in fixation of these fractures,
Medical history
SS
Medial malleolus isolated
Bimalleolar
Trimalleolar
DS
Medial malleolus isolated
Bimalleolar
Trimalleolar
P
Mean (6SD) or Count
Baseline
SS (n = 54)
DS (n = 60)
3 mo
SS (n = 54)
DS (n = 58)
24 mo
SS (n = 27)
DS (n = 41)
P
0.88
n = 10
n = 30
n = 21
n=3
n = 38
n = 25
although CTs were not performed in this study to check for
malrotation. Over the 2-year follow-up period, there was also
no indication of differences in implant pain or need for
implant removal in either group. As all other factors seem
equal between single and DS fixation of medial malleolar
fractures, the 14 patients who followed a crossover pattern
suggest treatment in favor of SS fixation.
The prospective randomized controlled trial study by Jones
and Slabaugh12 produced very similar results to this study.
Although they had a smaller sample size (n = 60) and less outcome data, they concluded that an SS was an equally safe and
efficient method of fixation and offered similar patient outcomes.
In addition, they found that SS fixation provided shorter operating times. The most notable difference from this study12 was the
lack of crossover, as no patients were reported to have changed
groups. Shah et al13 conducted analogous research in the form of
a retrospective case series of 76 medial malleolar fractures (single
n = 37, 2 screws n = 39). Using case notes, x-rays, and follow-up
contact with patients, they concluded that there was no significant
difference in clinical union, postoperative fracture displacement,
or return to their preinjury level of activity between groups.
There are multiple strengths with this study. This
prospectively designed and powered study with a large
sample size (n = 140) provides results that are applicable to
a wide demographic. In addition, the crossover between
groups occurred only in 1 direction, from the DS to the SS
group, strengthening the notion that an SS can be as effective
as 2 screws. This study will also be generalizable because it
was conducted by 4 experienced trauma surgeons on a fracture
that is common worldwide and treated regularly every day.
The limitations of this study include potential surgeon
bias toward the use of an SS, possibly explaining the one-way
crossover. Most anterior collicular fractures do not need
fixation, and this study did not look at this factor close enough
before the study was initiated. Also, patients were only
followed for 2 years postoperatively, and the late implant
removal pattern is still not clear when it comes to 1 or 2 screws.
Computed tomography scans were not performed to check for
malrotation in those cases where 1 screw was used. A few
cases had washers used to help with fixation, and these could
irritate the posterior tibial tendon and confound our results.
This study is too small to definitively determine that 1 screw is
as satisfactory as 2 screws for all medial malleolar fracture
types, but it is a starting point. Although this study was
powered to detect differences in clinical outcome scores, it is
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J Orthop Trauma Volume 32, Number 11, November 2018
Single Screw Fixation
not adequately powered to detect differences in the incidence
of more rare complications such as nonunion or failure of
fixation. A prospective study powered to show a difference in
the rate of nonunion or implant failure (less than 5% in this
study) would likely require over 1000 patients in each arm.
In conclusion, SS fixation seems to be an efficacious
treatment for most medial malleolar fractures. After medial
malleolar fixation with either 1 or 2 screws, we found no
significant difference with specific or general outcome scores,
operating time, or complications, indicating that single screw
and DS fixation provide equivalent medium-term patient
outcomes.
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