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Journal of Orthopaedic Trauma Publish Ahead of PrintDOI: 10.1097/BOT.0000000000001734
Early Definitive Care is as Effective as Staged Treatment Protocols for Open Ankle Fractures
caused by Rotational Mechanisms: A Retrospective Case Control Study
Daniel L. Peterson1, Meg Schuurman1, Andreea Geamanu, PhD1, Muhammad T. Padela, MD,
MSc1, Christopher J. Kennedy1, Joseph Wilkinson1, Rahul Vaidya, MD, FRCSc1,*
1Department of Orthopaedic Surgery, Detroit Medical Centre, 4201 St. Antoine, Detroit, MI
48201, Ph: 313-966-8013, Fax: 313-966-8400
*Corresponding Author: Rahul Vaidya, MD, FRCS Department of Orthopaedic Surgery Detroit
Medical Centre 4201 St. Antoine Detroit, MI 48201 Ph: 313-966-8013 Fax: 313-966-8400
Email: [email protected]
Conflict of Interest Disclosure: Dr. Rahul Vaidya has the following disclosures: European Spine
Journal: Editorial or governing board, JOT editorial Board, Smith & Nephew Institutional
Research Grant Funding, Depuy Synthes: IP Royalties, AO Foundation Paid Speaker
[email protected], [email protected], [email protected], [email protected],
[email protected],[email protected], [email protected]
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Abstract
Objectives : To compare immediate internal fixation with primary wound closure to temporary
fixation/stabilization with delayed fixation and wound closure protocols for management of open
ankle fractures.
Design : Retrospective Case Control Study
Setting : US Level 1 Trauma Center
Patients : Eighty- eight consecutive patients who presented with a Gustilo-Anderson (GA) type I,
II or IIIa open ankle fracture to a single center .
Intervention : Patients were divided into 2 cohorts :either immediate internal fixation with
primary wound closure (EARLY) or temporary fixation/stabilization with delayed fixation and
wound closure (STAGED) due to practice differences of the attending surgeons.
Main Outcome Measures : Infection, length of stay, number and type of operations, and clinical
measures. We also assessed the 2 groups with regard to demographics and radiographic
classification.
Results: Overall incidence of infection was six (6.8%) with no significant difference between
patients treated with EARLY versus STAGED protocols. The EARLY cohort had a significantly
shorter length of hospital stay, fewer number of reoperations, but similar clinical outcomes for
pain, ambulation and radiographic evidence of osteoarthritis for patients followed for >12
months.
Conclusion: Our study showed that early definitive treatment compared to a staged protocol for
GA type I, II, and IIIa open ankle fractures has similar rates of infection, shorter hospital stay,
fewer surgical interventions, and similar clinical outcomes.
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Level of Evidence: This study is a retrospective cohort study investigating the results of a
treatment with Level III evidence.
Keywords: Open Ankle Fractures, Infection, Internal Fixation, Staged Protocol, Rotational
Ankle Fractures
Introduction
The treatment of open fractures has evolved over time due to regimented antibiotics,
improvements in fixation, and an emphasis on soft tissue handling.1 The incidence of infection in
Gustilo-Anderson (GA) type III injuries has been reported to be as high as 50%.2 Recent studies
suggest that GA type IIIA injuries in tibia fractures may be comparable to GA type I and II
injuries when performing immediate internal fixation with primary wound closure.3,4 This may
decrease the requirement for subsequent debridement and soft-tissue procedures, decrease joint
stiffness, shorten hospital stay, reduce cost, reduce amputations, decrease time to union, expedite
rehabilitation, and reduce infection.3,5,6
Open ankle fractures are relatively uncommon injuries ranging from 1.5-4.5% of all ankle
fractures.7,8 The tenets of care for open ankle fractures include early antibiotics, expedient and
adequate debridement, operative reduction and fixation, and wound closure. Some authors
advocate a staged protocol for these injuries to allow for demarcation of nonviable soft tissue and
to prevent sealing in contaminating organisms.1,3 Published literature on this topic is inconsistent
regarding the definition of an open ankle fracture often including pilon injuries .1,3 Due to this
inconsistency, we found it necessary to clearly define our inclusion criteria to include only open
ankle fractures resulting from mechanisms described by Lauge-Hansen.
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The purpose of this study is to compare immediate internal fixation with primary wound
closure to a staged protocol for wound closure and fixation in open ankle fractures from
rotational mechanisms. The primary outcomes were: infection and complications. Secondary
measures included the number of reoperations, length of hospital stay, and return to painless
ambulation.
Patients and Methods
After obtaining Institutional Review Board approval, a retrospective study was performed
of all open ankle fractures from the institutional trauma database from 2004 to August 2016 at an
inner-city Level I US trauma center. A total of 191consecutive open ankle fractures were initially
identified. Exclusion criteria were: open pilon fracture, ankle fracture from a blast or crush
injury, ballistic injury, previously treated open ankle fracture at another facility, chronic open
ankle fracture, open ankle dislocation without fracture, open talus fracture without tibia or fibular
fracture, patients who were pregnant, terminally ill, those who were non-ambulatory, and had a
minimum of 6 months follow-up. Radiographs were classified by three residents and a
fellowship trained orthopaedic trauma surgeon using the OTA/AO9 , Lauge-Hansen 10 and
Danis-Weber 11,12 classification methods . When differences of opinion occurred, the case was
discussed, and a consensus was reached. Only fractures caused by an injury pattern as described
by Lauge-Hansen were included (rotational or bending mechanisms).9,10 The GA classification
was determined by the operating surgeon at the time of operation and recorded in the operative
note. These criteria also eliminated any GA type IIIB and IIIC injuries. This left 88 patients who
were included in the study.
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The cases were divided into two cohorts: immediate internal fixation with primary wound
closure (EARLY) and temporary fixation/stabilization with delayed fixation and wound closure
(STAGED). The decision to perform EARLY versus STAGED treatment was dependent on the
staff surgeon as one surgeon performed definitive treatment EARLY while all other surgeons
opted for the STAGED protocol.
All patients had reductions performed in the emergency room with splinting. The
treatment protocol for open injuries included: dry gauze dressings for the wounds (no irrigation
in the ER), plaster mold with stirrups, early antibiotics, and tetanus immunization with or
without immunoglobin as indicated. All patients were taken to the operating room within 24
hours for irrigation and debridement (I&D) and had either immediate internal fixation with
primary wound closure (EARLY Figure 1) or temporary fixation/stabilization (external fixator
for Weber type B and C or splint with A injuries) with delayed fixation and wound closure
(Figure 2). In the STAGED group the wound was closed loosely, anticipating a return to the OR
within 48 hrs for repeat I &D, definitive fixation and closure. Patients in the STAGED group
may have had a 3rd procedure 48 hrs later if the operating surgeon deemed the wound to not be
“clean enough” for definitive treatment. These patients were given antibiotics until 48 hrs after
definitive treatment. Patients were all given a minimal of 48 hours of antibiotics (Cefazolin or
Clindamycin in Penicillin allergic individuals) and extended antibiotics in patients receiving
multiple procedures. The post-operative regimens included immobilization after definitive
fixation in a plaster mold with stirrups for two weeks or until the wounds were stable. Post-
operative weight bearing was initiated between two to six weeks in most individuals depending
on surgeon preference. If the patient was diabetic or unreliable, an extended period of non-
weight bearing was implemented by the treating physician.
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Infection was defined as a return to the operating room for treatment after the patient had
completed definitive stabilization and wound closure.
Validated outcome scores were not recorded for this study and is a limitation. Pain levels
out of 10 at all clinic visits were recorded by our medical assistants. Radiographs were also taken
at every clinical visit. X-rays were graded as: normal ankle with no degenerative change, some
degenerative changes or severe changes consistent with post traumatic osteoarthritis. Ambulation
was recorded and divided into limited or unlimited. A simple grading system was devised based
on these criteria and only included patients with at least one year of follow-up.
Statistical Analysis
Statistical analysis was conducted using SAS (SAS 9.4, Cary, NC) with a 2-tailed alpha
of 0.05. Descriptive statistics for categorical variables are presented as frequencies, means, and
standard deviations. Differences between categorical variables were tested for significance using
the Fisher’s exact test. Continuous variables were first determined to be parametric or
nonparametric using the Shapiro-Wilk test. There were no parametric variables. Kruskal-Wallis
test was used to test nonparametric variables. Continuous variables are presented as means with
standard deviations (SD). All variables were assessed for confounding and interaction where
appropriate.
Results
A total of 88 acute rotational open ankle fractures were analyzed. There were 47 (53.4%)
males and 41 (46.6%) females. The mean follow-up period was 15.4 ± 20.2 months (range 6 to
105). Sixty-eight (77.3%) patients had only isolated trauma and 20 (22.7%) had polytrauma. GA
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type included: I (7), II (23), and IIIa (58) injuries. Mechanism of injury included: motor vehicle
collision 52 (59%), fall 35 (40%) and unknown 1 (1%). Forty-nine patients (56%) had a
bimalleolar fracture, 32 (36%) had a unimalleolar fracture and 7 (8%) had a trimalleolar fracture.
Immediate internal fixation and primary wound closure (EARLY) was performed in 40
patients (45.5%) and temporary fixation/stabilization with delayed fixation and wound closure
(STAGED) was performed in 48 patients (54.5%). The cohorts were compared with regards to
age, gender, comorbidities, American Society of Anesthesiologists (ASA) classification,
OTA/AO fracture and dislocation classification,13 fracture type, mechanism of injury, GA
classification, and time to initial operation and found similar distributions (Table 1 and extended
table 1 supplementary digital content 1, http://links.lww.com/JOT/A981). Mean length of follow-
up was 14.0 ± 16.6 months (range 6 to 78) for the EARLY cohort and 16.6 ± 22.9 months (range
6 to 105) for the STAGED cohort (p = 0.57).
Overall, six patients were diagnosed with infection, corresponding to an incidence of
6.8% (6/88) (Supplementary digital content 2, http://links.lww.com/JOT/A982). There were two
cases of infection out of 40 within the EARLY cohort (5%) and four cases out of 48 in the
STAGED cohort (8.3%). No significant difference was found between these cohorts, p = 0.68
(Figure 2).
In 58 of the 88 cases, secondary surgeries were performed during follow-up. Mean
number of reoperations was significantly greater in the STAGED cohort (121 reoperations; mean
2.5 ± 2.90; range 0 to 13) as compared to the EARLY cohort (25 reoperations; mean 0.6 ± 1;
range 0 to 4) (p < 0.0001) (Table 2). Additional surgeries in the STAGED cohort included:
repeat I&D with or without wound vacuum application, delayed closure, and delayed fixation.
However, some of these patients also later needed adjuvant treatment for soft tissue closure such
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as a skin graft (9) or local flap (1). There were no patients who had a below-knee amputation or
developed compartment syndrome in either cohort.
The STAGED cohort had a statistically longer length of hospital stay 10.6 ± 7.1 days
(range 3 to 35) versus the EARLY cohort 6.4 ± 4.7 days; (range 2 to 25 days) (p = 0.0003).
Of the six patients with infection, the mean number of reoperations was significantly
greater than patients without infection (6.33 ± 4.59; range 1 to 13 vs 1.32 ± 1.80; range 0 to 12, p
= 0.0016). Pre-operative risk factors were analyzed to rule out confounding variables for
infection. These included: diabetes (p = 0.98), smoking (p = 0.69), number of malleoli (p = 0.52),
rotational ankle fracture classifications Weber or Lauge-Hansen (p = 0.16 and p = 0.18,
respectively), time to initial OR (p = 0.10), OTA/AO classification (p = 0.12), and GA
classification (p = 0.80). ASA classification was found to be significant (p = 0.01).
Clinical outcomes were compared for patients (52) with greater than 12 months of
follow-up (Table 3). Categories including: pain, ambulation, or osteoarthritis had no significant
difference between cohorts. What was evident is that almost 30% of patients ranked their pain
>4/10, 60% of patients felt that they had some limitation in ambulation, and 37% of patients had
evidence of osteoarthritis at their latest follow up.
Discussion
Open ankle fractures occur from a wide array of injury types through multiple
mechanisms with variable energy levels. 2,3,7,14 Published literature on this topic is inconsistent
regarding pre- and postoperative measures. Even the very definition of what constitutes an open
ankle fracture is not clearly defined.1,3 Hong et al. excluded impaction injuries such as pilon
fractures4 and Wijendra et al. only included a single mechanism of action injury, a fall < 2
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meters.15 Due to this inconsistency, we found it necessary to clearly define our inclusion and
exclusion criteria.
To compare cohorts with similar osseous fractures and comparable soft tissue injuries, it
was fundamental to include only open ankle fractures resulting from mechanisms described by
Lauge-Hansen and excluding impaction or pilon injuries. The focus was on cases where the
decision on primary wound closure and definitive fixation could be made at the initial operation.
As in open tibia fractures, it was suspected that GA type I, II, and IIIa fractures were safe for this
early definitive treatment. The exclusion criteria utilized automatically excluded GA type IIIB
and IIIC fractures in the database.
Multiple studies have demonstrated the variable types of fixation and closure of open
ankle fractures. Some studies have reviewed immediate internal fixation without specifying
closure timing or type.16-18 Immediate internal fixation with delayed primary wound closure,19
secondary wound closure,20 or a combination of different closure types including flaps have also
been assessed. 8,15,21-23 Other studies have evaluated delayed internal fixation, 24 external
fixation,25 or immediate internal and external fixation.26 To the authors knowledge, this study is
the first to compare an EARLY versus a STAGED protocol including only mechanisms
classified by the Lauge-Hansen and excluding open impaction or pilon type injuries.
Multiple factors were compared between the two cohorts including: age, gender, co-
morbidities, ASA classification, OTA/AO classification, fracture type, mechanism of injury, GA
open fracture classification, and time to initial operation and found similar distributions.
Incidence of infection in open ankle fractures has been reported to be from 0 to 16%.
4,16,17,19-22, 27 Ovaska et al. reported a 16% rate of infection in open ankle fractures treated with
primary closure.8 The overall incidence of infection within our study was 6.82%. Infection was
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defined as an unplanned operation after initial treatment. No significant difference in infection
rates of patients treated with an EARLY versus a STAGED protocol was found.
White et al. had an infection rate of 16% in open ankles fractures in diabetics treated
operatively,28 the incidence of infection in diabetics was 6.67% (1/15) in this study; here were
no diabetic patients with an infection in the EARLY cohort. Diabetes was not found to be a
preoperative risk factor for infection (p = 0.73).
There were 36 (41%) patients who were active smokers at the time of injury. While it is
well known that smoking can contribute to post operative infection,29 no significant increase in
infection rates with patients who were active smokers at the time of injury (p = 0.69) was found
in this study. No significant difference between infection and non-infection groups was found
within GA types I, II or IIIA.
Length of hospital stay was significantly less in patients in the EARLY cohort (6.38 vs
10.63; p = 0.0003). In addition, patients within the EARLY cohort had significantly fewer mean
number of reoperations (p < 0.0001). It should be noted that the mean number of reoperations
within this cohort was not zero but rather 0.63 (± 0.95; range 0 to 4). This is due to the two
patients within this cohort developing an infection and requiring subsequent multiple operations.
The other reasons for reoperation were: late implant removal (13), bone graft (1), implant
revision (4) and skin graft (1).
Although we did not use a standardized functional score, we rated the patients based on
pain, walking (whether limited or unlimited), and radiographic findings at the latest follow-up.
No significant differences were noted. Thirty percent of the patients reported pain ≥ 4/10 at latest
follow-up, 60% had limited walking capacity, and 37% had evidence of osteoarthritis noted on
radiographs at latest follow up. This seems to be a large number and which is not explained by
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any factor we evaluated but it was similar in both groups. Perhaps many individuals had cartilage
damage that was not well appreciated or documented in the operative reports.
There are several limitations to this study primarily it being retrospective. In addition,
several patients were excluded because of inadequate follow-up, limiting our clinical results.
Also, there is moderate interobserver reliability which exists within the GA classification and
treatment recommendations based on it should be interpreted with caution.30 Although our study
did not include a validated functional outcome scoring system, preliminary functional outcomes
were compared. Furthermore, patients treated with an EARLY versus a STAGED protocol were
primarily done by surgeon preference. Lastly, only GA type I, II, and IIIa fractures were
included to compare similar osseous fracture types and soft tissue injuries. Although statistical
analysis showed no difference in patient demographics or injury parameters between the two
groups, there were a lower percentage of patients with GA IIIA wounds in the EARLY group as
compared to the STAGED group (50% EARLY vs 80% STAGED) which was significant
(p=.0079 Table 1). GA Type IIIa was not an independent predictor of infection when compared
to type I or II in this study, there is moderate variability in GA classification30 and all wounds
were closeable.
Conclusion
Our study showed that early definitive treatment compared to a staged protocol for GA
type I, II, and IIIa open ankle fractures has similar rates of infection, shorter hospital stay, fewer
surgical interventions, and similar clinical outcomes.
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Funding Statement
No benefits in any form have been received or will be received from a commercial party related
directly or indirectly to the contents of this study.
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Figure Legends
Figure 1: A patient with an open ankle fracture treated with irrigation/debridement and
immediate internal fixation with primary wound closure (EARLY group).
Figure 2: A patient with an open ankle fracture treated with irrigation/debridement and
temporary stabilization with delayed fixation and wound closure (STAGED group).
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Table 1 Pre-Operative Bivariate Analysis of Open Ankle Fractures
Immediate Internal Fixation with Primary Wound Closure (EARLY)
(n=40)
Temporary Fixation/Stabilization with
Delayed Fixation and Wound Closure (STAGED)
(n=48)
P-Value
Patient Demographics
Age (mean) 43.8 (± 15.6; 22 to 82) 44.8 (± 15.7; 20 to 80) 0.72
Gender 0.09
Male 17 (42.5%) 30 (62.50%)
Female 23 (57.5%) 18 (37.50%)
Comorbidities
Diabetes 7 (17.5%) 8 (16.7%) 0.92
Tobacco use 16 (40.0%) 20 (41.7%) 0.87
OTA/AO Class 0.19
A1 1 (2.5%) 8 (16.7%)
A2 4 (8.3%) 4 (10%)
B1 7 (17.5%) 4 (8.3%)
B2 10 (25%) 17 (35.4%)
B3 2 (4.2%) 2 (5%)
C1 6 (15%) 3 (6.3%)
C2 9 (22.5%) 10 (20.8%)
C3 1 (2.5%) 0 (0%)
ASA Class 0.40
1 2 (5.0%) 7 (14.6%)
2 24 (60.0%) 22 (45.8%)
3 12 (30.0%) 16 (33.3%)
4 2 (5.0%) 3 (6.3%)
Lauge Hansen Classification 0.14
SER 1, 2, 3, 4 0, 1 (2.5%), 1 (2.5%), 9 (22.5%) 1 (2.1%), 0, 1 (2.1%), 10 (20.8%)
PER 1, 2, 3, 4 0, 1 (2.5%), 2 (5.0%), 8 (20.0%) 1 (2.1%), 0, 1 (2.1%), 3 (6.3%)
PAD 1, 2 0, 4 (10.0%) 6 (12.5%), 3 (6.3%)
SAD 1, 2, 3 2 (5.0%), 4 (10.0%), 8 (20.0%) 3 (6.3%), 3 (6.3%), 16 (33.3%) Gustilo-Anderson Classification 0.0079
I 6 (15.0%) 1 (2.1%) II 14 (35.0%) 9 (18.8%) IIIA 20 (50.0%) 38 (79.2%)
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Table 2 Re-operative Classifications of Open Ankle Fractures
Immediate Internal Fixation with Immediate Primary Wound
Closure (EARLY) n=40
Temporary Fixation/Stabilization with Delayed Fixation and Wound
Closure (STAGED) n=48
I&D with wound vac 4 36
Implant removal 13 24
Bone graft 1 4
Implant revision 4 6
Skin graft 1 9
Local flap 0 1
I&D + delayed internal fixation 0 10
I&D + external fixation 0 16
I&D + delayed primary closure 0 15
I&D + primary closure 2 0
Total 25 121
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Table 3 Clinical Analysis of Patients with ≥ 1 Year Follow-up
Immediate Internal Fixation with Primary
Wound Closure (EARLY) (n=25)
Temporary Fixation/Stabilization with Delayed Fixation and Wound Closure (STAGED)
(n=27)
P-Value
Pain
≤ 3/10 19 (76%) 18 (66.7%) 0.46
≥ 4/10 6 (24%) 9 (33.3%)
Ambulation
Unlimited 12 (48%) 9 (33.3%) 0.40
Limited 13 (52%) 18 (66.7%)
Osteoarthritis
None/ Mild 17 (68%) 16 (59.3%) 0.57
Moderate/Severe 8 (32%) 11 (40.7%)
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