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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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Page 2: Early Definitive Care is as Effective as Staged …...The cases were divided into two cohorts: immediate internal fixation with primary wound closure (EARLY) and temporary fixation/stabilization

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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Page 16: Early Definitive Care is as Effective as Staged …...The cases were divided into two cohorts: immediate internal fixation with primary wound closure (EARLY) and temporary fixation/stabilization

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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