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Journal of Orthopaedic Trauma Publish Ahead of Print
DOI: 10.1097/BOT.0000000000001050
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Is it Safe to Prep the External Fixator in Situ During Second Stage Pilon Surgical
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Treatment?
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Investigation performed at the University of Nebraska Medical Center
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Paul J Nielsen, MD, University of Nebraska Medical Center
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Leonid S Grossman, MD, University of Nebraska Medical Center
Justin C Siebler, MD, University of Nebraska Medical Center
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Elizabeth R. Lyden, MS, University of Nebraska Medical Center
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Lori K Reed, MD, University of Mississippi Medical Center
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Matthew A Mormino, MD, University of Nebraska Medical Center
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Corresponding Author and Address for Reprints:
Justin Siebler MD
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Chief Orthopaedic Trauma
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Associate Professor
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Department of Orthopaedic Surgery & Rehabilitation
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University of Nebraska Medical Center
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981080 Nebraska Medical Center
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Omaha, NE 68198-1080
Phone: 402-559-4509
Fax: 402-559-5511
Email: jsiebler@unmc.edu
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Conflicts of Interest: None declared for all authors
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Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Objective: To evaluate the infection rate of our protocol of prepping the external fixator in
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situ during definitive second stage pilon fracture open reduction internal fixation.
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Design: Retrospective clinical investigation.
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Setting: Academic Level 1 Trauma Center.
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Patients/Participants: Out of 229 patients with distal tibia fractures presenting to our
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institution from 1999-2014, 100 were treated in a two-stage fashion utilizing this protocol.
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Intervention: Prepping the external fixator into the surgical field during the second
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stage/definitive open reduction internal fixation procedure.
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Main Outcome Measurement: The rates of deep and superficial infections after definitive
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fixation.
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Results: The deep infection rate was 13% and the superficial infection rate was 11%.
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Conclusions: Infection rates using this protocol are comparable to previously reported
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infection rates for two-stage surgical treatment of pilon fractures. This protocol provides
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the treating surgeon information about an alternative method to streamline definitive
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fixation.
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Keywords: Prepping External Fixator; Pilon Fracture; Two-Stage; Infection
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Level of Evidence: Therapeutic Level IV.
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INTRODUCTION
Surgical treatment of intra-articular distal tibia fractures is often challenging due to
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a compromised soft tissue envelope limiting the ability to safely reconstruct the articular
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surface. Unreliable soft tissue healing has led to a dramatic evolution in the treatment of
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pilon fractures over the last four decades. Ruedi and Allgower reported a series of intra-
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articular fractures treated with open reduction and internal fixation (ORIF) in 1979,
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challenging the prior standard of closed treatment.1 Subsequent attempts to utilize single
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stage open reduction led to frequent soft tissue complications and infections2-4, leading
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many to seek alternative approaches. Minimally invasive or hybrid fixation with external
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fixators was attempted with fewer soft tissue complications but did not allow for anatomic
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joint reconstruction or metaphyseal restoration to prevent nonunion or delayed collapse.5-7
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In 1999, Sirkin et al published the first of several series utilizing staged initial spanning
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external fixation with open fibula fixation and subsequent ORIF of the distal tibia after soft
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tissues improved.8 Other studies have concurred in showing improved anatomic joint
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reconstruction with low wound complication rates.9-11
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Infection rates in staged pilon fracture treatment studies have varied. Sirkin et al
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found deep infection in 1 out of 29 closed pilon fractures (3.4%) and 2 out of 19 open pilon
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fractures (10.5%).8 A more recent publication found an infection rate of 20.6% in two-
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stage pilon fracture treatment.12
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The surgical protocol in two-stage pilon fracture studies has varied. Sirkin et al. left
only pins in place to prep and utilized either a femoral distractor or flashed external
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fixator.8 In a study of open pilon fractures Boraiah et al. left the external fixator in place for
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some patients and replaced it with a distractor in others, but did not analyze whether
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retention of the external fixator during definitive fixation affected infection rates.9 Another
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study of 21 patients evaluating an extensile anterior approach for two-stage pilon fixation
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discussed leaving an external fixator in place for the majority of their patients for definitive
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fixation. These authors reported a 5% superficial and 0% deep infection rate.11
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Since two-stage pilon fracture fixation became the primary treatment method at our
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institution in 1997, our surgeons have left the external fixator intact while prepping in the
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lower extremity for definitive fixation. Retaining the external fixator during skin
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preparation for definitive fixation offers several potential advantages including
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streamlining patient preparation, stability during preparation, maintenance of initial
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ligamentotaxis reduction and decrease in cost. To our knowledge, no published studies
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have assessed specifically the potential infectious complications of this approach. We
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undertook this study to determine if the infection rate of our protocol is comparable to
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infection rates in the literature.
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MATERIALS AND METHODS
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Treatment Protocol
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The treatment protocol in this study consisted of initial stabilization with splinting
and ankle spanning external fixator placement within 24 hours of injury. Open fractures
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underwent an irrigation and debridement of their traumatic wounds emergently with
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repeat debridement as necessary to remove devitalized tissue. More often in the early part
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of this series, some patients underwent ORIF of the fibula at the initial surgery based on
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surgeon preference. Patients underwent a computerized tomography scan after external
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fixator placement to aid in definitive surgical planning. After the condition of the soft
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tissues had improved, typically 7-21 days, the patient underwent open reduction and
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internal fixation.
The external fixator remained in place and was cleansed in its entirety with a 4%
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chlorhexidine gluconate scrub brush followed by a standard surgical prep with a 8.3%
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povidone-iodine and 72.5% alcohol solution. The remainder of the lower extremity was
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prepped in a similar fashion and the external fixator was then covered with surgical towels
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as much as possible. The surgical approach was chosen based upon the fracture pattern. In
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some cases, intra-operatively the external fixator was manipulated or a portion removed at
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surgeon discretion to facilitate the approach or fracture reduction. At the end of the
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procedure, the external fixator was removed and pin sites were curetted and left open with
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dressings applied.
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Subjects
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The Institutional Review Board at our institution approved the study. Procedures
were performed by one of three surgeons at a single level one academic trauma center
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from May 1999 through April 2014. A searched utilizing Current Procedural Terminology
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(CPT) codes 27824 through 27828 was performed.
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Inclusion criteria were intra-articular fracture of the distal tibial plafond treated
with an initial ankle spanning external fixator and definitive open reduction with internal
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fixation performed by one of the three attending surgeons. A portion of the external
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fixators were placed at outside institutions and these patients were included if their
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definitive surgery was performed at our institution. All surgeries had been performed at
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12 months prior to review of the charts. Follow up was to at least radiographic union or
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clinical union with full weightbearing for all patients. Exclusion criteria included definitive
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external fixation or hybrid external fixation with limited internal fixation. Rotational ankle
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injuries were also excluded.
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The initial search of CPT codes in the hospital clinical database identified 229
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patients. There were 139 patients determined to have undergone two-stage pilon fracture
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fixation. The external fixator was removed prior to definitive fixation in 23 patients for
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unclear reasons and 4 patients underwent limited internal fixation with or without
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continued external fixation postoperatively. Twelve patients had inadequate follow up and
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were excluded. Therefore, 100 patients were included in the analysis. Demographic data
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for these patients are shown in Table 1. The AO/OTA classification of the patients was A2
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for 2, B1 for 3, B2 for 4, B3 for 14, C1 for 13, C2 for 27, and C3 for 31 fractures.13 At
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definitive fixation 12 patients had implants overlapping with previous pin sites.
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Outcome Data
The primary outcome of this study was deep infections given the focus on potential
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contamination from an external fixator left in situ on the sterile field. Deep infections were
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defined as infection requiring surgical intervention including irrigation and debridement
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with or without antibiotic spacer placement, or amputation. Superficial infections were
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defined as being diagnosed by clinician or antibiotics started after the first postoperative
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visit but excluding deep infections.
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Subsequent surgical procedures relating to the tibial pilon fracture were also
recorded for each patient, including soft tissue coverage, amputations, arthrodesis, bone
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grafting, and implant removal.
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Statistical Analysis
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Statistical analysis was comprised of descriptive statistics for the patient
characteristics. Fisher’s exact test was used to evaluate associations of patient
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characteristics with infection outcomes. A p-value of <0.05 was considered statistically
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significant.
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RESULTS
There were 100 pilon fractures in 100 patients treated with this protocol from
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1999-2014. The fractures were open in 35% of patients and closed in the remaining 65%.
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None of the patient characteristics of gender, diabetes, or tobacco usage was found to be
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significantly associated with superficial or deep infections (see Table 2 for these statistics).
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The average time from initial external fixation to definitive fixation was 13.1 days
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(range 5 to 28 days). There were 75 external fixators placed at our institution with the
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remaining 25 placed at outside institutions prior to our definitive care.
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The primary outcome of deep infection was found in 13% of patients. Within the
open fracture group, 4 of 35 patients developed a deep infection for a rate of 11.4%. In
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closed fractures 9 of 65 patients developed a deep infection for a rate of 13.8%. There was
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no statistically significant difference in the infection rate between the two groups (p=1.00).
The overall superficial infection rate was 11%. Within the open fracture group the
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rate was 14.3% (5 of 35 patients) while in the closed fracture group the rate was 9.2% (6 of
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65 patients). Again, these were not statistically significantly different (p=0.51).
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There were 12 patients with implants overlapping with external fixator pin sites.
Two of 12 patients with implant overlap had a deep infection and two additional patients
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with hardware overlap had superficial infections. We did not find any statistical
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significance of implants overlap with superficial infection (p=0.61) or with deep infection
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(p=0.65).
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There were 11 coverage procedures performed either in conjunction with ORIF or
afterward. Two free muscle flaps were completed at the time of definitive fixation and
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neither had an infection. An additional 6 free muscle flaps were completed in a delayed
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fashion after definitive fixation, of which 3 had a deep infection and 1 a superficial
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infection. One split thickness skin graft was attempted after definitive fixation in a patient
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who developed a deep infection. Internal fixation of the fibula was undertaken at the first-
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stage procedure in 7 patients; 1 of these developed a deep infection and none developed a
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superficial infection.
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Transtibial amputation was the eventual outcome for 4 patients. All 4 of these
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patients had developed deep infections. Two were treated initially with implant removal
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and antibiotic cement prior to their amputation. The other 2 patients elected to proceed to
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amputation without attempted eradication of the deep infection. All four fractures were
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AO/OTA type C fractures, one of which was open.
Tibiotalar arthrodesis was performed in 4 patients due to posttraumatic arthritis
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after healing of their distal tibia fractures. These were performed at 11, 15, 40, and 51
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months after their second stage ORIF procedures. Implants were electively removed from
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10 patients who did not develop deep infections or undergo arthrodesis. Nonunion
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developed in 6 patients requiring bone grafting before eventual union.
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DISCUSSION
Intra-articular fractures of the distal tibial plafond are challenging injuries for both
the patient and surgeon. They account for 3-10% of tibial fractures and 1% of lower
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extremity fractures.14 There is frequently a severe concomitant soft tissue injury, with 10-
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30% of fractures being open in prior studies.14
Many surgeons now utilize a two-stage fracture fixation protocol for high-energy
pilon fractures. This involves initial ankle spanning external fixation to maintain overall
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length and alignment while the condition of the soft tissue envelope improves for about 10-
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21 days. The second stage procedure involves definitive open reduction and internal
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fixation with removal of the external fixator. The primary goals of definitive ORIF are
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anatomic alignment of the articular surface and restoration of the metaphyseal
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architecture. Use of an external fixator or AO distractor during definitive fixation can assist
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in maintaining length and alignment as well as potentially allowing joint distraction to
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anatomically reduce the distal tibia joint surface.14 A external fixator or AO distractor can
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be placed during the definitive fixation. Alternatively, as in our study, the external fixator
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placed at the first-stage procedure can be left in situ. This has the potential to provide more
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stability while prepping the lower extremity for surgery and streamline the surgical
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procedure by removing steps.
The primary concern with leaving the external fixator in place for definitive fixation
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is the potential for increasing infections. No studies have evaluated the bacterial
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colonization of ankle spanning external fixators in pilon fractures. Many studies have
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assessed the pin tracts for colonization but not the pins, bars, or clamps themselves.
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Madsen et al evaluated the colonization of external fixator pins in distal radius fractures,
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finding that 53% were culture positive.15 Positive cultures of pins did not correlate to
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infections for the distal radius fracture patients. Even if this colonization rate translated to
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pilon fracture external fixators, it is unclear what the colonization rate would be after a
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cleaning process and further whether colonization would lead to surgical site infections.
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Therefore, the most practical method is to assess the actual rate of surgical site infections.
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Our study evaluated the infectious complications after leaving the external fixator in
place during definitive fixation in staged pilon fracture treatment. The overall deep
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infection rate was 13%. The superficial infection rate was 11%. Previous studies have
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found varying infection rates in two-stage pilon fracture surgical treatment. Sirkin et al in
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their early publication on staged fixation found a deep infection rate of 3.4% in closed
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fractures (1 of 29) and 10.5% in open pilon fractures (2/19).8 Their overall infection rate
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was 6.3%. Boraiah et al evaluated staged treatment of only open pilon fractures and found
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deep infection in 2 of 59 patients for a rate of 3.4%.9 Grose et al evaluated specifically the
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lateral approach found an infection rate of 4.5% in 44 patients.10 The authors of this study
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noted that only some fracture patterns and soft tissue envelopes were felt to be amenable
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to this approach, so only a subset of their pilon fractures were included in the study. Other
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studies have found infection rates of 1 out of 46 and 1 out of 27.16-17
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Assal and colleagues in 2007 evaluated an extensile anterior approach for definitive
fixation in pilon fracture fixation. They utilized initial external fixation and referenced
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leaving the external fixator on for definitive fixation in the majority of their patients, but
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did not specify how many of their 21 patients had this specific treatment. Their study also
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included only closed fractures, which often have less severe soft tissue injuries.
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Nonetheless, they found only 1 superficial infection and no deep infections out of 21 pilon
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fractures.11
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Molina et al. in a recent study evaluating risk factors for infection in pilon fractures
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found an infection rate of 20.6% in those treated with two-stage surgical fixation.12 This
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rate is higher than most others in the literature, but is also the largest cohort published to
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date.
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The deep infection rate in our study can be compared to these prior studies. It is
lower than the Molina study, but higher than the earlier studies. The inclusion criteria for
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each study may vary and influence the outcomes. Institutions or surgeons may also differ in
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which fractures are treated with two-stage surgical treatment instead of closed treatment,
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limited internal fixation, definitive external fixation, or amputation. This study
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demonstrated that an external fixator can be left in situ during definitive fixation with an
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overall deep infection rate of 13%. The proportion of patients with deep infection in our
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sample is borderline statistically significantly different from the known proportion of
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patients with deep infections in the literature (20.6% or 0.206; p=0.06).
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Our study had several other limitations. It is difficult to make a definitive statement
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about the infection rate in our protocol compared to alternative methods of treatment
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without a control group. A comparative group was not used, in order to obtain a power of
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80 we would need 200 in both the study group and the control group. This protocol was
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the primary method for treating pilon fractures at our institution during the period studied,
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meaning no control group was available. In general, the pilon fractures treated without
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two-stage fixation or which had the external fixator removed prior to prepping were less
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comminuted and had less severe compromise of the soft tissue envelope. This selection
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bias would not provide an adequate control group. Therefore, short of a randomized trial
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the best comparison we can provide is a comparison to previously published series.
A prospective study would potentially have collected more specific patient
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information and outcomes. It also may have led to a higher rate of follow up, decreasing the
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chances that a deep infection was treated elsewhere and therefore not found in our medical
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records.
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The relatively large number of patients in our study is a strength. Most prior studies
have included between 27 and 56 fractures8,9,10,16,17 except Molina et al.12 In addition
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multiple surgeons in the study is a more accurate representation of the treatment provided
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in the community.
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Surgeons must determine whether the rate of deep infection is acceptable when
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considering the potential benefit of leaving the external fixator in situ during definitive
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fixation of pilon fractures. This study provides treating surgeons an additional option for
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treating high energy pilon fractures.
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REFERENCES:
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1. Rüedi TP, Allgöwer M. The operative treatment of intra-articular fractures of the lower
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end of the tibia. Clin Orthop. 1979 Feb;(138):105–10.
2. Teeny SM, Wiss DA. Open reduction and internal fixation of tibial plafond fractures.
Variables contributing to poor results and complications. Clin Orthop. 1993
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Jul;(292):108–17.
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4. Ovadia DN, Beals RK. Fractures of the tibial plafond. J Bone Joint Surg Am. 1986
Apr;68(4):543–51.
5. Anglen JO. Early outcome of hybrid external fixation for fracture of the distal tibia. J
Orthop Trauma. 1999 Feb;13(2):92–7.
6. Pugh KJ, Wolinsky PR, McAndrew MP, et al. Tibial pilon fractures: a comparison of
treatment methods. J Trauma. 1999 Nov;47(5):937–41.
7. Blauth M, Bastian L, Krettek C, et al. Surgical options for the treatment of severe tibial
pilon fractures: a study of three techniques. J Orthop Trauma. 2001 Apr;15(3):153–60.
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of pilon fractures. J Orthop Trauma. 1992;6(2):195–200.
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3. McFerran MA, Smith SW, Boulas HJ, et al. Complications encountered in the treatment
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8. Sirkin M, Sanders R, DiPasquale T, et al. A staged protocol for soft tissue management in
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the treatment of complex pilon fractures. J Orthop Trauma. 1999 Feb;13(2):78–84.
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9. Boraiah S, Kemp TJ, Erwteman A, et al. Outcome following open reduction and internal
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fixation of open pilon fractures. J Bone Joint Surg Am. 2010 Feb;92(2):346–52.
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10. Grose A, Gardner MJ, Hettrich C, et al. Open reduction and internal fixation of tibial
pilon fractures using a lateral approach. J Orthop Trauma. 2007 Sep;21(8):530–7.
11. Assal M, Ray A, Stern R. The extensile approach for the operative treatment of high-
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energy pilon fractures: surgical technique and soft-tissue healing. J Orthop Trauma.
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2007 Mar;21(3):198–206.
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12. Molina CS, Stinner DJ, Fras AR, et al. Risk factors of deep infection in operatively treated
pilon fractures (AO/OTA: 43). J Orthop. 2015 Oct;12, Supplement 1:S7–13.
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13. Marsh JL, Slongo TF, Agel J, et al. Fracture and Dislocation Classification Compendium -
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2007: Orthopaedic Trauma Association Classification, Database and Outcomes
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Committee. J Orthop Trauma. 2007;21 Supplement 10 pp: S1-S163.
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14. Bartlett, Craig S, Hahn, Jesse C, Hall, Jonathon S, et al. Fractures of the TIbial Pilon. In:
Skeletal Trauma: Basic Science, Management, and Reconstruction. 5th ed. Philadelphia:
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Elsevier Saunders; 2014. p. 2119–88.
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15. Madsen J, Roberts C, Seligson D. The Control of Pin Tract Colonization with Antibiotic
Coated Sleeves: A Prospective Study of External Fixation of Distal Radius Fractures.
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Osteosynth Trauma Care. 2004;12(2):85–8.
16. Howard JL, Agel J, Barei DP, et al. A prospective study evaluating incision placement and
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wound healing for tibial plafond fractures. J Orthop Trauma. 2008 Jun;22(5):299–305;
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discussion 305–6.
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17. Wang C, Li Y, Huang L, et al. Comparison of two-staged ORIF and limited internal
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fixation with external fixator for closed tibial plafond fractures. Arch Orthop Trauma
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Surg. 2010 Oct;130(10):1289–97.
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Figure Legends:
Table 1. Patient Demographics.
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Table 2. Patient Characteristics and Infection Rates.
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Table 1. Patient Demographics
Value
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61
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12 to 84
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53
6
7
90
3
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Demographic
Age
Mean
Range
Gender
Female
Male
Laterality Injured
Right
Left
Tobacco Use
Yes
No
Unreported
Diabetes Mellitus
Yes
No
Unreported
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Table 2. Patient Characteristics and Infection Rates
Superficial
Infection Rate
Superficial
Infection p
Value
10/61 (16.4%)
3/39 (7.7%)
.2407
9/61 (14.8%)
2/39 (5.1%)
.1938
8/43 (18.6%)
4/51 (7.8%)
.1350
6/43 (14.0%)
4/51 (7.8%)
.5041
1/7 (14.3%)
11/90 (12.2%)
1.000
1/7 (14.3%)
10/80 (12.5%)
.5817
4/35 (11.43%)
9/65 (13.85%)
1.0000
5/35 (14.29%)
6/65 (9.23%)
.5094
D
Deep Infection p
Value
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C
Gender
Male
Female
Tobacco
Yes
No
Diabetes
Yes
No
Open Fracture
Yes
No
Deep Infection
Rate
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Characteristic
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