Journal of Orthopaedic Trauma Publish Ahead of Print DOI: 10.1097/BOT.0000000000001050 1 2 3 Is it Safe to Prep the External Fixator in Situ During Second Stage Pilon Surgical 4 Treatment? 5 6 Investigation performed at the University of Nebraska Medical Center 8 Paul J Nielsen, MD, University of Nebraska Medical Center 9 Leonid S Grossman, MD, University of Nebraska Medical Center Justin C Siebler, MD, University of Nebraska Medical Center 11 Elizabeth R. Lyden, MS, University of Nebraska Medical Center 12 Lori K Reed, MD, University of Mississippi Medical Center 13 Matthew A Mormino, MD, University of Nebraska Medical Center 14 15 EP TE 10 Corresponding Author and Address for Reprints: Justin Siebler MD 17 Chief Orthopaedic Trauma 18 Associate Professor 19 Department of Orthopaedic Surgery & Rehabilitation 20 University of Nebraska Medical Center 21 981080 Nebraska Medical Center 22 Omaha, NE 68198-1080 Phone: 402-559-4509 Fax: 402-559-5511 Email: firstname.lastname@example.org A 25 C 24 C 16 23 D 7 26 27 Conflicts of Interest: None declared for all authors 28 29 30 31 32 33 1 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 35 situ during definitive second stage pilon fracture open reduction internal fixation. 36 Design: Retrospective clinical investigation. 37 Setting: Academic Level 1 Trauma Center. 38 Patients/Participants: Out of 229 patients with distal tibia fractures presenting to our 39 institution from 1999-2014, 100 were treated in a two-stage fashion utilizing this protocol. 40 Intervention: Prepping the external fixator into the surgical field during the second 41 stage/definitive open reduction internal fixation procedure. 42 Main Outcome Measurement: The rates of deep and superficial infections after definitive 43 fixation. 44 Results: The deep infection rate was 13% and the superficial infection rate was 11%. 45 Conclusions: Infection rates using this protocol are comparable to previously reported 46 infection rates for two-stage surgical treatment of pilon fractures. This protocol provides 47 the treating surgeon information about an alternative method to streamline definitive 48 fixation. 49 Keywords: Prepping External Fixator; Pilon Fracture; Two-Stage; Infection 50 Level of Evidence: Therapeutic Level IV. EP TE C A 52 C 51 D 34 53 54 INTRODUCTION Surgical treatment of intra-articular distal tibia fractures is often challenging due to 55 a compromised soft tissue envelope limiting the ability to safely reconstruct the articular 56 surface. Unreliable soft tissue healing has led to a dramatic evolution in the treatment of 57 pilon fractures over the last four decades. Ruedi and Allgower reported a series of intra- 58 articular fractures treated with open reduction and internal fixation (ORIF) in 1979, 2 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. challenging the prior standard of closed treatment.1 Subsequent attempts to utilize single 60 stage open reduction led to frequent soft tissue complications and infections2-4, leading 61 many to seek alternative approaches. Minimally invasive or hybrid fixation with external 62 fixators was attempted with fewer soft tissue complications but did not allow for anatomic 63 joint reconstruction or metaphyseal restoration to prevent nonunion or delayed collapse.5-7 64 In 1999, Sirkin et al published the first of several series utilizing staged initial spanning 65 external fixation with open fibula fixation and subsequent ORIF of the distal tibia after soft 66 tissues improved.8 Other studies have concurred in showing improved anatomic joint 67 reconstruction with low wound complication rates.9-11 EP TE 68 D 59 Infection rates in staged pilon fracture treatment studies have varied. Sirkin et al 69 found deep infection in 1 out of 29 closed pilon fractures (3.4%) and 2 out of 19 open pilon 70 fractures (10.5%).8 A more recent publication found an infection rate of 20.6% in two- 71 stage pilon fracture treatment.12 72 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 74 fixator.8 In a study of open pilon fractures Boraiah et al. left the external fixator in place for 75 some patients and replaced it with a distractor in others, but did not analyze whether 76 retention of the external fixator during definitive fixation affected infection rates.9 Another 77 study of 21 patients evaluating an extensile anterior approach for two-stage pilon fixation A C C 73 78 discussed leaving an external fixator in place for the majority of their patients for definitive 79 fixation. These authors reported a 5% superficial and 0% deep infection rate.11 80 Since two-stage pilon fracture fixation became the primary treatment method at our 81 institution in 1997, our surgeons have left the external fixator intact while prepping in the 82 lower extremity for definitive fixation. Retaining the external fixator during skin 83 preparation for definitive fixation offers several potential advantages including 3 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 84 streamlining patient preparation, stability during preparation, maintenance of initial 85 ligamentotaxis reduction and decrease in cost. To our knowledge, no published studies 86 have assessed specifically the potential infectious complications of this approach. We 87 undertook this study to determine if the infection rate of our protocol is comparable to 88 infection rates in the literature. D 89 90 92 EP TE 91 93 MATERIALS AND METHODS 94 Treatment Protocol 95 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 97 underwent an irrigation and debridement of their traumatic wounds emergently with 98 repeat debridement as necessary to remove devitalized tissue. More often in the early part 99 of this series, some patients underwent ORIF of the fibula at the initial surgery based on 100 surgeon preference. Patients underwent a computerized tomography scan after external 101 fixator placement to aid in definitive surgical planning. After the condition of the soft 102 tissues had improved, typically 7-21 days, the patient underwent open reduction and A C C 96 103 104 internal fixation. The external fixator remained in place and was cleansed in its entirety with a 4% 105 chlorhexidine gluconate scrub brush followed by a standard surgical prep with a 8.3% 106 povidone-iodine and 72.5% alcohol solution. The remainder of the lower extremity was 107 prepped in a similar fashion and the external fixator was then covered with surgical towels 108 as much as possible. The surgical approach was chosen based upon the fracture pattern. In 4 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 109 some cases, intra-operatively the external fixator was manipulated or a portion removed at 110 surgeon discretion to facilitate the approach or fracture reduction. At the end of the 111 procedure, the external fixator was removed and pin sites were curetted and left open with 112 dressings applied. 113 115 Subjects D 114 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 117 from May 1999 through April 2014. A searched utilizing Current Procedural Terminology 118 (CPT) codes 27824 through 27828 was performed. 119 EP TE 116 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 121 fixation performed by one of the three attending surgeons. A portion of the external 122 fixators were placed at outside institutions and these patients were included if their 123 definitive surgery was performed at our institution. All surgeries had been performed at 124 12 months prior to review of the charts. Follow up was to at least radiographic union or 125 clinical union with full weightbearing for all patients. Exclusion criteria included definitive 126 external fixation or hybrid external fixation with limited internal fixation. Rotational ankle 127 injuries were also excluded. A C C 120 128 The initial search of CPT codes in the hospital clinical database identified 229 129 patients. There were 139 patients determined to have undergone two-stage pilon fracture 130 fixation. The external fixator was removed prior to definitive fixation in 23 patients for 131 unclear reasons and 4 patients underwent limited internal fixation with or without 132 continued external fixation postoperatively. Twelve patients had inadequate follow up and 133 were excluded. Therefore, 100 patients were included in the analysis. Demographic data 5 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 134 for these patients are shown in Table 1. The AO/OTA classification of the patients was A2 135 for 2, B1 for 3, B2 for 4, B3 for 14, C1 for 13, C2 for 27, and C3 for 31 fractures.13 At 136 definitive fixation 12 patients had implants overlapping with previous pin sites. 137 138 Outcome Data The primary outcome of this study was deep infections given the focus on potential 140 contamination from an external fixator left in situ on the sterile field. Deep infections were 141 defined as infection requiring surgical intervention including irrigation and debridement 142 with or without antibiotic spacer placement, or amputation. Superficial infections were 143 defined as being diagnosed by clinician or antibiotics started after the first postoperative 144 visit but excluding deep infections. EP TE 145 D 139 Subsequent surgical procedures relating to the tibial pilon fracture were also recorded for each patient, including soft tissue coverage, amputations, arthrodesis, bone 147 grafting, and implant removal. 148 Statistical Analysis 149 C 146 Statistical analysis was comprised of descriptive statistics for the patient characteristics. Fisher’s exact test was used to evaluate associations of patient 151 characteristics with infection outcomes. A p-value of <0.05 was considered statistically 152 significant. A C 150 153 154 155 RESULTS There were 100 pilon fractures in 100 patients treated with this protocol from 156 1999-2014. The fractures were open in 35% of patients and closed in the remaining 65%. 157 None of the patient characteristics of gender, diabetes, or tobacco usage was found to be 158 significantly associated with superficial or deep infections (see Table 2 for these statistics). 6 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 159 The average time from initial external fixation to definitive fixation was 13.1 days 160 (range 5 to 28 days). There were 75 external fixators placed at our institution with the 161 remaining 25 placed at outside institutions prior to our definitive care. 162 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 164 closed fractures 9 of 65 patients developed a deep infection for a rate of 13.8%. There was 165 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 EP TE 166 D 163 167 rate was 14.3% (5 of 35 patients) while in the closed fracture group the rate was 9.2% (6 of 168 65 patients). Again, these were not statistically significantly different (p=0.51). 169 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 171 with hardware overlap had superficial infections. We did not find any statistical 172 significance of implants overlap with superficial infection (p=0.61) or with deep infection 173 (p=0.65). 174 C 170 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 176 neither had an infection. An additional 6 free muscle flaps were completed in a delayed 177 fashion after definitive fixation, of which 3 had a deep infection and 1 a superficial A C 175 178 infection. One split thickness skin graft was attempted after definitive fixation in a patient 179 who developed a deep infection. Internal fixation of the fibula was undertaken at the first- 180 stage procedure in 7 patients; 1 of these developed a deep infection and none developed a 181 superficial infection. 182 7 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 183 Transtibial amputation was the eventual outcome for 4 patients. All 4 of these 184 patients had developed deep infections. Two were treated initially with implant removal 185 and antibiotic cement prior to their amputation. The other 2 patients elected to proceed to 186 amputation without attempted eradication of the deep infection. All four fractures were 187 AO/OTA type C fractures, one of which was open. Tibiotalar arthrodesis was performed in 4 patients due to posttraumatic arthritis D 188 after healing of their distal tibia fractures. These were performed at 11, 15, 40, and 51 190 months after their second stage ORIF procedures. Implants were electively removed from 191 10 patients who did not develop deep infections or undergo arthrodesis. Nonunion 192 developed in 6 patients requiring bone grafting before eventual union. EP TE 189 193 194 195 196 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 198 extremity fractures.14 There is frequently a severe concomitant soft tissue injury, with 10- 199 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 A 201 C 200 C 197 202 length and alignment while the condition of the soft tissue envelope improves for about 10- 203 21 days. The second stage procedure involves definitive open reduction and internal 204 fixation with removal of the external fixator. The primary goals of definitive ORIF are 205 anatomic alignment of the articular surface and restoration of the metaphyseal 206 architecture. Use of an external fixator or AO distractor during definitive fixation can assist 207 in maintaining length and alignment as well as potentially allowing joint distraction to 8 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 208 anatomically reduce the distal tibia joint surface.14 A external fixator or AO distractor can 209 be placed during the definitive fixation. Alternatively, as in our study, the external fixator 210 placed at the first-stage procedure can be left in situ. This has the potential to provide more 211 stability while prepping the lower extremity for surgery and streamline the surgical 212 procedure by removing steps. The primary concern with leaving the external fixator in place for definitive fixation D 213 is the potential for increasing infections. No studies have evaluated the bacterial 215 colonization of ankle spanning external fixators in pilon fractures. Many studies have 216 assessed the pin tracts for colonization but not the pins, bars, or clamps themselves. 217 Madsen et al evaluated the colonization of external fixator pins in distal radius fractures, 218 finding that 53% were culture positive.15 Positive cultures of pins did not correlate to 219 infections for the distal radius fracture patients. Even if this colonization rate translated to 220 pilon fracture external fixators, it is unclear what the colonization rate would be after a 221 cleaning process and further whether colonization would lead to surgical site infections. 222 Therefore, the most practical method is to assess the actual rate of surgical site infections. C 223 EP TE 214 Our study evaluated the infectious complications after leaving the external fixator in place during definitive fixation in staged pilon fracture treatment. The overall deep 225 infection rate was 13%. The superficial infection rate was 11%. Previous studies have 226 found varying infection rates in two-stage pilon fracture surgical treatment. Sirkin et al in A C 224 227 their early publication on staged fixation found a deep infection rate of 3.4% in closed 228 fractures (1 of 29) and 10.5% in open pilon fractures (2/19).8 Their overall infection rate 229 was 6.3%. Boraiah et al evaluated staged treatment of only open pilon fractures and found 230 deep infection in 2 of 59 patients for a rate of 3.4%.9 Grose et al evaluated specifically the 231 lateral approach found an infection rate of 4.5% in 44 patients.10 The authors of this study 232 noted that only some fracture patterns and soft tissue envelopes were felt to be amenable 9 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 233 to this approach, so only a subset of their pilon fractures were included in the study. Other 234 studies have found infection rates of 1 out of 46 and 1 out of 27.16-17 235 Assal and colleagues in 2007 evaluated an extensile anterior approach for definitive fixation in pilon fracture fixation. They utilized initial external fixation and referenced 237 leaving the external fixator on for definitive fixation in the majority of their patients, but 238 did not specify how many of their 21 patients had this specific treatment. Their study also 239 included only closed fractures, which often have less severe soft tissue injuries. 240 Nonetheless, they found only 1 superficial infection and no deep infections out of 21 pilon 241 fractures.11 242 EP TE D 236 Molina et al. in a recent study evaluating risk factors for infection in pilon fractures 243 found an infection rate of 20.6% in those treated with two-stage surgical fixation.12 This 244 rate is higher than most others in the literature, but is also the largest cohort published to 245 date. 246 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 248 each study may vary and influence the outcomes. Institutions or surgeons may also differ in 249 which fractures are treated with two-stage surgical treatment instead of closed treatment, 250 limited internal fixation, definitive external fixation, or amputation. This study 251 demonstrated that an external fixator can be left in situ during definitive fixation with an A C C 247 252 overall deep infection rate of 13%. The proportion of patients with deep infection in our 253 sample is borderline statistically significantly different from the known proportion of 254 patients with deep infections in the literature (20.6% or 0.206; p=0.06). 255 Our study had several other limitations. It is difficult to make a definitive statement 256 about the infection rate in our protocol compared to alternative methods of treatment 257 without a control group. A comparative group was not used, in order to obtain a power of 10 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 80 we would need 200 in both the study group and the control group. This protocol was 259 the primary method for treating pilon fractures at our institution during the period studied, 260 meaning no control group was available. In general, the pilon fractures treated without 261 two-stage fixation or which had the external fixator removed prior to prepping were less 262 comminuted and had less severe compromise of the soft tissue envelope. This selection 263 bias would not provide an adequate control group. Therefore, short of a randomized trial 264 the best comparison we can provide is a comparison to previously published series. A prospective study would potentially have collected more specific patient EP TE 265 D 258 266 information and outcomes. It also may have led to a higher rate of follow up, decreasing the 267 chances that a deep infection was treated elsewhere and therefore not found in our medical 268 records. 269 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 271 multiple surgeons in the study is a more accurate representation of the treatment provided 272 in the community. C 270 Surgeons must determine whether the rate of deep infection is acceptable when 274 considering the potential benefit of leaving the external fixator in situ during definitive 275 fixation of pilon fractures. This study provides treating surgeons an additional option for 276 treating high energy pilon fractures. A C 273 277 278 279 280 281 282 11 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 283 REFERENCES: 284 1. Rüedi TP, Allgöwer M. The operative treatment of intra-articular fractures of the lower 285 286 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. 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Boraiah S, Kemp TJ, Erwteman A, et al. Outcome following open reduction and internal 302 fixation of open pilon fractures. J Bone Joint Surg Am. 2010 Feb;92(2):346–52. 12 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 303 304 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- 306 energy pilon fractures: surgical technique and soft-tissue healing. J Orthop Trauma. 307 2007 Mar;21(3):198–206. 309 310 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. EP TE 308 D 305 13. Marsh JL, Slongo TF, Agel J, et al. Fracture and Dislocation Classification Compendium - 311 2007: Orthopaedic Trauma Association Classification, Database and Outcomes 312 Committee. J Orthop Trauma. 2007;21 Supplement 10 pp: S1-S163. 313 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: 315 Elsevier Saunders; 2014. p. 2119–88. 316 C 314 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. 318 Osteosynth Trauma Care. 2004;12(2):85–8. 16. Howard JL, Agel J, Barei DP, et al. A prospective study evaluating incision placement and A 319 C 317 320 wound healing for tibial plafond fractures. J Orthop Trauma. 2008 Jun;22(5):299–305; 321 discussion 305–6. 322 17. Wang C, Li Y, Huang L, et al. Comparison of two-staged ORIF and limited internal 323 fixation with external fixator for closed tibial plafond fractures. Arch Orthop Trauma 324 Surg. 2010 Oct;130(10):1289–97. 13 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 325 326 Figure Legends: Table 1. Patient Demographics. 328 Table 2. Patient Characteristics and Infection Rates. A C C EP TE D 327 14 Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. Table 1. Patient Demographics Value 39 61 EP TE 55 45 D 45.8 12 to 84 43 53 6 7 90 3 A C C Demographic Age Mean Range Gender Female Male Laterality Injured Right Left Tobacco Use Yes No Unreported Diabetes Mellitus Yes No Unreported Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. 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 A C C Gender Male Female Tobacco Yes No Diabetes Yes No Open Fracture Yes No Deep Infection Rate EP TE Characteristic Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.