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1 Research Article Management of Open Tibial Shaft Fractures: Does the Timing of Surgery Affect Outcomes? Oscar A. Duyos, MD David Beaton-Comulada, MD Ariel Davila-Parrilla, MD Jose Carlos Perez-Lopez, MD Krystal Ortiz, BS Christian Foy-Parrilla, MD Francisco Lopez-Gonzalez, MD From the Department of Orthopaedic Surgery, University of Puerto Rico, Medical Sciences Campus, San Juan, Puerto Rico. Correspondence to Dr. Duyos: Dr. Davila-Parrilla or an immediate family member is an employee of Merck. Dr. Lopez-Gonzalez or an immediate family member is a member of a speakers bureau or has made paid presentations on behalf of Arthrex and serves as a paid consultant to Arthrex. None of the following authors or any immediate family member has received anything of value from or has stock or stock options held in a commercial company or institution related directly or indirectly to the subject of this article: Dr. Duyos, Dr. Beaton-Comulada, Dr. Perez-Lopez, Ms. Ortiz, and Dr. Foy-Parrilla. J Am Acad Orthop Surg 2017;25: DOI: /JAAOS-D Copyright 2017 by the American Academy of Orthopaedic Surgeons. Abstract Background: Open tibial shaft fractures require emergent care. Treatment with intravenous antibiotics and fracture débridement within 6 to 24 hours is recommended. Few studies have examined outcomes when surgical treatment is performed.24 hours after occurrence of the fracture. Methods: This retrospective study included 227 patients aged $18 years with isolated open tibial shaft fractures in whom the time to initial débridement was.24 hours. The statistical analysis was based on time from injury to surgical débridement, Gustilo-Anderson classification, method of fixation, union status, and infection status. Results: Fractures débrided within 24 to 48 hours and 48 to 96 hours after injury did not show a statistically significant difference in terms of infection rates (P = 0.984). External fixation showed significantly greater infection rates (P = 0.044) and nonunion rates (P = 0.001) compared with intramedullary nailing. Conclusion: Open tibial shaft fractures should be débrided within 24 hours after injury. Our data indicate that after the 24-hour period and up to 4 days, the risk of infection remains relatively constant independent of the time to débridement. Patients treated with external fixation had more complications than did patients treated with other methods of fixation. Primary reamed intramedullary nailing appears to be a reasonable option for the management of Gustilo- Anderson types 1 and 2 open tibial shaft fractures. Level of Evidence: Level III retrospective study. Tibia fractures are the most common long-bone fractures. Extensive research has been done on the clinical management and outcome of these fractures. 1 Open tibial shaft fractures are complicated injuries with associated soft-tissue and neurovascular damage. Management of these injuries requires a multidisciplinary approach involving orthopaedic surgeons, plastic surgeons, and vascular surgeons. The management of an open tibial shaft fracture requires prompt history and physical examination, stabilization, systemic antibiotics, débridement and irrigation, temporary or definitive fixation, and, if needed, soft-tissue coverage and/or vascular repair. 2 Several classification systems have been used to guide appropriate management and outcomes of these fractures. The most widely recognized and used classification is the Gustilo-Anderson system, which evaluates open fractures on the basis of the size of the wound, the degree of contamination, and the extent of soft-tissue injury. 3 This 230 Journal of the American Academy of Orthopaedic Surgeons

2 Oscar A. Duyos, MD, et al classification is a practical system to guide management, but it has limitations, such as poor interobserver reliability. 4 Open tibia fractures have two major complications: infection and nonunion. Infection rates reported in the literature range between 5% and 50%, and nonunion rates range between 7% and 60%. 5 Because prevention of infection requires serious consideration in the management of these fractures, swift administration of antibiotics and débridement are recommended. In 1974, Patzakis et al 6 conducted a prospective study that showed a statistically significant reduction in infection rates attributed to the administration of cephatolin (2.3%) compared with no antibiotic administration (13.9%) in the management of open fractures. Additionally, time to start of antibiotics is an important issue. Patzakis and Wilkins 7 showed a considerable reduction in infection rates when antibiotics were administered #3 hours after injury compared with antibiotic administration.3 hours from the time of injury (4.7% versus 7.4%). Irrigation and excisional débridement is a crucial part of the treatment algorithm in the management of open tibial shaft fractures. Established guidelines clearly state that at least one débridement must be performed; however, the timing of the first débridement is still a subject of debate. 2,8-12 The historic recommendation is to perform cleansing and débridement within 6 hours after injury. This recommendation was based on an 1898 study by Friedrich 13 in guinea pigs and was later confirmed in a study of human wounds by Robson et al. 14 Kindsfater and Jonassen 15 showed a reduction in the rate of infection of open tibia fractures when the cleansing and débridement occurred within 5 hours. However, multiple studies have not shown the same results. Therefore, no definitive recommendation has been established as to the timing of the first cleansing and débridement of open tibia fractures. Pollak et al 16 examined 315 patients who sustained high-energy open lower extremity trauma and found no statistically significant differences in infection rate when surgery was performed within 24 hours. Weber et al 12 prospectively evaluated 736 patients who sustained open fractures, and their data showed no statistically significant difference in the rate of deep infection when initial surgical débridement was performed within 24 hours of the injury. The topic of stabilization of an open tibial shaft fracture is broad. Multiple factors need to be considered in the choice of fixation. These factors include soft-tissue coverage, gross contamination, mechanism of injury, and endosteal and periosteal bone circulation. Hemodynamic status and overall risk stratification based on laboratory studies and trauma scores are also taken into account in the choice of fixation. One of the most important goals in the management of tibial shaft fractures is quick stabilization, which is often attained by means of external fixation. External fixation has reported union rates of up to 94% and an overall infection rate of 16.2%. 17 However, the complications of pin loosening, malunion, nonunion, and hardware failure have been observed with the use of external fixation for.3 months after injury. 17,18 For these reasons, external fixation is usually used as a temporary method and, when possible, is converted to internal fixation, usually in the form of an intramedullary nail, which can be placed with or without reaming of the tibial medullary canal. Intramedullary nailing provides superior alignment and can also be done relatively quickly, depending on the surgeon s level of expertise. The literature includes reported union rates up to 95% for reamed intramedullary nails and up to 97% for unreamed nails. 17 Infection rates ranging from 6% to 7% have been reported for both reamed and unreamed nailing. 17 Plate fixation with screws is another method of fixation, but the use of this method has decreased because its complication rates (osteomyelitis, 19%; implant failure, 12%) are greater than those of other methods of fixation. 19 Time to débridement for open tibial shaft fractures is currently recommended to be within 6 to 8 hours. Studies taking into consideration the 24-hour period after injury have shown mixed results. Our literature review revealed only a few studies of outcomes in patients with open tibia fractures débrided after the 24-hour mark. In a level IV retrospective outcome study of 58 patients who underwent initial débridement of open tibia fractures after 24 hours, the average time to débridement was 29.7 hours, and deep infection developed in 29% of patients. 20 A retrospective study consisting of 6,099 patients evaluated whether delays.24 hours could occur and, if so, what factors may contribute to these delays. In this study, 24% of patients with open tibia fractures underwent initial surgical débridement beyond 24 hours. 11 Delayed management of open tibial shaft fractures may be more common than is thought and is a topic worthy of discussion. Our study aimed to present clinical data on the management and outcomes of open tibial shaft fractures whose initial débridement could not be performed within the first 24 hours after injury. The primary outcomes measured in our study are infection and nonunion rates according to the time to débridement and fixation type, with the Gustilo- Anderson classification status taken into account. We aspired to contribute information and recommendations on the management of open tibial shaft fractures when the time to surgical débridement is.24 hours. March 2017, Vol 25, No 3 231

3 Management of Open Tibial Shaft Fractures: Does the Timing of Surgery Affect Outcomes? Methods After Institutional Review Board approval was obtained, we performed a retrospective chart review of all open tibial shaft fractures managed at the Puerto Rico Medical Center between December 1993 and May Specifically, the cases came from patient records at the University District Hospital for Adults, a University of Puerto Rico School of Medicine teaching hospital and currently the only major trauma center in Puerto Rico and the Caribbean islands. We identified a total of 227 patients aged $18 years who sustained an isolated open tibial shaft fracture (Gustilo-Anderson type 1 to 3A) and in whom the time to initial débridement was.24 hours. Information gathered from patient charts included time from injury to initial antibiotic management, time from injury to surgical débridement and fixation, fracture classification by Gustilo-Anderson type, method of fixation, union status, and infection/overall complication status. Time periods were divided into 24-hour intervals and ranged from 24 to 96 hours. Complications were analyzed across time to débridement, mode of fixation, and Gustilo- Anderson fracture classification. On arrival at the emergency department, patients were treated per established Advanced Trauma Life Support protocol guidelines and basic orthopaedic fracture management protocol, including complete imaging studies. Initial fracture management consisted of a focused history and comprehensive physical examination, intravenous antibiotics (given to all patients within 3 hours of injury), and tetanus prophylaxis. Antibiotic selection and dosage was based on established guidelines. Specifically, patients with Gustilo-Anderson type 1 or 2 fractures were given a first-generation cephalosporin (1 g cefazolin intravenously every 6 hours). Patients with Gustilo-Anderson type 3 fractures were given a combination of a first-generation cephalosporin (1 g cefazolin intravenously every 6 hours) and an aminoglycoside (80 mg gentamicin intravenously every 8 hours). Patients with penicillin allergies were given vancomycin or clindamycin and/or an aminoglycoside if indicated. All patients underwent initial fracture irrigation at the time of evaluation in the emergency department with sterile normal saline (1 to 3 L, with or without povidone iodine 30 ml per liter). Fractures were then stabilized with long posterior splints. Medical optimization was undertaken as needed, and patients were admitted to the hospital by either the orthopaedic service or the trauma service before surgical management. After patients were medically optimized and cleared for surgical treatment, they were taken to the operating room for cleansing, débridement, and surgical stabilization. The fractures were classified intraoperatively on the basis of the Gustilo- Anderson classification system. The methods of fracture fixation used in our institution during the time frame of this study were external fixators, intramedullary nails with and without reaming, and plates. The choice of fixation was based on the preference of the treating physician. After surgical treatment, patients underwent close follow-up in both the inpatient setting and outpatient clinics. Clinical improvements and complications were evaluated and properly documented. The complications included deep infection, which was defined primarily on the basis of clinical signs and symptoms, laboratory workup, plain radiographs, and other imaging studies that can indicate the possibility of an active infection. Clinical signs and symptoms suggestive of infection included fever, chills, erythema, warmth, swelling of the limb, and purulent accumulation or an active draining sinus at or near the site of the open fracture wound and/ or the surgical wound. At our institution, we consider the laboratory values of C-reactive protein level.14 mg/dl, erythrocyte sedimentation rate.67 mm/h, and white blood cell count of as threshold markers for infection; however, these values are used as an adjunct to imaging studies and observation of clinical presentation. Another complication documented in our followup clinical notes was nonunion, which was defined as a fracture with no signs of bone healing or callus formation 9 months after initial management, or a fracture 6 months after initial management with no signs or progression of radiographic bone healing during 3 consecutive months. Data collected in this study included the patient s age, sex, Gustilo- Anderson classification (based on intraoperative findings), mechanism of injury, time of accident/injury, time to initial antibiotic management, and time to cleansing and débridement. Also, we documented the type of initial fixation (temporary or definitive) used to manage the fracture, as well as any complications that developed thereafter. Comparisons between categorical variables were made using a chi-square analysis. The results were considered significant if the P value was,0.05. All statistical analyses were performed using IBM SPSS statistics version 24 (IBM). Results For fractures débrided in the 24- to 48-hour period, the overall infection rates were 9%, 15%, and 27% for Gustilo-Anderson type 1, 2, and 3 injuries, respectively. For fractures débrided in the 48- to 72-hour period, the overall infection rates were 11%, 20%, and 29% for Gustilo-Anderson type 1, 2, and 3 injuries, respectively. 232 Journal of the American Academy of Orthopaedic Surgeons

4 Oscar A. Duyos, MD, et al For fractures débrided in the 72- to 96-hour period, the overall infection rates were 10%, 15%, and 25% for Gustilo-Anderson type 1, 2, and 3 injuries, respectively (Figures 1 to 4). When we compared the infection rate for patients who underwent débridement between 24 and 48 hours after injury with that of patients who underwent débridement later (48 to 96 hours after injury), no statistically significant differences were found (P = 0.984). Chi-square analysis of the relationship of Gustilo-Anderson fracture type and infection rate revealed a statistically significant association of higher Gustilo-Anderson type with increased rate of infection (P = 0.013; 95% confidence interval [CI], ). In patients with Gustilo-Anderson type 1 or 2 fractures, regardless of the time to débridement, reamed intramedullary nails had a 14.9% infection rate (18 of 121 patients), none of the 22 patients with unreamed intramedullary nails had infection, external fixation had a 26.8% infection rate (11 of 41 patients), and plates had a 0.05%infectionrate(1of22patients). Chi-square analysis of external fixation versus intramedullary nailing (reamed and unreamed) for Gustilo- Anderson type 1 and 2 fractures demonstrated that external fixation was twice as likely to result in an infection. This result was statistically significant (P = 0.027; 95% CI, ). In patients with Gustilo-Anderson type 3 fractures, regardless of the time to débridement, reamed intramedullary nails had a 50% infection rate (3 of 6 patients), neither of the 2 patients with unreamed intramedullary nails had infection, external fixation had a 23% infection rate (3 of 13 patients), and the 1 patient who underwent plating did not have infection. In patients with Gustilo- Anderson type 3 fractures, we found that external fixation was less likely than intramedullary nailing (reamed or unreamed) to result in an infection (23% for external fixation versus 37.5% for intramedullary nailing); however, this result was not statistically significant (P = 0.477; 95% CI, ). In the comparison of nonunion rates among types of fixation, we found that external fixation resulted in a 40.7% nonunion rate (22 of 54 patients), reamed intramedullary nails resulted in a 16.5% nonunion rate (21 of 127 patients), unreamed intramedullary nails resulted in a 29.2% nonunion rate (7 of 24 patients), and plates resulted in a 13.6% nonunion rate (3 of 22 patients). Chi-square analysis comparing nonunion rates of external fixation with those of definitive fixation (intramedullary nailing with or without reaming, or plate fixation) demonstrated that external fixation was twice as likely as definitive fixation to result in nonunion. Specifically, we observed nonunion rates of 40.7% for external fixation and 17.9% for all types of definitive fixation as a group. This result was statistically significant (P = 0.001; 95% CI, ). When external fixation was compared with intramedullary nailing (with or without reaming), we found that external fixation was twice as likely to result in nonunion (40.7% for external fixation versus 18.5% for intramedullary nailing). This result was also statistically significant (P = 0.001; 95% CI, ). Discussion During the time frame of our study, Puerto Rico had a population of approximately 3.6 to 4 million people and had approximately 100 active orthopaedic surgeons, not all of whom managed orthopaedic trauma. Additionally, the island has only one orthopaedic surgery residency. Current treatment guidelines indicate that open tibial shaft fractures should be débrided within 24 hours after injury. However, the management of these fractures, specifically the time to the first surgical débridement, is sometimes delayed. Reasons for delayed surgical débridement include lack of transportation in rural areas, distance to a trauma center, and initial treatment at smaller medical centers, where the lack of adequately trained personnel (ie, orthopaedic and/or trauma surgeons) and resources can lead to delays in transfer to a trauma center. Other delays in surgical management can occur because of the need for medical optimization and/or clearance for surgical treatment, which at times may not be granted immediately on arrival because of multiple medical comorbidities, hemodynamic/resuscitative status problems, other injuries that take priority and must be addressed first, and the overall complexity of the case. Through the years, we have treated several patients with open tibial shaft fracture whose treatment deviated from the standard management in terms of time to débridement. We decided to conduct the present study with the aim of establishing treatment recommendations for patients whose open tibial shaft fracture was managed after the 24-hour mark. Despite the delayed surgical treatment, it is important to note that all patients with open tibial shaft fractures included in this study were given their first intravenous antibiotic dose within 3 hours of the injury. As noted previously, our data showed that, for Gustilo-Anderson fracture types 1, 2, and 3, respectively, the overall infection rates were 9%, 15%, and 27% in the 24- to 48- hour period; 11%, 20%, and 29% in the 48- to 72-hour period; and 10%, 15%, and 25% in the 72- to 96-hour period. As expected, when we compare these infection rates with those found in previous studies in which the March 2017, Vol 25, No 3 233

5 Management of Open Tibial Shaft Fractures: Does the Timing of Surgery Affect Outcomes? Figure 1 Bar graphs demonstrating infection rates in patients with Gustilo-Anderson type 1 fractures, according to fixation method and time to initial débridement at 24 to 48 hours (A), 48 to 72 hours (B), and 72 to 96 hours (C). IM = intramedullary data were based on surgical débridement at,24 hours after injury, we see a considerable increase in the rate of infection across Gustilo-Anderson types past the 24-hour mark. Specifically, previous studies show infection rates of none to 2%, 2% to 10%, and 10% to 50% for Gustilo-Anderson types 1, 2, and 3, respectively. 7,21 Our data show that the infection rates nearly doubled when the first débridement is past the 24-hour mark. However, after 24 hours and up to 4 days (96 hours), the rate of infection remains relatively constant within each Gustilo- Anderson type, independent of the time to débridement. When we analyzed our data across types of fixation past the 24-hour mark, we found several clinically pertinent findings. Compared with intramedullary nailing, external fixation was found to be twice as likely to result in a deep wound infection, specifically in patients with Gustilo- Anderson type 1 and 2 fractures. This 234 Journal of the American Academy of Orthopaedic Surgeons

6 Oscar A. Duyos, MD, et al Figure 2 Infection rates in patients with Gustilo-Anderson type 2 fractures, according to fixation method and time to initial débridement at 24 to 48 hours (A), 48 to 72 hours (B), and 72 to 96 hours (C). IM = intramedullary finding was statistically significant (P = 0.027). However, the finding for Gustilo-Anderson type 3 fractures was not statistically significant and was deemed inconclusive. We also compared external fixation versus all definitive fixation methods (intramedullary nails with or without reaming, and plates) and versus intramedullary nailing alone. Our data showed that external fixation was twice as likely to result in nonunion, compared with definitive fixation methods as a group and compared with intramedullary nailing alone. These outcomes were found to be statistically significant (P = for both comparisons). On the basis of this study, we recommend that patients with open tibial shaft fractures undergo their initial débridement as soon as medically possible. However, if débridement of an open tibial shaft fracture ends up being delayed past the 24-hour mark, we recommend that medical optimization take precedence over surgical management. This recommendation is backed by our data, which showed that although infection rates double after the 24-hour mark, they stabilize and plateau between 24 and 96 hours within March 2017, Vol 25, No 3 235

7 Management of Open Tibial Shaft Fractures: Does the Timing of Surgery Affect Outcomes? Figure 3 Infection rates in patients with Gustilo-Anderson type 3 fractures, according to fixation method and time to initial débridement at 24 to 48 hours (A), 48 to 72 hours (B), and 72 to 96 hours (C). IM = intramedullary each Gustilo-Anderson fracture type. Additionally, taking into consideration the risk of infection versus the risk of nonunion, our opinion, based on the data, is that primary intramedullary nailing is a reasonable option for patients with Gustilo- Anderson fracture types 1 and 2. For Gustilo-Anderson type 3 fractures, many confounding variables were involved, and our data were inconclusive. At our institution, we have previously used intramedullary nailing as the initial management of Gustilo-Anderson type 3 fractures regardless of time to débridement and have obtained good outcomes. However, we currently perform staged fixation (external fixation with later conversion to intramedullary nailing) of Gustilo- Anderson type 3 fractures when the initial débridement cannot be performed within 24 hours after injury, 236 Journal of the American Academy of Orthopaedic Surgeons

8 Oscar A. Duyos, MD, et al Figure 4 Overall infection rates according to Gustilo-Anderson fracture type and time to initial débridement at 24 to 48 hours (A), 48 to 72 hours (B), and 72 to 96 hours (C). as well as in patients who are medically unstable and need rapid orthopaedic treatment for damage control. Conclusions This level III retrospective study addresses a controversial topic and may open the door for surgeons in other centers to evaluate their experience with these fractures. It raises the possibility of a level I prospective randomized study; however, such a study may be ethically challenging. For now, the fixation method remains a personal choice of the treating physician and the patient. The decision should not be based on an algorithm but should be made on a case-by-case basis, with medical optimization and trauma resuscitation always taking precedence over orthopaedic fixation. The time to the administration of the first antibiotic dose and the quality of the initial débridement and/or subsequent débridement are of utmost importance. References Evidence-based Medicine: Levels of evidence are described in the table of contents. In this article, references 2, March 2017, Vol 25, No 3 237

9 Management of Open Tibial Shaft Fractures: Does the Timing of Surgery Affect Outcomes? 6, 10, and are level I studies. References 8, 12, 14, and 16 are level II studies. References 1, 3-5, 7, 9, 11, 15, 20, and 21 are level III studies. Reference 13 is level V expert opinion. References printed in bold type are those published within the past 5 years. 1. Court-Brown CM, McBirnie J: The epidemiology of tibial fractures. J Bone Joint Surg Br 1995;77(3): Griffin M, Malahias M, Khan W, Hindocha S: Update on the management of open lower limb fractures. Open Orthop J 2012;6: Gustilo RB, Mendoza RM, Williams DN: Problems in the management of type III (severe) open fractures: A new classification of type III open fractures. J Trauma 1984; 24(8): Brumback RJ, Jones AL: Interobserver agreement in the classification of open fractures of the tibia: The results of a survey of two hundred and forty-five orthopaedic surgeons. J Bone Joint Surg Am 1994;76 (8): Singh J, Rambani R, Hashim Z, Raman R, Sharma HK: The relationship between time to surgical debridement and incidence of infection in grade III open fractures. Strategies Trauma Limb Reconstr 2012;7(1): Patzakis MJ, Harvey JP Jr, Ivler D: The role of antibiotics in the management of open fractures. J Bone Joint Surg Am 1974;56(3): Patzakis MJ, Wilkins J: Factors influencing infection rate in open fracture wounds. Clin Orthop Relat Res 1989;243: Enninghorst N, McDougall D, Hunt JJ, Balogh ZJ: Open tibia fractures: Timely debridement leaves injury severity as the only determinant of poor outcome. J Trauma 2011;70(2): , discussion Hull PD, Johnson SC, Stephen DJ, Kreder HJ, Jenkinson RJ: Delayed debridement of severe open fractures is associated with a higher rate of deep infection. Bone Joint J 2014;96-B(3): Melvin JS, Dombroski DG, Torbert JT, Kovach SJ, Esterhai JL, Mehta S: Open tibial shaft fractures: I. Evaluation and initial wound management. J Am Acad Orthop Surg 2010;18(1): Namdari S, Baldwin KD, Matuszewski P, Esterhai JL, Mehta S: Delay in surgical débridement of open tibia fractures: An analysis of national practice trends. J Orthop Trauma 2011;25(3): Weber D, Dulai SK, Bergman J, Buckley R, Beaupre LA: Time to initial operative treatment following open fracture does not impact development of deep infection: A prospective cohort study of 736 subjects. J Orthop Trauma 2014;28(11): Friedrich PL: Die aseptische Versorgung frischer Wunden. Archiv für Klinische Chirurgie 1898;57: Robson MC, Duke WF, Krizek TJ: Rapid bacterial screening in the treatment of civilian wounds. JSurgRes1973;14(5): Kindsfater K, Jonassen EA: Osteomyelitis in grade II and III open tibia fractures with late debridement. J Orthop Trauma 1995;9(2): Pollak AN, Jones AL, Castillo RC, Bosse MJ, MacKenzie EJ; LEAP Study Group: The relationship between time to surgical debridement and incidence of infection after open high-energy lower extremity trauma. J Bone Joint Surg Am 2010;92(1): Giannoudis PV, Papakostidis C, Roberts C: A review of the management of open fractures of the tibia and femur. J Bone Joint Surg Br 2006;88(3): French B, Tornetta P III: High-energy tibial shaft fractures. Orthop Clin North Am 2002;33(1): , ix. 19. Bach AW, Hansen ST Jr: Plates versus external fixation in severe open tibial shaft fractures: A randomized trial. Clin Orthop Relat Res 1989;241: Yusof NM, Khalid KA, Zulkifly AH, et al: Factors associated with the outcome of open tibial fractures. Malays J Med Sci 2013;20(5): Gustilo RB, Anderson JT: Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: Retrospective and prospective analyses. J Bone Joint Surg Am 1976;58(4): Journal of the American Academy of Orthopaedic Surgeons