➢ Although timely irrigation and debridement within six hours after injury has been established as the standard of care in the management of open tibial fractures, current evidence does not support such practice. The ideal irrigation solution and pressure remain equivocal.
➢ Antibiotic prophylaxis should be commenced as soon as possible. All patients should receive antimicrobial coverage against gram-positive bacteria, typically with a first-generation cephalosporin. Gustilo and Anderson type-III injuries require additional coverage, and it is reasonable to use an aminoglycoside, although the optimal regimen has not conclusively been established. Local antibiotic administration at the site of injury, as an adjunct to systemic prophylaxis, considerably reduces the risk of infection, and the benefit is most pronounced for type-III injuries.
➢ Both reamed and unreamed intramedullary nailing are reasonable options for fracture fixation of open tibial fractures and have demonstrated comparable outcomes. Although external fixation should not typically be used as definitive fixation, it is a useful temporizing measure in more severe injuries when it is used for a short duration of time (i.e., twenty-eight days or less).
➢ Primary wound closure is recommended for fractures with less severe soft-tissue injury, allowing for tension-free closure. For those injuries requiring delayed closure, definitive coverage should not be delayed beyond seven days, even in the setting of negative-pressure wound therapy.
Fractures of the tibial diaphysis represent the most common major long-bone fractures that currently confront practicing orthopaedic surgeons1,2. The overall incidence has been estimated to be seventeen to twenty-three fractures per 100,000 person-years, and it is young males in particular who carry the highest risk of sustaining these fractures, with a reported incidence of thirty-nine fractures per 100,000 person-years in males from ten to nineteen years of age3,4.
Unfortunately, up to 24% (a total of 123 open fractures in 523 fractures) of all tibial diaphyseal fractures present as open injuries and are second only to phalanx fractures as the most prevalent type of open fracture3,5. Furthermore, a considerable proportion of open tibial fractures are associated with severe soft-tissue compromise (Gustilo and Anderson type III)3. Road-traffic accidents, inclusive of pedestrians and cyclists, have been implicated as the predominant causative mechanism, as they account for 43% to 65% (sample size = 12754 and 1233) of open tibial shaft fractures3,4. Furthermore, falls represent the second most common mechanism and are responsible for up to 25% (sample size = 12754 and 676) of these fractures4,6. Although sporting injuries remain a common cause of closed tibial shaft fractures, they infrequently result in open injuries (<10%; sample size = 502)7.
Given that as many as one in four patients with tibial shaft fracture presents with an open injury, surgeons are often required to make a series of acute management decisions that carry substantial prognostic implications for these patients who are at a higher risk of having an infection, a fracture nonunion, or a wound complication8. The importance of proceeding with evidence-based interventions that optimize patient outcomes in the setting of these potentially devastating injuries cannot be overstated. Despite the growing body of literature surrounding the treatment of open tibial shaft fractures, several crucial aspects in the surgical management of these patients remain equivocal and thus varied across the global orthopaedic community9.
In this review, we explore the practice patterns and emerging clinical evidence with regard to four aspects of treatment that are central to the management of open tibial diaphyseal fractures: (1) irrigation and debridement techniques, (2) antibiotic prophylaxis, (3) fracture stabilization, and (4) wound management. Types of fracture will be referred to by their Gustilo and Anderson classification throughout this review.
Irrigation and Debridement
There are several issues regarding the irrigation and debridement of open tibial shaft fractures that are currently controversial. The true urgency of initial surgery has been called into question, and the optimal techniques of irrigation remain equivocal. At present, there are several variations of irrigation solution, pressure, and volume from which to select, including normal saline solution with or without additives (antiseptics, antibiotics, and soaps), delivered at low or high pressures8.
Although emergency irrigation and debridement within six hours after injury has been advocated and adopted as the standard of care, there remains a paucity of evidence to conclusively support such practice8. Several retrospective series have demonstrated no significant difference in infection rates for patients who undergo initial surgery before or after the six-hour mark after injury or presentation, including those patients with type-III fractures6,10,11. These findings have been validated in a recent meta-analysis, in which a pooled analysis of fourteen prospective and retrospective studies demonstrated no significant difference in overall infection rates between late and early debridement (odds ratio, 0.91 favoring late debridement; 95% confidence interval [CI], 0.70 to 1.18)12. The time threshold for defining late versus early debridement in this analysis was based on the varying definitions set by the individual studies, although the majority used a six-hour threshold12.
Fittingly, an assessment of national practice trends across the United States and involving 6099 patients with open tibial fractures demonstrated that 42% of patients waited longer than six hours for initial surgery after arriving at the hospital. Factors associated with delayed treatment included patient characteristics (e.g., severe head or thoracic injury or presentation after 6:00 pm) and hospital characteristics (e.g., level-I trauma center or university hospital)13.
Ultimately, in the absence of evidence from randomized trials, formal irrigation and debridement within six hours after injury remains the historically established recommendation of care. However, there is a growing recognition that delayed surgery for less severe fractures (type I) may be an acceptable practice as long as debridement is performed as a priority procedure no later than the morning after admission8.
An international survey of 984 orthopaedic surgeons who assessed practice preferences for irrigation techniques of open fractures found no global consensus on the preferred choice of irrigation solution or pressure. Although the predominant preferences were normal saline solution alone and low-pressure irrigation, only 71% of respondents endorsed these practices9. Furthermore, it has been suggested that types I, II, and III fractures should be irrigated with 3, 6, and 9 L of solution, respectively8. However, practice patterns regarding volume of irrigation solution used for open fracture management remain varied and may in large part be attributable to insufficient clinical evidence8,9.
There are recent randomized clinical trials that are providing further insight into the relative efficacy of these irrigation techniques. Anglen randomized 400 patients with open fractures of the lower extremity (111 tibial shaft fractures) to irrigation with either castile soap or antibiotic (bacitracin) solution and found no significant difference with regard to infection risk between the two agents (13% castile soap versus 18% bacitracin). There was, however, an increased risk of wound-healing failure with the antibiotic solution (4% castile soap versus 9.5% bacitracin)14. The Fluid Lavage of Open Wounds (FLOW) study is an international, multicenter, 3 × 2 randomized trial that has recruited over 2500 patients to evaluate the efficacy of high-pressure, low-pressure, and bulb-syringe lavage as well as normal saline solution versus castile soap solution15. The initial pilot study of 111 patients suggested that low-pressure lavage may reduce reoperation rates due to infection, nonunion, and wound-healing problems but that ultimately the final results of this landmark trial will provide more definitive guidance16.
The merits of meticulous irrigation and debridement of open fracture wounds in mitigating infection risk are universally accepted8,16. Beyond this uncontested matter, however, strong recommendations for specific solutions or irrigation pressures for the management of open tibial shaft fractures cannot be put forth.
Infection is a known complication related to open fractures, as open injuries are prone to microbial contamination17. Numerous studies have been carried out over the years, investigating the role of antibiotic prophylaxis in the setting of open fractures. A Cochrane review of randomized trials (n = 913 patients) demonstrated a pooled relative risk reduction of 59% for acute infection in patients with open fractures treated with prophylactic antibiotics18. It was concluded that for every thirteen patients treated with prophylactic antibiotics, one acute infection would be circumvented18.
Although the merits of administering systemic antibiotic prophylaxis are well established, there are few randomized trials that have added to our knowledge regarding the urgency of administration, the necessary duration of treatment, and the optimal regimen of antibiotic therapy.
As per accepted practice, antibiotic prophylaxis should be commenced as early as possible after injury. Earlier work by Patzakis and Wilkins identified timely antibiotic administration as the most important factor in reducing the risk of infection19. In their case-control study of more than 1100 open fractures, antibiotics administration more than three hours after injury was associated with a 1.63 times greater odds of infection in comparison with treatment within the first three hours after injury19.
It has been recommended that both type-I and type-II open fractures require antibiotic coverage for twenty-four hours after wound closure20,21. For type-III injuries, it is suggested that antibiotic administration continue for seventy-two hours after injury but no longer than twenty-four hours after wound closure20,21. As demonstrated by Dellinger et al. in their blinded randomized trial comparing a one-day course of antibiotic prophylaxis to a five-day course, there is no clear benefit to prolonged antibiotic prophylaxis in preventing fracture-site infections in open fractures, including those of type-III severity22.
With regard to specific antibiotic selection, there is strong evidence supporting coverage against gram-positive organisms for all open fractures, typically with a first-generation cephalosporin unless specific contraindications exist (e.g., allergy)8,20,23.
Additional coverage against gram-negative organisms is indicated for type-III injuries, and the use of an aminoglycoside has been suggested20. The best-available evidence in the form of randomized trials, however, has not conclusively validated the optimal regimen. In a randomized study by Patzakis et al., antibiotic prophylaxis treatment of type-III open fractures with a combined regimen of cefamandole and gentamicin substantially reduced infection rates compared with prophylaxis with ciprofloxacin alone (infection rate, 7.7% versus 31%, respectively)24. It must be noted that the sample size of patients with type-III injuries was relatively small (n = 52) and that significance was not reached despite the magnitude of difference in infection rates24. Sorger et al. were unable to substantiate such a low infection rate in their randomized trial, as 10% to 25% of patients with type-III open fractures (n = 20) developed an infection despite prophylaxis with a similar antibiotic course consisting of cefazolin and gentamicin25. Other antibiotic options for type-III open fractures have also been explored in randomized trials. Prophylaxis with use of a third-generation cephalosporin (cefotaxime) alone for type-II and type-III open tibial fractures was evaluated in an earlier trial by Johnson et al. Despite a considerably lower infection rate with cefotaxime compared with cefazolin in type-III fractures (infection rate, 18% versus 37%, respectively), the effect size was statistically insignificant because only twenty-seven patients with such high-grade injuries had been recruited26. Vasenius and colleagues further underscored the need for appropriate gram-negative coverage of type-III injuries in a randomized trial that demonstrated unacceptably high infection rates when clindamycin or cloxacillin was used alone for antibiotic prophylaxis27.
In light of the available evidence, a combined regimen consisting of an aminoglycoside in conjunction with a first-generation cephalosporin appears to be a reasonable approach for type-III injuries (Table I). However, the above-mentioned studies must be interpreted with the understanding that trials consisting of small sample sizes are susceptible to spurious findings—small changes in the number of outcome events could substantially alter the percentage of infections reported and possibly the significance of results. Accordingly, sufficiently powered trials with large sample sizes are still needed to provide unequivocal guidance on the optimal antibiotic regimen for type-III open fractures.
Local delivery of antibiotics has also piqued the interest of researchers in recent years, as antibiotic-laden polymethylmethacrylate cement beads have been demonstrated to improve antibiotic delivery at the target site8. In their retrospective review of 1085 open fractures, Ostermann et al. demonstrated a significant reduction in infection rate (acute and chronic) for type-III injuries with use of systemic antibiotics in conjunction with tobramycin-impregnated cement beads as compared with systemic prophylaxis alone (infection rate, 6.5% versus 20.6%, respectively; p < 0.001). This significance was not found in lower-grade injuries28. However, a recent meta-analysis of twenty-one studies demonstrated a significantly lower deep-infection risk with use of local antibiotic administration as an adjunct to systemic antibiotics across all types of open tibial fractures treated with intramedullary nailing. The effect was most pronounced for type-III injuries, which demonstrated a pooled infection risk of 2.4% (95% CI: 0.0% to 9.4%) with an adjunct local antibiotic as compared with 14.4% (95% CI: 10.5% to 18.5%) with systemic prophylaxis alone (odds ratio, 0.17; p value not reported)29.
Options for stabilization following open tibial shaft fracture include either internal fixation or external fixation. Internal fixation may be performed with plates (e.g., dynamic compression plates or limited contact dynamic compression plates) or with an intramedullary nail. External fixation may be either definitive or temporary (e.g., preceding a second-stage internal fixation procedure). The standard of care for open tibial shaft fractures has evolved considerably over the past several decades, and we present the latest evidence on the stabilization of these injuries.
There is both biologic and clinical rationale that favors the plating of open tibial shaft fractures over alternative options. First, external fixation is cumbersome and not convenient for the patient. Among internal fixation devices, plating does not risk further injury to bone that is likely already denuded of periosteum (especially in higher-grade open fractures), whereas intramedullary nailing has the potential to further compromise the intraosseous blood supply and lead to osteonecrosis30,31. Arguments against plating have focused on the possibility of chronic infection and resultant infectious nonunion, as the inert surface of a metal plate could provide a medium for bacterial growth to flourish. Evidence from clinical studies has largely fallen against plating. Therefore, this option is no longer recommended in the primary treatment of open tibial shaft fractures32.
Van der Linden and Larsson evaluated 100 consecutive patients in a randomized controlled trial comparing Arbeitsgemeinschaft für Osteosynthesefragen (AO) plating to conservative management. Only six patients in each group had open fractures. The investigators reported that healing times were almost double in the plated open-fracture group and that only two of the six patients that received plating had no complications. Of note, the protocol used by the investigators required waiting for the wound to heal before proceeding with surgical management33.
Bach and Hansen performed a randomized trial in which fifty-nine patients with open type-II or type-III tibial shaft fractures were allocated to either external fixation with half-pins or to AO plating with a 4.5-mm plate. The investigators reported higher rates of wound infections (35% versus 13%), chronic osteomyelitis (19% versus 3%), and fixation failure (12% versus 7%) in the plate group. External fixation had a low incidence of pin-track infection (10%) and a slightly higher rate of malunion (10% versus 4%)34.
Clifford and colleagues performed a noncomparative chart review of ninety-seven plated fractures (sixty of ninety-seven fractures were type II or type III). They reported a deep infection rate of 10.3%; in addition, a deep infection developed in almost half (44.4%) of type-III fractures. Eleven of ninety-five patients developed stiffness in one or both knees35. These results are unacceptable in the context of alternative fixation options.
Intramedullary nailing offers the advantages of avoiding further disruption of soft tissues and periosteum and may potentially allow for immediate postoperative weight-bearing. Further, because incision and nail insertion occur remotely from the open wound, there is a lower likelihood of hardware being contaminated and colonized by bacteria. Clinical studies have largely upheld the superiority of intramedullary nailing in terms of improved fracture-healing and reduced risk of deep infection.
Kakar and Tornetta performed a prospective longitudinal cohort evaluation of 143 type-I to type-III open tibial shaft fractures that were managed with unreamed tibial nailing. All fractures received irrigation, debridement, and closure within fourteen days postoperatively. These authors found an overall low incidence of deep infections (3%) and implant failures (3.5%). Although this study lacked a comparator group, the results are better than those quoted in the aforementioned literature on plating. However, the investigators reported a high incidence of ipsilateral ankle stiffness (21%), knee pain (20%), and fracture-site pain despite union (21%)36.
Inan and colleagues compared circular wire external fixation with unreamed tibial nails in a randomized trial of type-IIIA open tibial shaft fractures. They reported a significantly shorter time to union (nineteen versus twenty-one weeks, respectively; p = 0.04) and fewer knee contractures (0% versus 10%, respectively; p value not reported) in favor of the unreamed tibial nails37. They were unable to detect any significant difference in the number of deep infections. In another randomized trial, Henley et al. compared half-pin external fixators to unreamed tibial nails in type-II, type-IIIA, and type-IIIB open tibial shaft fractures. The use of an intramedullary nail resulted in better alignment and fewer reoperations, with no significant difference in infection rates38. A systematic review that indirectly compared reamed nails to external fixators has also demonstrated a decreased risk of reoperation with the use of intramedullary nails39.
Overall, the evidence supports the use of intramedullary nailing (either reamed or unreamed) over both plating and external fixation for open tibial shaft fractures on the basis of lower reoperation rates and faster time to fracture union. If used in place of plating, there is a reduced risk of deep infection as well.
Reamed Versus Unreamed Nailing
Surgeons have the option of reaming the intramedullary canal of the tibial shaft prior to nail insertion. Reaming before nailing allows for insertion of a larger diameter intramedullary nail with resultant greater stability. However, reaming can disrupt the endosteal bloody supply through thermal injury, physical disruption of blood vessels, increased intramedullary pressure, and fat-emboli occlusion of blood vessels30,31. Unreamed techniques require smaller nails and therefore result in comparatively less stability, but preserve the endosteal blood supply. The latter consideration is potentially important when periosteum has been denuded during the initial injury. Thermal necrosis during reamed nailing can also lead to increased rates of postoperative infection and other complications40.
Bhandari and colleagues conducted a systematic review that identified two studies that compared reamed and unreamed nails for the treatment of open tibial shaft fractures. They were unable to demonstrate significant superiority of one technique over the other in the context of open fractures39. Subsequently, the Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) investigators randomized 1319 patients to either reamed or unreamed intramedullary nailing; 406 of these patients had an open fracture, and 137 of these fractures were type-III injuries. Reamed nailing was shown to be superior in the closed fracture group but not in the open fracture group, which trended instead in the opposite direction but did not reach significance41. Therefore, neither the reamed nor the unreamed nailing technique has proven superior in the treatment of open tibial shaft fractures.
Owing to a lack of evidence supporting superiority of external fixation over intramedullary nailing, as well as patient discomfort and the high incidence of pin-track infections, definitive external fixation is generally not a highly recommended treatment option. However, external fixation can still be an appropriate option for certain injuries. For instance, orthopaedic surgeons may utilize external fixation for severely contaminated type-IIIA and type-IIIB fractures that are associated with severe bone loss42,43. However, improvements in our knowledge of soft-tissue reconstruction techniques and infection control have largely usurped the practice of definitive external fixation in favor of intramedullary nailing.
There remains, however, a strong role for temporary external fixation in the management of severely contaminated tibial shaft fracture in association with extensive soft-tissue injury. The literature has demonstrated acceptable results for open tibial shaft fractures that are treated sequentially with external fixation followed by intramedullary nailing44-47.
Bhandari and colleagues conducted a systematic review of both tibial and femoral fractures managed with intramedullary nailing secondary to external fixation. The vast majority of tibial fractures in the analyzed studies were open fractures. They found that tibial shaft fractures treated with a shorter duration of external fixation (i.e., fewer than twenty-eight days) had a relative risk reduction of 83% (n = 263) for infection (p < 0.001). Following removal of the external fixator, tibial shaft fractures in which there was a shorter interval between the time of fixator removal and the time of intramedullary nailing (i.e., fewer than fourteen days) had a relative risk reduction of 85% (n = 268) for infection (p < 0.001)48. Therefore, external fixators should be used for a short duration, and the interval between removal and internal fixation should be less than fourteen days. Some surgeons have advocated near-immediate conversion, with a very short interval (i.e., less than ten days) if there are concerns pertaining to pin-track infections32.
An optimal time for wound closure of open tibial shaft fractures has yet to be established, although primary closure under specific circumstances is warranted2. In a retrospective cohort study of ninety-five open tibial fractures (type I to type IIIA), Hohmann et al. found no significant difference in infection rates between patients who underwent primary closure (4% average infection rate) and patients who underwent delayed closure (2% average infection rate with wound closure at a mean of nine days from the time of initial debridement). It is important to note that only seven fractures were type-III injuries, with the study primarily including less severe, isolated injuries of the tibia49. There is, however, further evidence endorsing primary closure in type-III fractures. In a prospective, noncomparative series of 173 patients with type-IIIA and type-IIIB open fractures treated with primary closure, Rajasekaran and colleagues found that 87% of patients had an “excellent” result, which collectively entailed osseous union, primary wound-healing with no or marginal necrosis, and no infection. However, stringent criteria for primary closure were utilized in this study, including no skin loss, debridement within twelve hours of injury, stable skeletal fixation during primary surgery, skin apposition without tension, and no sewage or organic contamination, among other criteria50. In general, primary closure has been suggested for type-I to type-IIIA tibial fractures when adequate viable soft tissue allows for tension-free closure and the patient has undergone meticulous debridement of the injury along with timely antibiotic prophylaxis8. Intraoperative cultures after debridement have demonstrated poor yield in predicting subsequent infection and should not dictate the timing of wound closure51. For fracture wounds requiring flap coverage, location of the injury, size of the defect, and zone of injury must collectively be assessed to determine if rotational or free flap coverage is optimal. Typically, fractures in the proximal two-thirds of the tibia are treated with rotational muscle flaps, whereas fractures in the distal third of the tibia require treatment with free flaps32. In a study of 174 patients with an open fracture in the distal third of the tibia, Yazar et al. found that free muscle flaps were comparable with free fasciocutaneous flaps with respect to flap survival, bone healing, and infection rates52.
Negative pressure wound therapy has garnered much attention as a method of providing provisional coverage for such wounds not amenable to primary closure. Stannard et al. randomized fifty-eight patients with severe open fractures requiring serial debridements to coverage with either negative pressure wound therapy or saline-solution-soaked dressings. The predominant fracture type included in this study was that of the tibia (42%), and 92% of the injuries were of type-III severity. The study found that there was a significant reduction in total infection rate (acute and late combined) with negative pressure therapy, although this estimate lacked precision as demonstrated by a wide confidence interval (relative risk [RR] = 0.20; 95% CI = 0.045 to 0.874). Furthermore, when acute and late infections were assessed independently, no significant difference was detected, likely due to insufficient study power53.
Irrespective of the use of negative pressure wound therapy, flap closure of open tibial fracture wounds should not be delayed beyond seven days after injury, as the risk of subsequent infection and other complications increases with time32,54,55. A recent systematic review evaluating open fracture wounds that required flap coverage corroborated the importance of early coverage. In a pooled analysis of seven studies—six of which specifically studied open tibial fractures—early coverage was associated with a significant reduction in infection risk (RR = 0.31; 95% CI = 0.18 to 0.53). Surprisingly, several of these studies employed an aggressive early flap-coverage practice (less than seventy-two hours after injury)56. In the absence of any randomized trials, however, the true efficacy of such aggressive timing for coverage remains to be explored.
Open tibial shaft fractures are a common yet challenging injury for the orthopaedic surgeon to manage. Several paramount strides have been made in establishing evidence-based treatment strategies for these patients, as study findings have endorsed the need for meticulous irrigation and debridement, prompt antibiotic prophylaxis, and primary wound closure under the appropriate circumstances. Furthermore, stabilization techniques of tibial shaft fractures have evolved considerably, with current evidence demonstrating superior outcomes with either reamed or unreamed intramedullary nailing for definitive management.
Nevertheless, there remains a need for additional high-quality evidence to clarify the efficacy of specific techniques and treatment practices under the umbrella of these accepted treatment areas. For instance, guidelines detailing the optimal irrigation solution and pressure, as well as the ideal duration of antibiotic prophylaxis, are difficult to establish due to a paucity of high-quality trials. Through large-scale randomized trials, the answers to such fundamentally important questions can hopefully be answered such that a global consensus on optimizing all aspects of management for these patients is reached.
Source of Funding: No funding was obtained in relation to the preparation of this manuscript.
Investigation performed at the Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada
Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.
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