Extensive bone and soft tissue defects may be observed in the setting of high-energy tibial shaft fractures. Although significant bone loss is only observed in an estimated 11.4% of open fractures, tibia fractures account for roughly two-thirds of these.1 This is due to the tibia's limited soft tissue envelope which predisposes it to bone extrusion in the setting of open fractures. Furthermore, iatrogenic bone loss from surgical debridement of highly comminuted fractures may lead to the development of a segmental defect, particularly in the setting of blunt trauma or crush injuries.1
Surgical reconstruction of these defects represents a major challenge for the treating surgeon and numerous techniques for managing segmental tibial bone loss have been described throughout the literature. Previously, amputation was the mainstay of treatment given the relatively high morbidity associated with these injuries.2 Limb salvage procedures including bone transport using the Ilizarov technique,3 acute limb shortening and relengthening,4 reconstruction using massive allografts5 or vascularized fibular grafts,6 and bone grafting with bone morphogenetic protein7 have all been adopted. The induced membrane technique described by Masquelet is now quickly becoming a frequently used technique for addressing large segmental defects in a variety of settings.8,9 This procedure typically employs traditional autogenous bone graft to fill the defect, and more recent studies have described the use of intramedullary bone graft harvest as a technique to provide large volumes of autogenous graft.10,11
Various schools of thought exist in regard to how a highly comminuted open tibial fracture is best managed to promote osseous union and prevent infection. Some may advocate for the use of provisional external fixation, followed by minimal bony debridement and definitive intramedullary fixation to preserve fracture biology and promote healing of the highly comminuted fragments. A conservative “wait and see” approach might then be used, addressing nonunion with a secondary surgery, should it occur. A second group, to which we belong, would perform a radical debridement of all comminuted, nonviable fragments to create a defect which would then subsequently be reconstructed using the techniques detailed below.
The patient is taken to the operating room and placed in a supine position. General anesthesia is induced and the leg is prepped and draped in the standard fashion. Working through the open fracture sites and extending these wounds both proximally and distally, a complete excisional debridement of all nonviable skin, subcutaneous tissue, muscle, periosteum, and bone is then performed with the goal of achieving a healthy and clean surgical wound. Surgical debridement may also proceed through the planned surgical incision to avoid additional trauma to the already injured soft tissues. Although color, consistency, contractility, and capacity to bleed (the 4Cs) are still frequently taught and used to assess muscle viability,12 recent work has shown that these may be poor indicators and lead to the excision of normal tissue.13 The “tug test” is then used to assess the viability of cortical bone fragments within the wound. Those that can be easily removed by a pair of forceps or 2 fingers are assumed to have insufficient viability and are thus discarded.14 This algorithm is modified slightly for bone fragments in the diaphyseal region compared with the metaphyseal region. In our opinion, when diaphyseal cortical fragments are completely free with no soft tissue attachments, they are nonviable and should be completely excised. However, in the metaphyseal region, given the rich periosteum, fragments that are free, yet maintain a healthy appearing periosteum, may be preserved. Particularly, if these fragments will be critical for the reduction of articular segments. In this circumstance, stabilization with lag screws, position screws or even fragment specific external fixation can help preserve fragment viability. This tactic must be considered carefully in that retention of grossly contaminated bone, regardless of potential viability may increase the risk for deep wound infection and nonunion. All viable fragments and reconstructable osteochondral or articular fragments are preserved. Once a meticulous debridement of the wound bed has been completed, the tourniquet (if used) should be deflated to ensure that all nonviable soft tissue and bone (that without punctate bleeding) has been adequately debrided.14–16 We recommend against the use of a tourniquet if possible, due to the increased difficulty of assessing the viability of the injured soft tissues. Furthermore, ischemia/reperfusion damage may result from tourniquet use, causing additional injury to this already compromised tissue.17
A thorough irrigation of the wound is then performed with 9 liters of normal saline,18 after which all gowns, gloves, drapes, and instruments are exchanged. Because many Gustilo type IIIB fractures will continue to demarcate after the initial debridement,19 we typically will return to the operating room for repeat excisional debridement every 24–96 hours until the soft tissue envelope is amenable to definitive reconstruction. Our assessment of viability, both for soft tissues and bone, is somewhat subjective based on the discretion of the surgeon; however, muscle tissue that is contractile has potential for survival and is often preserved. In terms of bone viability, we use the same assessment strategy for subsequent debridements as we do for the initial debridement. Diaphyseal segments that are free are discarded as “stripped” metaphyseal fragments. Osteochondral fragments are retained whenever possible unless they are grossly contaminated or unreconstructable based on small size.
Provisional or definitive bone stabilization may occur at the initial procedure and this is typically at the discretion of the surgeon based on the degree of bone and soft tissue injury and the adequacy of debridement. Provisional stabilization is typically achieved with either a joint spanning external fixator or with a proximal—distal tibial external fixator. The goal of provisional fracture reduction is to restore length, alignment and rotation and provide a stable soft tissue environment.
In the setting of high-energy trauma resulting in severe comminution, a thorough debridement may lead to the creation of a significant iatrogenic soft tissue or bone defect. Critical bone defects have traditionally been defined as a fracture gap ≥2 cm in length or involving >50% of the cortical diameter, which are unlikely to heal without a secondary intervention.20 Our technique for managing these critical defects has evolved over time. Previously, gentamicin-impregnated polymethylmethacrylate (PMMA) beads were used to fill larger bone voids followed by autologous bone grafting or bone transport. We now use PMMA intercalary spacers impregnated with antibiotics to preserve a healthy wound bed and allow for definitive reconstruction with massive bone graft or bone transport. We typically use 1–2 grams of vancomycin and 1.2–2.4 grams of tobramycin per 40 gram bag of cement. Once the spacer is placed, irrigation of the curing cement spacer is performed to prevent thermal necrosis of the surrounding tissue. Careful attention to the fascial closure is then necessary to ensure that the spacer remains within the segmental defect. Primary wound closure, a negative pressure wound dressing, or flap coverage are used as necessary. Typically, definitive reconstruction with autogenous bone grafting occurs within 4–8 weeks after wound closure or coverage based on the status of the soft tissue envelope.
One caveat to the previously described technique for managing comminuted segmental tibial fractures is our approach to the treatment of gunshot wounds. In the setting of low velocity (<2000 ft/s), low-energy gunshot wounds resulting in comminuted, open tibial fractures with a small external soft tissue injury, intravenous antibiotics and local wound care are sufficient treatment and do not require formal debridement before stabilization (see Figure 1, Supplemental Digital Content 1, http://links.lww.com/JOT/A132).21–24 Furthermore, in the case of low-energy gunshot wounds that do not require surgical fixation, antibiotics are not recommended.25 However, high-velocity (>2000 ft/s), high-energy gunshots may produce extensive cavitation and fractures with significant comminution, bone loss and soft tissue injury similar to Gustilo type IIIB and IIIC open fractures (see Figure 2, Supplemental Digital Content 2, http://links.lww.com/JOT/A133).22,24,26 Low-caliber bullets and shotguns fired from a close range may also produce extensive soft tissue injury and bone necrosis. In these cases, broad-spectrum intravenous antibiotics and repeat excisional debridement of devitalized tissue and contaminants using the technique previously described are required.21,24,26
A 29-year-old female with no past medical history presented to our institution as a pedestrian struck by a motor vehicle travelling at an unknown rate of speed. On examination, the patient had an obvious deformity of the left lower extremity and a Gustilo type IIIA open distal tibia and fibula fracture. The patient was completely neurovascularly intact. Radiographs were obtained which demonstrated a comminuted fracture of the left distal third tibia with a segmental bone defect (see Figure 3, Supplemental Digital Content 3, http://links.lww.com/JOT/A134). A bedside irrigation was performed in the emergency department to remove gross contaminants and the patient was started on intravenous antibiotics.
The patient was taken to the operating room later that day, where a thorough debridement of the open wound was performed. The full extent of the bone defect was appreciated intraoperatively, where she was observed to still have some posterior cortical contact, but nearly complete loss of 80% of the circumference of the tibia anteriorly over a distance of approximately 4 cm. All nonviable soft tissue and gross debris were removed from the wound. Additionally, several comminuted bone fragments were removed and a curette was used to debride the remaining bone edges before irrigation. Fluoroscopy was used to restore the tibia to length using the fibula as a guide. A reamed, statically locked intramedullary nail was then placed. In light of the large bone defect remaining, a PMMA antibiotic-impregnated spacer was created to fill in the bone void (see Figure 4, Supplemental Digital Content 4, http://links.lww.com/JOT/A135). The traumatic open wound was closed primarily at the end of the case.
Eight weeks later, the soft tissues had recovered and the decision was made to return to the OR for the second stage of the reconstruction. Intramedullary autogenous bone graft was harvested from the ipsilateral femur using the reamer-irrigator-aspirator. Dissection was performed at the defect site, and the antibiotic spacer was removed. The induced membrane wound bed was packed with the harvested bone graft (see Figure 5, Supplemental Digital Content 5, http://links.lww.com/JOT/A136). At her 10-week postoperative follow-up, the patient was allowed to begin to weightbear as tolerated and full consolidation of the graft was observed 6 months after surgery (see Figure 6, Supplemental Digital Content 6, http://links.lww.com/JOT/A137).
In the setting of highly comminuted, grossly contaminated open fractures, the role of an initial thorough debridement is well understood and is one of the basic tenets of managing orthopaedic trauma. Devitalized bone serves as an ideal substrate for bacterial colonization and biofilm adhesion.15,27–29 The hypovascular environment induced by soft tissue trauma does not allow for an appropriate immune response and thus provides a potential nidus for an acute or delayed infection.15,28,30 Furthermore, there is limited healing potential in this compromised environment due to significant soft tissue stripping, which increases the risk of delayed union or nonunion.31,32
In regard to the timing of the initial debridement of open fractures, previous guidelines favored surgical debridement within 6 hours of the injury.33,34 However, these guidelines have largely not been supported by recent literature. In a retrospective review of long bone fractures treated at a trauma center, Harley et al demonstrated no increase in the incidence of infections or nonunions from open fractures debrided up to 13 hours after the time of injury when early antibiotics were initiated. The strongest predictors of deep infection in this series were the Gustilo and Anderson fracture type and lower extremity fractures (P < 0.05).35 Similarly, the LEAP study group found the timing of debridement (less than 6 hours vs. 6–24 hours after the injury) did not impact the infection or union rates of type III open tibial diaphyseal fractures.36 In a recent systematic review of 16 studies including a total of 3539 open fractures, there was no evidence of an association between delayed debridement and infection in the treatment of open long-bone fractures, regardless of whether all infections or only deep infections were considered.37 In contrast, a study by Hull et al demonstrated a 3% per hour increased risk of deep infection for each hour the initial debridement of type II and III open fractures was delayed. In light of these findings, we feel that urgency is warranted in the timing of the initial debridement, but this should be balanced against the availability of an experienced and alert operative team and the physiologic stability of the patient to undergo surgery. Consistent with previous authors, we also advocate that large, grossly contaminated wounds or injuries sustained in the marine, sewage, or agricultural setting may benefit from earlier irrigation and debridement, without primary closure at the time of initial debridement.14,38,39
Although the timing of the initial debridement remains an ongoing area of investigation, numerous studies have validated the role of early administration of antibiotic prophylaxis for the treatment of open fractures.25,40–42 In early animal work by Burke, a short period of antibiotic prophylactic efficacy (<3 hours) was noted for the prevention of staphylococcal dermal or incisional infections.43 Patzakis and Wilkins later demonstrated a reduction of infection from 7.4% to 4.7% when antibiotics were administered within 3 hours versus delayed beyond that time frame.42 A recent retrospective study by Lack et al of type III open tibial fractures found that a delay greater than 66 minutes to the administration of antibiotics was an independent predictor of infection.44 Therefore, intravenous antibiotics should be administered as soon as possible to reduce the risk of infection.38,40
Wound irrigation remains a universally accepted part of the successful management of open fractures; however, there has historically been very little literature to support best practices in terms of irrigation method, volume, and solution additives used.18,45–47 Previously, Gustilo had advocated for “copious” irrigation to remove all gross debris and devitalized tissue from open fracture wounds.22 Although there is limited evidence to support this practice, many have adopted the recommendation by Anglen for the use of 3 L to irrigate type I fractures, 6 L for type II fractures, and 9 L for type III fractures based on the availability of 3 L irrigation bags.18
In terms of irrigation pressure, high pressure irrigation was previously thought to allow for greater removal of devitalized tissue and particulate debris.18,48,49 However, animal and in vitro models have demonstrated that high pressure irrigation further inoculates the surrounding soft tissues with bacteria and potentially compromises osseous integrity and healing.50–53 In a study by Bhandari et al, high-pressure pulsatile lavage (HPPL) was associated with significantly more macroscopic and microscopic osseous damage than low pressure pulsatile lavage (LPPL). Although both high and low pressure lavage were effective in removing adherent bacteria from bone within 3 hours following contamination, only high-pressure lavage effectively removed bacteria from bone when delayed greater than 6 hours.53 In an in vitro study by Draeger et al, HPPL was associated with greater tissue damage than both bulb syringe or brush-suction irrigation. Brush-suction irrigation was associated with significantly greater removal of inorganic contaminant than bulb syringe irrigation, but HPPL was not suggesting that this method of irrigation is perhaps less efficacious.52 Recently, the results of the Fluid Lavage of Open Wounds (FLOW) trial have suggested that reoperation rates are similar regardless of whether high pressure (13.2%), low pressure (12.7%), or very low pressure irrigation were used (13.7%). Although of questionable significance, a subgroup analysis from the trial suggested that very low pressure was superior to low or high pressure irrigation for tibial fractures in regard to the reoperation endpoint.45 Given the inconclusive data regarding pressure for open fracture irrigation, we continue to use high pressure irrigation for the debridement of open fractures.
The use of normal saline with or without solution additives has been an area of ongoing debate and investigation. Various studies have demonstrated in animal and in vitro models that antiseptic additives are detrimental to wound healing18,54–56 and may provide limited benefit in decreasing infection rates.18,57,58 The use of antibiotics such as neomycin and bacitracin in the irrigation of open fractures is relatively common despite inconsistent results regarding their efficacy.59–62 Furthermore, concerns exist related to the additional cost of antibiotics and the risk for increasing antibiotic resistance.18,47 Alternatively, surfactants such as soap have been shown to have superior efficacy,63,64 with decreased cost65 and no risk of antibiotic resistance. A study by Anglen demonstrated that bacitracin was no more effective than castile soap in reducing the rate of infections and that bacitracin may be associated with significantly more wound healing issues.65 More recently, the results of the FLOW trial indicated however that reoperation rates were significantly higher with castile soap (14.8%) than with normal saline (11.6%, P = 0.01). Although, we still routinely use bacitracin in our irrigation, the results of the FLOW trial suggest that patients irrigated with normal saline without additives are not receiving a lesser standard of care and may have an optimal outcome.
Many acknowledge the potential need for repeat excisional debridement in some type II and nearly all type III open fractures, particularly in the setting of highly contaminated wounds or those with an inadequate initial debridement. Previous authors have described an evolving zone of injury, in which damage to the soft tissues which is not immediately apparent upon the initial debridement manifests over a period of days, requiring repeat debridements, particularly in the setting of crush or blast injuries.66–68 However, Park et al previously demonstrated using an animal model that the effect of repeat irrigation and debridement may lead to the development of delayed healing and atrophic nonunions.50 Although delayed wound closure was previously widely accepted due to the associated high rates of infection with primary closure,41,69,70 more recent studies have demonstrated the safety and efficacy of early wound closure.71–74 However, certain wounds may not be amenable to primary closure or coverage within 72 hours. Rajasekaran proposed certain criteria that must be met for primary closure to be considered including: debridement within 12 hours of the injury, no skin loss during injury or from subsequent debridement, ability to approximate skin without tension, no gross contamination with feces, dirt or stagnant water, adequate debridement of all nonviable tissue, and no vascular insufficiency.75
We recommend primary closure of all type I, type II, and some type IIIA open fractures, with special attention given to the mechanism of injury, the adequacy of debridement, and the degree of gross contamination. We maintain a low threshold to return to the operating room if a healthy surgical wound is not achieved at the time of the initial debridement. Given that a delayed closure increases the risk for nosocomial infection,19,76,77 we advocate for definitive wound closure within 72 hours if possible. When delayed closure is necessary, there is increasing evidence to suggest that negative pressure wound therapy is an effective adjunctive therapy to reduce the infection rates and flap procedures required for open fracture wounds.78–80 Antibiotic beads also may serve as an excellent adjunctive therapy which can be used to elute high concentrations of antibiotics and obliterate dead space in the setting of tissue loss before definitive closure.38,81,82
In the setting of a radical debridement of nonviable bone in both open fractures or highly comminuted closed fractures, a significant bone defect may result requiring further management. Antibiotic-impregnated PMMA spacers provide an excellent option for managing both iatrogenic and traumatic bone voids. Cement spacers afford multiple benefits including the ability to locally administer high concentrations of antibiotics and increase fracture stability, maintain adequate soft tissue tension, and prevent fibrous ingrowth.2,81,83 Additionally, the induced membrane technique can be used to provide a well-vascularized periosteal envelope which will minimize bone graft resorption and allow for enhanced incorporation of the graft to facilitate fracture healing.2,8,9,83 The induced membrane produces high quantities of osteoinductive factors such as bone morphogenic protein-2 and growth factors including transforming growth factor-[beta]1 and vascular endothelial growth factor that stimulate cellular proliferation and promote bone marrow stromal cells to the osteoblastic lineage.9,84–86
Recent work by Nau et al using a femoral bone defect in a mouse model has demonstrated altered membrane characteristics with PMMA spacers impregnated with different antibiotics. When the groups were compared, significantly increased membrane thickness was observed with a gentamicin-impregnated PMMA spacer and a gentamicin plus vancomycin PMMA spacer as compared to a gentamicin plus clindamycin PMMA spacer and a pure PMMA spacer 6 weeks following membrane induction. Furthermore, the ratio of immature to more mature blood vessels increased significantly in groups with gentamicin and gentamicin plus vancomycin PMMA spacers with no significant alterations in the gentamicin plus clindamycin PMMA spacers or pure PMMA spacers.87 Previous work by Greene et al has demonstrated that tobramycin has superior elution characteristics from an antibiotic spacer compared to vancomycin.88 However, when tobramycin is used in combination with vancomycin, it has been shown to improve elution properties of both of the antibiotics and increase the bactericidal activity of vancomycin.89,90 Although additional work is needed to determine the ideal cement and antibiotic combination for these spacers, we have achieved reasonable success using a PMMA spacer impregnated with tobramycin and vancomycin, which provides a broad range of microbiologic coverage with notable synergistic effects against a majority of methicillin-susceptible and methicillin-resistant strains of Staphylococcus aureus.91
Along with newer means for treating open fractures, newer systems are emerging to better classify these injuries with a focus on prognosis and treatment. Numerous systems have previously been described for the classification of open fractures22,92–95; however, the Gustilo and Anderson classification system (introduced in 1976) remains the most widely adopted.22,70 This system was originally designed for use with open tibial fractures and has subsequently been applied more broadly for all open fractures. Despite the usefulness of this classification scheme, various authors have demonstrated poor to moderate interobserver reliability with this system.96,97 As such, a newer classification system for open fractures has been proposed. The Orthopaedic Trauma Association Open Fracture Classification (OTA-OFC) scheme classifies open fractures of the upper extremity, lower extremity, and pelvis in adult and pediatric populations. The goals of this classification scheme are to develop a system which: (1) focuses on injury characteristics defined by pathoanatomy, (2) provides an improved assessment of the various factors to be considered for treatment, (3) describes the extent of tissue system injury, and (4) provides a reliable tool for use in clinical and research settings.98,99 Various subcategories are used to assess the severity of the open fracture including the extent of skin injury, muscle injury, arterial injury, contamination, and bone loss.98
In regard to assessing the severity of the open fracture using the OTA-OFC, the end of the initial debridement was selected as the optimal time for evaluating the extent of the injury as accurate assessment of the deep tissues may not be possible before surgical exploration. Bone loss, in particular, is graded as (1) none, (2) bone missing or devascularized but still some contact, or as (3) segmental bone loss, depending on the severity of the injury.98 Due to the timing of the initial evaluation, extensive debridement of highly comminuted fractures may result in iatrogenic bone loss of devitalized fragments.
Although the OTA-OFC has only recently begun to be used in the literature, several studies have provided early validation of this emerging classification system. Agel et al demonstrated relatively high interobserver reliability of the system when used by both attending and resident orthopaedic surgeons. Nearly perfect reliability was observed for arterial injuries, whereas the reliability of skin injury, bone loss, and contamination ranged from moderate to substantial. Muscle injury had only fair reliability but was still superior to that related to the Gustilo and Anderson classification assessment.99 Another study by Agel et al sought to determine whether or not the OTA-OFC was predictive of early amputation and particular clinical outcomes. This retrospective study demonstrated that multiple debridements (≥2) were best predicted by the severity of the skin injury and muscle injury, whereas bone loss was the strongest predictor of antibiotic bead placement. Early amputation was predicted by the extent of skin injury, contamination, and arterial injury.100 These results were supported by another recent study by Hao et al, which found that the severity of the skin injury component of the OTA-OFC was an independent predictor for limb amputation (OR = 5.44). Additionally, this study demonstrated that a summative score of ≥10 of OTA-OFC was also highly predictive of limb amputation (P < 0.001).101 Taken together, this early work demonstrates that the OTA-OFC has superior interobserver reliability and predictive capacity as compared to the Gustilo and Anderson classification; however, more prospective studies are needed to validate this.
In the case of severely comminuted tibial shaft fractures, the role of an initial early debridement cannot be understated. All nonviable bone fragments and soft-tissue can serve as a potential nidus for infection or result in the development of a nonunion and therefore should be excised. In the setting of a resulting iatrogenic bone void, newer reconstructive techniques continue to emerge, providing the orthopaedic surgeon with a variety of approaches to address these defects. The appropriate method of reconstruction must be considered on an individualized basis and tailored to each patient to help them achieve their desired level of postoperative function. Although the care of open fractures has evolved immensely over the last century, there is still a great deal of research being done to determine best practices and provide empiric treatment recommendations. It is likely that larger multicenter studies and collaboration will help us to better define these. Ultimately, this will allow us to further optimize patient outcomes following these devastating injuries.
We would like to acknowledge Dr John Wyrick and Dr Toan Le for their assistance in providing representative cases demonstrating our preferred reconstructive techniques for segmental defects.
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