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Femoral fractures may fail to unite because of the severity of the injury. Nail dynamization, exchange nailing, and plate osteosynthesis can help. Some of the currently available treatment techniques are successful in only 50% to 80% of patients.
Femoral fractures may fail to unite because of the severity of the injury. Nail dynamization, exchange nailing, and plate osteosynthesis can help. Some of the currently available treatment techniques are successful in only 50% to 80% of patients.
Femoral fractures may fail to unite because of the severity of the injury. Nail dynamization, exchange nailing, and plate osteosynthesis can help. Some of the currently available treatment techniques are successful in only 50% to 80% of patients.
Treatment Options Abstract Despite advances in surgical technique, fracture fixation alternatives, and adjuncts to healing, femoral nonunion continues to be a significant clinical problem. Femoral fractures may fail to unite because of the severity of the injury, damage to the surrounding soft tissues, inadequate initial fixation, and demographic characteristics of the patient, including nicotine use, advanced age, and medical comorbidities. Femoral nonunion is a functional and economical challenge for the patient, as well as a treatment dilemma for the surgeon. Surgeons should understand the various treatment alternatives and their role in achieving the goals of deformity correction, infection management, and optimization of muscle strength and rehabilitation. Used appropriately, nail dynamization, exchange nailing, and plate osteosynthesis can help minimize pain and disability by promoting osseous union. A review of the potential risk factors and treatment alternatives should provide insight into the etiology and required treatment of femoral nonunion. M anagement of femoral diaphy- seal fractures with a medul- lary device typically results in union rates ranging between 90% and 100%. 1-3 Nevertheless, femoral non- union does occur. The incidence may be higher than previously re- ported, given the greater likelihood of survival of the polytraumatized patient and improved limb salvage techniques. The patient with femo- ral nonunion is faced with signifi- cant functional and economic prob- lems, including persistent disability, gait abnormality, and prolonged physical and psychological disabili- ty. Some of the currently available treatment techniques are successful in achieving union in only 50% to 80% of patients, 4-6 which is much lower than indicated by the older lit- erature. 7,8 These relatively poor re- sults have sparked interest in the de- velopment of newer implants 9 and biologic agents. 10,11 Surgeons must counsel patients appropriately and choose the optimal intervention for the specific characteristics of the pa- tient and nature of the injury. Definition of Nonunion The definition of nonunion typically hinges on three important variables: the duration of time since the injury, characteristics of the fracture noted on serial radiographs, and clinical pa- rameters that the treating surgeon can identify with a careful history and thorough physical examination. Currently, the US Food and Drug Ad- ministration (FDA) defines nonunion Joseph R. Lynch, MD Lisa A. Taitsman, MD, MPH David P. Barei, MD Sean E. Nork, MD Dr. Lynch is Fellow and Acting Instructor, Department of Orthopaedics and Sports Medicine, University of Washington School of Medicine, Seattle, WA. Dr. Taitsman is Assistant Professor, Department of Orthopaedics and Sports Medicine, University of Washington School of Medicine. Dr. Barei is Associate Professor, Department of Orthopaedics and Sports Medicine, University of Washington School of Medicine. Dr. Nork is Associate Professor, Department of Orthopaedics and Sports Medicine, University of Washington School of Medicine. None of the following authors or a member of their immediate families has received anything of value from or owns stock in a commercial company or institution related directly or indirectly to the subject of this article: Dr. Lynch, Dr. Taitsman, Dr. Barei, and Dr. Nork. Reprint requests: Dr. Lynch, Department of Orthopaedics and Sports Medicine, University of Washington Medical Center, Box 356500, 1959 NE Pacific Street, Seattle, WA 98195. J Am Acad Orthop Surg 2008;16: 88-97 Copyright 2008 by the American Academy of Orthopaedic Surgeons. 88 Journal of the American Academy of Orthopaedic Surgeons as a fractured bone that has not com- pletely healed within 9 months of injury and that has not shown pro- gression toward healing over 3 con- secutive months on serial radio- graphs. 12 Many authors suggest that the optimal time for healing is from 4 to 12 months, depending on the bone in question, the location of the fracture, the nature of the injury, and the quality of the soft tissues. 5,7,8,13-18 The time it takes a bone to heal is variable and depends not only on the aforementioned factors but on the physiologic capability of the individ- ual patient. Radiographic criteria that support the diagnosis of nonunion include the absence of bone crossing the fracture site (bridging trabeculae), sclerotic fracture edges, persistent fracture lines, and lack of evidence of progressive change toward union on serial radiographs. The presence or absence of callus is less reliable as an indicator of nonunion; its useful- ness is dependent on the index treat- ment chosen by the surgeon. Callus formation associated with secondary bone healing is expected in a diaphy- seal femoral fracture treated with a bridging implant (eg, medullary nail); thus, the absence of a callus may be indicative of nonunion. However, the surgeon should expect primary bone healing in the fracture treated with compression plate os- teosynthesis in which absolute sta- bility was achieved. In this instance, the absence of callus would not nec- essarily be suggestive of nonunion. Clinically, nonunion may pro- duce persistent pain or motion at the fracture site, both of which may be elicited by either direct manipula- tion during physical examination or with attempted weight bearing. A patient may demonstrate an antalgic gait and require narcotic pain medi- cation and ambulatory assistive de- vices (eg, cane, crutches). These ra- diographic and clinical criteria are important in accurately diagnosing femoral nonunion. Classification Femoral nonunions can be classified according to the criteria described by Weber and Cech. 19 This classification is based on the principle of osseous viability, with fractures divided into viable and nonviable subtypes. A vi- able nonunion has an intact blood supply and is capable of mounting a healing response to injury. Subtypes within this classification include hypertrophic nonunion and oligo- trophic nonunion. A hypertrophic nonunion displays exuberant callus on anteroposterior (AP) and lateral ra- diographs, demonstrates increased uptake on radionuclide scans, and represents inadequate stability in the setting of an adequate blood supply and healing response (Figure 1, A). In contrast, oligotrophic nonunion, which also has an intact blood sup- ply and demonstrates radiotracer up- take on radionuclide scans, differs in that it possesses an inadequate heal- ing response characterized by evi- dence of little or no callus on AP and lateral radiographs (Figure 1, B). A nonviable femoral nonunion is often called an atrophic or avascular nonunion. These nonunions demon- strate ischemic or cold radionuclide scans, indicating a complete lack of the normal biologic response to inju- ry. Radiographically, atrophic non- unions demonstrate eburnated, os- teopenic, and/or sclerotic bone ends. On occasion, these injuries are radio- graphically similar, if not indistin- guishable, from oligotrophic non- unions (Figure 2). In clinical practice, viable and nonviable nonunions usually are identified based on characteristics observed on serial ra- diographs. Radionuclide scans are infrequently used. Nevertheless, dis- Figure 1 A, Lateral radiograph of a viable hypertrophic nonunion of the distal femoral diaphysis demonstrating abundant fracture callus and an adequate healing response to the original injury in the setting of inadequate stability. B, Lateral radiograph of a viable oligotrophic nonunion of the femoral diaphysis demonstrating little to no fracture callus and an inadequate healing response to the original injury in the setting of adequate stability. A technetium bone scan would show increased uptake in this case. Joseph R. Lynch, MD, et al Volume 16, Number 2, February 2008 89 tinction is important because this classification can help guide appro- priate treatment. Diagnosis and Evaluation The diagnosis and evaluation of fem- oral nonunion begins with the pa- tient history and a careful account of the original injury, including identi- fication of any associated traumatic open wounds. The patients charac- terization of pain and fracture site mobility is important in understand- ing the nature of the nonunion. De- mographic and patient characteristics that are potential risk factors for non- union (eg, tobacco use, peripheral vascular disease, use of nonsteroidal anti-inflammatory drugs [NSAIDs]) should be recognized. Additionally, it is important to identify clinical symptoms of infection, such as mal- aise, fever, fatigue, night pain, and/or a history of wound healing problems (eg, persistent drainage). The physical examination should identify deformity, pain at the frac- ture site, disruption of the soft tis- sues, warmth, erythema, and drain- age. Fracture site stability and pain on manipulation should be assessed. An objective evaluation of limb vas- cularity should document distal pulses, skin temperature, and hair distribution. A more formal assess- ment of vascular integrity may be warranted for the patient with a his- tory of vascular injury during either the initial injury or subsequent treatment. This may be done with measurement of the ankle-brachial index or an arterial duplex examina- tion. 20 The initial radiographic evalua- tion includes AP, lateral, and oblique views (45 internal and external) of the affected limb. In most patients, this is sufficient to confirm the ra- diographic diagnosis of nonunion. The character of the nonunion (via- ble versus nonviable), measurement of the mechanical and anatomic axes, and preoperative planning can be determined from these studies. Examination under fluoroscopy to assess motion can occasionally be helpful when the clinical and radio- graphic diagnoses are inconclusive. Occasionally, a technetium bone scan is useful for distinguishing be- tween viable and nonviable non- unions, for diagnosing an occult nonunion, and for helping choose an appropriate treatment modality. This distinction between viable and nonviable is important when deter- mining the appropriate treatment for an individual patient. For a patient with oligotrophic nonunion, the sur- geon may opt to attempt a minimal- ly invasive (eg, nail dynamization) or a noninvasive (eg, ultrasound) tech- nique to achieve union. For a truly atrophic or nonviable nonunion, os- teogenic techniques combined with an open procedure and skeletal stabi- lization are recommended. Computed tomography has been shown to be more accurate than plain radiography in the diagnosis of tibial nonunion. 21 Although limited by metal artifact, it can accurately assess the integrity of bridging cal- lus, the presence and character of a pseudarthrosis, and the location and size of sequestrumin cases associat- ed with infection. Infection should be a consider- ation in all cases of femoral non- union. Thus, preoperative laboratory analysis should include a complete blood count with differential, eryth- rocyte sedimentation rate, and C-reactive protein level. When the clinical presentation and laboratory analysis are suggestive of infection, radionuclide and indium 111la- beled leukocyte scans may be help- ful in localizing the extent of dis- ease. 22 The benchmark for diagnosis of infection is tissue culture at the time of a secondary surgical proce- dure. 23 Antibiotics should be discon- tinued 7 to 14 days before surgery to improve the yield of the intraopera- tive cultures. Intraoperative speci- mens should be evaluated with a Gram stain and processed for aero- bic, anaerobic, and fungal cultures, as well as acid-fast stain. Risk Factors The four main causes of nonunion are motion (inadequate fracture sta- bility), avascularity (open fracture, stripping during surgery), fracture gap (bone loss, nailing in distrac- tion), and infection. Excessive mo- tion in surgically managed fractures may result from inadequate initial fixation and/or implant failure. In the setting of adequate vascularity, excessive motion typically results in hypertrophic nonunion, character- ized by an abundance of callus, wid- ening of the fracture site, and failure of fibrocartilage mineralization. Avascularity resulting from open fractures, aggressive reaming, and excessive surgical stripping may contribute to the development of a Figure 2 Anteroposterior radiograph of a nonviable nonunion of the femoral diaphysis demonstrating an atrophic and osteopenic fracture with no callus formation, indicating a lack of an appropriate healing response to the original injury. A technetium bone scan would show decreased uptake in a case such as this. Femoral Nonunion: Risk Factors and Treatment Options 90 Journal of the American Academy of Orthopaedic Surgeons nonunion by injuring the periosteal and endosteal blood supply. 24,25 Open fractures 26 have been associated with femoral nonunion, as has the need for open reduction during closed nailing. 15 Multivariate analyses indi- cate that open femur fractures with significant comminution, indicating greater soft-tissue stripping, have an increased risk of nonunion. 16 The ef- fect of reaming before nailing is less clear. Although vascular studies demonstrate that reaming has a neg- ative impact on endosteal circula- tion, these studies also demonstrate a paradoxical rise in periosteal circu- lation, which is thought to play a larger role in callus formation. 25 Clinical studies analyzing the effects of reaming for femoral shaft frac- tures have shown a significantly greater risk of femoral nonunion when a nail is inserted without reaming (7.5%) compared with cases in which the canal is reamed before nail insertion (1.7%; P = 0.049). 1 The presence of a gap, either be- cause of traumatic bone loss or the treatment used (nailing in distrac- tion, bony dbridement) also may contribute to the development of nonunion. 17 Any gap present after definitive treatment must be bridged by fracture callus during the healing process. When bridging cannot oc- cur, further intervention is required to manage the resulting cortical de- fect. The magnitude of this defect is variable and depends on the constel- lation of injury characteristics as well as the physiologic capability of the patient. Infection can occur as a complica- tion of the injury (eg, open fracture) or as a complication of treatment. Infection typically results in the for- mation of necrotic bone (seques- trum), ingrowth of granulation tis- sue, osteolysis, and excessive fracture motion secondary to im- plant loosening or failure. Recent studies have demonstrat- ed associations between nonunion and specific patient variables, such as tobacco use, NSAIDs, and medi- cal comorbidities. In a review ana- lyzing the Ilizarov technique for re- construction of the femur and tibia, McKee et al 27 demonstrated signifi- cant associations between smoking and the development of nonunion (P = 0.031). Retrospective clinical studies have demonstrated a greater union rate in nonsmokers (84%) compared with smokers (58%). 28 In a case-control study of 32 femoral di- aphyseal nonunions, Giannoudis et al 14 demonstrated no significant as- sociation between smoking and the development of nonunion. However, they did find that the use of NSAIDs increased the relative odds of non- union dramatically (OR, 10.75; CI, 3.5 to 33.2). In a case-control study of diaphyseal injuries involving the femur, tibia, and humerus, Malik et al 15 demonstrated that a higher American Society of Anesthesiolo- gists (ASA) score (a surrogate for medical comorbidities; P < 0.001) was predictive of nonunion. Treatment of Nonunion of the Femur Achieving osseous union without complications is the ultimate goal of treatment, but it is not the only goal. Correction of malalignment, eradi- cation of infection, optimization of muscle strength, and rehabilitation are also important. All of these ob- jectives should be considered when planning a treatment strategy. Be- yond a well-planned and executed surgical procedure, the patients medical comorbidities and nutri- tional status should be optimized to maximize the chances for success. Additionally, nicotine use and other medications (eg, NSAIDs, metho- trexate) that may negatively affect os- teogenesis should be stopped or mod- ified. Treatment options include nail dynamization, exchange nailing, plate osteosynthesis, external fixation, and adjuvant alternatives (eg, electrical stimulation, bone grafting, bone mor- phogenetic proteins [BMPs]). Nail Dynamization Dynamizationrefers to the conver- sion of a statically locked nail to a dy- namically locked nail. This is accom- plished by the removal of some combination of the proximal or dis- tal interlocking screws, thereby al- lowing for controlled axial instability of the bone-implant construct. Inthe- ory, dynamization allows transfer of weight-bearing forces to the non- unionsite, thereby stimulating osteo- genesis and fracture union 29 (Figure 3). The stimulus of weight bearing and intermittent loading in a fracture not previously subjected to loading may be sufficient to induce healing. 30 This treatment alternative is relatively simple to perform and may be effec- tive in axially stable injuries origi- nally managed with statically locked medullary nails. 18 The current literature suggests that dynamization has a 50%success rate of achieving union. 17,18,31 How- ever, a significant prevalence of com- plications has been reported. The most notable is shortening of >2 cm, which is estimated to occur in 20% of patients treated with nail dynam- ization. 17,18,31 Fracture characteristics associated with shortening and treat- ment failure include long oblique, spiral, and highly comminuted frac- tures. Close follow-up is recom- mended for patients with these frac- ture characteristics who are treated with nail dynamization, and careful consideration should be given to al- ternative treatment. 18 Nail dynam- ization is best reserved for the axially stable femoral shaft nonunion. The use of the dynamic locking hole is advocated to minimize anticipated shortening and maintain rotational stability. Dynamization may be more effective when performed early (3 to 6 months after injury) rather than late (ie, with established nonunion). Exchange Nailing Exchange nailing refers to the practice of removing an already present medullary implant, reaming the medullary canal to a larger diam- Joseph R. Lynch, MD, et al Volume 16, Number 2, February 2008 91 eter, and inserting a larger-diameter nail (Figure 4). This technique stim- ulates bone union mechanically and biologically. Sequential reaming en- larges the medullary canal and facil- itates insertion of a larger and stiffer implant. Additionally, exchange nailing affords greater stability by in- creasing the length of the isthmic portion of the medullary canal, which increases the implant- endosteal contact area. The biologic stimuli that promote union follow- ing exchange nailing include the deposition of autogenous bone graft at the nonunion site and the stimu- lation of a periosteal healing re- sponse through the process of fem- oral canal reaming. The actual amount of reamings that are depos- ited at the site of the nonunion is un- known but likely is minimal. Variable rates of fracture consoli- dation have been reported after ex- change nailing for primary treatment of femoral diaphyseal nonunion. 4,7,8,13 Kempf et al 7 reported a 93% union rate in their review of 27 patients with femoral nonunion who were treated with exchange nailing. Webb et al 8 reported a 97% union rate. In this series, the fractures that did not heal following the first exchange nailing did so after a repeat exchange nailing procedure. More recent series demonstrate much lower union rates following exchange nailing for fem- oral nonunion. 5,13,32 In these series, a higher prevalence of persistent non- union among smokers was reported, but the authors were unable to dem- onstrate a statistically significant correlation with other factors, in- cluding type of nonunion, fracture lo- cation, type of nail, and the use of statically or dynamically locked nails. 4,5,13 In a retrospective reviewof 19 femoral nonunions managed with exchange nailing, Weresh et al 5 re- ported a persistent nonunion rate of 53% at 35 weeks, which challenges the efficacy of exchange nailing as a panacea for femoral nonunion. In this series, 47% of patients required an additional procedure, including open autogenous bone grafting, to achieve osseous union. An attempt should be made to ex- change the existing implant for a nail that is both larger in diameter (by 1 to 2 mm) and stiffer by increasing the nail diameter or wall thickness, or both. The canal should be reamed un- til osseous chatter is heard; the goal is to ream1 to 1.5 mmlarger than the anticipated implant. In axially stable patterns, consideration should be given to placing nails in a dynami- cally locked fashion using the dy- namic holes currently available in most nail designs. Unless significant atrophic changes are noted on preop- erative radiographs, adjuvant open bone grafting procedures generally are not performed during the first at- Figure 3 Anteroposterior (A) and lateral (B) radiographs of femoral diaphyseal nonunion in a 26-year-old man who was treated with a reamed antegrade statically locked medullary nail. At 7 months following fracture, he presented with an antalgic gait. Anteroposterior (C) and lateral (D) radiographs demonstrating healing of the femoral diaphyseal nonunion 6 months following nail dynamization. Femoral Nonunion: Risk Factors and Treatment Options 92 Journal of the American Academy of Orthopaedic Surgeons tempt at exchange nailing. Openbone grafting with autogenous graft, how- ever, should be considered when re- peat exchange nailing is attempted af- ter failure of one exchange nailing. Despite union rates that are more modest than initially reported, ex- change nailing for femoral nonunions allows early weight bearing and un- restricted motion of adjacent joints, while typically producing higher rates of fracture consolidation than do less invasive techniques such as nail dy- namization. Reamed nailing also may be used as a salvage procedure for nonunion following plate fixation of the fe- mur. 33 Following plate removal, an appropriately sized locked reamed nail is placed in the usual fashion. Consideration should be given to closing the soft-tissue envelope fol- lowing plate removal and before reaming to allowfor local deposition of the reamings. Plate Osteosynthesis Plate osteosynthesis offers specif- ic advantages over nail dynamiza- tion and exchange nailing. Plating offers enhanced mechanical stability for hypertrophic nonunion. For oli- gotrophic and atrophic nonunion, plating may be combined with bone grafting to enhance both the biolog- ic and the mechanical environment for union. Although exchange nail- ing may be considered in oligo- trophic and atrophic nonunions, some of the theoretical advantages of performing a closed technique are diminished in patients in whom ad- junctive open bone grafting is simul- taneously performed to enhance the local biology. In these situations, the surgeon should give consideration to plate osteosynthesis. Open plating also is indicated in some proximal and distal metadiaphyseal nonunions (Figure 5). These injuries can be dif- ficult to manage withmedullary nails because these regions of the femur will not have direct endosteal contact with the medullary implant, thus di- minishing the stability of the overall construct. Open reduction and plate fixation facilitates correction of asso- ciated deformity, affords better axial and torsional stability, and allows for the application of direct compression across the nonunion site. 34 The treat- ment of active or indolent infection associated with femoral nonunion may be facilitated with plate fixation by allowing a thorough dbridement of sequestrum and involucrum via open techniques. Bellabarba et al 35 reported a 91% union rate at 3 months in 23 patients treated with plating for femoral non- union following medullary nailing. The authors used the AO 95 condy- lar blade plate in distal and proximal one third nonunions of the femo- ral shaft. They used the broad large- fragment dynamic compression plate Figure 4 Anteroposterior (A) and lateral (B) radiographs of a 52-year-old man with a distal one third femoral diaphyseal nonunion 6 months following treatment with a reamed antegrade statically locked medullary nail. Note the broken distal locking screws. Anteroposterior (C) and lateral (D) radiographs demonstrating a healed femoral diaphyseal nonunion 6 months following exchange nailing with a larger-diameter and stiffer implant placed in a dynamic fashion. Joseph R. Lynch, MD, et al Volume 16, Number 2, February 2008 93 in nonunions of the middle one third of the femur and emphasized metic- ulous attention to the protection of soft tissues. Adjunctive autogenous bone grafting was used for all atro- phic nonunions and selective oli- gotrophic nonunions that demon- strated a significant bony defect or unfavorable bony architecture that would prevent compression without significant shortening. These authors considered this technique particu- larly valuable in the presence of de- formity. Abdel-Aa et al 36 reported a 100% union rate in their series of femoral nonunions managed with plate osteosynthesis. Severely recal- citrant nonunions treated with the wave plate have been reported to re- sult in union rates between 95%and 98% at 6 to 12 months. 9,37 Although these studies are not directly compa- rable because of their retrospective nature, these results are superior to those reported for exchange nailing. Plate osteosynthesis is not with- out risks and disadvantages. Com- pared with closed medullary nailing, plate osteosynthesis has been shown to be associated with a higher risk for infection, greater blood loss, and fur- ther devascularization to soft tissues in an area that has been previously injured. 9,35,37-39 Additionally, plate os- teosynthesis frequently requires re- stricted postoperative weight bearing, possibly decreasing the benefits of mechanical loading of the nonunion site, as well as slowing rehabilitation. In the study by Abdel-Aa et al, 36 13% of patients required quadricepsplasty and knee arthrolysis postoperatively for significant stiffness at 1 year. Another technique involves the use of compressionplating around the existing medullary implant. In three reviews of femoral nonunions man- aged withthis technique, a unionrate of 100% was reported at an average of 7 months. 39-41 This method com- bines the advantages of medullary nailing (eg, immediate weight bear- ing) with the advantages of plate os- teosynthesis (eg, the ability to apply interfragmentary compression) and offers improved stability in the meta- diaphyseal regionof a long bone. If de- sired, autogenous bone grafting may be performed through the same sur- gical exposure. We do not have suffi- cient experience with this technique to support or refute the evidence pre- sented; however, the advantage of al- lowing earlier weight bearing com- bined with the benefits attributed to compression plate osteosynthesis make this technique an attractive al- ternative inthe appropriate situation. Plate osteosynthesis for the man- agement of femoral nonunion fol- lowing nailing results in a high rate of union. The authors primary indi- cation for plate osteosynthesis is metaphyseal and metadiaphyseal femoral nonunions associated with Figure 5 Anteroposterior (A) and lateral (B) radiographs of a 32-year-old man with a femoral diaphyseal nonunion 10 months following treatment with a reamed retrograde statically locked medullary nail. Anteroposterior (C) and lateral (D) radiographs demonstrating a healed femoral diaphyseal nonunion 4 months following nail removal, open dbridement, autogenous bone grafting, and plate osteosynthesis. Femoral Nonunion: Risk Factors and Treatment Options 94 Journal of the American Academy of Orthopaedic Surgeons significant malalignment. In situa- tions requiring open dbridement of infected tissue or in nonunions re- quiring bone grafting, plate osteo- synthesis through the same surgical exposure is a logical and successful form of nonunion stabilization. De- spite the high reported union rates, plate osteosynthesis requires large surgical exposures and may be asso- ciated with increased perioperative morbidity. Important considerations for successful plate osteosynthesis include meticulous surgical dissec- tion, limited soft-tissue stripping, and, when possible, compression of the nonunion site. External Fixation External fixation has been re- ported for the treatment of femoral nonunion. The Ilizarov technique has been described in small case se- ries, with good results in aseptic nonunions. 42,43 The small patient numbers indicate that these tech- niques are used less frequently than dynamization, exchange nailing, and plate osteosynthesis. Compression and distraction using half-pin and tensioned-wire external fixators has been described as being capable of providing a mechanical stimulus that facilitates union. 44 However, pain necessitating strong analgesic agents and pin-related complications (eg, osteomyelitis, septic arthritis, pin failure) continue to be significant limitations. The complexity and as- sociated economic costs suggest that these techniques should be limited to tertiary care centers with experi- enced surgeons. 43 External fixation may be most useful for managing in- fected femoral nonunion. Adjuvant Treatment Alternatives Additional treatments have been used either in isolation or, more commonly, as adjuvants to one of the skeletal stabilization methods previously described. These include electrical stimulation, bone grafting and bone graft substitutes, and the application of newer biologics such as BMPs. The principal advantage of electri- cal stimulation as an adjuvant treat- ment is its minimal risk. For this reason, many surgeons choose to use it for difficult femoral nonunions in conjunction with medullary nailing or plate fixation. Electrical stimula- tion as a stand-alone procedure for the ununited tibia has produced higher rates of healing than casting alone, but there are few data con- cerning the femur. 45,46 We rarely use it in isolation. The numerous con- traindications to the use of electrical stimulation include the presence of a gap at the nonunion site, synovial pseudarthrosis, and significant os- seous devascularization. Autogenous bone, allograft bone, bone marrow aspirate, BMPs, and combinations thereof may be added to the nonunion site as isolated pro- cedures. The results of aseptic fem- oral nonunions treated with bone grafting as an isolated and open pro- cedure have not demonstrated great- er efficacy than exchange nailing alone, and we rarely choose this technique. 47 Most commonly, they are used as adjuvants along with ex- change nailing and plate osteosyn- thesis techniques. We choose one of these adjuvants for patients requir- ing repeat exchange nailing, or when plate osteosynthesis is used and ad- equate compression across the frac- ture site cannot be obtained. BMP has been studied extensively in animal models as well as in pro- spective randomized clinical trials in humans. It is effective as a treatment alternative for recalcitrant nonunion in the tibial diaphysis. 10,11 In one study, 11 patients with tibial non- union were randomized to either re- combinant human BMP-7 (rhBMP-7) or autogenous bone grafting as an ad- junct to medullary nailing. Efficacy of rhBMP-7 was similar to autoge- nous bone grafting in this study (81% union with rhBMP-7 versus 85% with graft; P = 0.524). The FDA issued a humanitarian device exemp- tion for the application of rhBMP-7 as an alternative to autograft in re- calcitrant long bone nonunion in which the use of autograft is not fea- sible and alternative treatments have failed. However, the efficacy of this adjunctive treatment has not been specifically reported with femoral nonunion. Also, the robust bone for- mation and healing potential demon- strated in animal models has not, as yet, been as impressive in clinical se- ries evaluating ununited fractures of long bones in humans. 10,11 Summary Management of acute femoral diaphy- seal fracture with a medullary device has one of the most predictable out- comes in orthopaedic surgery, with unionrates ranging between90%and 100%in most series. However, when a femoral shaft fracture fails to unite, it becomes a difficult problemfor the surgeonand presents significant func- tional and economic challenges for the patient. Careful history, physical examination, and radiographic eval- uation can confirm the diagnosis of nonunion and are essential in formu- lating an appropriate treatment plan. Consideration should be given to the optimization of modifiable risk fac- tors such as nutritional status, nico- tine, NSAIDuse, and medical comor- bidities. Treatment options should be individualized based on patient and fracture characteristics to achieve os- seous union, correct malalignment, eradicate infection, and optimize muscle strength and rehabilitation. References Evidence-based Medicine: There are six level I/II studies (references 1, 11, 21, 22, 45, and 46), along with several level III/IV cohort and case-control studies (references 2-9, 13-18, 26-28, 30-33, 35-37, 39-44, and 47). Citation numbers printed in bold type indicate references published within the past 5 years. Joseph R. Lynch, MD, et al Volume 16, Number 2, February 2008 95 1. CanadianOrthopaedic Trauma Society: Nonunion following intramedullary nailing of the femur with and without reaming: Results of a multicenter ran- domized clinical trial. J Bone Joint Surg Am 2003;85:2093-2096. 2. Winquist RA, Hansen ST Jr, Clawson DK: Closed intramedullary nailing of femoral fractures: A report of five hundred and twenty cases. J Bone Joint Surg Am 1984;66:529-539. 3. Wolinsky PR, McCarty E, Shyr Y, Johnson K: Reamed intramedullary nailing of the femur: 551 cases. J Trauma 1999;46:392-399. 4. Hak DJ, Lee SS, Goulet JA: Success of exchange reamed intramedullary nailing for femoral shaft nonunion or delayed union. J Orthop Trauma 2000;14:178-182. 5. Weresh MJ, Hakanson R, Stover MD, Sims SH, KellamJF, Bosse MJ: Failure of exchange reamed intramedullary nails for ununited femoral shaft frac- tures. J Orthop Trauma 2000;14:335- 338. 6. Wu CC, Shih CH: Effect of dynamiza- tion of a static interlocking nail on fracture healing. Can J Surg 1993;36: 302-306. 7. Kempf I, Grosse A, Rigaut P: The treatment of noninfected pseudar- throsis of the femur and tibia with locked intramedullary nailing. Clin Orthop Relat Res 1986;212:142-154. 8. Webb LX, Winquist RA, Hansen ST: Intramedullary nailing and reaming for delayed union or nonunion of the femoral shaft: A report of 105 consec- utive cases. Clin Orthop Relat Res 1986;212:133-141. 9. Cove JA, Lhowe DW, Jupiter JB, Silis- ki JM: The management of femoral di- aphyseal nonunions. J Orthop Trauma 1997;11:513-520. 10. Einhorn TA: Clinical applications of recombinant human BMPs: Early ex- perience and future development. J Bone Joint Surg Am 2003;85(suppl 3):82-88. 11. Friedlaender GE, PerryCR, Cole JD, et al: Osteogenic protein-1 (bone mor- phogenetic protein-7) in the treat- ment of tibial nonunions. 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Wu CC, Shih CH, Chen WJ, Tai CL: Effect of reaming bone grafting on treating femoral shaft aseptic non- union after plating. Arch Orthop Trauma Surg 1999;119:303-307. 34. Meyer RW, Plaxton NA, Postak PD, Gilmore A, Froimson MI, Greenwald AS: Mechanical comparisonof a distal femoral side plate and a retrograde in- tramedullary nail. J Orthop Trauma 2000;14:398-404. 35. Bellabarba C, Ricci WM, Bolhofner BR: Results of indirect reduction and plating of femoral shaft nonunions af- ter intramedullary nailing. J Orthop Trauma 2001;15:254-263. 36. Abdel-Aa AM, Farouk OA, Elsayed A, Said HG: The use of a locked plate in the treatment of ununited femoral shaft fractures. J Trauma 2004;57: 832-836. 37. Ring D, Jupiter JB, Sanders RA, et al: Complex nonunion of fractures of the femoral shaft treated by wave-plate osteosynthesis. J Bone Joint Surg Br 1997;79:289-294. 38. Rozbruch SR, Mller U, Gautier E, Ganz R: The evolution of femoral shaft plating technique. Clin Orthop Relat Res 1998;354:195-208. 39. Ueng SW, Chao EK, Lee SS, Shih CH: Femoral Nonunion: Risk Factors and Treatment Options 96 Journal of the American Academy of Orthopaedic Surgeons Augmentative plate fixation for the management of femoral nonunion af- ter intramedullary nailing. J Trauma 1997;43:640-644. 40. Choi YS, KimKS: Plate augmentation leaving the nail in situ and bone graft- ing for non-union of femoral shaft frac- tures. Int Orthop 2005;29:287-290. 41. Ueng SW, Shih CH: Augmentative plate fixation for the management of femoral nonunion with broken inter- locking nail. J Trauma 1998;45:747- 752. 42. Brinker MR, OConnor DP: Ilizarov compressionover a nail for aseptic fem- oral nonunions that have failed ex- change nailing: A report of five cases. J Orthop Trauma 2003;17:668-676. 43. Patil S, Montgomery R: Management of complex tibial and femoral non- union using the Ilizarov technique, and its cost implications. J Bone Joint Surg Br 2006;88:928-932. 44. Inan M, Karaoglu S, Cilli F, Turk CY, Harma A: Treatment of femoral non- unions by using cyclic compression and distraction. Clin Orthop Relat Res 2005;436:222-228. 45. Barker AT, Dixon RA, Sharrard WJ, Sutcliffe ML: Pulsed magnetic field therapy for tibial non-union: Interim results of a double-blind trial. Lancet 1984;1:994-996. 46. Sharrard WJ: A double-blind trial of pulsed electromagnetic fields for de- layed union of tibial fractures. J Bone Joint Surg Br 1990;72:347-355. 47. Wu CC, Chen WJ: Treatment of fem- oral shaft aseptic nonunions: Com- parison between closed and open bone-grafting techniques. J Trauma 1997;43:112-116. Joseph R. Lynch, MD, et al Volume 16, Number 2, February 2008 97