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Treatment of diaphyseal nonunion of the femur and tibia using an expandable nailing system
Injury, Int. J. Care Injured 40 (2009) 309–314
Contents lists available at ScienceDirect
Injury journal homepage: www.elsevier.com/locate/injury
Treatment of diaphyseal nonunion of the femur and tibia using an expandable nailing system Ely L. Steinberg *, Ori Keynan, Amir Sternheim, Michael Drexler, Elhanan Luger Department of Orthopaedic Surgery ‘‘B’’, Tel-Aviv Sourasky Medical Center, Tel-Aviv University, 6 Weizmann Street, Tel-Aviv 64239, Israel
A R T I C L E I N F O
A B S T R A C T
Article history: Accepted 1 July 2008
Introduction: We evaluated the efficacy of the expandable nailing system for treating femur and tibia shaft nonunions. Patients and methods: Records of 24 patients (25 fractures) were retrospectively reviewed: 16 with femur and 8 with tibia nonunions. The bones underwent reaming, and the largest possible nail sizes were inserted during re-operation. Bone debris obtained from the reaming was used for bone graft at the site of the nonunion. Results: The mean age of the patients was 32 years for the tibia group and 49 years for the femur group. The respective intervals between trauma and re-operation were 11 and 13 months, the operation times 60 and 78 min, and the fluoroscopy times 21 and 32 s. Twenty-four of the 25 nonunions healed satisfactorily without requiring additional procedures. In 1 case, demineralised bone matrix was injected percutaneously and the femoral nonunion resolved. Healing time was 23 weeks (6–52) and 17 weeks (6– 40) in the tibia and femur groups, respectively. We were able to reduce the need of an autologous bone graft to only two cases by using reamed debris in 17 of the 19 patients who required grafting. Conclusions: Our results demonstrated satisfactory healing for the treatment of diaphyseal nonunions of the femur and tibia. The expandable nail offers the theoretical advantages of improved load sharing and rotational control without the need for interlocking screws. We recommend expandable nail systems for femur and tibia shaft nonunions and the use of reamed debris in order to decrease the use of autogenous bone graft. ß 2008 Elsevier Ltd. All rights reserved.
Keywords: Femur and tibia nonunion Expandable nails Reaming Reamed bone debris
Introduction Diaphyseal nonunion of a long bone is an extreme disabling factor that prolongs patient recovery after an injury. The initial treatment is vitally important because the surgeon could later face the more difficult challenge of treating any consequent bony nonunions. Many elements are associated with the nonunion process, and the surgeon must be aware of and consider them all.1,26 There is a choice of a number of modalities for treating nonunions, among them stabilisation with the help of plates and screws, intramedullary nails, external fixation, bone grafting, artificial bone substitutes and iliac crest-aspirated bone marrow.6–9,12,16,17,19,23,28,29,32,37 Depending on the nature of the fracture, each treatment has its merits, and it is the surgeon’s judgment that determines the choice of management, given the conditions of the available setup and the level of surgical skill.
* Corresponding author. Tel.: +972 3 6974727; fax: +972 3 6974546. E-mail address: [email protected] (E.L. Steinberg). 0020–1383/$ – see front matter ß 2008 Elsevier Ltd. All rights reserved. doi:10.1016/j.injury.2008.07.029
An interlocking nail is the preferred technique for stabilising a fracture in long bone shaft nonunions. This approach involves a process of reaming to create a larger internal diameter and to enable the insertion of the largest possible nail size.3,15,38 Due to its simplicity, the expandable nail has become a well-accepted alternative to the standard intramedullary interlocking nail.4,10,30 Reaming permits greater contact area, so that the nail can abut to a larger segment of the bone and thus achieve better stability of the construct. Given the satisfactory results of the expandable nail system in the setting of fractures, the current study evaluated the efficacy of the system for resolving nonunions of long bones, specifically, the tibia and the femur. Patients and methods The records of patients who were treated in our medical center between 2000 and 2006 were retrieved and retrospectively reviewed. They fulfilled the criteria of having undergone previous surgeries had left of them with aseptic femoral and tibial
310
E.L. Steinberg et al. / Injury, Int. J. Care Injured 40 (2009) 309–314
nonunions or delayed unions. Delayed union was defined as the absence of any clinical or radiographic evidence of progression of fracture healing after 2–3 months following the expected time for healing had passed. After removal of previous fracture fixation devices, the bones underwent reaming to 2–3 mm less than the maximal expandable size of the nail (The Fixion nail, Disc-O-Tech, Herzelia, Israel). The largest possible nail sizes were inserted during re-operation. In cases that required an open approach to the fracture, an intracortical osteotomy was performed and slivers of living bone attached to the undersurface of the soft-tissue flap were elevated. When necessary, two sources of additional bone were available from the iliac crest or reamed debris. In cases of closed nail exchange, the obtained reamed bone was inserted into the fracture site by a small incision using 6–10 mm diameter biopsy sleeves. Postoperatively, early mobilisation was allowed and physical therapy was started within the first week, taking care to protect the limb from excessive rotational stresses. We assessed malrotation clinically by comparing the injured side to the normal side. Results Twenty-five patients (10 females and 15 males) with a diagnosis of 17 femoral, 8 tibia nonunions or delayed unions were operated in our department during the study period. The mean age of the patients was 31 years (26–49) in the tibia group and 49 years (23–85) in the femur group. The mechanisms of injury in these patients were motor vehicle accidents (n = 17), falls (n = 5), gunshot injuries (n = 3) and 1 skiing injury. The average interval between the trauma/first surgery and re-operation was 11 months in the tibia group and 13 months in the femur group (Table 1). In our department, union is defined when solid bony bridging of three cortexes is visible on two radiographic views (anteroposterior and lateral views) and the patients are able to use their extremity without significant pain. All patients are followed-up at 1 week, 3 weeks and every 6 weeks until the fracture healed. Our search of the orthopedic surgical database yielded 17 femoral nonunions in 16 patients. These patients underwent reoperation for 12 hypertrophic and 5 atrophic nonunions. They included 9 males and 7 females with an age range of 18–85 years. Seven nonunions had initially been treated by intramedullary nails, 5 by side plates and screws, 3 by external fixators and 2 by proximal femoral nail. Seven cases had a mid-shaft fracture, 7 a subtrochanteric fracture and 3 a distal fracture. The nails had been Table 1 Details of results. Femur Patients Females Males
16 7 9a
Mean age (years) Average time to the nonunion operation (months)
49 (23–85) 13
Type of nonunion Atrophic Hypertrophic
5 12
Fluoroscopy time (s) Operation time (min) Reamed bone debris Iliac bone graft Average healing time (weeks)
32 (12–65) 78 (20–150) 13 2 16 (8–40)
a
Tibia 8 2 6 31 (26–49) 11
7 1 21 (10–30) 60 (35–70) 4 – 23b (6–52)
One patient had two nonunions. Two patients with prolonged healing time (52 weeks) that refused further interventions. b
inserted antegrade in 14 cases and retrograde in 3 cases. According to AO/OTA classification, 2 had 32A1, 4 had 32A2, 5 had 32A3, one had 32B1, 2 had 32B2, 2 had 32C1, and one had 32C3. Fourteen were closed fractures and 3 were open fractures. Four patients had associated injuries (fractures of the acetabulum, pelvis, tibia plateau, ipsilateral tibiae and femoral neck). The patient with a gunshot wound needed skin grafting. A 12-mm nail was inserted in 10 cases and a 10-mm nail in the remaining 7. An open approach was needed in 8 cases, mainly for the removal of a plate or a broken nail, after closed removal methods failed. A closed exchange of the nail was performed in 9 patients. Reamed bone debris was used in 13 patients and supplementary iliac bone graft was used in 2. The average operation and fluoroscopy times for the femur group were 78 min (20–150) and 32 s (12–65), respectively. The average healing time for femoral nonunions was 16 weeks. One immuno-compromised patient (connective tissue disease) with an open fracture and severe soft tissue injury had an infection at the operation site and the nail needed to be removed. This was the only infection in this group. One patient needed demineralised bone matrix grafting, which was performed percutaneously 7 month after the re-operation. No apparent related osteonecrosis of the bone was observed during the follow-up period. Analysis of the risk factors for the nonunions were obesity (n = 2), inadequate reduction (n = 9), hardware failure (n = 3), inadequate stabilisation by external fixation (n = 3), biological compromise of the nonunion site by excessive de´pe´riostage and osteosynthesis (n = 4). Note: 17 patients and 21 factors. Eight patients were operated with tibial nonunion. They included 6 males and 2 females with an age range of 18–50 years. There were 7 atrophic and one hypertrophic nonunions. Five patients were initially treated by intramedullary nails (3 unreamed nails) and 3 by external fixators. Six patients had a midshaft fracture and 2 had a distal fracture. According to AO/OTA classification, 2 had 42A2, 3 had 42B2, 2 had 42B3, and 1 had 42C3. Three patients had closed fractures and the other 5 had open fractures. Six patients had associated injuries, including pelvic, femur, tibia plateau and shoulder fractures, and peroneal nerve injury; 1 patient had an above-knee amputation of the contralateral limb. One patient with an open fracture needed skin graft to cover the wounds. The only 8.5 mm nail that was used was on the first patient, and all the others received a 10-mm nail. Six patients underwent a closed exchange of the nail. Reamed bone debris was used in 4 patients and a fibular osteotomy was performed in one early case. The average operation and fluoroscopy times for the tibia nonunion group were 60 min (35–70 min) and 21 s (10–30 s), respectively. The average healing time for the tibia nonunion group was 23 weeks because of the prolonged time (52 weeks) of 2 patients who refused further interventions. Excluding them would have lowered the healing to 17 weeks for this group. There were 2 cases of limb shortening that were apparently related to the original trauma. One was a shortening of 10 cm in the patient who underwent above-knee amputation of the contra-lateral leg immediately after a severe injury in a pedestrian versus motorcycle accident. The other was a shortening of 4 cm in a comminuted fracture that had initially been treated with external fixation for 11 months in a patient who refused bone transport surgery with the Ilizarov apparatus to equalise size of the limbs. No infection was recorded in this group. No apparently related osteonecrosis of the bone was observed during the follow-up period. There were no secondary procedures. The risk factors for the tibia nonunions were inadequate stabilisation by external fixation (n = 3), insufficient dynamisation (n = 4) and high-energy trauma (n = 6). Note: 9 patients and 13 factors.
E.L. Steinberg et al. / Injury, Int. J. Care Injured 40 (2009) 309–314
311
Fig. 1. A closed fracture Type 32C1 in a 73-year-old heavy smoker male, treated by a primary, 958 dynamic hip plate (A–C). Nine months after the injury, the surgeon decided to remove the nail because of local discomfort (D), revealing that the fracture had not healed and needed immediate re-operation (E). A long bridging plate was used, and hardware failure and nonunion were diagnosed seven months after the second operation (F). The patient underwent a third operation in which an expandable nail was inserted (G). The fracture healed within 16 weeks and the remodeling process continued for more than 16 months to complete the coverage of the nail (H).
Discussion
fixation has long been the preferred method to treat them.6,9,19– Reaming facilitates removal of interposed scar tissue that grows between the nail and the inner cortex and enlarges the size of the medullary canal to permit the insertion of a larger nail. The
21,32,37
Long bone nonunions can be severely disabling and frequently need several re-operations. Reaming and intramedullary nail
312
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Fig. 1. (Continued ).
impact of nail size on the healing rate is still controversial.3,9,13 We assume that a bigger nail will assure better stability with minimal axial movements and with an increased friction coefficient of rotation control. When it is necessary to replace a nail, there is essentially no other option but to increase the size of the inner cortex. Some reported cases needed more than 2 nail replacements to achieve complete healing of the fracture.9 For them, the medullary canal was enlarged by more than 2 mm to accommodate a bigger nail. Caution must be exercised after plating and continuing on to the reaming procedure: some bony segments can be biologically compromised and reaming may endanger or penetrate the outer cortex. In this study, we tried to insert the biggest nail possible. This was the 12-mm diameter nail that expands to 19 mm for the femur and the 10-mm nail that expands to 16 mm for the tibia. We therefore reamed the inner cortex of 13 or 14 mm in the tibia group and 15 or 16 mm in the femur group in order to acquire the maximal expansion of the nail (Fig. 1). By doing this, we increased the abutment area of the nail both longitudinally and circularly in the
central part of the bone in addition to achieving an extra expansion of 2–3 mm in the proximal and distal metaphysis (i.e., creating an hourglass-like appearance). This may require some explanation. We had formerly reamed the medullary canal to a diameter larger than the inserted nail for the traditional nail. Now, with the expandable nail, we ream and insert a nail that has an expansion potential larger than the reamed canal. Unlike the traditional interlocking nail that has several contact points with the bone, the expandable nail abuts along as much of the area as the reamed medullary canal permits, meaning, a relative long abutment area. In order to increase nail strength, all the nails were expanded to a maximal pressure of 70 bar. We observed no cracks and no bone propagation during the operation or during the follow-up. Because we are not totally dependable on inventory due to the advantage of the variable diameter of each expandable nail the reaming can be restrained to different diameters depends on bone diameter and quality. The patients treated in this study were suitable candidates for use of the expandable nail by having proximal and distal diaphyseal fragments long enough to control rotational stability (this based on the
E.L. Steinberg et al. / Injury, Int. J. Care Injured 40 (2009) 309–314
experience of the surgeon with the optimal fragment length that can support the nail without failure). While the expandable nail is not always indicated for fresh Type C fractures, we found that the expandable nails are safe for nonunions since most of the rotational stability is provided by the partial stiffness of the surrounding soft tissue fibrosis and adhesions.30 Reaming was demonstrated to increase periosteal new bone formation,11,24 and the generated bone debris is an excellent source of vital and multipotent cells as supplementary bone graft to fill bone defects.33,35 Harvesting autologous bone graft (i.e., from the iliac crest) requires an additional surgical site and can be associated with multiple complications.2,17,36 In the current study, we were able to reduce the need of an autologous bone graft to only two cases by using reamed debris in 17 of the 19 patients who required grafting. It is reasonable to speculate that a bone graft was not needed in all the cases in which reamed debris was used, but it would not make much sense to waste it rather than use the already obtained material for grafting. The required fluoroscopy times for our cohort were relatively short in comparison to the figures quoted in the literature.5,18,22,25,27,31 This is because 3 retrograde nails for femur nonunions could be inserted at the distal end only. It should be noted, however, that all those studies had been performed in fresh fractures and involved a procedure that consumes time for passing the guidewire for a closed reduction or for distal locking. We did not perform an osteotomy of the fibula in 8 of our 9 tibial cases because we believe that the fibula contributes to the stability of the fracture fixation.9,14,34 The 1 exception was an early case not operated by the senior author (ELS). Analysis of the risk factors of nonunions revealed that they can be associated with inadequate reduction, excessive biological compromise, hardware failure, obesity, insufficient dynamisation and high-energy trauma. Some authors voiced their concern about systemic or local risk factors for nonunion, such as malnutrition, morbid obesity, immunocompromised patients, bone loss, infection, small nail diameter, and insufficient stabilisation of the fracture.1,3,13 The surgeon can avoid some of the potential complications related to the surgery per se, such as gentle soft tissue handling and less biological bone damage, proper fracture stabilisation and choosing the correct implant. The weakness of a study such as our current one is that it was not prospectively randomised for comparison to the standard interlocking nails. Our results, however, were similar to those of other studies that support the use of the intramedullary interlocking nail and, especially, the expandable nail for the treatment of nonunions,3,10,15,32,38 with the benefit of methodological simplicity and a shorter operation. In summary, the expandable nail offers the theoretical advantages of improved load sharing and rotational control without the need for interlocking screws. Our results demonstrated satisfactory healing and alignment for the treatment of diaphyseal nonunions of the femur and tibia. This surgical approach is faster and requires less irradiation time than the interlocking nail. Finally, reamed debris can always be used in order to decrease the use of autogenous bone graft. Conflict of interest None. Acknowledgment The authors wish to thank Esther Eshkol for editorial assistance.
313
References 1. Alonso S, Hahn D. Surgical treatment of non-unions: a case for internal fixation. Injury 2006;37:681–90. 2. Arrington ED, Smith WJ, Chambers HG, et al. Complications of iliac crest bone graft harvesting. Clin Orthop Relat Res 1996;329:300–9. 3. Baht AK, Rao SK, Bhaskaranand K. Mechanical failure in intramedullary interlocking nails. J Orthop Surg (Hong Kong) 2006;14:138–41. 4. Ben-Galim P, Rosenblatt Y, Parnes N, et al. Intramedullary fixation of tibial shaft fractures using an expandable nail. Clin Orthop Relat Res 2007;455:234–40. 5. Blattert TR, Fill UA, Kunz E, et al. Skill dependence of radiation exposure for the orthopaedic surgeon during interlocking nailing of long-bone shaft fractures: a clinical study. Arch Orthop Trauma Surg 2004;124:659–64. 6. Bone LB, Johnson KD. Treatment of tibial fractures by reaming and intramedullary nailing. J Bone Joint Surg Am 1986;68:877–87. 7. Carpenter CA, Jupiter JB. Blade plate reconstruction of metaphyseal nonunion of the tibia. Clin Orthop Relat Res 1996;332:23–8. 8. Chin KR, Nagarkatti DG, Miranda MA, et al. Salvage of distal tibia metaphyseal nonunions with the 908 cannulated blade plate. Clin Orthop Relat Res 2003;409:241–9. 9. Court-Brown CM, Keating JF, McQueen MM. Exchange intramedullary nailing: its use in aseptic tibial nonunion. J Bone Joint Surg Br 1995;77:407–11. 10. Daccaret M, Walz BM, Selison D. Use of an expandable nail in the treatment of non-union fractures of the femur, tibia and humerus. Osteo Trauma Care 2004;12:130–4. 11. Danckwardt-Lilliestro¨m G. Reaming of the medullary cavity and its effect on diaphyseal bone. Acta Orthop Scand 1969;28(Suppl 1):1–153. 12. Ebraheim NA, Skie MC, Jackson WT. The treatment of tibial nonunion with angular deformity using an Ilizarov device. J Trauma 1995;38:111–7. 13. Gaebler C, Berger U, Schandelmaier P, et al. Rates and odds ratios for complications in closed and open tibia fractures treated with undreamed, small diameter tibial nails: a multicenter analysis of 467 cases. J Orthop Trauma 2001;15:415– 23. 14. Goh JC, Mech AMI, Lee EH, et al. Biomechanical study on the load-bearing characteristics of the fibula and the effects of fibular resection. Clin Orthop Relat Res 1992;279:223–8. 15. Hak DJ, Lee SS, Goulet JA. Success of exchange reamed intramedullary nailing for femoral shaft nonunion or delayed union. J Orthop Trauma 2000;14:178–82. 16. Helfet DL, Jupiter JB, Gasser S. Indirect reduction and tension band plating of tibial non-union with deformity. J Bone Joint Surg Am 1992;74:1286–97. 17. Hierholzer C, Sama D, Toro JB, et al. Plate fixation of ununited humeral shaft fractures: effect of type of bone graft on healing. J Bone Joint Surg Am 2006;88:1442–7. 18. Levin PE, Schoen RW, Browner BD. Radiation exposure to the surgeon during closed interlocking intramedullary nailing. J Bone Joint Surg Am 1987;69:761– 6. 19. Lottes JO. Treatment of delayed or nonunion fractures of the tibia by a intramedullary nail. Clin Orthop Relat Res 1965;43:111–28. 20. Mayo KA, Benirschke SK. Treatment of tibial malunions and nonunions with reamed intramedullary nails. Orthop Clin North Am 1990;21:715–24. 21. Miller ME, Ada JR, Webb LX. Treatment of infected nonunion and delayed union of tibia fractures with locking intramedullary nails. Clin Orthop Relat Res 1989;245:233–8. 22. Miller ME, Davis ML, MacClean CR, et al. Radiation exposure and associated risks to operating room personnel during use of fluoroscopic guidance for selected orthopaedic surgical procedures. J Bone Joint Surg Am 1983;65: 1–4. 23. Paley D, Chaudray M, Pirone AM, et al. Treatment of malunions and malnonunions of the femur and tibia by detailed preoperative planning and the Ilizarov techniques. Orthop Clin North Am 1990;21:667–91. 24. Reichert ILH, McCarthy ID, Hughes SPF. The acute vascular response to intramedullary nailing. J Bone Joint Surg Br 1995;77:490–3. 25. Riley SA. Radiation exposure from fluoroscopy during orthopedic surgical procedures. Clin Orthop Relat Res 1989;248:257–60. 26. Rosen H. The treatment of nonunions and pseudoarthroses of the humeral shaft. Orthop Clin North Am 1990;21:725–42. 27. Sanders R, Koval KJ, DiPasquale T, et al. Exposure of the orthopaedic surgeon to radiation. J Bone Joint Surg Am 1993;75:326–30. 28. Schwartsman V, Choi SH, Schwartsman R. Tibial nonunions. Treatment tactics with the Ilizarov method. Orthop Clin North Am 1990;21:639–53. 29. Sen MK, Miclau T. Autologous iliac crest bone graft: should it still be the gold standard for treating nonunions? Injury 2007;38(Suppl 1):S75–80. 30. Steinberg EL, Geller D, Yacoubian SV, et al. Intramedullary fixation of tibial shaft fractures using an expandable nail: early results of 54 acute tibial shaft fractures. J Orthop Trauma 2006;20:303–9. 31. Sutherland AG, Finlayson DF. Screening times with image intensifier in orthopaedic trauma surgery. J R Coll Surg Edinb 1998;43:265–6. 32. Templeman D, Thomas M, Varecka T, Kyle R. Exchange reamed intramedullary nailing for delayed union and nonunion of the tibia. Clin Orthop Relat Res 1995;315:169–75. 33. Trinkaus K, Wenisch S, Siemers C, et al. Reaming debris: a source of vital cells! First results of human specimens. Unfallchirurg 1995;108:650–6. 34. Wang Q, Whittle M, Cunningham J, Kenwright J. Fibula and its ligaments in load transmission and ankle joint stability. Clin Orthop Relat Res 1996;330: 261–70.
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35. Wenisch S, Trinkaus K, Hild A, et al. Human reaming debris: a source of multipotent stem cells. Bone 2005;36:74–83. 36. Westrich GH, Geller DS, O’Malley MJ, et al. Anterior iliac crest bone graft harvesting using the corticocancellous reamer system. J Orthop Trauma 2001;15:500–6.
37. Wiss DA, Stetson WB. Nonunion of the tibia treated with a reamed intramedullary nail. J Orthop Trauma 1994;8:189–94. 38. Wu CC, Shih CH, Chen WJ, Tai CL. High success rate with exchange nailing to treat a tibial shaft aseptic nonunion. J Orthop Trauma 1996;13:33–8.
Contents lists available at ScienceDirect
Injury journal homepage: www.elsevier.com/locate/injury
Treatment of diaphyseal nonunion of the femur and tibia using an expandable nailing system Ely L. Steinberg *, Ori Keynan, Amir Sternheim, Michael Drexler, Elhanan Luger Department of Orthopaedic Surgery ‘‘B’’, Tel-Aviv Sourasky Medical Center, Tel-Aviv University, 6 Weizmann Street, Tel-Aviv 64239, Israel
A R T I C L E I N F O
A B S T R A C T
Article history: Accepted 1 July 2008
Introduction: We evaluated the efficacy of the expandable nailing system for treating femur and tibia shaft nonunions. Patients and methods: Records of 24 patients (25 fractures) were retrospectively reviewed: 16 with femur and 8 with tibia nonunions. The bones underwent reaming, and the largest possible nail sizes were inserted during re-operation. Bone debris obtained from the reaming was used for bone graft at the site of the nonunion. Results: The mean age of the patients was 32 years for the tibia group and 49 years for the femur group. The respective intervals between trauma and re-operation were 11 and 13 months, the operation times 60 and 78 min, and the fluoroscopy times 21 and 32 s. Twenty-four of the 25 nonunions healed satisfactorily without requiring additional procedures. In 1 case, demineralised bone matrix was injected percutaneously and the femoral nonunion resolved. Healing time was 23 weeks (6–52) and 17 weeks (6– 40) in the tibia and femur groups, respectively. We were able to reduce the need of an autologous bone graft to only two cases by using reamed debris in 17 of the 19 patients who required grafting. Conclusions: Our results demonstrated satisfactory healing for the treatment of diaphyseal nonunions of the femur and tibia. The expandable nail offers the theoretical advantages of improved load sharing and rotational control without the need for interlocking screws. We recommend expandable nail systems for femur and tibia shaft nonunions and the use of reamed debris in order to decrease the use of autogenous bone graft. ß 2008 Elsevier Ltd. All rights reserved.
Keywords: Femur and tibia nonunion Expandable nails Reaming Reamed bone debris
Introduction Diaphyseal nonunion of a long bone is an extreme disabling factor that prolongs patient recovery after an injury. The initial treatment is vitally important because the surgeon could later face the more difficult challenge of treating any consequent bony nonunions. Many elements are associated with the nonunion process, and the surgeon must be aware of and consider them all.1,26 There is a choice of a number of modalities for treating nonunions, among them stabilisation with the help of plates and screws, intramedullary nails, external fixation, bone grafting, artificial bone substitutes and iliac crest-aspirated bone marrow.6–9,12,16,17,19,23,28,29,32,37 Depending on the nature of the fracture, each treatment has its merits, and it is the surgeon’s judgment that determines the choice of management, given the conditions of the available setup and the level of surgical skill.
* Corresponding author. Tel.: +972 3 6974727; fax: +972 3 6974546. E-mail address: [email protected] (E.L. Steinberg). 0020–1383/$ – see front matter ß 2008 Elsevier Ltd. All rights reserved. doi:10.1016/j.injury.2008.07.029
An interlocking nail is the preferred technique for stabilising a fracture in long bone shaft nonunions. This approach involves a process of reaming to create a larger internal diameter and to enable the insertion of the largest possible nail size.3,15,38 Due to its simplicity, the expandable nail has become a well-accepted alternative to the standard intramedullary interlocking nail.4,10,30 Reaming permits greater contact area, so that the nail can abut to a larger segment of the bone and thus achieve better stability of the construct. Given the satisfactory results of the expandable nail system in the setting of fractures, the current study evaluated the efficacy of the system for resolving nonunions of long bones, specifically, the tibia and the femur. Patients and methods The records of patients who were treated in our medical center between 2000 and 2006 were retrieved and retrospectively reviewed. They fulfilled the criteria of having undergone previous surgeries had left of them with aseptic femoral and tibial
310
E.L. Steinberg et al. / Injury, Int. J. Care Injured 40 (2009) 309–314
nonunions or delayed unions. Delayed union was defined as the absence of any clinical or radiographic evidence of progression of fracture healing after 2–3 months following the expected time for healing had passed. After removal of previous fracture fixation devices, the bones underwent reaming to 2–3 mm less than the maximal expandable size of the nail (The Fixion nail, Disc-O-Tech, Herzelia, Israel). The largest possible nail sizes were inserted during re-operation. In cases that required an open approach to the fracture, an intracortical osteotomy was performed and slivers of living bone attached to the undersurface of the soft-tissue flap were elevated. When necessary, two sources of additional bone were available from the iliac crest or reamed debris. In cases of closed nail exchange, the obtained reamed bone was inserted into the fracture site by a small incision using 6–10 mm diameter biopsy sleeves. Postoperatively, early mobilisation was allowed and physical therapy was started within the first week, taking care to protect the limb from excessive rotational stresses. We assessed malrotation clinically by comparing the injured side to the normal side. Results Twenty-five patients (10 females and 15 males) with a diagnosis of 17 femoral, 8 tibia nonunions or delayed unions were operated in our department during the study period. The mean age of the patients was 31 years (26–49) in the tibia group and 49 years (23–85) in the femur group. The mechanisms of injury in these patients were motor vehicle accidents (n = 17), falls (n = 5), gunshot injuries (n = 3) and 1 skiing injury. The average interval between the trauma/first surgery and re-operation was 11 months in the tibia group and 13 months in the femur group (Table 1). In our department, union is defined when solid bony bridging of three cortexes is visible on two radiographic views (anteroposterior and lateral views) and the patients are able to use their extremity without significant pain. All patients are followed-up at 1 week, 3 weeks and every 6 weeks until the fracture healed. Our search of the orthopedic surgical database yielded 17 femoral nonunions in 16 patients. These patients underwent reoperation for 12 hypertrophic and 5 atrophic nonunions. They included 9 males and 7 females with an age range of 18–85 years. Seven nonunions had initially been treated by intramedullary nails, 5 by side plates and screws, 3 by external fixators and 2 by proximal femoral nail. Seven cases had a mid-shaft fracture, 7 a subtrochanteric fracture and 3 a distal fracture. The nails had been Table 1 Details of results. Femur Patients Females Males
16 7 9a
Mean age (years) Average time to the nonunion operation (months)
49 (23–85) 13
Type of nonunion Atrophic Hypertrophic
5 12
Fluoroscopy time (s) Operation time (min) Reamed bone debris Iliac bone graft Average healing time (weeks)
32 (12–65) 78 (20–150) 13 2 16 (8–40)
a
Tibia 8 2 6 31 (26–49) 11
7 1 21 (10–30) 60 (35–70) 4 – 23b (6–52)
One patient had two nonunions. Two patients with prolonged healing time (52 weeks) that refused further interventions. b
inserted antegrade in 14 cases and retrograde in 3 cases. According to AO/OTA classification, 2 had 32A1, 4 had 32A2, 5 had 32A3, one had 32B1, 2 had 32B2, 2 had 32C1, and one had 32C3. Fourteen were closed fractures and 3 were open fractures. Four patients had associated injuries (fractures of the acetabulum, pelvis, tibia plateau, ipsilateral tibiae and femoral neck). The patient with a gunshot wound needed skin grafting. A 12-mm nail was inserted in 10 cases and a 10-mm nail in the remaining 7. An open approach was needed in 8 cases, mainly for the removal of a plate or a broken nail, after closed removal methods failed. A closed exchange of the nail was performed in 9 patients. Reamed bone debris was used in 13 patients and supplementary iliac bone graft was used in 2. The average operation and fluoroscopy times for the femur group were 78 min (20–150) and 32 s (12–65), respectively. The average healing time for femoral nonunions was 16 weeks. One immuno-compromised patient (connective tissue disease) with an open fracture and severe soft tissue injury had an infection at the operation site and the nail needed to be removed. This was the only infection in this group. One patient needed demineralised bone matrix grafting, which was performed percutaneously 7 month after the re-operation. No apparent related osteonecrosis of the bone was observed during the follow-up period. Analysis of the risk factors for the nonunions were obesity (n = 2), inadequate reduction (n = 9), hardware failure (n = 3), inadequate stabilisation by external fixation (n = 3), biological compromise of the nonunion site by excessive de´pe´riostage and osteosynthesis (n = 4). Note: 17 patients and 21 factors. Eight patients were operated with tibial nonunion. They included 6 males and 2 females with an age range of 18–50 years. There were 7 atrophic and one hypertrophic nonunions. Five patients were initially treated by intramedullary nails (3 unreamed nails) and 3 by external fixators. Six patients had a midshaft fracture and 2 had a distal fracture. According to AO/OTA classification, 2 had 42A2, 3 had 42B2, 2 had 42B3, and 1 had 42C3. Three patients had closed fractures and the other 5 had open fractures. Six patients had associated injuries, including pelvic, femur, tibia plateau and shoulder fractures, and peroneal nerve injury; 1 patient had an above-knee amputation of the contralateral limb. One patient with an open fracture needed skin graft to cover the wounds. The only 8.5 mm nail that was used was on the first patient, and all the others received a 10-mm nail. Six patients underwent a closed exchange of the nail. Reamed bone debris was used in 4 patients and a fibular osteotomy was performed in one early case. The average operation and fluoroscopy times for the tibia nonunion group were 60 min (35–70 min) and 21 s (10–30 s), respectively. The average healing time for the tibia nonunion group was 23 weeks because of the prolonged time (52 weeks) of 2 patients who refused further interventions. Excluding them would have lowered the healing to 17 weeks for this group. There were 2 cases of limb shortening that were apparently related to the original trauma. One was a shortening of 10 cm in the patient who underwent above-knee amputation of the contra-lateral leg immediately after a severe injury in a pedestrian versus motorcycle accident. The other was a shortening of 4 cm in a comminuted fracture that had initially been treated with external fixation for 11 months in a patient who refused bone transport surgery with the Ilizarov apparatus to equalise size of the limbs. No infection was recorded in this group. No apparently related osteonecrosis of the bone was observed during the follow-up period. There were no secondary procedures. The risk factors for the tibia nonunions were inadequate stabilisation by external fixation (n = 3), insufficient dynamisation (n = 4) and high-energy trauma (n = 6). Note: 9 patients and 13 factors.
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Fig. 1. A closed fracture Type 32C1 in a 73-year-old heavy smoker male, treated by a primary, 958 dynamic hip plate (A–C). Nine months after the injury, the surgeon decided to remove the nail because of local discomfort (D), revealing that the fracture had not healed and needed immediate re-operation (E). A long bridging plate was used, and hardware failure and nonunion were diagnosed seven months after the second operation (F). The patient underwent a third operation in which an expandable nail was inserted (G). The fracture healed within 16 weeks and the remodeling process continued for more than 16 months to complete the coverage of the nail (H).
Discussion
fixation has long been the preferred method to treat them.6,9,19– Reaming facilitates removal of interposed scar tissue that grows between the nail and the inner cortex and enlarges the size of the medullary canal to permit the insertion of a larger nail. The
21,32,37
Long bone nonunions can be severely disabling and frequently need several re-operations. Reaming and intramedullary nail
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Fig. 1. (Continued ).
impact of nail size on the healing rate is still controversial.3,9,13 We assume that a bigger nail will assure better stability with minimal axial movements and with an increased friction coefficient of rotation control. When it is necessary to replace a nail, there is essentially no other option but to increase the size of the inner cortex. Some reported cases needed more than 2 nail replacements to achieve complete healing of the fracture.9 For them, the medullary canal was enlarged by more than 2 mm to accommodate a bigger nail. Caution must be exercised after plating and continuing on to the reaming procedure: some bony segments can be biologically compromised and reaming may endanger or penetrate the outer cortex. In this study, we tried to insert the biggest nail possible. This was the 12-mm diameter nail that expands to 19 mm for the femur and the 10-mm nail that expands to 16 mm for the tibia. We therefore reamed the inner cortex of 13 or 14 mm in the tibia group and 15 or 16 mm in the femur group in order to acquire the maximal expansion of the nail (Fig. 1). By doing this, we increased the abutment area of the nail both longitudinally and circularly in the
central part of the bone in addition to achieving an extra expansion of 2–3 mm in the proximal and distal metaphysis (i.e., creating an hourglass-like appearance). This may require some explanation. We had formerly reamed the medullary canal to a diameter larger than the inserted nail for the traditional nail. Now, with the expandable nail, we ream and insert a nail that has an expansion potential larger than the reamed canal. Unlike the traditional interlocking nail that has several contact points with the bone, the expandable nail abuts along as much of the area as the reamed medullary canal permits, meaning, a relative long abutment area. In order to increase nail strength, all the nails were expanded to a maximal pressure of 70 bar. We observed no cracks and no bone propagation during the operation or during the follow-up. Because we are not totally dependable on inventory due to the advantage of the variable diameter of each expandable nail the reaming can be restrained to different diameters depends on bone diameter and quality. The patients treated in this study were suitable candidates for use of the expandable nail by having proximal and distal diaphyseal fragments long enough to control rotational stability (this based on the
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experience of the surgeon with the optimal fragment length that can support the nail without failure). While the expandable nail is not always indicated for fresh Type C fractures, we found that the expandable nails are safe for nonunions since most of the rotational stability is provided by the partial stiffness of the surrounding soft tissue fibrosis and adhesions.30 Reaming was demonstrated to increase periosteal new bone formation,11,24 and the generated bone debris is an excellent source of vital and multipotent cells as supplementary bone graft to fill bone defects.33,35 Harvesting autologous bone graft (i.e., from the iliac crest) requires an additional surgical site and can be associated with multiple complications.2,17,36 In the current study, we were able to reduce the need of an autologous bone graft to only two cases by using reamed debris in 17 of the 19 patients who required grafting. It is reasonable to speculate that a bone graft was not needed in all the cases in which reamed debris was used, but it would not make much sense to waste it rather than use the already obtained material for grafting. The required fluoroscopy times for our cohort were relatively short in comparison to the figures quoted in the literature.5,18,22,25,27,31 This is because 3 retrograde nails for femur nonunions could be inserted at the distal end only. It should be noted, however, that all those studies had been performed in fresh fractures and involved a procedure that consumes time for passing the guidewire for a closed reduction or for distal locking. We did not perform an osteotomy of the fibula in 8 of our 9 tibial cases because we believe that the fibula contributes to the stability of the fracture fixation.9,14,34 The 1 exception was an early case not operated by the senior author (ELS). Analysis of the risk factors of nonunions revealed that they can be associated with inadequate reduction, excessive biological compromise, hardware failure, obesity, insufficient dynamisation and high-energy trauma. Some authors voiced their concern about systemic or local risk factors for nonunion, such as malnutrition, morbid obesity, immunocompromised patients, bone loss, infection, small nail diameter, and insufficient stabilisation of the fracture.1,3,13 The surgeon can avoid some of the potential complications related to the surgery per se, such as gentle soft tissue handling and less biological bone damage, proper fracture stabilisation and choosing the correct implant. The weakness of a study such as our current one is that it was not prospectively randomised for comparison to the standard interlocking nails. Our results, however, were similar to those of other studies that support the use of the intramedullary interlocking nail and, especially, the expandable nail for the treatment of nonunions,3,10,15,32,38 with the benefit of methodological simplicity and a shorter operation. In summary, the expandable nail offers the theoretical advantages of improved load sharing and rotational control without the need for interlocking screws. Our results demonstrated satisfactory healing and alignment for the treatment of diaphyseal nonunions of the femur and tibia. This surgical approach is faster and requires less irradiation time than the interlocking nail. Finally, reamed debris can always be used in order to decrease the use of autogenous bone graft. Conflict of interest None. Acknowledgment The authors wish to thank Esther Eshkol for editorial assistance.
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