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Treatment of femoral diaphyseal non-unions: Our experience
Injury, Int. J. Care Injured 41 (2010) 1156–1160
Contents lists available at ScienceDirect
Injury journal homepage: www.elsevier.com/locate/injury
Treatment of femoral diaphyseal non-unions: Our experience Francesco Benazzo *, Mario Mosconi, Federico Bove, Fabrizio Quattrini Clinic of Orthopaedics and Traumatology, Foundation IRCCS Policlinico S. Matteo, Viale Golgi 19, 27100 Pavia, Italy
A R T I C L E I N F O
A B S T R A C T
Keywords: Non-union Femur Diaphysis Shaft Plate fixation ORIF
Despite the continuous advances of surgical solutions, still 1–7% of fractures develop non-unions. The delays in fracture healing increase the period of incapacity of the patient with major consequences, on the psychological and functional recovery, but also on the direct and indirect health-related costs. In particular, femoral diaphyseal non-unions are often characterised by a challenging and long-lasting period of healing. The clinician treating these complex cases has to consider amongst other parameters, the condition of the soft tissue envelope, the adequacy of any pre-existing fixation, the alignment and length of the affected limb, the potential presence of an infection, as well as the general condition of the patient. Open reduction and plate fixation of femoral diaphyseal non-unions offers a valid alternative of stabilisation and if applied to carefully selected cases, can give optimal results. ß 2010 Elsevier Ltd. All rights reserved.
Introduction Recent advances made in osteosynthesis techniques have not managed to eliminate the incidence of fracture non-unions. The incidence of diaphyseal long bone non-unions is estimated to be in the region of 7%.11,24,30 However, for femoral shaft fractures a rate of less than 5% has been reported.11,33 The impact of femoral non-unions on the functional recovery of the patients and the allied socioeconomic implications can be momentous.8,15 At a best case scenario Kanakaris and Giannoudis18 recorded the direct medical costs of treating femoral nonunions to be higher than those of the other long bones (tibia and humerus). Taking into account that the concurrent indirect costs (associated to reduced quality of life and psychosocial consequences) represent the 80% of the total costs,4 the burden of monetary costs, health system workload, and patients’ psychosomatic problems are still underestimated. Consequently, the constant pressure for increased efficacy in the management of long bone fracture non-unions, including the femoral ones, fuelled clinical research in order to optimise the methods of treatment. Although good results are reported with the use of intramedullary nailing methods,16,17,23,24,29 there is also evidence advocating for other solutions.1,2,7,8,24,31 The aim of this study was to present the experience of our institution in the management of aseptic femoral diaphyseal nonunions, with the use either of exchange nailing or and plate
* Corresponding author. Tel.: +39 (0) 382 526 294. E-mail address: [email protected] (F. Benazzo). 0020–1383/$ – see front matter ß 2010 Elsevier Ltd. All rights reserved. doi:10.1016/j.injury.2010.08.010
fixation, as well as to compare the recorded clinical outcome to the published results of other authors.
Patients and methods A retrospective analysis of the outcome (union or non-union) of all femoral diaphyseal fractures treated over a period of 8 years (between 2002 and 2009) to our university clinic was carried out. Non-union was defined as the absence of complete radiological healing (three out of four bridged cortices in two planes of plain Xrays) over a period of 6 months, as well as local pain over the fracture area while weight bearing. All non-unions were classified using the Weber and Cech criteria.32 As diaphyseal fractures/nonunions we considered lesions positioned at least 5 cm distal from the level of the lesser trochanter, or 5 cm proximal from the adductor tubercle. From this dataset of consecutive patients, the ones that developed non-union of the femoral diaphysis and were treated operatively formed the study group of this cohort study. All cases where a local infection was suspected were excluded from this study as well as all non-unions of pathological fractures. In order to exclude septic non-unions, all patients were evaluated clinically including specific laboratory tests (ESR, CRP, blood count, dosage procalcitonin). Besides the standard plain X-ray control (anteroposterior and lateral), further imaging studies (CT-scan) were used in three selected cases for pre-operative planning of the surgical approach. Bone scintigraphy (99mTc) was performed in four patients to assess bone metabolism locally and to define and classify the type of non-union.3,27
F. Benazzo et al. / Injury, Int. J. Care Injured 41 (2010) 1156–1160
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Table 1 Dataset of diaphyseal femoral fractures managed at our unit between the years 2002–2009. Diaphyseal femoral fractures
Total Open Pathological Non-operative management Operative management IMN Plate fixation Wire/screw fixation
Number of frxs
Gender
Age mean (range)
Side right/left
125, (123 pts) 9, 7.2% 3, 2.4% 17, 13.6% 108, 86.4% 77, 61.6% 29, 23.2% 2, 1.6%
88/35 7/2 2/1 11/6 76/32 58/19 18/11 0/2
39.7 years (2–92) 31.6 years (16–53) 83 years (73–92) 6.1 years (2–10) 40.1 years (5–91) 41.2 years (15–59) 57.8 years (20–92) 9.5 years (6–13)
61/64 5/4 2/1 9/8 52/56 42/35 8/21 2/0
Abbreviations: frxs, fractures; IMN, reamed intramedullary nailing; pts, patients.
All non-union cases were reassessed after the revision surgery with clinical and radiographic examinations on a monthly basis, until the first evidence of radiographic healing and afterwards every 3 months. The collected data for the cases enrolled to this study included details related to demographics, methods of initial fracture treatment, presence or not of implant failure, timing of secondary intervention, type of revision surgery, use or not of bone graft, post-revision rehabilitation, final outcome over a minimum period of 12 months. Descriptive statistical methods were applied in order to compare the different methods of revision surgery for the femoral diaphyseal aseptic non-unions, and to present our results in a comprehensive manner. Statistical significance was assumed when p < 0.05.
[()TD$FIG]
well as progressive increase of the weight bearing status, depending on the radiographic evolution of callus formation.
Results From the cohort of 125 consecutive femoral diaphyseal fractures (123 patients), 11 of them developed an aseptic nonunion (incidence 8.8%, over a period of 7 years) (Table 1). There were nine men and two women, with an age range between 26 and 78 years (mean 48). Seven of them (64%) represented referral cases, initially operated in other institutions. The primary treatment was reamed intramedullary nailing (IMN) in seven cases and plating (ORIF) in four cases. Implant failure (breakage of elements of the nailing system or of the plate) was recorded in four cases (two cases of each different method of fixation) (Figs. 1a, b and 2a, 2b). One case of femoral non-union also developed severe deformity consisting of varus angulation. Limb length discrepancy was evident in six of the cases (55%), with a maximum shortening of 3 cm. The average time which elapsed from the first surgery to the revision was 11.6 months (6–22 months). Revision surgery included the use of open reduction – plate fixation with an LCP1 plate (Synthes) in seven cases and exchange nailing in four cases (two Grosse Kempf1 nails Stryker, and two T21 Stryker) (Table 2). The initial intramedullary nail was left in place and a plate was used as additional fixation to achieve greater stability in a single case (Fig. 3). In all cases where open reduction plate fixation was used, autologous iliac crest bone graft was also inserted at the non-union site. In three cases additional biological stimulation was applied by implanting in association with the autologous iliac crest bone graft autologous platelet rich plasma (PRP),6 bone marrow aspiratemesenchymal stem cell concentrate (BMAC),5 and BMP-7 (Osigraft1 Stryker)9,19,21 (each one to a different patient respectively). The post-revision rehabilitation protocol included immediate supervised assisted mobilisation, non-weight bearing for at least 30 days, knee continuous passive motion (CPM) and isometric muscle strengthening exercises for the first 30 days, Subsequently, isotonic exercises were added to the rehabilitation programme, as
Fig. 1. (a) Male, 40 years old, 17 months after initial treatment with an intramedullary nail. Non-union, with implant failure (breakage of distal static locking screw. (b) Consolidation at 6 months after treatment with a locking periarticular distal femoral plate.
[()TD$FIG]1158
[()TD$FIG]
F. Benazzo et al. / Injury, Int. J. Care Injured 41 (2010) 1156–1160
Fig. 3. Supplementation of the original fixation device (IMN) with a locking plate and autologous bone graft. The nail keeps the alignment, the locking plate increases the stability, and the autologous bone graft enhances the local biology and feels the gap after the debridement of the soft callus of the non-union.
Fig. 2. (a) Male, 52 years old, non-union 8 months after initial treatment with an antegrade intramedullary nail. (b) Anteroposterior X-ray taken 4 months after revision to a plate fixation.
The mean post-revision follow-up of these 11 patients was 23.6 months (range 12–40). All cases healed in an average time of 6.1 months (range 4–11 months). Nine non-unions (82%) healed after a single revision surgery. The two cases whereas a third operation (second revision surgery) was necessary, were both femoral non-unions treated with open reduction – plate fixation. One of these patients after the removal of the plate underwent intramedullary nailing and eventually healed his non-union at 9 months from the first revision surgery. A second plate was inserted to the second patient to increase the construct stability. This non-union eventually united 10 months from the first revision surgery. A different case, treated with open reduction, plate fixation and autologous bone graft, developed extensive heterotopic ossifica-
tion over the non-union site, which had to be removed 4 months later. At that setting the same patient sustained an intraoperative fracture of the femoral neck, which was managed with a total hip arthroplasty. The case with the severe deformity before the nonunion revision was managed with nail removal and implantation of a plate and autograft. This non-union healed at 6 months and the patient returned to his physically demanding work (bricklayer) 9 months after the revision surgery. Residual post-revision surgery limb length discrepancy of >1 cm was recorded in three patients. Regarding the final functional outcome, in three out of the seven cases treated with a plate, and in one of the four cases treated with a nail, an improvement of the knee function was noted in comparison to their pre-revision condition. At the last follow-up assessment (mean 23.6 months ranging from 12 to 40 months), three patients still needed the use of walking aids. This group was markedly older from the rest (mean age 65 years vs. 40 years of the rest). Discussion Exchange nailing appears to be the gold standard method of treatment of aseptic femoral non-unions. Reaming of the femoral canal and its local biologic effect,20,22 as well as the mechanical advantages of placing a wider and stronger intramedullary nail have been proven efficient by many authors.8,16,26 Alternatively, the use of open reduction and fixation with LCP plates has been used at our institution and others over the years with variable results.1,7,25,28,31 Adequate exposure, usually via a lateral approach of the non-union site, and careful resection of the fibrous non-union tissue is mandatory for optimal results.15 For these reasons, the concept of supplementing an existing intrame-
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F. Benazzo et al. / Injury, Int. J. Care Injured 41 (2010) 1156–1160 Table 2 Diaphyseal femoral non-union 2002–2009. A/A
Gender
Age (years)
Side
Initial fixation
Type of non-union32
Revision
Time to healing (months)
1 2 3 4 5 6 7 8
M M F M M M M M
45 78 73 40 34 47 42 52
R L L R L L R L
IMN broken PLATE Plate broken IMN IMN broken IMN Plate IMN
Atrophic Oligotrophic Hypertrophic Atrophic Hypertrophic Atrophic Atrophic Atrophic
Plate IMN IMN Plate IMN Plate Plate Plate
4 9 5 10 5 4 4 7
9 10 11
M M F 9 M/2 F
26 43 40 Mean 47.3 years Range (26–78)
L R L 4 R/7 L
IMN IMN Plate broken 7 IMN/4 plates
Atrophic Hypertrophic Atrophic 7 Atrophic 3 Hypertrophic 1 Oligotrophic
Plate Plate IMN 4 IMN/7 plates
11 4 4 Mean 6.1 Range 4–11
dullary device with an additional extramedullary device (locking plate, Fig. 3) has been recently introduced.7,10,25 The adequacy of the mechanical factor (stability of the final fixation construct), as well as the correct alignment of the extremity, are of paramount importance to achieve optimal function. In this small series of patients the overall success rate of plating diaphyseal femoral non-unions was 5/7 (71%). We are aware that exchange nailing with or without bone grafting is considered nowadays as the gold standard of treatment. The intramedullary nail, being a load sharing device provides an ideal mechanical environment. Reaming of the intramedullary canal possesses great osteoinductive properties and generates abundant reaming debris (autologous endogenous grafting). Both of these parameters facilitate stimulation of the underlying bone repair mechanisms.20 On the other hand the plating option while being more invasive compromising the biological environment of the non-union, allows excision of the fibrous tissue, direct visualisation of the non-union site and correction of both the rotational and the mechanical axis. In four out of the seven cases revision of the previous plating fixation was performed. The addition of autologous bone graft while plating, offers the advantages of minimising any bone shortening (leg length discrepancy) as well as optimising the biological substrate at the non-union site.1 The supplementation of the biological factor with potent osteoinductive (PRP, BMP-7) – osteogenic agents (BMAC), appears nowadays a common feature in publications dealing with the cases of recalcitrant atrophic non-unions.12–14 Limitations of this study include its’ retrospective nature, the small numbers of cases, the inability to perform proper comparative subgroup analysis of this dataset, as well as the absence of any randomisation between the different methods of femoral non-union treatment. However, this cohort study represents a descriptive presentation of the accumulated experience of a single university unit, which is familiar with the management of non-unions of long bones, using different means depending on the specific characteristics of each patient and the nature of the non-union site. Sound knowledge of the inherent differences between the types of bone non-unions is essential for proper planning of the treatment strategy. We believe that plate fixation with biological augmentation can also be considered as an alternative option for the treatment of femoral shaft aseptic non-unions. Larger scale studies can provide further evidence about the efficacy of this method of treatment. Conflict of interest statement None of the authors have any conflicts of interest. The corresponding author has had full access to all the data in the study and has final responsibility for the decision to submit for publication.
Complications II revision II revision
Periarticular calcification and fracture of femoral neck
Role of the funding source No external funding was used for this study. References [1] 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;57:832–6. [2] Banaszkiewicz PA, Sabboubeh A, McLeod I, Maffulli N. Femoral exchange nailing for aseptic non-union: not the end to all problems. Injury 2003;34:349–56. [3] Barros JW, Barbieri CH, Fernandes CD. Scintigraphic evaluation of tibial shaft fracture healing. Injury 2000;31:51–4. [4] Bozic KJ, Rosenberg AG, Huckman RS, Herndon JH. Economic evaluation in orthopaedics. J Bone Joint Surg Am 2003;85-A:129–42. [5] Burastero G, Scarfi S, Ferraris C, et al. The association of human mesenchymal stem cells with BMP-7 improves bone regeneration of critical-size segmental bone defects in athymic rats. Bone 2010;47:117–26. [6] Calori GM, D’Avino M, Tagliabue L, et al. An ongoing research for evaluation of treatment with BMPs or AGFs in long bone non-union: protocol description and preliminary results. Injury 2006;37(Suppl. 3):S43–50. [7] Choi YS, Kim KS. Plate augmentation leaving the nail in situ and bone grafting for non-union of femoral shaft fractures. Int Orthop 2005;29: 287–90. [8] Crowley DJ, Kanakaris NK, Giannoudis PV. Femoral diaphyseal aseptic nonunions: is there an ideal method of treatment? Injury 2007;38(Suppl. 2): S55–63. [9] DeBiase P, Capanna R. Bone morphogenetic proteins and growth factors: emerging role in regenerative orthopaedic surgery. J Orthop Traumatol 2007;8:43–8. [10] Ekere AU, Echem RC. Dual implant application in the treatment of aseptic femoral shaft nonunions – case series. West Afr J Med 2008;27:117–9. [11] el Moumni M, Leenhouts PA, ten Duis HJ, Wendt KW. The incidence of nonunion following unreamed intramedullary nailing of femoral shaft fractures. Injury 2009;40:205–8. [12] Giannoudis PV, Einhorn TA, Schmidmaier G, Marsh D. The diamond concept – open questions. Injury 2008;39(Suppl. 2):S5–8. [13] Giannoudis PV, Kanakaris NK, Dimitriou R, et al. The synergistic effect of autograft and BMP-7 in the treatment of atrophic nonunions. Clin Orthop Relat Res 2009;467:3239–48. [14] Giannoudis PV, Kontakis G. Treatment of long bone aseptic non-unions: monotherapy or polytherapy? Injury 2009;40:1021–2. [15] Gomes JL, Ruthner RP, Moreira L. Femoral pseudoarthrosis and knee stiffness: long-term results of a one-stage surgical approach. Arch Orthop Trauma Surg 2009;130:277–83. [16] 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. [17] Heiple KG, Figgie 3rd HE, Lacey SH, Figgie MP. Femoral shaft nonunion treated by a fluted intramedullary rod. Clin Orthop Relat Res 1985;218–25. [18] Kanakaris NK, Giannoudis PV. The health economics of the treatment of longbone non-unions. Injury 2007;38(Suppl. 2):S77–84. [19] Kanakaris NK, Lasanianos N, Calori GM, et al. Application of bone morphogenetic proteins to femoral non-unions: a 4-year multicentre experience. Injury 2009;40(Suppl. 3):S54–61. [20] Kanakaris NK, Paliobeis C, Manidakis N, Giannoudis PV. Biological enhancement of tibial diaphyseal aseptic non-unions: the efficacy of autologous bone grafting, BMPs and reaming by-products. Injury 2007;38(Suppl. 2):S65–75. [21] Kirker-Head CA. Development and application of bone morphogenetic proteins for the enhancement of bone healing. J Orthop Traumatol 2005;6:1–9.
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[22] Kouzelis AT, Kourea H, Megas P, et al. Does graded reaming affect the composition of reaming products in intramedullary nailing of long bones? Orthopedics 2004;27:852–6. [23] Megas P, Syggelos SA, Kontakis G, et al. Intramedullary nailing for the treatment of aseptic femoral shaft non-unions after plating failure: effectiveness and timing. Injury 2009;40:732–7. [24] Mora R. Nonunion of the long bones: diagnosis and treatment with compression–distraction techniques. New York: Springer; 2006. p. 13–5. [25] Nadkarni B, Srivastav S, Mittal V, Agarwal S. Use of locking compression plates for long bone nonunions without removing existing intramedullary nail: review of literature and our experience. J Trauma 2008;65:482–6. [26] Pihlajamaki HK, Salminen ST, Bostman OM. The treatment of nonunions following intramedullary nailing of femoral shaft fractures. J Orthop Trauma 2002;16:394–402. [27] Romano` C, Meani E, et al. Le tecniche di immagine nella diagnosi e nel monitoraggio delle infezioni osteoarticolari. Notiziario allergologico anno 1993;XII:79–81.
[28] Spitzer AB, Davidovitch RI, Egol KA. Use of a ‘‘hybrid’’ locking plate for complex metaphyseal fractures and nonunions about the humerus. Injury 2009;40: 240–244. [29] Steinberg EL, Keynan O, Sternheim A, et al. Treatment of diaphyseal nonunion of the femur and tibia using an expandable nailing system. Injury 2009;40: 309–314. [30] Tzioupis C, Giannoudis PV. Prevalence of long-bone non-unions. Injury 2007;38(Suppl. 2):S3–9. [31] Ueng SW, Chao EK, Lee SS, Shih CH. Augmentative plate fixation for the management of femoral nonunion after intramedullary nailing. J Trauma 1997;43: 640–4. [32] Weber BG, Cech O. Pseudoarthrosis: pathology, biomechanics, therapy, results. Berne, Switzerland: Hans Huber Medical Publisher; 1976. [33] Winquist RA, Hansen Jr ST, Clawson DK. Closed intramedullary nailing of femoral fractures. A report of five hundred and twenty cases. J Bone Joint Surg Am 1984;66:529–39.
Contents lists available at ScienceDirect
Injury journal homepage: www.elsevier.com/locate/injury
Treatment of femoral diaphyseal non-unions: Our experience Francesco Benazzo *, Mario Mosconi, Federico Bove, Fabrizio Quattrini Clinic of Orthopaedics and Traumatology, Foundation IRCCS Policlinico S. Matteo, Viale Golgi 19, 27100 Pavia, Italy
A R T I C L E I N F O
A B S T R A C T
Keywords: Non-union Femur Diaphysis Shaft Plate fixation ORIF
Despite the continuous advances of surgical solutions, still 1–7% of fractures develop non-unions. The delays in fracture healing increase the period of incapacity of the patient with major consequences, on the psychological and functional recovery, but also on the direct and indirect health-related costs. In particular, femoral diaphyseal non-unions are often characterised by a challenging and long-lasting period of healing. The clinician treating these complex cases has to consider amongst other parameters, the condition of the soft tissue envelope, the adequacy of any pre-existing fixation, the alignment and length of the affected limb, the potential presence of an infection, as well as the general condition of the patient. Open reduction and plate fixation of femoral diaphyseal non-unions offers a valid alternative of stabilisation and if applied to carefully selected cases, can give optimal results. ß 2010 Elsevier Ltd. All rights reserved.
Introduction Recent advances made in osteosynthesis techniques have not managed to eliminate the incidence of fracture non-unions. The incidence of diaphyseal long bone non-unions is estimated to be in the region of 7%.11,24,30 However, for femoral shaft fractures a rate of less than 5% has been reported.11,33 The impact of femoral non-unions on the functional recovery of the patients and the allied socioeconomic implications can be momentous.8,15 At a best case scenario Kanakaris and Giannoudis18 recorded the direct medical costs of treating femoral nonunions to be higher than those of the other long bones (tibia and humerus). Taking into account that the concurrent indirect costs (associated to reduced quality of life and psychosocial consequences) represent the 80% of the total costs,4 the burden of monetary costs, health system workload, and patients’ psychosomatic problems are still underestimated. Consequently, the constant pressure for increased efficacy in the management of long bone fracture non-unions, including the femoral ones, fuelled clinical research in order to optimise the methods of treatment. Although good results are reported with the use of intramedullary nailing methods,16,17,23,24,29 there is also evidence advocating for other solutions.1,2,7,8,24,31 The aim of this study was to present the experience of our institution in the management of aseptic femoral diaphyseal nonunions, with the use either of exchange nailing or and plate
* Corresponding author. Tel.: +39 (0) 382 526 294. E-mail address: [email protected] (F. Benazzo). 0020–1383/$ – see front matter ß 2010 Elsevier Ltd. All rights reserved. doi:10.1016/j.injury.2010.08.010
fixation, as well as to compare the recorded clinical outcome to the published results of other authors.
Patients and methods A retrospective analysis of the outcome (union or non-union) of all femoral diaphyseal fractures treated over a period of 8 years (between 2002 and 2009) to our university clinic was carried out. Non-union was defined as the absence of complete radiological healing (three out of four bridged cortices in two planes of plain Xrays) over a period of 6 months, as well as local pain over the fracture area while weight bearing. All non-unions were classified using the Weber and Cech criteria.32 As diaphyseal fractures/nonunions we considered lesions positioned at least 5 cm distal from the level of the lesser trochanter, or 5 cm proximal from the adductor tubercle. From this dataset of consecutive patients, the ones that developed non-union of the femoral diaphysis and were treated operatively formed the study group of this cohort study. All cases where a local infection was suspected were excluded from this study as well as all non-unions of pathological fractures. In order to exclude septic non-unions, all patients were evaluated clinically including specific laboratory tests (ESR, CRP, blood count, dosage procalcitonin). Besides the standard plain X-ray control (anteroposterior and lateral), further imaging studies (CT-scan) were used in three selected cases for pre-operative planning of the surgical approach. Bone scintigraphy (99mTc) was performed in four patients to assess bone metabolism locally and to define and classify the type of non-union.3,27
F. Benazzo et al. / Injury, Int. J. Care Injured 41 (2010) 1156–1160
1157
Table 1 Dataset of diaphyseal femoral fractures managed at our unit between the years 2002–2009. Diaphyseal femoral fractures
Total Open Pathological Non-operative management Operative management IMN Plate fixation Wire/screw fixation
Number of frxs
Gender
Age mean (range)
Side right/left
125, (123 pts) 9, 7.2% 3, 2.4% 17, 13.6% 108, 86.4% 77, 61.6% 29, 23.2% 2, 1.6%
88/35 7/2 2/1 11/6 76/32 58/19 18/11 0/2
39.7 years (2–92) 31.6 years (16–53) 83 years (73–92) 6.1 years (2–10) 40.1 years (5–91) 41.2 years (15–59) 57.8 years (20–92) 9.5 years (6–13)
61/64 5/4 2/1 9/8 52/56 42/35 8/21 2/0
Abbreviations: frxs, fractures; IMN, reamed intramedullary nailing; pts, patients.
All non-union cases were reassessed after the revision surgery with clinical and radiographic examinations on a monthly basis, until the first evidence of radiographic healing and afterwards every 3 months. The collected data for the cases enrolled to this study included details related to demographics, methods of initial fracture treatment, presence or not of implant failure, timing of secondary intervention, type of revision surgery, use or not of bone graft, post-revision rehabilitation, final outcome over a minimum period of 12 months. Descriptive statistical methods were applied in order to compare the different methods of revision surgery for the femoral diaphyseal aseptic non-unions, and to present our results in a comprehensive manner. Statistical significance was assumed when p < 0.05.
[()TD$FIG]
well as progressive increase of the weight bearing status, depending on the radiographic evolution of callus formation.
Results From the cohort of 125 consecutive femoral diaphyseal fractures (123 patients), 11 of them developed an aseptic nonunion (incidence 8.8%, over a period of 7 years) (Table 1). There were nine men and two women, with an age range between 26 and 78 years (mean 48). Seven of them (64%) represented referral cases, initially operated in other institutions. The primary treatment was reamed intramedullary nailing (IMN) in seven cases and plating (ORIF) in four cases. Implant failure (breakage of elements of the nailing system or of the plate) was recorded in four cases (two cases of each different method of fixation) (Figs. 1a, b and 2a, 2b). One case of femoral non-union also developed severe deformity consisting of varus angulation. Limb length discrepancy was evident in six of the cases (55%), with a maximum shortening of 3 cm. The average time which elapsed from the first surgery to the revision was 11.6 months (6–22 months). Revision surgery included the use of open reduction – plate fixation with an LCP1 plate (Synthes) in seven cases and exchange nailing in four cases (two Grosse Kempf1 nails Stryker, and two T21 Stryker) (Table 2). The initial intramedullary nail was left in place and a plate was used as additional fixation to achieve greater stability in a single case (Fig. 3). In all cases where open reduction plate fixation was used, autologous iliac crest bone graft was also inserted at the non-union site. In three cases additional biological stimulation was applied by implanting in association with the autologous iliac crest bone graft autologous platelet rich plasma (PRP),6 bone marrow aspiratemesenchymal stem cell concentrate (BMAC),5 and BMP-7 (Osigraft1 Stryker)9,19,21 (each one to a different patient respectively). The post-revision rehabilitation protocol included immediate supervised assisted mobilisation, non-weight bearing for at least 30 days, knee continuous passive motion (CPM) and isometric muscle strengthening exercises for the first 30 days, Subsequently, isotonic exercises were added to the rehabilitation programme, as
Fig. 1. (a) Male, 40 years old, 17 months after initial treatment with an intramedullary nail. Non-union, with implant failure (breakage of distal static locking screw. (b) Consolidation at 6 months after treatment with a locking periarticular distal femoral plate.
[()TD$FIG]1158
[()TD$FIG]
F. Benazzo et al. / Injury, Int. J. Care Injured 41 (2010) 1156–1160
Fig. 3. Supplementation of the original fixation device (IMN) with a locking plate and autologous bone graft. The nail keeps the alignment, the locking plate increases the stability, and the autologous bone graft enhances the local biology and feels the gap after the debridement of the soft callus of the non-union.
Fig. 2. (a) Male, 52 years old, non-union 8 months after initial treatment with an antegrade intramedullary nail. (b) Anteroposterior X-ray taken 4 months after revision to a plate fixation.
The mean post-revision follow-up of these 11 patients was 23.6 months (range 12–40). All cases healed in an average time of 6.1 months (range 4–11 months). Nine non-unions (82%) healed after a single revision surgery. The two cases whereas a third operation (second revision surgery) was necessary, were both femoral non-unions treated with open reduction – plate fixation. One of these patients after the removal of the plate underwent intramedullary nailing and eventually healed his non-union at 9 months from the first revision surgery. A second plate was inserted to the second patient to increase the construct stability. This non-union eventually united 10 months from the first revision surgery. A different case, treated with open reduction, plate fixation and autologous bone graft, developed extensive heterotopic ossifica-
tion over the non-union site, which had to be removed 4 months later. At that setting the same patient sustained an intraoperative fracture of the femoral neck, which was managed with a total hip arthroplasty. The case with the severe deformity before the nonunion revision was managed with nail removal and implantation of a plate and autograft. This non-union healed at 6 months and the patient returned to his physically demanding work (bricklayer) 9 months after the revision surgery. Residual post-revision surgery limb length discrepancy of >1 cm was recorded in three patients. Regarding the final functional outcome, in three out of the seven cases treated with a plate, and in one of the four cases treated with a nail, an improvement of the knee function was noted in comparison to their pre-revision condition. At the last follow-up assessment (mean 23.6 months ranging from 12 to 40 months), three patients still needed the use of walking aids. This group was markedly older from the rest (mean age 65 years vs. 40 years of the rest). Discussion Exchange nailing appears to be the gold standard method of treatment of aseptic femoral non-unions. Reaming of the femoral canal and its local biologic effect,20,22 as well as the mechanical advantages of placing a wider and stronger intramedullary nail have been proven efficient by many authors.8,16,26 Alternatively, the use of open reduction and fixation with LCP plates has been used at our institution and others over the years with variable results.1,7,25,28,31 Adequate exposure, usually via a lateral approach of the non-union site, and careful resection of the fibrous non-union tissue is mandatory for optimal results.15 For these reasons, the concept of supplementing an existing intrame-
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F. Benazzo et al. / Injury, Int. J. Care Injured 41 (2010) 1156–1160 Table 2 Diaphyseal femoral non-union 2002–2009. A/A
Gender
Age (years)
Side
Initial fixation
Type of non-union32
Revision
Time to healing (months)
1 2 3 4 5 6 7 8
M M F M M M M M
45 78 73 40 34 47 42 52
R L L R L L R L
IMN broken PLATE Plate broken IMN IMN broken IMN Plate IMN
Atrophic Oligotrophic Hypertrophic Atrophic Hypertrophic Atrophic Atrophic Atrophic
Plate IMN IMN Plate IMN Plate Plate Plate
4 9 5 10 5 4 4 7
9 10 11
M M F 9 M/2 F
26 43 40 Mean 47.3 years Range (26–78)
L R L 4 R/7 L
IMN IMN Plate broken 7 IMN/4 plates
Atrophic Hypertrophic Atrophic 7 Atrophic 3 Hypertrophic 1 Oligotrophic
Plate Plate IMN 4 IMN/7 plates
11 4 4 Mean 6.1 Range 4–11
dullary device with an additional extramedullary device (locking plate, Fig. 3) has been recently introduced.7,10,25 The adequacy of the mechanical factor (stability of the final fixation construct), as well as the correct alignment of the extremity, are of paramount importance to achieve optimal function. In this small series of patients the overall success rate of plating diaphyseal femoral non-unions was 5/7 (71%). We are aware that exchange nailing with or without bone grafting is considered nowadays as the gold standard of treatment. The intramedullary nail, being a load sharing device provides an ideal mechanical environment. Reaming of the intramedullary canal possesses great osteoinductive properties and generates abundant reaming debris (autologous endogenous grafting). Both of these parameters facilitate stimulation of the underlying bone repair mechanisms.20 On the other hand the plating option while being more invasive compromising the biological environment of the non-union, allows excision of the fibrous tissue, direct visualisation of the non-union site and correction of both the rotational and the mechanical axis. In four out of the seven cases revision of the previous plating fixation was performed. The addition of autologous bone graft while plating, offers the advantages of minimising any bone shortening (leg length discrepancy) as well as optimising the biological substrate at the non-union site.1 The supplementation of the biological factor with potent osteoinductive (PRP, BMP-7) – osteogenic agents (BMAC), appears nowadays a common feature in publications dealing with the cases of recalcitrant atrophic non-unions.12–14 Limitations of this study include its’ retrospective nature, the small numbers of cases, the inability to perform proper comparative subgroup analysis of this dataset, as well as the absence of any randomisation between the different methods of femoral non-union treatment. However, this cohort study represents a descriptive presentation of the accumulated experience of a single university unit, which is familiar with the management of non-unions of long bones, using different means depending on the specific characteristics of each patient and the nature of the non-union site. Sound knowledge of the inherent differences between the types of bone non-unions is essential for proper planning of the treatment strategy. We believe that plate fixation with biological augmentation can also be considered as an alternative option for the treatment of femoral shaft aseptic non-unions. Larger scale studies can provide further evidence about the efficacy of this method of treatment. Conflict of interest statement None of the authors have any conflicts of interest. The corresponding author has had full access to all the data in the study and has final responsibility for the decision to submit for publication.
Complications II revision II revision
Periarticular calcification and fracture of femoral neck
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