|Year : 2020 | Volume
| Issue : 2 | Page : 115-120
A Comparative Study of Management of Femoral Shaft Fracture in Children: A Prospective Study
Ramji Lal Sahu, Bharat Goswamy
Department of Orthopaedics, SMS and R Sharda University, Greater Noida, Uttar Pradesh, India
|Date of Submission||13-Mar-2020|
|Date of Acceptance||27-Jul-2020|
|Date of Web Publication||28-Dec-2020|
Prof. Ramji Lal Sahu
11284, Laj Building No. 1, Doriwalan, New Rohtak Road, Karol Bagh, New Delhi
Source of Support: None, Conflict of Interest: None
Context: Femoral shaft fracture is the most common major pediatric orthopedic fractures and treatment of them carries a lot of controversies. Aims: The aim of this study was to compare the functional outcome after internal fixation with titanium elastic nail and stainless steel Kirschner wire in unstable femoral shaft fracture in children. Settings and Design: This prospective study was conducted at Sharda University between December 2010 and December 2017 and were followed up for 12 months. Materials and Methods: A total of hundred children between the ages of 2–14 years having closed unstable fracture of the femoral shaft were included in the present study. Fifty children were managed with titanium nails (Group 1) and the same number of children was managed with stainless steel Kirschner wires (K-wires) (Group 2). Functional outcomes were evaluated using the criteria of Flynn et al. Statistical Analysis Used: Statically analysis was limited to calculation of percentage of patients who had unions, malunions, delayed unions, or nonunions and excellent, good, and poor outcomes. Results: Based on the Flynn criteria, 92% of patients had excellent results, 8% had satisfactory results, and no one showed poor results. There was no clinically significant difference between the two groups with respect to time to union, functional outcome, and complication. Conclusion: The clinic-radiological results were not significantly different between titanium nail and Kirschner wire at 1-year follow-up as observed by our study. The cost of Kirschner wire is one-third the cost of titanium nail.
Keywords: Children, femoral shaft fractures, Kirschner wire, titanium nail
|How to cite this article:|
Sahu RL, Goswamy B. A Comparative Study of Management of Femoral Shaft Fracture in Children: A Prospective Study. J Orthop Traumatol Rehabil 2020;12:115-20
|How to cite this URL:|
Sahu RL, Goswamy B. A Comparative Study of Management of Femoral Shaft Fracture in Children: A Prospective Study. J Orthop Traumatol Rehabil [serial online] 2020 [cited 2021 Jun 17];12:115-20. Available from: https://www.jotr.in/text.asp?2020/12/2/115/305078
| Introduction|| |
The material properties of titanium and stainless steel are very different. The titanium nails are quite flexible when bent, but they must be very inclined to maintain a curvature. This “elastic” nature of titanium is a characteristic that has been considered important to achieve success with this technique of femoral fixation. Stainless steel, on the other hand, is much stiffer and requires more force to bend the nails. In vitro mechanical studies have demonstrated equal or superior fixation of pediatric femoral fractures with the use of titanium elastic nails compared to the elastic nails of stainless steel. The biomechanical properties of titanium are often considered superior to those of stainless steel for the fixation of intramedullary fractures with respect to biocompatibility, modulus of elasticity, osseointegration, resistance to corrosion, and compatibility with magnetic resonance imaging. Intramedullary titanium nails are associated with a lower infection rate, as shown by several animals' studies. Wall reported the unexpected finding that the rate of malunion was almost four times higher in association with titanium nails compared to stainless steel nails. He reported that their results indicate that less costly stainless steel elastic nails are clinically superior to titanium nails for pediatric femoral fixation, mainly due to a much lower rate of malunion. The aim of this study was to compare the functional outcome after internal fixation with titanium elastic nail and stainless steel Kirschner wire in unstable femoral shaft fracture in children.
| Materials and Methods|| |
This prospective study was conducted between December 2010 to December 2017. A total of 100 children between the ages of 2–14 years having closed unstable fracture of the femoral shaft were included in the present study. Institutional medical ethics committee approved it. All children were given above-knee plaster slab prior to operation and preanesthetics checkup was done. Fifty children were managed with titanium nails (Group 1) and the same number of children was managed with stainless steel Kirschner wires (K-wires) (Group 2).
Inclusion and exclusion criteria
The inclusion criteria were displaced fractures; multiple fractures which were found to be unstable in close reduction; fractures displaced in traction; fractures in patients with polytrauma and under intensive care to facilitate nursing; and irritable patients with brain injury.
The exclusion criteria were undisplaced fractures and fractures in good position treated by traction and plaster; age <2 years and more than 14 years; open fractures; fractures requiring open reduction; and nonunited fractures.
The objective of this study was to provide rapid healing of the fracture in a correct position, ease of nursing care, and early mobilization. Written informed consent was obtained from the parents of the children. They were followed after the surgery and were evaluated clinically and radiologically for the healing of fractures, joint movements, and implant failure. According to the criteria, the results were rated as excellent when the fractures were joined within 10 weeks (clinically and radiologically) without any complications, good when the union occurred within 16 weeks with treatable complications such as superficial infection and stiffness of the knee and poor when the union occurred before or after 16 weeks with one or more permanent complications such as deep infection, implant failure, lack of union, shortening of the limb, and permanent rigidity of the knee. Delayed union was recorded when the fracture united in more than 2–4 months (radiograph showed external callus traversed by a zone of radiolucency, a typical picture of fibro cartilaginous delayed union). Nonunion was noted when union had not occurred following 6 months of treatment. The follow-up was carried out for 1 year. In majority of the patients, fixation of the femur was performed within 1 week of the injury. Patients in Group 1 were treated by closed reduction and stabilization with the Titanium Elastic Nailing System (Tens). Elastic nails of standard length were used, that is, 440 mm and 2.0–4.0 mm in diameters. The diameter of the individual nail was selected according to the formula of Flynn et al. (diameter of the nail ¼ width of the narrowest point of the medullary canal in the anteroposterior (AP) and lateral views was_ 0.4 mm). The length of the nail was determined intraoperatively by fluoroscopy. Two nails of the same diameter were used. Group 2 patients were treated by closed reduction and stabilization with K-wires. Two stainless steel K-wires of 30–45 cm length and 2–4 mm diameter (depending on the size of the medullary canal and the child) were prepared by bending them at an approximate angle of 45°, 2 cm from the tip, and cutting off the sharp points to prevent inadvertent penetration of the cortex. The wires were not prebent in a “C” or “s” curve. The patients were taken on an orthopedic fracture table and a reduction of the fracture by traction was done under image intensifier. Preangled nails that were angled at 45° about 2 cm from one end were used. An entry point was made with the help of bone awl approximately 2 cm above the physis on the lateral side. A nail or K-wire loaded onto a T-handle was then inserted through the entry point into the medullary canal by rotator movements of the wrist and advanced up to fracture site. Another nail or K-wire was introduced using the same technique from the medial side and advanced up to the fracture site. The nails or K-wires were then crossed across the already reduced fracture site one by one. It was ensured that both nails and K-wires were in the canal across the fracture site by image intensifier. Traction was released when the nails or K-wire crossed the fracture site and then they were advanced further. Medial nail or K-wire was advanced till it was within 2 cm of proximal femoral capital physis, whereas lateral nail or K-wire was inserted till it was about 1 cm from greater trochanteric physis. Nails or K-wires were left protruding about 0.5–1.0 cm at the distal end for easy removal later on. No cast supplements were performed in the immediate postoperative period. The evaluation in the follow-up was performed according to a fixed protocol. The time to weight-bearing and for the union was recorded, as well as the range of motion of the knee and the discrepancy in the length of the limb. Union was defined radiographically when bridging callus was visible on two standard views with partial obliteration of the fracture line and clinically when bony tenderness and pain on weight-bearing were absent. Any difference in limb length was measured, keeping both lower extremities in identical position (with the pelvis squared) and measuring the distance from the anterior superior iliac spine to the inferior tip of the medial malleolus. The rotational deformity was measured, with the patient prone and the knee flexed at 90°. The flexed leg was then moved to the sides and the angle between the leg and the midline was measured. Any significant varus or valgus angulations at the fracture site was measured radiologically (more than 15° varus or valgus angulations). The patients were taught isometric exercises of straight leg elevation, strengthening exercises of the quadriceps and hamstrings with active, active, and passive mobility of the knee. No weight-bearing with axillary crutches was started immediately after the operation when tolerated. Patients were called for an outpatient visit on the 12th postoperative day (for stitch removal), 4 weeks postoperatively (for partial -earing walking), and at 8 weeks (for full weight-bearing when bridging callus appeared and fracture line was not visible on X-rays). Patients were followed up at regular intervals of 1 month, 3 months, 6 months, 9 months, and 12 months postoperatively. At each follow–up, patients were assessed clinically and radiologically and the complications were noted. The nails were removed when complete healing of the fracture occurred usually between 10 and 12 months. These patients were clinically and radiographically evaluated to determine union timing at 12 months after surgery [Figure 1]a,[Figure 1]b,[Figure 1]c and [Figure 2]a and [Figure 2]b. Patients were evaluated for delayed union (more than 8–16 weeks postoperatively) and nonunion (24 weeks after surgery). The final results were evaluated using the criteria of Flynn et al. The statistical analysis was limited to the calculation of the percentage of patients who had unions, malunions, delayed, or non-unions and excellent, good, and poor results. As a part of the subjective assessment, patients were asked in questionnaire if they were very satisfied, satisfied, or not satisfied with the outcome of treatment.
|Figure 1: (a) Preoperative anteroposterior and lateral view of the right thigh showing fracture at lower one-third shaft of the femur. (b) Postoperative anteroposterior and lateral view of the right thigh showing fracture fixation with two K-wires. (c) Follow-up case showing fracture healing of lower one-third shaft of the femur|
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|Figure 2: (a) Preoperative anteroposterior and lateral view of the left thigh showing fracture at the middle one-third shaft of the femur. (b) Postoperative anteroposterior and lateral view of the left thigh showing fracture fixation with two titanium nails|
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| Results|| |
The average age of the patients in this study was 7.7 years in Group 1 and 7.2 years in Group 2. Males were more than the female in both the groups, 68% male were in Group 1 and 70% in Group 2, while female were 32% in Group 1 and 30% in Group 2. The right side was involved in 54% in Group 1 and 60% in Group 2. As for the fracture location, the middle third femoral shaft was mostly involved accounting for 60% in Group 1 and 54% in Group 2. Transverse was the most common fracture type in both the groups, 44% in Group 1 and 36% in Group 2. Oblique fracture was 36% in Group 1 and 20% in Group 2, spiral fracture was 10% in Group 1 and 18% in Group 2, comminuted fracture was 6% in Group 1 and 4% in Group 2, and segmental fracture was 4% in Group 1 and 2% in Group 2. The main cause of fracture was road traffic accident in both the groups, 44% in Group 1 and 60% in Group 2. While fracture due to fall from height was 22% in Group 1 and 14% in Group 2, fracture due to sports injury was 34% in Group 1 and 26% in Group 2. The average hospital stay was 5.58 ± 2.16 days in Group 1 and 6.24 ± 2.05 days in Group 2 [Table 1]. At 6 weeks postoperatively, bridging callus was seen across three or more cortices in all patients in both the groups. All patients in both the groups were followed up for 12 months. None was lost to follow-up. At the final follow-up, all patients in both the groups showed mature callus across all four cortices as seen on two orthogonal views of the femur. The time for clinical union of fracture was 8.2 weeks in Group 1 and 8.2 weeks in Group 2. There was no clinic-radiological difference in terms of time to fracture site union between the two groups. Minor complications were observed in 34% of the patients in Group 1 and 36% of the patients in Group 2 with no major complications. Seven patients in Group 1 and six patients in Group 2 reported pain, nail tip irritation, and insignificant superficial infection which resolved in a few days with analgesic and antibiotics. Six patients in Group 1 and five patients in Group 2 had limb length shortening of <1 cm and six patients in Group 1 and five patients in Group 2 had implant protrusion which had been corrected. Two patients in each group had insignificant limb lengthening of <1.5 cm. Four patients in each group had delayed union and two patients in each group had malunion. None of the patients in both the groups had nonunion. Four patients in Group 1 and 3 patients in Group 2 had varus angulation of <1.2° [Table 1]. Two patients in each group had valgus angulation of <15° and three patients in each group had angulations in AP plane of <8°. There was no statistically significant difference in complication rate in both the groups. All the patients in both the groups had a full range of motion of their knees and hips. The clinical results of our study were based on the criteria of union, nonunion, delayed union, and malunion. Functional outcomes were evaluated using the criteria of Flynn et al. [Table 2]. According to Flynn et al. criteria, each group had 92% excellent and 8% good results [Table 3]. In subjective overall assessment, 92% of the patients were fully satisfied and 8% of the patients were satisfied with the outcome of treatment.
| Discussion|| |
The ideal tool for treatment of most femur fractures in children should be simple, load sharing internal splint allowing early mobilization while maintaining length and alignment for several weeks until bridging callus forms, without endangering the blood supply to the epiphysis. In the past few years, majority of literature had described that the flexible intramedullary nailing was a safe method in femoral fractures in children. The treatment of femoral fractures in children changed in 1982 when Métaizeau and the team of Nancy, France, developed the technique of stable and flexible intramedullary fixation using titanium nails., In the past two decades, there was a growing interest in the surgical treatment of pediatric fractures, although the debate about its indications persisted. There is a slight disagreement regarding the treatment of long-bone fractures in children under 6 years of age Plaster of Paris (POP) and adolescents over 16 years of age (closed intramedullary interlock). The controversy persists with respect to the age between 6 and 16 years, with several options available: traction followed by hip spike, external fixation, flexible stable intramedullary nails (Ender or titanium), plate fixation, and blocked intramedullary nailing. Whatever the method of treatment, the objectives should be to stabilize the fracture, control length and alignment, promote bone healing, and minimize morbidity and complications for the child and family. Orthopedic surgeons will continue to face the challenge of treating this age group with less morbidity at a lower cost, since until now, no clear guidelines are available despite the efforts initially made by French surgeons, later by European surgeons and recently by the Pediatric Orthopedic Society of North America., The fixation of the elastic titanium nail was originally understood as an ideal treatment method for femoral fractures but was gradually applied to other long-bone fractures in children since it represents a compromise between conservative and surgical therapeutic approaches with satisfactory results and minimal complications., Kumar et al., Shakeel et al., and Al-Zahrani et al. recommend the efficacy of K-wires for flexible intramedullary nailing of femoral shaft fractures in children. Shakeel's reports reduced psychological trauma on the child and the parents. Based on the concept of flexible intramedullary nails, Al-Zaharani, et al. and Qidwai and Khattak recently advocated the use of intramedullary Kirschner wire fixation for pediatric femoral fractures with encouraging results. Huber, et al. recommended flexible titanium nailing for the treatment of all pediatric femoral shaft fractures. Like the Nancy nails, flexible K-wires allow for microcontrolled oscillating movements that allow compression to be changed in different parts of the fracture line, leading to the early formation of external calluses. Each K-wire provides three attachment points: one at the entry point, one at the apex of the K-wire curve, and a third at the tip, which is embedded in the cancellous bone of the proximal metaphysis. Stability is provided not only by the intramedullary K-wires but also by the bone itself and the surrounding soft tissues.,, The bone provides axial stability and each wire provides three-point fixings. The bent tips provide rotational stability. The surrounding muscles also provide stability by acting as guide cords. Increasing the number of K–wires increases the stability of the fixation.,, Kiely et al. tested the mechanical properties of different flexible nail combinations in a pediatric femoral fracture model. They did not find differences in the mechanical properties of the straight, paired, S-shaped and C-shaped nails. In our study, there was no statistically significant difference in terms of time to fracture site union between the two groups. At the final follow-up, all patients in both the groups showed mature callus across all four cortices as seen on two orthogonal views of the femur. The time for clinical union of fracture was 8.2 weeks in Group 1 and 8.2 weeks in Group 2. As the timing of appearance of bridging callus in both the groups was similar, it can be reasonably inferred that both the types of implants provided the required stability at the fracture site to promote healing. There were no cases of nonunion in both the groups in our study. Similar observation was found by studies conducted by Flynn et al., Crammer et al., Galpin et al., and Sahu et al. when titanium elastic nails were used. In the study by Rios et al. where both titanium and steel nails were used, there were no cases of nonunion. Contrary to our study, Wall reported that the malunion rate was significantly higher in the titanium group (23.2%) than in the stainless steel group (6.3%). The risk of malunion was nearly four times higher in the titanium group than in the stainless steel group. However, Rios et al. and Goyal N et al. have reported no statistically significant difference between the malalignment in the coronal and sagittal plane when titanium and stainless steel nails were used. Similar results have been found in our present study.
Rios et al. and Sahu et al. have reported no statistically significant difference between the malalignment in the coronal and sagittal plane when stainless steel flexible nails were used. Similar results have been found in our present study. However, none of our patients with angulations in the coronal/sagittal plane complained of any functional disability. It raises the question whether the angulation of these magnitudes is clinically significant. In the present study, according to Flynn et al. criteria, each group had 92% excellent and 8% good results. In subjective overall assessment, 92% of the patients were fully satisfied and 8% of the patients were satisfied with the outcome of treatment. These results compare favorably with other published outcomes [Table 4].,,, There was no statistically significant difference in terms of outcome between the two groups., Flexible intramedullary nail fixation for femoral shaft fractures in children has distinct advantages over other conservative and over operative techniques. This is a minimally invasive technique with small stab incisions at the entry point. The amount of blood loss is small as compared to plating. Cosmetic damage is minimal (as compared to other open techniques like plating). In contrast with the hip spica, it affords advantages of easy nursing care, early mobilization, and avoidance of psychological problems due to prolonged immobilization.,,, As the children are mobilized early on axillary crutches, they can return to school and playing activities earlier. The technique is of considerable value in head injury and comatose patients when compared to traction or spica cast immobilization. Percutaneous flexible intramedullary nail fixation is a biological method of fixation, which provides a combination of elastic stability and mobility. Closed methods leave the fracture hematoma intact, leading to the formation of early bridging callus. This is an easy to learn technique, with a small learning curve. It may be adapted to treat other diaphyseal fractures in children.,,,
| Conclusion|| |
We conclude that titanium nail and Kirschner wire (K-wire) are equally effective treatment modalities for femoral shaft fractures in children in the age group of 2–14 years with a similar rate of complications, but titanium nail is more cost-effective as compared to K-wire. Radiographic angulations in the coronal and sagittal plane in both the study groups were comparable.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]