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Plate Augmentation for Nonunion of Femoral Shaft Fractures
Shafa Orthopedic Journal: In Press (In Press); e88673
February 5, 2019
Article Type: Research Article
January 4, 2019
January 7, 2019
January 25, 2019
H , Moghtadaei
M. Plate Augmentation for Nonunion of Femoral Shaft Fractures,
Shafa Ortho J.
Online ahead of Print
; In Press(In Press):e88673.
Femoral nonunion is an important complication, which can occur after intramedullary nailing and it requires surgical intervention. Plate augmentation over intramedullary nail is emerging as an acceptable option with satisfactory results for femoral nonunion.
The aim of the present study was to determine whether plate augmentation over retained intramedullary nail is an effective treatment for nonunion of femoral shaft fracture.
Overall, 35 cases of femoral nonunion, initially treated with intramedullary nailing, were managed with plating augmentation. Patients with oligotrophic or atrophic nonunion also received iliac cancellous auto graft. The outcome was evaluated by the rate and duration of union and complications were recorded.
All patients achieved bony union during an average time of 21 weeks (± 3.94) and no union occurred later than 35 weeks. In plain radiography, evidence of callus formation was seen at mean time of 10 weeks. There was no statistically significant difference in union time among different types of nonunion (P: 0.466) while a significant difference was noticed in the time for callus formation (P < 001). Also, no complications were observed.
Plating augmentation is an effective and safe treatment option for nonunion of femoral shaft fractures.
Copyright © 2019, Shafa Orthopedic Journal. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.
Intramedullary nailing with its minimally invasive nature is considered the standard treatment for the majority of patients with femoral shaft fractures and it has shown excellent union outcome with reported high union rates (
1, 2). Femoral nonunion is an important complication, which can occur in up to 57% of patients after intramedullary nailing and it requires a surgical intervention ( 3, 4). Several treatment options exist for femoral nonunion after intramedullary nailing, including reamed re-nailing ( 5, 6), dynamization ( 7), nail removal followed by plating ( 8), stable fixation with or without bone grafting ( 9, 10), and external fixation ( 11).
Currently, exchange nailing with or without bone graft is the standard of care for femoral nonunion. Some studies have reported secondary union rates as low as 53% after exchange nailing, which questions the efficacy of this treatment paradigm (
Plate augmentation over intramedullary nail is emerging as an acceptable option with satisfactory results for femoral nonunion. Many studies have indicated high union rates of this method (
This study sought to evaluate the efficacy of plating augmentation over retained intramedullary nail in achieving bony union in patients with nonunion of femoral shaft fracture.
3.1. Study Design and Patients
This was a prospective interventional study conducted between 2015 and 2018. Patients with current unilateral femoral nonunion, initially treated by intramedullary nailing, were recruited in the study. Patients were included if they had clinical manifestation of non-union and also depicted no sign of bony union on X-ray for at least six months, postoperatively. Patients with nonunion due to infection were excluded. The outcome parameters were rate and time to union. Patients were also categorized to three groups, according to their non-union type, including hypertrophic, atrophic, and oligotrophic. The mean weeks to obtain cross-bridge or solid union was reported in the study population and compared between groups.
Femoral shaft was defined as a part of femoral diaphysis between 5 cm distal to lesser trochanter and 5 cm proximal to adductor tubercle (
15). Non-union was defined as the lack of radiographic union at least for six months combined with persistent pain at the fracture site ( 16). Patients were evaluated at the scheduled intervals to investigate for evidence of clinical and radiographic bony union. Union was defined as the absence of clinical symptoms in addition to visualized bridging callus over three-fourths of the diameter of the fracture site of femur on both anteroposterior and lateral view ( 15). 3.2. Intervention
All the procedures were performed by the senior author (AY). Blood tests were obtained from patients to exclude infectious causes of non-union, preoperatively. Direct lateral approach was used by splitting the tensor fascia latae and vastus lateralis muscles to expose the nonunion site. Following incision on the previous scar, all the fibrotic tissues were resected and the bone edges were completely freshened with curettage, drilling, and rongeur while osteotome was applied to perform thin layers decortication on the posterior, lateral, and anterior edges of the bone. Samples were taken for laboratory analysis of infection then the researchers applied a 4.5-mm Dynamic Compression Plate (DCP) or anatomical locking plate for the distal part of the shaft. The plates were between 8 to 14 holes and at least three cortical screws were implanted on each side of the fracture based on the type of fracture to gain rigid fixation over the retained intramedullary nail. Following plate fixation, 6 to 10 cc of iliac cancellous auto graft was harvested and injected to the nonunion sites in patients with oligotrophic or atrophic nonunion while the non-union gap was closed rigidly (
Figure 1). Patients were discharged after 48 hours of empirical antibiotic therapy and allowed protected partial weight bearing gait. Partial weight bearing with the aid of crouches was allowed immediately after surgery whereas full weight bearing began after satisfactory bony union and clinical improvement. Also, nutritional supplement of vitamin D and calcium for three months and oral antibiotics for one week were prescribed.
Figure 1. A, Femoral shaft fracture; B, Primary Intramedullary nailing; C and D, 6 months postoperative nonunion of femoral fracture; E and F, 9 months postoperative nonunion of femoral fracture; G, 4 months post-plate augmentation; H, 6 months post-plate augmentation
3.3. Statistical Analysis
All statistical analysis was performed using SPSS 18.0. Descriptive data were reported as a mean ± standard deviation for continuous values and frequency for categorical values. Repeated measure analysis was used to compare the outcome between subgroups. Spearman correlation was also conducted to evaluate the relationship between baseline characteristics of patients and union time. P values below 0.5 were considered statistically significant.
The mean ± SD age of patients was 34.31 ± 14.59, including 25 (71.4%) males. Motor vehicle accidents was the major mechanism of fractures and 13 cases initially presented open fractures. Diabetes mellitus occurred in 10 patients as a comorbidity disorder. In 9 patients, fractures were located at the distal part of shaft and the rest of patients had fractures located at either proximal or middle third of femoral bone. In terms of non-union typing, 10 fractures revealed hypertrophic non-union, 15 patients depicted oligotrophic and 10 cases had atrophic nonunion. Among these 35 non-union circumstances, 28 patients had ineffective nonunion treatment; 12 cases underwent dynamization followed by weight bearing exercise, 14 cases sustained re-nailing with replacement of a larger nail and in two patients bone marrow injection was done. The mean time of nonunion between primary surgery of intramedullary nailing and the plate augmentation was 20.03 (± 6.37). Mean surgical time was 90 minutes (with a range of 70 to 150 minutes).
All patients achieved solid bony union in a mean time of 21 weeks (± 3.94) and no union occurred later than 35 weeks. The mean time of follow-up was 21.09 (± 6.22).
Table 1 summarizes patients’ profile. In the radiographic study, evidence of callus formation was seen at mean time of 10 weeks. In the hypertrophic non-union group, radiographic callus formation was earlier than other nonunion types. There was no statistically significant difference in union time among different types of nonunion (P: 0.466) while a significant difference was noticed in time to visualize callus formation (P < 001) ( Table 2).
Table 1. Patients’ Profile
No. Sex Age, y Site Type of Nonunion Nonunion Time, mo BG from ASIC Cross Bridge, wk Solid Union, wk Op Time, min Blood Loss, mL Hospital Stay, d F/U, mo 1 F 45 M/3 Hypertrophy 9 (-) 8 17 75 200 3 15 2 M 36 M/3 Oligotrophy 12 (+) 10 19 100 350 4 21 3 M 54 L3 Oligotrophy 14 (+) 11 22 70 450 3 13 4 F 25 M3 Atrophy 16 (+) 10 16 140 150 5 17 5 M 26 U/3 Hypertrophy 30 (-) 9 18 80 250 3 30 6 M 33 U/3 Atrophy 18 (+) 12 18 70 350 3 25 7 M 20 M/3 Atrophy 28 (+) 10 24 95 300 7 24 8 M 28 L/3 Oligotrophy 22 (+) 11 26 75 400 4 20 9 F 19 M/3 Hypertrophy 30 (-) 9 25 85 250 4 12 10 M 67 M/3 Oligotrophy 18 (+) 11 17 120 200 3 14 11 F 59 L/3 Oligotrophy 25 (+) 9 16 105 500 4 19 12 M 29 L/3 Hypertrophy 24 (-) 8 19 70 150 4 26 13 F 21 U/3 Hypertrophy 14 (-) 8 20 75 200 5 24 14 M 69 M/3 Oligotrophy 9 (+) 10 21 75 150 3 12 15 M 42 M3 Oligotrophy 29 (+) 8 20 70 250 3 28 16 M 21 U/3 Atrophy 29 (+) 14 19 75 200 4 32 17 M 26 U/3 Oligotrophy 19 (+) 10 23 80 600 5 30 18 F 24 M/3 Hypertrophy 17 (-) 8 35 140 300 4 17 19 M 46 L/3 Atrophy 13 (+) 10 18 80 350 3 30 20 F 41 M/3 Atrophy 19 (+) 12 20 70 250 5 14 21 M 51 M/3 Oligotrophy 25 (+) 8 23 125 600 4 18 22 M 42 M/3 Atrophy 30 (+) 10 20 100 300 5 21 23 F 49 L3 Atrophy 18 (+) 12 19 75 400 4 19 24 M 22 U/3 Oligotrophy 27 (+) 9 16 90 300 4 28 25 M 20 M/3 Atrophy 23 (+) 12 22 70 250 3 27 26 M 20 L/3 Hypertrophy 21 (-) 8 24 150 150 5 13 27 M 24 M/3 Oligotrophy 14 (+) 10 24 85 400 6 19 28 F 22 M/3 Oligotrophy 20 (+) 13 26 115 200 4 25 29 M 34 M/3 Oligotrophy 16 (+) 11 16 70 400 3 25 30 M 54 U/3 Oligotrophy 28 (+) 9 18 75 150 4 21 31 M 21 U/3 Hypertrophy 20 (-) 7 23 75 200 4 12 32 F 18 M/3 Hypertrophy 17 (-) 9 22 90 400 5 30 33 M 35 L/3 Atrophy 12 (+) 14 24 110 150 4 26 34 M 38 M/3 Hypertrophy 23 (-) 9 19 80 450 3 17 35 M 20 L/3 Oligotrophy 12 (+) 11 26 90 300 4 14
Table 2. Analysis of Nonunion Type
Hypertrophic Oligotrophic Atrophic P Value Callus formation (Weeks) 8.30 ± 0.67 10.07 ± 1.33 11.60 ± 1.57 < 001 Solid union (weeks) 22.20 ± 5.22 20.87 ± 3.75 20 ± 2.62 0.466
aValues are expressed as mean ± SD.
Statistical evaluation demonstrated that there was no significant relationship between union time and gender (P: 0.986), and primary fracture type (P: 0.193). There was a significant negative relationship between age and union time (P: 0.005, correlation coefficient:- 0.493).
The average blood loss during the surgery was 300 mL (± 124.85). No complications, including infection, discharge, pain, malalignments, and device failure, were observed. The range of motion in the hip and knee in addition to the limb length did not change postoperatively.
Femoral nonunion is a rare yet difficult to treat complication of fractures, in which standard treatment, such as re-nailing has failed to produce consistent results in different studies. In the recent years, plate augmentation has emerged as a promising treatment option. The current results indicated that the combination of plate augmentation and bone auto graft over retained intramedullary nail is an effective and safe treatment option for femoral nonunion with union rate of 100%. In a meta-analysis by Somford et al. applying a plate over existing intramedullary nail had more union rate compared with other techniques, including re-nailing (
17). Reports of results of augmentation plating over retained intramedullary nailing in femoral nonunion are limited. The number of patients in these studies are generally less than 50 cases and favorable outcome in all cases were reported ( 15, 18, 19). The findings are aligned with the results of previous studies. In the study of Hakeos et al. using a plate over intramedullary nailing associated with bone graft, particularly for complex fractures around the metadiaphyseal region, resulted in satisfactory outcome and they concluded that this procedure appears to be effective in reducing pain and improving function, and predictably leads to radiographic consolidation of the nonunion ( 20). In a retrospective study by Vaishya et al., this method was performed in 16 cases. All patients had bony union and bone graft was applied in four cases. The average surgical time was acceptable and no major complication occurred yet they had some cases of limb shortening ( 21). Ueng et al. as in the current study reported successful bony union after augmentation plating over intramedullary nailing. However, this study additionally applied bone autograft to nonunion sites in atrophic and oligotrophic nonunion patients to stimulate further callus formation ( 13).
This surgical technique has benefits over other available treatments for femoral shaft nonunion, including shorter time of surgery because of no need for nail removal, independence of this method from fracture reduction and alignment or direct approach to fracture site, less blood loss due to minimal incision and localized surgery, early weight bearing and walking, and less pain because of smaller incision and retaining of nailing. There is no need for new alignment and limb length correction unlike nailing exchange and solitary plating. This method makes surgery much easier and more comfortable for patients. Lower rate of infection and complications and complete range of motion after surgery in patients, who may have undergone several failed surgical treatments and may not bear another failed trial are other benefits of this method. Other important findings of this study, including no effect of gender or nonunion type or primary fracture type on outcome, point out the effectiveness of this method in patients with different profiles. There were some limitations in the current study. Lack of a control group and nature of the study, clinical score sheets, and the small population of the study are drawbacks of the study. More studies with an RCT design, larger number of patients and longer duration of follow-up are required to establish the definitive outcome of augmentation plating for femoral nonunion.
The current literature and the present study have shown the effectiveness of plate augmentation over retained intramedullary nail for patients with nonunion of femoral shaft fractures, who failed to respond to conventional surgical treatments, including dynamization, reamed renailing.
5.2. Compliance with Ethical Standards
Ethical approval was obtained from the ethics committee of Iran University of Medical Sciences. This study was also in accordance with the Helsinki Declaration and its later amendments and prior to entering the study, patients gave their informed consent to participate in this study.