INTRODUCTION
Amongst the most frequent diaphyseal fractures in children, femoral shaft fractures are thought to occur in 2–20 cases per 100,000 children in the United States each year.[1-3] They represent a substantial cause of illness and even mortality in children, and a variety of fixation techniques have been developed with scant high-quality data to back them up.[2] The best way to treat these injuries is still up for debate in the literature,[4,5] with different approaches depending on the patient’s age, size/mass and fracture pattern.[6,7] For paediatric femur shaft fractures, the American Academy of Orthopaedic Surgeons reports that there is insufficient evidence to support a number of therapeutic approaches, such as intramedullary nailing (IMN) and submuscular plating.[8]
For the treatment of paediatric femur shaft fractures, flexible IMN has gained popularity over the last 20 years.[9] This approach, based from previous flexible rodding techniques, was developed in Nancy, France.[10] Numerous benefits come with flexible nailing, such as less invasiveness, quick hospital stays, early mobilisation and less problems. Differentiating the elastic stable IMN from other flexible nail systems as Ender’s nails have been established. The latter tend to straighten the natural curvature of the bone and are insufficiently elastic for fractures in youngsters. It is generally acknowledged that IMN is a suitable option for femoral fracture patterns that are length-stable (transverse and short oblique patterns). Furthermore, because IMNs use flexible intramedullary methods, they prevent early greater trochanteric epiphysiodesis and femoral head osteonecrosis. The application of IMNs in unstable fractures is still debatable. According to some writers, there is a correlation between high rates of angular and rotational deformity and the use of titanium elastic nails to stabilise children’s unstable fracture patterns.[11] Ellis claims that Ender’s nails are amongst the few flexible implants that allow screws to be utilised to manage implant backout and stop the fracture site from shortening.[12] Submuscular bridge plating is advocated by certain other writers for the treatment of length-unstable femur fractures.[13]
Plating approaches, which have gained popularity as an alternative to IMN, were mostly recommended for patients who weighed more above 49 kg or for length-unstable fracture patterns. Less malunion occurs, there is greater axial and torsional stability during loading, and the submuscular technique is exposed to less exposure when using plates.[14] Furthermore, reliable fixation with favourable outcomes in the paediatric population is made possible by plate osteosynthesis. Conventional plates necessitate prolonged exposure and damage to soft tissues. Submuscular methods and minimally invasive plating have developed to minimise soft-tissue dissection.[15] The goal of the current study was to compare the usage of plating methods and IMN in children with femur fractures by doing a meta-analysis of the literature and conducting a systematic review of the literature.
METHODS
This study was registered with PROSPERO (CRD42024548210).
By adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines,[16] we conducted our systematic review and meta-analysis.
Our search strategy was established based on the following primary keywords: ‘Intramedullary,’ ‘Nailing,’ ‘Plate,’ ‘Femur’ and ‘Fracture.’ We searched the PubMed, Web of Science, Cochrane Library and Scopus databases for relevant publications. The final articles were uploaded to Internet spreadsheets in Excel format so that the whole text could be screened once the title and abstract were checked. Two authors worked independently on the same articles during these procedures, and any conflicts were settled by consensus. If the disagreement persisted, a senior author handled it.
A protocol was developed including the population, intervention, comparison and outcome criteria to identify the inclusion and exclusion of articles. Therefore, the population was children with femoral fractures, the intervention was IMN, the comparison was plating techniques and the outcomes were any outcomes related to surgery. We included randomised controlled trials (RCTs) and observational studies such as cohort and case–control studies. We excluded reviews and case reports.
A senior author resolved any differences between the assessments made by two authors who evaluated the work independently for quality and bias risk. The New Castle Ottawa Scale (NOS) was utilised to assess the quality of observational research, assigning a score ranging from 0 to 9. Every question has the option to receive one, two or zero stars, with the exception of the comparison question, which can receive any number of stars. A study is classified as moderately good if it receives 4–6 stars, outstanding if it receives 7–9 stars and low quality if it receives 0–3 stars.[17] We employed the Cochrane risk-of-bias instrument (RoB 2.0),[18] which consists of five domains and linked sets of questions. Randomisation, deviation from planned interventions, outcome evaluation, inadequate outcome data and outcome selection of the published result are a few of these domains. For these questions, you may respond with ‘yes,’ ‘no,’ ‘possibly yes,’ ‘possibly no’ and ‘no information.’ Subsequently, a visual depiction illustrating one of three bias levels – high danger, significant worries or low risk – is created by combining the data. Only when each of the five categories is rated as low risk separately can a study be said to have an overall low RoB. The study is deemed to have some issues if any domain raises questions. Nonetheless, if any domain is judged to be at high risk or if multiple domains raise some red flags, the study is labelled as having a high RoB.
Using Microsoft Excel spreadsheets, two authors conducted the process of data extraction independently with any difference being solved by consensus or the senior author if necessary. The data extraction of baseline characteristics such as study design, sample size, age and gender were conducted in addition to the extraction of outcome data of blood loss, operation time, hospital stay, healing time, complications and outcome of surgery.
The statistical analysis was conducted using Review Manager version 5.4[19] software to calculate the mean difference (MD) between the continuous variables in the two techniques and the odds ratio (OR) for the dichotomous variables. This was conducted at a confidence interval (CI) of 95% and P = 0.05. Heterogeneity was assessed using I2 and P values.
RESULTS
The applied search strategy resulted in a total of 1244 studies, 476 were duplicates and 768 were screened using their titles and abstracts. A total of 21 studies were included in the full-text screening process and a final 15 articles[20-34] were eligible for our systematic review and meta-analysis [Figure 1].
Regarding the quality assessment of cohort studies by NOS, six articles were found to be of high quality, while two articles were of moderate quality [Table 1]. Four of the included RCTs were considered to have low RoB, two had high risk and one had some concerns [Figure 2].
Amongst the 15 included articles, eight were of cohort design, while we had seven included RCTs. These studies included a total of 470 patients undergoing nailing techniques and 388 patients undergoing plating techniques. Their age ranged from 5.9 to 10.6 years old [Table 2].
Regarding blood loss, IMN was associated with a lower amount of blood loss compared to plating techniques with MD of − 57.27 (95% CI: −68.09, −46.45, P < 0.00001) and I2 = 97%, P < 0.00001 [Figure 3].
IMN was also associated with shorter operation time compared to plating techniques with an overall MD of − 25.16 (95 CI: −44.27, −6.04, P = 0.01) and I2 = 100%, P < 0.00001 [Figure 4].
Moreover, IMN was statistically significant associated with lower hospitalisation with MD of − 0.82 (95% CI: −1.49, −0.15, P = 0.02) and I2 = 93%, P < 0.00001 [Figure 5]. However, no significant difference was observed between both techniques regarding healing time with an MD of 0.04 (−0.38, 0.47, P = 0.84) [Figure 6].
IMN was associated with a higher incidence of complications compared to plating techniques with OR of 3.88 (95% CI: 1.75, 8.58, P = 0.0008) and I2 = 39%, P = 0.12 [Figure 7].
No significant difference was observed between both groups regarding the functional outcomes of the two surgeries with an OR of 1.04 (95% CI: 0.47, 2.3, P = 0.91) [Figure 8].
DISCUSSION
The current study showed that in children with femoral fractures, IMN is associated with a lower amount of blood loss in addition to shorter operation time and hospitalisation compared to plating techniques. However, plating techniques were statistically significant associated with a lower incidence of complications compared to IMN. Moreover, they were comparable regarding the outcomes of surgery.
For the treatment of diaphyseal femoral fractures in the paediatric population aged 5–12, two options are available: IMN and plating.[3,35,36] The research reports positive results with both approaches; however, little differences between the two may favour one over the other for a given patient. Due to an increase in IMN complications – of which estimates state that 75% are caused by a lack of surgical experience – Sink noted that institutional practice has shifted away from IMN and towards bridge plating.[11,36]
When compared to other surgical procedures, IMN is generally acknowledged to have higher rates of union, shorter hospital stays, reduced surgical dissection and short time before ambulation for length-stable fracture patterns. However, there is still debate over the applicability of IMN for length-unstable fracture patterns. Furthermore, increased reported rates of complications, LLD and malunion, particularly in patients weighing more than 49 kg, restrict IMN.[37,38] When patients weigh more than 49 kg or when there are length-unstable fracture patterns, plating procedures are a valuable substitute for IMN. For restricted exposure, the submuscular plate method has grown in popularity.[39,40]
Compared to patients treated with alternative surgical techniques, children treated with flexible nailing exhibited a markedly increased rate of malunion and implant discomfort. After elastic nail insertion, implant sensitivity is common and usually the result of skin irritation at the nail tip. Prior research revealed that up to 52% of implants had discomfort during flexible nailing.[41] Following the removal of the implants, all of these children’s symptoms were completely resolved. Furthermore, flexible nailing was associated with a higher probability of malunion (22.4%) as opposed to rigid nailing (2%), according to the current results. A 7.7% incidence of malunion was discovered by Moroz et al.[42] in 234 patients who received elastic nailing. Unstable length fractures and higher patient weight were linked to poor results and an increased chance of malunion.[42,43] In accordance with this, there were two malunions in children who weighed over 45 kg, one malunion in a patient who had an unstable length fracture and one malunion in a child who weighed more than 45 kg and had an unstable length fracture. Rigid IMN with a trochanteric starting point facilitates early weight bearing, high rates of union and quick mobilisation in bigger patients with fractures of unstable length.[44,45]
One well-known side effect of employing a piriformis entry point for IMN is proximal femoral avascular necrosis.[33] Because the pericapsular vasculature is avoided, the use of an entry point at the greater trochanter’s tip or lateral to it can reduce the incidence of this problem.[46] Risks associated with trochanteric entry include the potential for growth disruption of the proximal femoral apophysis in patients with underdeveloped skeletons. Gage and Cary[47] discovered, however, that trochanteric growth was unaffected by the greater trochanter apophysis’s stop after 8 years. The study also discovered that the group receiving rigid IMN had a higher rate of heterotopic ossification. Heterotopic ossification was present in about 24% of the patients, but none of them experienced any symptoms and did not need any additional care.
Small wounds and no soft-tissue damage during insertion are two advantages of IMN nailing as a therapy option. Bridge plating can be used on larger, heavier paediatric patients with or without unstable fracture patterns, allowing healing with the least amount of damage to the soft-tissue envelope. Its application to individuals with narrow medullary canals who are not responsive to conservative therapy techniques offers further advantages. Some authors have suggested that IMN nailing should be preferred instead of solid IMN due to its favourable biomechanics and reduced rates of avascular necrosis.[48] This change also promotes faster weight bearing and shorter hospital stays.[1,7,49] This is especially helpful for individuals who are lightweight (<50 kg), younger (6–12 years old) and have fractures that are constant in length.[7,35] An increasing corpus of research and knowledge on the subtleties of various fixation choices, their dangers and complications is continuing to emerge. It has been seen that up to 75% of difficulties are directly related to surgical inexperience with IMN.[36] These are typically caused by rotational malunion (up to 11%) and angular abnormalities in the coronal and sagittal planes (up to 39%).[11,50] Leg length disparity can also happen in up to 58% of instances, meaning that the affected limb may lengthen or shorten.[50] Moreover, most malunions, lingering abnormalities and differences in limb length are not clinically noteworthy.[50,51] IMN nailing has a weight limit ‘ceiling’ of 50 kg,[38,52] because these abnormalities are more common in overweight children. Applying IMN to children who weigh more than this increases the risk of sagittal and coronal plane deformity.[32]
A rise in the use of different plating techniques for operative fixation has been caused by these difficulties.[53,54] The report’s proponents note earlier radiological union rates, quicker healing and a rare, if any, instance of plate failure. Plate fixation has demonstrated favourable biomechanical properties in comparison to IMN nailing.[40] They also have a reduced reported complication rate of 4%–8%,[3,35] and although some argue more exIMNive periosteal stripping with plating, modern low contact bridge plating minimises this. These can be used in bigger patients who weigh more over the 50 kg criteria for IMN.[55] In the study by Sutphen et al.,[33] rigid nailing, IMN and plating were compared with 344 paediatric femur fractures, and a minimum follow-up of 12 weeks was followed. In comparison to IMN, they found that plate fixation resulted in a statistically significant shorter mean time to union (6 versus 8 weeks), faster mobilisation (7 vs. 12 weeks), lower incidence of malunion, less hardware discomfort and fewer complications. Flynn provided a description of a four-parameter scoring system for diaphyseal femoral fracture repair in children. These parameters were limb length inequality, malalignment, discomfort and the occurrence of complications. Statistically comparable groups of IMN and plate patients with subtrochanteric fractures were compared by Li et al. In comparison to IMN, they showed quicker mobilisation times, improved Flynn result scores and higher union rates in plates.[23] In addition, according to the authors, IMN nailing had four times greater complication rates than plating (48% vs. 14%; P = 0.008), especially in cases of length-unstable fracture configurations.
The current study may be limited by different study designs which were pooled, but we provide comprehensive overview for the comparison between IMN and plating in children femoral fractures. Small sample sizes in most of the studies may be considered a limitation as well, but the inclusion of 16 studies increased the number of included patients. Future RCTs may be recommended to determine which technique to use in special cases such as high-weight and long-length fractures.
CONCLUSION
According to the current study, IMN is linked to less blood loss, a quicker recovery period following surgery and less hospitalisation than plating procedures in children with femur fractures. In contrast to IMN, plating procedures were statistically significantly linked to a decreased incidence of problems. Furthermore, they were similar in terms of the surgical results.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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Keywords:
Children; femur; fracture; intramedullary nailing; plating