Elastic Stable Intramedullary Nailling Femoral Shaft Fracture in Paediatric from six to ten years age
*Millad Mohammed AllafiKamsawi[1], Ahmed Hashim Amin[2],Ahmed Mohamed Nahla[2], Ahmed MashhourGaber[2]
[1]Orthopedic department, Faculty of medicine, Sabha University- Libya.
[2]Orthopedic department, Faculty of medicine,Zagazeg University, Egypt.
Corresponding Author: Millad Mohammed AllafiKamsawi E-mail :[email protected]
ABSTRACT
Background:Femoral-shaft fractures are among the most common fractures of the lower extremity in children, with an annual incidence of up to 1 per 5,000. This study aimed to evaluate the clinical, functional and radiological outcome of femoral shaft fractures which are managed by elastic stable intramedullary nailing (ESIN) in pediatric age 6-10 years. Patients and Methods: A prospective clinical randomized trial study was conducted on18 children underwent elastic stable intramedullary nailing (ESIN) for treating femoral shaft fractures at Orthopedic department, Zagazig University Hospitals during the period from Abril to December 2020. Plain X- rays of the femur Antero-posterior (AP) &Lateral (Lat.) views (from hip to the knee joint)was taken. Results: The time to surgery was (1.39±1.12) days ranged from 1 to 6 days, The time till full union was (9.4± 1.76) weeks ranged from 7to 12 weeks, more than half of the studied group (55.5%) ranged from 7 to 9 weeks and the time of full weight bearing was (9.6± 1.7) weeks ranged from 7to 12 weeks, Half of the studied group (50.0%) ranged from 7 to 9 weeks. So the final outcome was (83.3%) had excellent functional outcome, (11.1%) of them hadsatisfactoryfunctional outcome and (5.6%) had poor functional outcome, (88.8%) didn’t have any complications, (5.6%) of them had irritation and (5.6%) had superficial infection. Conclusion: ESIN is the choice treatment for transverse and short oblique shaft fractures and in patients over the age of 6-10 years.
Keywords:Femoral shaft fractures, femur, ESIN, intramedullary nail INTRODUCTION
Femoral shaft fractures are a common pediatric orthopedic injury, accounting for fewer than 2% of all fractures in children. 90 percent of femoral shaft fractures in children are caused by motor vehicle accidents. The global yearly incidence of femoral shaft fractures from transportation accidents ranges between 1.0 and 2.9 million[1].
Pediatric femur shaft fractures tend to heal quickly and have a high remodelling potential. As a result, a wide range of first healed bone deformities is regarded acceptable.
The allowable coronal and sagittal plane angulation ranges from 30o at birth to 15o at 10 years. Rotational misalignment does not remodel, and deformity greater than 10 in the axial plane is not tolerated. Growth acceleration can compensate for limb shortening of up to 15 mm in children as young as 12 years old[1,2].
A variety of factors influence whether a femoral shaft fracture should be treated conservatively or surgically, including the patient's age and weight, the type of fracture, accompanying injuries/ polytrauma, and the family's socioeconomic status[3].
Because of its excellent results and lack of serious problems, elastic stable intramedullary nails (ESINs) have become the standard treatment for femur shaft fractures in children aged 5 to 15 years. It is a closed surgery that allows for early weight bearing and
walking. The ESIN procedure was created in 1982 by a team from Nancy and represents a balance between conservative and surgical therapy approaches[4,5].
ESIN fits all of the minimally invasive bone surgery criteria, including shorter operating times, little soft tissue dissection, fewer incisions and consequently smaller scars, less pain, quicker mobilization, and relatively straightforward implant removal[6].
Flexible nail implantation is done through very small incisions and does not jeopardize the physes or the blood supply to the femoral head. The implant is sufficiently elastic to accommodate natural bone curvature and functions as a load-sharing device (internal splint) to sustain reduction until callus development emerges. It strives for quick bone continuity restoration, no joint stiffness, and early rehabilitation[7].This study was performed to evaluate the clinical, functional and radiological outcome of femoral shaft fractures which are managed by elastic stable intramedullary nailing (ESIN) in pediatric age 6-10 years.
PATIENTS AND METHODS
A prospective clinical randomized trial study was conducted on18 patients (13 males, 5 females) ages (6-10) years old and the mean age (7.7) was years with fracture shaft of femur (11 suffered from right side fracture and 7 had left side fracture) on the orthopedic department, Zagazig university hospital and treated surgically by elastic intramedullary nailing.
There were 16 cases with closed fracture. 2 cases with open fracture Gustilo,s type I. There were (12) cases with transverse fracture, (4) cases with oblique fracture, (2) cases with short spiral fracture.Approval taking Institutional Review Board (IRB)approval and also informed written consent was taken from patients and/or their caregivers. This Work was performed according to the code of Ethics of the World Medical Association (Declaration of Helsinki) for studies involving humans.Inclusion criteria:Age and sex: between 6 and 10 years; boys or girls. Fracture: diaphysis of femur: Non pathologic origin,Closed fracture or Gustiloʼs type I and II. Fracture in the area between lesser trochanter and 5 cm proximal to distal femoral epiphysis.Exclusion criteria: Age less than 6 years or more than 10 years. Open fractures:
infected second degree or more, Significant Systemic Co-morbidities / Injuries. Patients parents not willing to participate in the study. Patients unfit for surgery or anesthesia.
Pre-operative:
All patients underwent full clinical examination to know the type, mechanism and time of injury, any previous injuries and previous surgical interventions, and any medical comorbidity and medications. All the cases of trauma; were examinated by trauma team. The initial assessment wias directed to the Airway, Breathing and Circulation (ABCs). Plain X- rays of the femur Antero-posterior (AP) &Lateral (Lat.) views (from hip to the knee joint) was taken. Laboratory investigations included Complete blood count (CBC), Renal function tests (RFT), Bleeding profile. The procedure was performed under general anesthesia.
Surgical technique:
The procedure was done with the patient in supine position with C.arm guide. Under complete aseptic conditions and after dropping. Incisions were made on the medial and lateral side (about 2.5 cm in length) were done about 2 cm proximal to the physis Figure (1).
Under fluoroscopy guidance, the drill bit or awl was used to make a hole in the cortex of the bone at angle of 45 degrees in the coronal plane.The distal femoral metaphysis was opened 2.5 cm proximal to the distal femoral physis.The nail size measured by the diameter of the narrowest point of medullary canal on the x-ray. The diameter of one nail must be 40%
of the narrowest canal diameter.“Nail diameter = 0.4 x diameter of medullary canal”[8].
Nails were contoured according to the type and location of the fracture the nail tip pointing to the concave side of the bowed nail.The apex of the bow was at the level of the fracture.
This shape allowed the nail to generate optimal resistance to deforming forces[9]. Both medial and lateral rods were inserted to the level of the fracture. At this point, the fracture reduction was optimized if necessary Figure (2).The two nails then were driven into the proximal end of the femur, one toward the femoral neck and the other toward the greater trochanter. After the nails were introduced across the fracture and before they were seated, fluoroscopy is used to confirm satisfactory reduction of the fracture.The nails were pulled back about 2cm, the end of each nail is cut, then driven back to the femur to prevent irritation of the soft tissues. The end of the nails are exposed just enough to allow easy removal after healing of the fracture Figure (3).
Figure (1): medial incision.
Figure (2): 2 nails inserted to the level of the fracture.
Figure (3): cut end of 2 nails.
Post-operative follow up:
The thomas splint applied for rotational stability postoperative. Immediate postoperative anteroposterior and lateral radiographs was done. All patients were followed up at two weeks post-operative for removal of sutures, then every 6 weeks post-operative for check x-ray and assessment of callus formation. The patients were followed for assessment of range of motion of the knee, knee pain, deformities, and limb length discrepancy (LLD). The patients were followed at six months post-operative for final outcome and Flynn’s scoring criteria was applied.
Statistical analysis
Data were checked, entered and analyzed using SPSS version 23 for data processing. Data were expressed as number and percentage for qualitative variables and mean + standard deviation (SD) for quantitative one. The threshold of significance was fixed at 5% level (P- value).
RESULTS
Table (1), showed that the age of the studied group was (7.7±1.6) years ranged from 6 to 10 years, half of the group (50.0%) had age ranged from 6 to 8 years and (50.0%) from 8 to 10 years. that (61.1%) of the studied group were right sided affected and (38.9%) of them were left sided. Middle femur was the commonest fracture level (50.0%) of the studied group followed by proximal level (27.8%) and (11.1%) had distal fracture level. The transvers fracture was the commonest fracture type (66.7%) of the studied group followed by oblique fracture (22.2%) and (11.1%) had spiral fracture. The commonest mechanism of injury was RTA among (61.1%) of the studied group followed by Falldown and falling from height (16.7%) for each of them then direct trauma among (5.6%) of the studied group.
Grave (2,3), showed that the time to surgery of the studied group was (1.39±1.12) days ranged from 1 to 6 days, most of the studied group (83.3%) waited only one day, (11.1%) two days and (5.6%) 6 days.The time till full union among the studied group was (9.4± 1.76) weeks ranged from 7 to 12 weeks, more than half of the studied group (55.5%) ranged from 7 to 9 weeks. The time of full weight bearing among the studied group was (9.6± 1.7) weeks ranged from 7to 12 weeks, Half of the studied group (50.0%) ranged from 7 to 9 weeks.
Grave (4), showed that (83.3%) of the studied group didn’t have limb length discrepancy, (11.1%) had 1cm Lengthening and (5.6%) had 1 cm Shortening. Regarding pain intensity, this table shows that most (94.4%) of the studied group didn’t have pain while only (5.6%) of them had mild pain. Concerning deformity, about two thirds (77.8%) of the studied group didn’t have deformity while ˂5 ° Varus, ˂5° Anterior and ˂5° Posterior were occurred in (11.1%, 5.6%, 5.6%) of the studied group respectively.
Grave (5), showed that most of the studied group (88.8%) didn’t have any complications, (5.6%) of them had irritation and (5.6%) had superficial infection.
Table (1): Patients characteristics among the studied group
Variable
The studied group(18) mean ± SD
(Range) median Age (years):
7.7±1.6 (6-10)
7.5
Variable NO(18 ) %
Age grouping
6-8 years 8-10 years
9 9
50.0%
50.0%
Sex
Male Female
13 5
72.2%
27.8%
Side affected Right Left
11 7
61.1%
38.9%
Fracture level Distal
Middle distal junction Middle Proximal junction
Middle Proximal
2 1 1 9 5
11.1%
5.6%
5.6%
50.0%
27.8%
Fracture type
Oblique Spiral Transvers
4 2 12
22.2%
11.1%
66.7%
Mechanism of injury Fall from height
Direct trauma RTA Fall down
3 1 11
3
16.7%
5.6%
61.1%
16.7%
Injury
Open Closed
2 16
11.1%
88.9%
Range of motion of knee Full R.O.M 10 degree flexion limitation
17 1
94.4%
5.6%
Grave (1): Pie chart for time to surgery among the studied group
Grave (2): Bar chart for union duration among the studied group
83.30%
11.10%
5.60%
Time to surgery (days)
1 day 2 days 6 days
Time of union 0.00%
20.00%
40.00%
60.00%
7 TO 9 weeks
9 TO 12 weeks 55.50%
45.50%
Time of union
Grave (3): Bar chart for limb length discrepancy, pain intensity, &deformity among the studied group
Grave (4): Bar chart for complications among the studied group
83.30%
11.10%
5.60%
77.80%
11.10%
5.60% 5.60%
94.40%
5.60%
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
80.00%
90.00%
100.00%
Flynn's Score
Complications 0.00%
20.00%
40.00%
60.00%
80.00%
100.00%
No
Irritation
Superficial infection 88.80%
5.60%
5.60%
Complications
DISCUSSION
The age range of the investigated group was (7.71.6) years ranging from 6 to 10 years, with half of the group (50.0 percent ) ranging from 6 to 8 years and the other half (50.0 percent ) ranging from 8 to 10 years. The majority (72.2 percent ) of the participants in the study were males, while the remainder (27.8 percent ) were girls. The same age was discovered in a study conducted by Govindasamy et al, [9] in a total of 52 children were included in their retrospective analysis, the average age of the studied group was 9.5 years (range 6 – 16) at the time of injury, there were 30 boys (57.6 percent) and 18 girls (42.4 percent) in their study[9].
Frei et al[8] .'s concurrent investigation had the same age and gender composition as there were 22 children (14 boys [63.6 percent ], 8 girls [36.4 percent ]). The average age at the time of injury was 7.5 years (range: 2.0–15.0) [8].
The male predominance may be related to boys' heightened risk of all fractures as a result of higher-risk play activities being more acceptable for boys. In addition, they are more exposed to the outside environment, such as riding a vehicle and participating in sports, than their female counterparts, as demonstrated by Mughal et al, [10], who discovered a male:
female ratio of 2.2:1 in their study[10].
In terms of affected side, 61.1 percent of the examined group were right sided and 38.9 percent were left sided, which might be explained by leg dominance. In contrast, Frei et al [8] discovered that the left femur was fractured in 15 children (68.2 percent). In a train accident, one youngster (4.5 percent) suffered multiple injuries [8].
In terms of fracture site, we discovered that the middle femur was the most common fracture level (50.0 percent ) of the examined group, followed by the proximal level (27.8 percent ) and the distal fracture level (11.1 percent ). This was consistent with the findings of Govindasamy et al. [9], who discovered that 36 fractures were in the middle third, followed by seven proximal one-third and five distal-third fractures, with 28 right-sided fractures (58%) and 20 left-sided fractures (42%).
In the current study, transvers fracture was the most common fracture type (66.7 % ) of the analyzed group, followed by oblique fracture (22.2 %) and spiral fracture (11.1 %).
This was comparable to the findings of Akinyoola et al. [11], who studied 134 patients and found that the fracture line was transverse in 38.4 percent, oblique in 26.1 percent, spiral in 24.6 percent, comminuted in 10.1 percent, and greenstick in 0.7 percent [11].
Also, our findings were consistent with those of Frei et al. [8], who discovered 9 transverse (40.9 percent ), 6 spiral (27.3 percent ), 4 comminuted (18.2 percent ), and 3 long oblique (13.6 percent ) fractures.
Concerning mechanism of injury, the most common mechanism of injury was RTA among (61.1 percent ) of the studied group, followed by FD and falling from height (16.7 percent ) for each of them, then direct trauma among (5.6 percent ) of the studied group, and (88.9 percent ) of the studied group had closed injury while (11.1 percent ) had open injury.
The majority of the study group (94.4%) had full R.O.M, while only (5.6%) had 10 degree flexion limitation. Similar to Govindasamy et al, [9], the most common mechanism of injury was a road traffic accident (n=34, 70%), followed by a fall from a great height (n=14, 30%), and clinical evaluation of patients in Govindasamy et al, [9] study revealed full range of motion of hip, knee, and ankle in all patients at final follow-up period[9].
The time to surgery of the examined group was (1.391.12) days, ranging from 1 to 6 days; the majority of the studied group (83.3%) waited just one day, (11.1%) two days, and (5.6%) six days. The time till full union among the studied group was (9.4 1.76) weeks ranging from 7 to 12 weeks, with more than half of the studied group (55.5 percent ) ranging from 7 to 9 weeks. The time of full weight bearing among the studied group was (9.6 1.7)
weeks ranging from 7 to 12 weeks, with half of the studied group (50.0 percent ) ranging from 7 to 9 weeks. This was consistent with the findings of Nascimento et al. [12], who found that the average traction time before surgery was 5.3 days, with a minimum of 1 and a high of 14 days. Closed reduction was used to treat all fractures. The average length of stay in the hospital for ESIN insertion was 9.4 days. The average period for recovering after surgery was 7.7 weeks. On average, partial weight bearing was permitted after 3.3 weeks (ranging from 1 to 8 weeks). The average period for total weight bearing was 8.8 weeks[12].
Also, our findings were comparable to those of Govindasamy et al. [9], who found that all fractures were joined with grade III callus in an average of 9.7 weeks (9-12 weeks), and that full weight bearing and school attendance were initiated at the same time. In an average of 8.6 weeks, functional range of motion of the knee was obtained (6 to 14 weeks).
An average of 8.6 weeks (6 to 14 weeks) was required to attain functional knee range of motion [9].
After six months, a clinical examination was performed using Flynn's criteria, which were categorised as given in the table below. Govindasamy and colleagues [9]
Variables Excellent result Satisfactory result Poor result
Length discrepancy ≤ 1cm <2cm >2cm
Mal-alignment 5 degrees 5 to 10 degrees >10 degrees
Pain No No Yes
Complications None Minor and solved Major and/or residual morbidity
In terms of limb length disparity, the current study found that (83.3 %) of the examined group had no limb length discrepancy, (11.1 %) had 1cm Lengthening, and (5.6 %) had 1cm Shortening. In terms of pain intensity, the majority (94.4 % of the studied group did not have pain, while only (5.6 %) of them had mild pain. In terms of deformity, approximately two- thirds (77.8 %) of the studied group did not have deformity, while 5° Varus, 5° Anterior, and 5° Posterior were observed in (11.1 percent, 5.6 percent, and 5.6 percent ) of the studied group, respectively.
So the ultimate result was that (83.3%) of them had outstanding functional outcome, (11.1%) had adequate functional outcome, and (5.6%) had bad functional outcome.
Our results were comparable to those of Govindasamy et al. [9], whose clinical examination was performed using Flynn's criteria and whose outcomes were excellent in 40 children (83 percent) and satisfactory in eight children (17 percent ). No child received a low grade. Out of 48 cases, 5 (10%) experienced limb length shortening, with four children having a shortening of less than 5 mm, which was inconsequential [9].
The ultimate results of Nascimento et al, [12] were abnormalities such as Valgus 12 (40.0 percent), Varus 3 (10.0 percent), Anterior angulation 23 (76.7 percent), Posterior angulation 5 (16.7 percent), Other hospitalizations 28 (93.3 percent), and complaints 3. (10.0 percent ).
Nascimento et al [12] discovered that after at least 24 months of follow-up, the final shortening of the limb occurred in 6.7 percent of the cases (two patients), with an average of 0.25 cm. Overgrowth was present in 60% (18) of the patients, with an average overgrowth of 0.66 cm (range 0 to1.50 cm). Three (10%) of the patients expressed dissatisfaction with the treatment. One patient complained about knee pain. The second patient complained of knee pain as well as a deformity (18 of valgus). A third patient complained of thigh pain[12].
In contrast to our findings, Frei et al. [8] stated that out of 22 youngsters, Excellent result 6 (27.3%), Satisfactory result 10 (45.5%), and Poor result 6 (27.3%) [8].
Concerning problems in the current study group, the majority of the study group (88.8%) had no issues, (5.6 percent ) had irritation, and (5.6 percent ) had superficial infection, which was similar to Shemshaki et al, [13]. Three patients (13 percent) out of 23 suffered postoperative infection[13].
In addition, Govindasamy et colleagues [9] discovered that the most prevalent problem identified in their study was skin irritation and impingement due to the distal nail ends in 12 cases (25%)[9].
Finally, in the Frei et al [8] investigation, two of 22 children (9%) had reactive bursitis, one kid (4.5%) had subcutaneous nerve irritation due to a projecting distal nail end, and one child (4.5%) had proximal cortical perforation of the nail end [8].
CONCLUSION
Elastic stable intramedullary nailing (ESIN) is minimally invasive, safe, physical protective, relatively easy to use and an effective treatment for fracture femur in properly selected children with minimal complications. The surgical method brings few complications and results in good limb alignment, with a short period of hospitalization and early return to daily activities and school. Most of the complications are in fact due to improper technique which can be eliminated by strictly adhering to the basic principles and technical aspects.
We recommend ESIN for pediatric femoral shaft fractures in younger children. Further trials with longer follow-ups and comparison of elastic stable intramedullary nailing (ESIN) with other methods, such as external fixation, in children’s femoral fractures are warranted.
Further studies conducted with more subjects and using further classification scores. We therefore recommend obtaining intraoperative Dunn images at the end of the operation to confirm correct rotational alignment of the fracture fragments after stabilization with ESIN.
Further multicentric prospective studies are required to confirm our findings.
REFERENCES
1. John R, Sharma S, Raj GN, Singh J, C. V, RHH A, et al. Current Concepts in Paediatric Femoral Shaft Fractures. Open Orthop J. 2017;11(1):353–68.
2. Rapp M, Kaiser MM, Grauel F, Gielok C, Illing P. Femoral shaft fractures in young children (< 5 years of age): operative and non-operative treatments in clinical practice.
Eur J Trauma Emerg Surg. 2016; 1;42(6):719-24.
3. Flynn JM, Curatolo E. Pediatric femoral shaft fractures: a system for decision making.
Instr Course Lect. 2015; 64: p. 453–60.
4. El-Sayed AS. Treatment of the femoral shaft fractures in children by a single elastic stable intramedullary nail. Egyp Orthop J. 2018 Jan 1;53(1):83
5. Oetgen ME, Blatz AM, Matthews A. Impact of clinical practice guideline on the treatment of pediatric femoral fractures in a pediatric hospital. JBJS. 2015;
21;97(20):1641-6.
6. Pogorelic Z, Vodopić T, Jukić M, Furlan D. Elastic Stable Intramedullary Nailing for Treatment of Pediatric Femoral Fractures; A 15-Year Single Centre Experience. Bull Emerg Trauma. 2019;7(2):169–75.
7. John R, Sharma S, Raj GN, Singh J, C. V, RHH A, et al. Current Concepts in Paediatric Femoral Shaft Fractures. Open Orthop J. 2017;11(1):353–68.
8. Rapp M, Kaiser MM, Grauel F, Gielok C, Illing P. Femoral shaft fractures in young children (< 5 years of age): operative and non-operative treatments in clinical practice.
European Journal of Trauma and Emergency Surgery. 2016 Dec 1;42(6):719-24.
9. Flynn JM, Curatolo E. Pediatric femoral shaft fractures: a system for decision making.
Vol. 64, Instructional course lectures. 2015. p. 453–60.
10. El-Sayed AS. Treatment of the femoral shaft fractures in children by a single elastic stable intramedullary nail. The Egyptian Orthopaedic Journal. 2018 Jan 1;53(1):83.
11. Oetgen ME, Blatz AM, Matthews A. Impact of clinical practice guideline on the treatment of pediatric femoral fractures in a pediatric hospital. JBJS. 2015 Oct 21;97(20):1641-6.
12. Pogorelic Z, Vodopić T, Jukić M, Furlan D. Elastic Stable Intramedullary Nailing for Treatment of Pediatric Femoral Fractures; A 15-Year Single Centre Experience. Bull Emerg Trauma. 2019;7(2):169–75.
13. Lokesh DB, K DRB, R DS, Reddy DAK, S DS. Evaluation of pediatric femoral shaft fractures managed with intra-medullary titanium elastic nails [TENS]: A prospective study. Int J Orthop Sci. 2019;5(3):397–401.
14. Frei B, Mayr J, de Bernardis G, Camathias C, Holland-Cunz S &Rutz E. Elastic stabile intramedullary nailing (ESIN) of diaphyseal femur fractures in children and adolescents: A strobe-compliant study. Medicine 2019; 98(14).
15. Govindasamy R, Gnanasundaram R, Saravanan I &Melepuram J. Elastic stable intramedullarry nailing of femoral shaft fracture-experience in 48 children. Archives of Bone and Joint Surgery 2018; 6(1), 39.
16. Mughal A, Dix-Peek I & Hoffman B. The epidemiology of femur shaft fractures in children. SA Orthopaedic Journal 2013; 12(4), 23-27.
17. Akinyoola L, Orekha O, Taiwo O &Odunsi O. Outcome of non-operative management of femoral shaft fractures in children. African Journal of Paediatric Surgery 2011; 8(1), 34
18. Nascimento P, Santili C, Akkari M, Waisberg G, Reis Braga D & de Barros Fucs M.
Short hospitalization period with elastic stable intramedullary nails in the treatment of femoral shaft fractures in school children.Journal of children's orthopaedics 2010; 4(1), 53-60.
19. Shemshaki HR, Mousavi H, Salehi G, Eshaghi MA. Titanium Elastic Nailing Versus Hip Spica Cast in Treatment of Femoral Shaft Fractures in Children. Journal of Orthopedics and Traumatology 2011; 12(1):45-8.
