Over past recent years, paediatric orthopaedists have tried a variety of methods to treat paediatric long bone fractures to avoid prolonged immobilization and complications. Treatment of long bones fractures in children continues to improve as newer techniques evolve. Though most of the fractures can be effectively managed conservatively, unstable and displaced fractures need fixation to provide good results. Orthopaedic surgeons have long maintained that all children who have sustained a diaphyseal long bone fracture recover well with conservative treatment. The remodelling capacity of the paediatric bone can compensate for less than a perfect reduction. But time and experience of many clinicians have also shown that children with diaphyseal long bone fracture do not always recover completely with conservative treatment. Angulations, shortening and malrotation are not always corrected1. There is little disagreement regarding the treatment of younger children (usually less than 5 years of age) and these can be treated with immediate spica casting2. These young children tolerate the cast well, are easily managed at home and mild to moderate fracture displacement and angulations correct well by growth and remodelling. The cost of care is low and outcome is generally good. Older children (usually older than 15 years of age) show good response with standard locked intramedullary nailing techniques. For children that occupy the middle age group between 5-15 years, there are a wide variety of surgical and nonsurgical treatment options available as early spica casting, traction followed by casting, external fixation, plate fixation, reamed intramedullary rods and flexible intramedullary nails with no clear consensus as to the preferred treatment3. A systematic review of the literature provides little evidence to support one method of treatment over another4. Over the past two decades the advantages of fixation and rapid mobilization has been increasingly recognised5. Health care cost containment and a desire for early discharge from the hospital have become important factors in treatment of femoral shaft fracture. As a result newer techniques have become popular. An ideal fixation device for paediatric femur and tibia fracture would be a load sharing internal splint maintaining reduction for a few weeks until callus forms. Most importantly implant should endanger neither the physis nor the blood supply to femoral head5.Titanium implants are increasingly being used for elastic stable intramedullary nailing. Titanium elasticity limits the amount that the nail is permanently deformed during insertion. More importantly elasticity promotes callus formation by limiting stress shielding. Titanium also has excellent biocompatibility5.Titanium elastic nail (TEN) fixation was originally meant as an ideal treatment method for femoral fractures, but was gradually applied to other long bone fractures in children, as it represents a compromise between conservative and surgical therapeutic approaches with satisfactory results and minimal complications6.

As soon as the child was bought to ER, child’s general condition was assessed. A complete survey was carried out to rule out head, chest, pelvis or abdominal injuries. Plain radiographs of antero posterior and lateral views of the involved limb including one joint above and one joint below were taken to assess the extent and geometry of fracture.

Patient was admitted to the ward. Detailed history relating to the age, sex, adress, mode of injury, and past and associated medical illness was asked to the informant. Systemic examination was performed to recognize any preexisting medical and surgical illness. Thorough local examination was done to know about the deformity, extent of swelling, local tenderness, and abnormal mobility. The neurovascular status was recorded. Any associated injury was recorded and treatment carried out accordingly.

Routine blood investigations were done for all patients. This included haemoglobin, bleeding time, clotting time, complete blood count, urine examination, blood urea, and blood sugar. X-ray chest was also done to diagnose any pre-existing chest disease. Patients were operated as early as possible once the general condition of the patient was stable and patient was fit for surgery. Post operatively clinically (pain, range of movements, limb length discrepancy and time of weight bearing) and radiologically (alignment and callus formation) the patient was assessed. Post operative complications were monitored and assessed. Patient was followed up at 6, 8, 12 weeks and 6 months.

Selection and description of Participants:

It is a prospective study with a study sample of about 50 paediatric patients presenting to the ER with diaphyseal fracture of femur and tibia meeting the inclusion and the exclusion criteria, admitted to Bapuji Hospital and Chigateri Government Hospital, Davanagere attached to J.J.M. Medical college, Davanagere were taken up for the study after obtaining the informed consent.

INCLUSION CRITERIA:

1. 5-15 years of age
2. Diaphyseal fractures Femur & Tibia
3. Simple fractures (closed fractures)
4. Ipsilateral fractures

EXCLUSION CRITERIA

1. Metaphyseal fractures
2. Open fractures
3. Pathological fractures
4. Fracture with head injury

Surgical Technique

Femur Under general / spinal anaesthesia the patient is placed in supine on a radiolucent fracture table. The operative extremity is then scrubbed, painted and draped. Physis was identified by fluoroscopy, and mark its location on the skin. An incision was made on the lateral or medial aspect of the distal femur, starting 3 cm above the physis. Using the bone awl entry point was made keeping it 450 to the femoral shaft and advanced forwards. The opening was made slightly larger than the selected nail diameter. The nail of suitable length and diameter which was selected with pre –op preparation was then stressed and bend according to the requirement and fracture pattern. First nail was loaded to T handle. The nail was inserted into the medullary canal with the nail tip at right angles to the bone shaft. Rotated through 180° and with the inserter the nail tip was aligned with the axis of the medullary canal. By rotation movements of the T-handle with or without limb manipulation, the nail was directed to the proximal fragment which was pushed into better alignment by the nail. At the same time the second nail was advanced to enter the proximal fragment. The nails were advanced as far as the metaphysis. The tips of the nails in the proximal fragment were correctly aligned in the frontal plane. At this point the stability and rotation were checked. Once the nails are fixed in the metaphysis it is no longer possible to adjust the rotation. The tips of the nail that entered the lateral femoral cortex should come to rest just distal to the trochanteric epiphysis. The opposite nail should be at the same level towards the calcar region. After the nails were inserted and its length adapted, the corresponding bevelled impactor for TEN was used to bring the nails into their planned anchorage position.

Tibia Nail entry point was marked as 1.5–2.0 cm distal to the physis, sufficiently posterior to avoid injury to the tibial tubercle apophysis. A longitudinal 2 cm incision was made on both the lateral and medial side. Using an awl nail entry was made entering perpendicular to the bone surface then changing the angle to 45 degrees. One nail was loaded in a T handle and then slowly under fluoroscopic guidance with rotator movements the nail was inserted till the fracture site. Both the nails were advanced until the tips lie just proximal to the distal tibial physis and under Fluoroscopic guidance proper fracture reduction as well as nail position was confirmed. Before hammering the nails in their final position in the distal metaphysic, the tips of both nails were turned slightly posteriorly in order to achieve the physiological antecurvation of the tibia. The fracture was compressed to prevent fixation in distraction and the nails were cut to length.

Post-operative treatment after usual post operative protocol followed. Patient was discharged. Sutures were removed on POD 10. Patient was called for periodic follow up at 6 weeks, 8 weeks, 12 weeks, 6 months for clinical and radiological assessment. Post-operatively, in some cases of unstable fracture and where surgeon deemed necessary patients were immobilized with high groin POP slab for femur fracture or above knee POP slab for tibia fracture for 2 weeks and later changed to POP cast in deemed necessary at time of discharge and continued for another 6 weeks based on radiological assessment. Partial weight bearing was started at 3 weeks as tolerated or after immobilization removal in cases put on slab/cast. Full weight bearing was started by 8 - 12 weeks depending on the fracture configuration and callus response.

Follow up examination Clinical assessment of pain, range of movements, limb length discrepancy, time for weight bearing was assessed – both partial and complete weight bearing. Radiological evaluation was done. Alignment, circumferential callus formation and fracture line visibility was assessed. Minor complications such as Pain at the site of nail insertion, Minor angulation (< 100 – sagittal/coronal; <100 rotational malalignment) at final follow-up (24 weeks), Minor leg length discrepancy (< 2cm – shortening/lengthening) at final follow-up (24 weeks), inflammatory reaction to nails, Superficial infection at site of nail insertion, Delayed union. Major complications such as Angulation exceeding the guidelines (>100 – sagittal/coronal; or > 100 rotational malalignment) at final follow-up, Leg length discrepancy exceeding the guidelines (>2cm – shortening/lengthening) at final follow-up, Deep infection, Loss of reduction requiring revision surgery, Surgery to revise nail placement, Compartment syndrome requiring surgery, Neurological damage after nailing, Delayed or non-union leading to revision was followed up. The final outcome based on the above observations is done as per Flynn’s criteria.

Statistics: R (Version 4.3.0, 2023 The R Foundation for Statistical Computing) was used for data processing with the Chi square test. Significance was assumed at a p ≤0.05. Baseline data are, if not stated different, presented in mean and range.

Patients’ characteristics

Between November 2021 to January 2024,

50 patients (mean age 10.4 years (range 5-15 years),

Majority of them being in the age group of 9-12 years (n=21,42%) followed by 5-8 years (n=20,40%) followed by 13-15 years (n=9,18%). Most of them being male (n=21,42%), female (n=29, 58%) with femur or tibia diaphyseal fractures were treated with Titanium Elastic Nailing System.

History of injury was asked to the patients. Majority of the patient gives alleged history Road Traffic accident (n=21,42%) followed by self-fall/ sports (n=19,38%) followed by fall from height (n=10, 20%). Tibia was more commonly affected (n=33,66%) followed by femur shaft fractures (n=17,34%) and right (n=28, 56%) was more affected than left (n=22,44%). Most of the fractures were transverse pattern (n=19,38%) followed by oblique (n=13,26%), spiral (n=12,24%) and small number of segmental (n=2,4%) and communited fractures (n=2,4%) seen in older children. Large number of fractures were middle 1/3^rd (n=35,70%) followed by proximal 1/3^rd (n=8,16%) and distal 1/3^rd (n=7,14%). Most of the children presented to ER from 24-48hr after the injury (n=34,68%) followed by 10-24 hrs after the injury (n=9, 18%) and minority of the patients presented within 10 hrs of the injury (n=7, 14%).

Surgery and immediate post op care

Duration of the surgery was also noted which was found to have majority of the surgeries were done in 51-60 min (n=18, 36%), followed by 41-50 min (n=16, 32%) and 30-40 min (n=14, 28%) and <30 min (n=2,4%). Average nail size used was 2.8mm (range 2.5-3mm) majority of them being 2.5 mm and 3 mm (n=15, 30%), followed by 3.5 mm (n=12,24%) and 2mm (n=8,16%). Most of the patients were discharged within 1 week (n=34, 68%) followed by 8-10 days (n=10, 20%). Some patients were hospitalized for >10 days (n=6,12%) attributed to complications.

Follow up examination

Time taken for union of fractures was decided by clinical and radiological assessment following surgery (CRIF+TENS) for tibia and femur diaphyseal fractures. Most of the fractures were united within 12 weeks (n= 39, 78%) followed by 12-14 weeks (n=9, 18%). Post operative immobilization was given to patients till starting of partial weight bearing. During immobilization, patients were allowed for non-weight bearing ambulation with the help of walking aid. Majority of the patients were immobilized for 3-4 weeks (n=22, 44%) followed by 1-2 weeks (n=20, 40%). After patients were rehabilitated, time taken for full weight bearing was noted. About 2/3^rd of the cases took <12 weeks for full weight bearing (n=35, 70%) followed by 12-14 weeks (n=12,24%). Patients were called for follow up after 24 weeks and range of movements was assessed. Almost all the patients had full range of movements (n=48, 96%) and only few had mild restriction (n=2,4%).

COMPLICATIONS AND OUTCOME:

At the same times complications was noted and most had no complications (n=37, 74%) and some patients had minor complications (n=13, 26%). Among the patients who had minor complications, most had residual pain at the operated site (n=10, 20%) and few had superficial infection (n=3, 6%). Only 1 patient had varus and 1 had valgus angulation (n=1, 2%). Outcomes as per Flynn’s criteria was calculated and majority had excellent result (n=44, 88%) and remaining patients had satisfactory results (n=6, 12%).

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There have been many attempts by the paediatric orthopaedic surgeons to avoid the ill effects and complications of tractions and hip spica and also the prolonged immobilization in paediatric femur shaft fractures. Spica casting is safe and effective for many cases, it particularly suits children with high-energy trauma, children with head injuries or spasticity7. External fixation has also been used successfully but often surgeons face complications like temporary loss of knee motion and pin-track infection and re-fracture after fixator removal which is more troublesome8. Solid ante grade IM nailing is better than casting for adolescent femur fractures, but incidences of avascular necrosis of femur head, trochanteric growth arrest and coxa valga has restricted their use in children with open proximal femoral phises9,10.  Although the majority of tibia shaft fractures in children can be treated with closed reduction and casting, occasionally surgical stabilization is required. Historically, external fixation has been the treatment of choice; however, risks include pin-track infections, non-union, and refracture11,12. Reamed locked intramedullary nails, while shown to be effective in the skeletally mature, pose unnecessary risk to the proximal tibial physis, and have limited indications in those children with growth remaining13.

TENS is effective fracture stabilization method for femur and tibia fractures in children, only if principles of TENS has been followed for greater mechanical stability. These biomechanical principles are more important in older children especially in weight bearing lower limb bones. TENS are more commonly used in femoral diaphyseal fractures than in tibial diaphyseal fractures. There is a need for strict vigilance for the complications associated with it. Patients and their families must be adequately counselled preoperatively about potential complications related to TENS13.

This is a prospective study undertaken to analyse the outcomes of diaphyseal fractures of femur and tibia in children in age group 5 to 15 years treated with titanium elastic nails among 50 patients presenting to ER in a tertiary health care hospital.

The outcomes were assessed clinically and radiologically at 6 weeks, 12 weeks and 24 weeks follow ups and any complications arising were identified, assessed and reported.

The average age distribution of in our study is 10.4 years which results in good outcome and less post-operative complication and morbidity. Most of patients presented to ER in our study gives alleged history of RTA of about 42% which is similar to other studies.

The studies conducted by Gamal Ed ALD Et al. shows majority of the patients had fractures at proximal 1/3rd femur and tibia shaft fractures in contrast to our study where most the patient had fractures were in the mid 1/3rd femur and tibia shaft fractures. All cases coming to our institute were operated within first 48 hours of trauma. The average time interval between trauma and surgery was a little over one day at 29.1 hours (1.2 days). 34 cases (73.33%) got operated within 24-48hrs and 9 cases got operated within 24hrs. In study by Sinha SK16 all cases operated within 24 hours of trauma. The time interval between trauma and surgery in study by Bhuyan15 was ranging from 1day to 8 days, with average of 3.8 days. The average duration of surgery was 49.3 minutes. The study conducted by Bhuyan15 the average duration of surgery was 20 to 45 minutes while Sinha16 reported that the average duration of surgery of 59.4 ± 16.6 minutes. 42(84%) cases were immobilized with an average of 2.23 weeks of which maximum immobilization was for the period of 6 weeks. Cases which were immobilized for 6 weeks had communited pattern of fracture. After immobilization, exercises and weight bearing were started as tolerated. Bhuyan15 in his study had immobilized 7 (17.5%) cases due to unstable fracture fixation and started non weight bearing ambulation of post-op day 2-3. Gamal El Ald6 immobilized 20(33.33%) cases post operatively.

Minimum duration of stay was 6 days and maximum were 11 days, which was for a patient with superficial infections and was treated with oral antibiotics. Bhuyan15 reported a hospital stay ranging from 5 days to 12 days with a mean of 8.1 days. In study by Sinha16 a mean hospital stay was for a duration of 6.6 days while the study conducted by Mann DC17 had a hospital stay of 11.4 days.

In our study fracture union was achieved in < 12 weeks in 39 (78%) cases, between 12-14 weeks in 9(18%) cases and between 15-18 weeks in 2 case (4%). Average time for fracture union union was 10 weeks. Bhuyan15 reported a mean union time of 9 weeks with time for union ranging from 8 to 10 weeks. Aksoy C, et al. compared the results of compression plate fixation and flexible intramedullary nail insertion. Average time to union was 7.7 (4 to 10) months in the plating group and 4 (3 to 7) months for flexible intramedullary nailing18.  All the patients were followed up for a period of 24 weeks post-surgery and any complications in patients were noticed. Out of the total 50 cases, 13 cases had complications which were seen till the 24 week follow up. Bhuyan15 reported complications in 16 of the total 40 cases (40%). Skin irritation at site of entry was one of the most common complications. Sinha52 reported a complication rate of 24.5%, Gamal El Ald6 and Wudbhav13 had complications rate of 16.6% and 36.84% respectively. The most commonly reported complication related to TENS involves nail prominence and irritation at the nail entry site. Other serious complications which follows are skin breakdown, superficial or deep infection, effusion and stiffness at the adjacent joint, bursitis and reoperation to perform nail trimming or nail advancement. Angular malunion (valgus, varus, anterior, posterior) and limb-length discrepancy are relatively common, whereas rotational malunion is uncommon19. In our study we observed 1(2%) case of limb length discrepancy (1cm lengthening in fracture of tibia) and 2 cases (4%) of coronal plane deformity, one each varus deformity (femur fracture 5 degrees) and valgus (femur fracture 8 degrees). None of the deformities were major and required any further manipulation or surgery. No case of sagittal plane deformity and rotational deformity were observed in our study. Restriction of movement at the knee joint was seen in 3 cases (6%). All 3 cases had femur diaphyseal fracture and the restriction was mild restriction of knee joint (active painless flexion of 0 – 120 degrees present, terminal 20 degrees of flexion restricted) at 24 weeks of follow up.

In our study for the final outcome assessment Flynn’s criteria was used. Out of the total 50 cases studies, excellent outcomes were seen in 38 patients (76%), satisfactory results were seen in 12 patients (24%). Poor outcomes were observed in none. The outcomes in 12 patients were assessed as satisfactory because of minor complications seen: delayed union in one case of communited middle femur shaft fracture, superficial pain infection at nail entry site in 3 cases, limb lengthening of 1cm in one tibia fracture case and coronal plane deformity ( <10 degrees) in 2 cases of femur fracture. All these complications resolved within 20 weeks of follow up and there was so no lasting morbidity in the patients. Bhuyan et al.15 in their study of 40 cases, reported excellent outcomes in 33 (82.5%) cases and satisfactory in 7 cases (17.5%). The reason for satisfactory outcome was complications like limb length discrepancy in 3 cases and angular deformity in 4 cases. In a study by Sinha et al.16 where out of 60 cases, 53 cases were followed up till final outcome, they reported excellent outcome in 40 (80%) cases, satisfactory in 8 (16%) and poor in 2 (4%) cases. Poor outcome was due to transient neurological deficit and refracture which needed re surgeries. Gamal El Adl et al.6 in their study of 66 children with 48 femoral and 25 tibial shaft fractures reported (75.8%) excellent, 24.2% satisfactory and no poor results.

Based on the results of our study, we conclude that TITANIUM ELASTIC NAIL SYSTEM surgical technique is not only safe and simple but also reliable and effective method for management of paediatric femoral and tibial shaft fractures between the age of 5 to 15 years. TITANIUM ELASTIS NAILS gives elastic mobility which helps in rapid union at fractures site and stability which is one of the ideal methods for early mobilization as well as its physeal protective technique and this causes minimal damage to bone growth.  TENS has several advantages in terms of short hospital stay, and early mobilization, short bone healing time, good functional outcome and lesser complications. The surgical technique itself is easy to learn and implement with moderate need of equipment and surgical skills. Minimally invasive approach, shorter operative time, less blood loss, lesser radiation exposure resonates with idea of an ideal surgical technique.

Overall experience in our study shows that TITANIUM ELASTIC NAILING for paediatric femur and tibia shaft fracture is a safe, cost effective, physiological procedure with a relatively easy learning curve resulting in very few short-term complications with mostly excellent outcomes irrespective of fracture location and pattern provided that the important biomechanical principles of TENS are followed.

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