Introduction
Complex long bone fractures—particularly those of the tibia—are becoming more common as a result of the growth of the transportation sector and the progress of industrialization.1 Bone defects can result from trauma (car accidents, fire injuries, falls, etc.), the removal of a diseased section (infection), or the disease process itself (tumour). When addressing gap non-union, it is important to address both of the two main issues: non-union and bone loss. Because of the impaired vascularity, bone loss, and soft tissue injury at the fracture site, tibial non-unions with a gap pose special complications. In order to encourage union, these elements impede the normal process of bone healing and need for intervention. Dr Gavriil Ilizarov, a Russian orthopaedic surgeon, created the Ilizarov ring fixator, which offers a dynamic approach to fracture care by increasing biological stimulation of bone regeneration through the concepts of distraction osteogenesis and offering regulated mechanical stability. Although there are a number of methods for treating tibial non-union with bone abnormalities that resulted in amputation, the rate of limb amputation has decreased since the advent of methods like Ilizarov osteosynthesis.2
Materials and Methods
Aim of our study is “To Prospectively assess the radiological and Functional outcome of management of gap non-union of the tibia using Ilizarov ring fixator.” A prospective study on topic “management and outcome of gap non-union of tibia by Ilizarov Ring Fixator” was done at Index Medical College, Hospital and Research Centre, Indore (M.P) in time frame of November 2022 to February 2024 in 25 patients. Inclusion criteria in our study was, Age > 18years and < 60years, all patients with gap non-union, psychological stable patients and patients/legally accepted representative willing to provide written/informed consent and exclusive criteria was acute fractures, patients with pathological fractures, patients unable to take selfcare, patients with non-compliance for long duration of fixators, patients with psychiatric Illness, patients/legally accepted representative not willing to provide written/informed consent.
In the event of a chronic infection, debridement was carried out and the material was sent for sensitivity and culture testing. In each case, a free-hand method was employed to apply the Ilizarov-based ring fixator. In each segment, the wires were installed in the designated safe areas. When intraoperative deformity correction proved unfeasible, hinges were positioned appropriately to enable progressive postoperative correction. In each instance, a corticotomy was performed. After soaking gauze pieces in povidone iodine, the pin locations were dressed with a rubber stopper. Sterile gauze was used to treat the wounds from the debridement, fibulectomy, and corticotomy procedures. To avoid oedema, the limb was kept in elevation after surgery.
The status of the distal neurovascular system was continuously observed. Six dosages of intravenous Cefuroxime were prescribed. Oral and intravenous antibiotics were then administered for a duration of three weeks, depending on the culture and sensitivity results. Patients were taught how to apply pin tract dressing using spirit or povidone iodine, and they were encouraged to perform it on their own. Before beginning the distraction, a latent period of seven days was granted. Following the latent phase, distraction was initiated at the corticotomy site at a rate of 1 mm/day, or 0.25 mm every six hours. The patient was told to use two crutches and increase his/her weight bearing gradually when walking. The frame has a foot orthosis fastened to it.3
Eventually, the support was reduced to just one crutch, and then the patient was allowed to bear their whole weight on their own. Ankle and knee physical therapy was started. Adjusting the speed of distraction was done based on regenerate appearance on follow-up radiography. The rate of compression was reduced to 0.25 mm/3days after docking. In any instance, there was no bone transplantation.
Based on radiological and clinical standards, Union was evaluated. Clinical criteria included the lack of discomfort and soreness at the docking site and the absence of aberrant mobility, which was determined by moving the bone segments and detaching the rings on either side of the docking site. The emergence of trabecular continuity and the consolidation of regeneration in at least three of the four cortices were the radiological criteria that were applied.
A patellar tendon bearing cast was given to a few patients following the removal of the frame, allowing them to bear their entire weight for three weeks. Following the cast's removal, the patient was permitted to walk alone. Functional outcomes and bone healing were used to evaluate the management's overall success.3 According to ASAMI standards, when union was attained together with the absence of infection, a deformity < 7˚, and a disparity in limb length of less than 2.5 cm, the bone healing was rated as excellent. When there was a union and at least two of the other three requirements were met, it was rated as good; when only one of the three requirements was met along with the union, it was rated as fair. A persistent or recurring illness combined with nonunion was seen as a bad outcome.4
According to the ASAMI criteria, the functional outcomes were rated as satisfactory when the patient was mobile, had no discomfort, no limp, little stiffness (<15° knee flexion deformity/15° loss of ankle dorsiflexion), and no reflex sympathetic dystrophy (RSD). When the patient was active and had one or two of the following symptoms: a limp, stiffness, RSD, or significant pain, it was graded as good; when three or more of the following symptoms were present: a limp, stiffness, RSD, or significant pain; a poor result occurred when the patient was unemployed, inactive, or unable to perform activities of daily living because of the injury. An amputation was viewed as unsuccessful. The patients were monitored for a mean of 17 months throughout a period of 14 to 22 months.4
Observations and Results
Table 1
Age distribution
|
Age group |
No. of patients |
Percentage |
|
20-30 years |
04 |
16% |
|
31-40 years |
13 |
52% |
|
41-50 years |
05 |
20% |
|
51 and above |
03 |
12% |
The mean age of patients was 37.8 years with 60% being in 30-40 years age group.
Table 3
Evaluation of bone result, based on ASAMI scoring system
There were almost 76% of the patients showing excellent plus good bone results i.e. 40% and 36% respectively. Excellent and good bone results together were considered as good outcome i.e. 76%.
Table 4
Functional results of patients based on ASAMI scoring system
There were 48% excellent, 28% good, 16% fair and 08% poor results in our study. There were no failures in our study. Excellent and good results were considered as good outcome.
Table 5
Post operative complications
Most common post-operative complications we came across is pin tract infection and equinus. Nearly all the complications were managed and outcome was good in these cases except for 2 cases wherein there were non-union, in which results were poor.
Discussion
Our study comprises 25 instances, with an average age of 38 years. Results from several additional studies have been comparable. Magadum et al (2006),5 Sachin R Jain et al (2012),6 Xie J et al (2021),7 Agrawal(2022),8 Kumar A. (2024)9 with an average age of 39 years, 38.87 years, 37.5years, 36.5 years, 35.75 years respectively. Given that this age group is the most active and mobile, this is also predicted.
Man, predominance in RTA (Road Traffic Accidents) can indeed be influenced by societal factors such as gender roles and occupational patterns. Our study is also male predominant with 23 males and 2 females like others. Male to Female Ratio in different studies are: P Yin et al (2014)10 62:4, Vel. Sarath (2016), 11 17:3, Rohilla (2016)12 30:5, Amit Kumar Sharma, Jayant Sharma (2017)4 13:3, Hrishikesh P (2017)13 16:2.
In our study right side is commonly more involved as compared to left side i.e. 16 right sided and 09 left sided which is quite similar in studies of Farmanullah et al. (2007),14 Paresh et al (2022),15 N Gaurav (2023)16 as well. These are mere a coincidence or a point to further research about the right-side predominance.
Initial trauma in majority of patients in our study were due to RTA i.e. 19, rest due to fall from height and simple fall. The series of Farmanullah et al (2007),14 Vel. Sarath et al (2016),11 G. Testa et al (2020),17 Paresh (2022)15 also had same findings.
Mean time of union in our study is 8.5 months. There is very discrete data on mean time of union in different studies. The studies of Rajesh Chandra et al (2001),18 Vel. Sarath et al (2016),11 Hrishikesh Pande et al (2017),13 Paresh et al (2022)15 have similar results but studies of Paley D, Cattaneo R (1989),19 Patil S (2006)20 had opposite results. We can deduce from above data that mean time to union depends on various factors including environmental, patient and surgeon dependent and the results of various studies rely on that too.
In our study, case series of 25 patients, Average time in the fixator was 241 days i.e., approximately 8 months. There are various studies which showed similar results. Krishnan A (2006):21 234 days, Madhusudan et al (2008):22 279 days, P Yin et al (2014):10 284 days, Vel. Sarath (2016):11 240 days. In all our cases the assembly removal was done post union and dynamization except two cases in which union was delayed.
Evaluation of bone result was based on ASAMI scoring system, and in our study, results was excellent in 10, good in 9, fair in 4 and poor in 2 patients. In series of Krishnan A, Pamecha C, Patwa J21 Excellent: Good: Fair: poor fraction is 13:4:1:2, Patil, S., & Montgomery, R. (2006)20 is 17:14:4:6, Amit Kumar Sharma, Jayant Sharma (2017)4 11:4:0:1, Kumar A et al.(2024)9 16:7:5:2.
In terms of functional results which was also based on ASAMI scoring and the fraction of Excellent: Good: Fair: Poor: Failure is 12:7:4:2 with no failure. 2013 Mohammad Shahid23 6:4:2:2, Hrishikesh Pande (2017)13 7:6:3:1:1, Amit Kumar Sharma, Jayant Sharma (2017)4 10:4:0:2, Kumar A et al. (2024)9 15:6:5:4.
Conclusion
Though the study was not free of complications, all the patients of the study were satisfied with the results. But good to excellent functional outcomes can be achieved in majority of patients. Ring fixator systems reliably achieve union in infected large bone defects of tibia and help in treating infection, shortening, bone and soft tissue loss simultaneously. We advocate early freshening of fracture ends and removal of interposed soft tissue at docking sites to achieve union. This prevents the need of bone grafting. The transporting fragment carries overlying skin along with-it during distraction, thus avoiding the need of flap or skin grafting. Ilizarov’s ring fixator is a good treatment option in tibia non-union with bone defect. It helps in control of infection as well as restores the tibial length. Moreover, Ilizarov’s fixation helps in early mobilization and decreases morbidity due to immobilization.