Congenital talipes equinovarus (CTEV, clubfoot), is one of the most common complex congenital deformities of the foot and ankle in infants. The deformities are ankle forefoot adductus, midfoot cavus, ankle equinus and hindfoot varus 1. CTEV occurs in 1 in every 1,000 live births, with male-to-female ratio of 2:1, and approximately half of them have bilateral clubfoot.¹

The management of CTEV have been in debate since the beginning. Hippocrates provided the earliest descriptions of clubfoot care and was the first to recommend bandaging and massage as a treatment modality for clubfoot.²

The development of clubfoot treatment is guided through two methods over two centuries. The first is the concepts of manipulation, strapping, and serial plaster treatment, while the second favours a variety of surgical techniques for clubfoot correction. However, in recent practices, the Ponseti method contribute to a functioning, painless, and morphologically normal foot. Due to several pitfalls of surgical release procedures of CTEV, such as recurrence, stiffness, overcorrection, discomfort, and ankylosis, there appears to be a reinvigoration of interest in conservative techniques for the management of congenital clubfoot.²

Ignacio Ponseti gave us the accurate basis of clubfoot correction by manipulation and casting, stand on the principles of kinematics and pathoanatomy of the deformity, which successfully treats clubfoot in infants without any major surgery. The current treatment consists of corrective manipulation and casting every week, resulting in progressive correction of the deformity. The final plaster requires a percutaneous tendoachilles tenotomy which reduces surgical intervention in 98% of cases. Today, ponseti method is the pinnacle for the initial treatment of clubfoot. Parents and their education about the disease aids in getting successful results.³

Malhotra R et al (2018) discovered CTEV, is a complicated congenital foot abnormality that can make walking unpleasant and difficult for a person if left untreated. Most of the children born with clubfoot worldwide live in low- and middle-income nations. The study set intended to measure the functional outcome of CTEV care by the application of the Ponseti procedure, investigate the degree of deformity in CTEVs using the Pirani score, and appraise the approach's cost-effectiveness. The Ponseti technique was used to treat 356 patients, or 402 feet, with CTEV. The children's mean age and the quantity of casts placed prior to complete correction were 4.03 months and 6.91, respectively. At the most recent follow-up, there was a favourable functional outcome in 95.45% of cases (score > 30). The Ponseti approach for managing CTEV results in an excellent functional and aesthetic outcome. This way of managing clubfoot is safe, simple, and affordable in a developing nation like India.⁴

Sharma A et al (2018) discovered that they evaluated the Pirani score's significance in figuring out how many casts are needed and its capacity to indicate the need for tenotomy in the Ponseti way of treating clubfoot. An initial high Pirani score indicates a likely requirement for tenotomy and a greater number of casts to achieve correction. With a rise in the initial Pirani score, more castings are needed to achieve complete rectification. A simple surgical procedure called a percutaneous tendoachilles tenotomy is likely required if the 46 initial high hindfoot score (2.5–3) is present. The expected length of treatment and the necessity of a tenotomy can be communicated to parents based on the initial Pirani score.⁵

Gelfer Y et al (2019) found that the Ponseti method is the benchmark treatment for the correction of clubfoot. Although the first rate of correction is very high, the results are less predictable as one proceeds through the treatment pathway. There have been reports of multiple approaches to determining severity upon presentation. Classification becomes more difficult as treatment progresses. The assessment of clubfoot at presentation, correction, and relapse is determined by this systematic review, which also takes into account the Ponseti method's outcome in terms of relapse. With idiopathic clubfoot, the likelihood of recurrence and additional surgical intervention rises with the length of follow-up. The lack of clarity in defining the corrected and relapsed foot adds to the variation in results. The findings imply that a definition of relapse needs to be agreed upon.⁶

Baghdadi T et al (2017) study was to assess the idiopathic congenital clubfoot deformity treated with the Ponseti method and identify variables, such as radiological studies, that may be related to the patients' mid-term follow-up failure and recurrence risk. Their findings showed that there was either little or no association after using the Ponseti technique of treatment. Since the diagnosis of clubfoot is a clinical determination, the treatment's effectiveness can only be assessed clinically. The Ponseti procedure can restore the foot's natural shape, but it is unable to address the underlying bone defects, which ultimately results in the radiologic abnormality remaining. To reduce the danger, more research is advised to determine an alternative alteration that can address the aberrant angles between the ankle and foot bones to minimize the risk of recurrence.⁷ 

It is a hospital based interventional prospective study conducted in district hospital, Tumkur, Karnataka for a period of 12 months which included follow up every week for first five weeks and 8^th week and every two months thereafter. The aim of the study was to analyse the Functional outcome of serial cast correction of congenital talipes equinovarus by ponseti method. Sample size was calculated to be 59¹ and all the children from birth to 3 months of age with congenital idiopathic clubfoot were recruited from CTEV clinic after taking written informed consent from the parents. Infants with Non-idiopathic clubfoot like myelodysplasia, complex idiopathic clubfoot, paralytic clubfoot and infants previously operated for clubfoot and infants with associated neurological defects, spine and hip conditions, and previously treated by other methods, were excluded from the study.  

PIRANI SCORING SYSTEM was used to assess functional outcome. Recording the extent of involvement allows the treating surgeon to assess where he or she is on the roadmap of management, asses the need for tenotomy, and to inform and reassure parents about the progress in management. The Pirani method measures six clinical parameters. These parameters are graded as normal, moderately abnormal, or severely abnormal and scored as 0, 0.5, 1 respectively. The three components included in the Mid Foot Score (MFS) are Curved lateral border, Medial crease, Coverage of the talar head. Three components are included in the Hind Foot Score (HFS) are Posterior crease, Rigid equinus, Empty heel.⁸

The data are entered in Excel Spread Sheet. Descriptive statistical analysis was carried out by mean and standard deviation for quantitative variables and frequency and percentages for categorical variables. The association between functional outcomes of different variable are analysed by using Chi Square Test.a

In our study, 15 (25.4%) patients were 1-10 days of age, 19 (32.2%) patients were 11-20 days of age, 20 (33.9%) patient were 21-30 days of age and 5 (8.5%) patients were ≥31 days of age.

In our study, 16 (27.1%) patients were Female, and 43 (72.9%) patients were male. In our study, 46 (78.0%) patients had Birth order 1, 11 (18.6%) patients had Birth order2 and 2 (3.4%) patients had Birth order 3. In our study, 13 (22.0%) patients had Consanguinity. In our study, 28 (47.5%) patients had Bilateral, 16 (27.1%) patients had Left and 15 (25.4%) patients had Right.

TABLE 1: DISTRIBUTION OF FINAL PIRANI SCORE

TABLE 2: DISTRIBUTION OF MEAN NUMBER OF CASTS

TABLE 3: DISTRIBUTION OF MEAN FOLLOW UP (MONTHS)

This study is a time bound, hospital based, prospective study. Cases satisfying the inclusion criteria managed in District Hospital, Tumakuru during the study period of 2022-23 was included. Patients are followed up and evaluated functionally with PIRANI SCORING SYSTEM.59 patients were included in this study In our study, the majority of patients, 20 days (33.9%), were 21-30 days of age, and this distribution was statistically significant (Z=3.3793, p=0.00072). Gender distribution revealed that the majority of patients were male, with 43 (72.9%) male patients compared to 16 (27.1%) female patients, and this result was statistically significant (Z=4.9711, p<0.00001). Similar study by Malhotra R et al 4(2018) found that . A total of 356 cases with 402 feet with CTEV were treated by the Ponseti method. The average age of the children and the number of casts applied before full correction were 4.03 months and 6.91, respectively. Similar study by Barik S et al 9(2019) showed that Children with CTEV with age less than 1 year with no previous intervention were included in the study. Functional score devised by Ponseti was determined at final follow-up. Study by Ayehualem S et al 10(2019) examined that besides, the number of Ponseti cast required may not be affected by age of a child at the commencement of treatment

Regarding birth method, Majority number of patients, 45 (76.3%), had Full-Term Normal Delivery (FTND). This was followed by 9 (15.3%) patients who had Lower Segment Cesarean Section (LSCS), 3 (5.1%) patients who had Preterm births, and 2 (3.4%) patients with Breech births. The statistical significance of this distribution was high (Z=8.086, p<0.00001).

Educational levels among patients varied, with the majority being SSLC graduates, accounting for 40 (67.8%) patients. Other educational levels included 10 (16.9%) patients who were 12th pass, 4 (6.8%) B.Sc graduates, 2 (3.4%) B.Com graduates, and one patient each (1.7%) who were 8th pass, 9th pass, and B.E. graduates. This distribution was also statistically significant (Z=7.5399, p<0.00001).

In terms of birth order, most patients were first-born, with 46 (78.0%) patients being of birth order 1. This was followed by 11 (18.6%) patients of birth order 2 and 2 (3.4%) patients of birth order 3, a statistically significant finding (Z=8.2456, p<0.00001).

Consanguinity was present in 13 (22.0%) patients, which was statistically significant (Z=6.0758, p<0.00001).

When examining the affected side, 28 (47.5%) patients had bilateral involvement, 16 (27.1%) had left-side involvement, and 15 (25.4%) had right-side involvement, a statistically significant finding (Z=2.4867, p=0.01278).Similar study by Shylaja D et al 11(2016) found that Males are more frequently affected (2:1 male to female ratio), bilateral in approximately 50% of all cases, and the right foot is more often affected in unilateral cases.

All patients in the study, 59 (100.0%), underwent Tenotomy.

Compliance with treatment was generally good, with 50 (84.7%) patients showing good compliance compared to 9 (15.3%) patients with bad compliance, which was statistically significant (Z=7.5487, p<0.00001).

Pirani scores indicated that 53(89.8%) patients had a score of 0/0, and the rest had varied scores of 0.5, and 1.0, all statistically significant (Z=5.3305, p<0.00001).

In summary, our study shows significant trends in age, gender, birth method, education, birth order, consanguinity, affected side, compliance, and Pirani scores among the patients. The mean age of patients was 21.1356 ± 15.0579 days, the mean birth order was 1.2542 ± 0.5117, the mean number of casts was 5.3729 ± 0.7404, and the mean follow-up period was 9.5254 ± 2.0031 months. These findings provide important insights into the demographic and clinical characteristics of the patient population in our study. Similar study by Sharma A et al 5(2018) found that they assessed the role of the Pirani score in determining the number of casts and its ability to suggest requirement for tenotomy in the management of clubfoot by the Ponseti method. Initial high Pirani score suggests the need for greater number of casts toachieve correction and probable need for tenotomy Similar study by Ayehualem S et al 10(2019) examined that . The Pirani scoring system is now routinely used in most clubfoot clinics, including Cure Ethiopia, Children's Hospital. The study revealed that severity of initial Pirani score can be used to estimate the number of Ponseti cast required for correction of clubfoot deformity and the need for tenotomy. The study revealed that manipulation is a key part of the Ponseti method. It involves series of manipulation techniques before application of each plaster. We accommodated additional manipulation method to stretch contracted TendoAchilles by longitudinal pull of leg by holding ankle.

The final total number of casts required depends on how effectively foot can be manipulated to correct deformities before putting cast. Our study reiterates that fact that maintenance phase with good brace compliance is equally important compared to corrective phase of manipulation and casting.

LIMITATIONS OF THE STUDY: The notable short comings of this study are: 1. The sample size was small. Only 59 cases are not sufficient for this kind of study. 2. The study has been done in a single centre. 3. The study was carried out in a tertiary care hospital, so hospital bias cannot be ruled out.

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