Retrospective Observational Cohort Study of Mid-Term Outcomes Following Ponseti Method for Idiopathic Clubfoot

Abstract

Background/Objectives: Commonly known as clubfoot, congenital talipes equinovarus (CTEV) is a structural deformity characterized by cavus, adductus, varus, and equinus (CAVE) positioning of the foot. Idiopathic clubfoot requires prompt treatment to achieve functional, pain-free, and aesthetically normal feet. The Ponseti method is a conservative treatment involving serial manipulation, casting, and Achilles tenotomy, which has demonstrated high success rates. The purpose of this study is to report 10 years of experience using the Ponseti method. Methods: A retrospective and follow-up analysis were conducted with 72 patients (118 feet) with idiopathic clubfoot were treated between 2011 and 2023 who met the minimum follow-up requirement of 12 months (mean follow-up: 54.15 months). The severity of deformities was assessed using the Pirani score. Data collection included demographic details, number of casts, tenotomy procedures, adherence to the Denis Browne brace protocol, and complications. Results: Initial correction of deformities was achieved in all 91 patients (100%). Outcomes were measured using the Ponseti functional scoring system. The average number of casts applied was 9.51 per patient. Percutaneous Achilles tenotomy was performed in 91.21% of cases. Relapse occurred in 22.2% of patients, which required additional treatments. The outcomes were excellent in 77.7% of cases, good in 13.88%, fair in 6.94%, and poor in 1.38%. Discussion: The Ponseti method is effective for idiopathic clubfoot treatment and achieves high rates of initial correction, favorable mid-term outcomes, and minimal complications. These results confirm its reliability and align with previously reported success rates.

1. Introduction

Congenital clubfoot refers to a spectrum of foot deformities characterized by a permanent deviation of the anatomical axes of the foot in relation to the leg and to one another. This deviation disrupts normal weight-bearing and impairs foot function [1]. From an etiopathogenetic perspective, clubfoot is typically classified into three main categories: postural (or positional), congenital (or idiopathic), and syndromic (or teratogenic).

Idiopathic congenital clubfoot is distinct from postural clubfoot, which is a flexible positional deformity that can be corrected manually after birth. In contrast, idiopathic clubfoot presents at birth as a rigid deformity that cannot be passively corrected and often leads to functional disability if left untreated. The term “talipes” originates from the Latin words talus (ankle) and pes (foot), literally meaning “to walk on the ankles.” It is crucial to distinguish idiopathic clubfoot—where no identifiable cause is present—from syndromic clubfoot, which is associated with underlying conditions such as arthrogryposis, muscular dystrophies, spina bifida, myelomeningocele, cerebral palsy, or poliomyelitis. Misclassification can result in inappropriate management and prognosis [2].

Also known as congenital talipes equinovarus (CTEV), idiopathic clubfoot affects approximately 1 in 1000 live births globally. A recent systematic review of 48 studies from 20 low- and middle-income countries reported a prevalence ranging from 0.51 to 2.03 per 1000 live births [3]. Around 50% of cases are bilateral, and when unilateral, the right foot is more frequently affected [4]. The most common clinical pattern—accounting for up to 79% of cases—is described by the acronym CAVE: cavus (high medial arch), adductus (inward forefoot), varus (inward-turned heel), and equinus (plantar flexion of the ankle). These deformities result from soft tissue contractures and bone misalignments, primarily affecting the midfoot and hindfoot, often leading to medial displacement relative to the talus [3].

The etiology of idiopathic clubfoot remains uncertain, though a multifactorial origin involving genetic, neuromuscular, and environmental factors is widely accepted. Diagnosis is typically clinical, as radiographic imaging in neonates is limited due to the presence of unossified cartilage. Ultrasound, however, may aid in evaluating the morphology and severity of the deformity in early infancy [2,4]

The primary goal of treatment is to achieve a pain-free, plantigrade, functional, and cosmetically acceptable foot. Among conservative treatment options, the Ponseti method has become the gold standard due to its high success rate and mid-term efficacy. The technique involves gentle weekly manipulations of the foot, followed by serial long leg casting. After the desired correction is achieved, a percutaneous Achilles tenotomy is often required to address residual equinus. To maintain correction and prevent relapse, patients must wear a foot abduction brace—initially full-time, then part-time for several years [5].

Mid-term outcomes of the Ponseti method are generally favorable, with treated children achieving excellent functional results and unrestricted participation in physical activities. Moreover, results are comparable across genders and between unilateral and bilateral cases [5].

Despite the extensive use of the Ponseti method worldwide, mid-term follow-up studies in specific regional contexts remain limited. There is a need for data evaluating the real-world effectiveness and relapse rates associated with the method across different clinical settings.

The purpose of this study is to report 10 years of experience at the Orthopedic Clinic of the “G. Rodolico” Hospital of Catania in the treatment of CTEVs and to demonstrate the effectiveness of the Ponseti method through a retrospective follow-up study of 72 patients.

2. Materials and Methods

2.1. Sample

This study was conducted in accordance with the STROBE guidelines (Strengthening the Reporting of Observational Studies in Epidemiology) and the Declaration of Helsinki. Ethical approval was obtained from the Institutional Review Board of A.O.U. Policlinico Rodolico—San Marco of Catania (approval number: 117/2020/PO). Written informed consent was obtained from the legal guardians of all participants prior to inclusion in the study.

This was a retrospective observational cohort study involving pediatric patients with idiopathic congenital clubfoot treated at the Orthopedic Clinic of the University of Catania. A total of 115 patients born between February 2011 and July 2023 were initially considered. Exclusion criteria included non-idiopathic clubfoot (e.g., spontaneously resolved conditions, syndromic or neurogenic cases, cerebral palsy, or non-CAVE variants). After applying the exclusion criteria, 91 patients were included in the final analysis. These patients were followed clinically until November 2023. Although 91 patients met the initial inclusion criteria, only those with a minimum follow-up duration of 12 months were considered eligible for the outcome analysis. As a result, the final study cohort consisted of 72 patients. The remaining 19 were excluded due to ongoing treatment (n = 10), loss to follow-up (n = 6), or incomplete clinical documentation (n = 3).

Data collection was carried out retrospectively by reviewing medical records and institutional databases, including documentation from orthopedic consultations, plaster cast applications, surgical interventions (e.g., percutaneous Achilles tenotomy), and treatments for relapses during follow-up. Additional information was gathered through structured interviews conducted by telephone and through a questionnaire administered via Google Forms. The collected data included patient name, sex, date of birth, telephone number, affected side, degree of initial deformity, date of the first visit, number of plaster casts applied prior to tenotomy, tenotomy date (if applicable), adherence to use of the Denis Browne brace, treatment outcomes, occurrence and timing of relapses, types of secondary interventions, and total follow-up duration.

To assess the initial severity of the deformity, the Pirani score was used prior to the initiation of the Ponseti method. The Pirani score was introduced partway through the study period and was therefore available only for a subset of patients. Specifically, it was recorded in 30 out of 91 cases, depending on the availability of standardized assessment forms during the initial evaluation phase.

2.2. Clinical Assessment

The Ponseti functional scoring system was used to evaluate the success of the tenotomy and clinically monitor the patients during follow-up. The system uses an index that is based on the incidence of relapses of the deformity, amplitude of passive movement (measured with a goniometer), aesthetic appearance, muscular strength, calf atrophy, and foot dimensions, walking quality, functional limitations, footwear use, presence and intensity of pain, and degree of patient satisfaction. The rating scale is based on a maximum score of 100 points, which represents a normal foot.

The scores are classified as excellent (90–100 points), good (80–89 points), fair (70–79 points), and poor (less than 70 points) [6]. For those with fair and poor scores, additional treatment was deemed necessary to correct the residual deformities. Patients were monitored weekly during the initial stages of treatment until tenotomy was performed. They were then monitored monthly after applying a brace for the first 3 months and then quarterly thereafter. Existing comorbidities were also noted, along with the complications encountered during the application, containment and removal of the limb from the plaster cast and during the use of the Denis Browne brace, the age at which walking began, and sports activities (practice and type) for patients who have reached the relevant developmental stages. Radiographic follow-up was not used in this study.

We also established additional inclusion criteria for the analysis of the results and the search for statistical correlations. These criteria comprised a minimum follow-up of 12 months starting from the date of application of the Denis Browne brace after or without the execution of the Achillea tenotomy. For this purpose, we further divided the population into three subgroups based on the difference in time elapsed between the date of birth and the start date of the plaster cast cycles (less than 1 month of life, between 1 month and 1 year of life, and after 1 year of life).

2.3. Statistic Analysis

Data were analyzed using MATLAB software (version R2025a), a high-performance computing environment that integrates numerical analysis, visualization, and programming. Specific statistical methods included chi-square tests for categorical variables, t-tests for continuous variables, and logistic regression analysis to explore potential associations between demographic or treatment-related factors and clinical outcomes. A p-value of <0.05 was considered statistically significant.

3. Results

From February 2011 to July 2023, a total of 115 children diagnosed with congenital clubfoot were treated at our University Orthopedic Clinic. After applying specific inclusion and exclusion criteria, 24 of these patients were excluded due to diagnoses not compatible with idiopathic clubfoot. These included syndromic, postural, metatarso-varus, valgus-convex, and talo-valgus variants. The remaining 91 patients, with a total of 146 affected feet, formed the study population. The group was predominantly male, with 65 boys (71.4%) and 26 girls (28.6%), resulting in a male-to-female ratio of approximately 2.5 to 1 (Figure 1).

Bilateral clubfoot was observed in 55 patients (60.4%), while the remaining 36 (39.6%) had a unilateral deformity. Among the unilateral cases, 19 involved the right foot and 17 the left, producing a right-to-left ratio close to 1.1 to 1 (Figure 2).

Most patients did not present additional anomalies. However, a few comorbidities were recorded: three patients exhibited a contralateral talo-valgus deformity, two had clinodactyly, one child showed a mild hallux valgus, and two were diagnosed with bilateral congenital hip dysplasia. Only one case of positive family history of clubfoot was reported. For 30 of the 91 patients (involving 48 clubfeet), the severity of the deformity at presentation was quantified using the Pirani score. This assessment tool had been introduced during the study, explaining its use in only a portion of the cohort. The average Pirani score in this subgroup was 5.06, with most feet scoring between 5.5 and 6, indicating a high degree of initial deformity (Figure 3).

Treatment was conducted according to the Ponseti method. Most patients required a series of plaster casts—on average, about 9.5 per patient, although this number ranged from as few as 3 to as many as 20. Correction of the equinus deformity was achieved in 83 of the 91 children (91.2%) through percutaneous Achilles tenotomy. The remaining eight children achieved full correction without the need for surgery. Following casting and tenotomy, patients began wearing a Denis Browne brace full time for the first three months. Bracing time was then progressively reduced to 18 h per day until the age of four, and later continued only at night, according to standard recommendations. In all patients, initial correction of the deformity was achieved, as documented by a Ponseti functional score between 90 and 100, recorded three weeks after tenotomy or at the initiation of bracing. This outcome indicates that all children responded well to the initial phase of treatment. Complications during the casting and bracing period were rare and generally mild. A few patients developed mild skin issues, such as desquamative erythema in areas of pressure. One patient experienced a superficial wound (grade I), and another showed signs of mild quadriceps hypotrophy due to temporary disuse. In five cases, parents reported problems related to cast loosening and wear, which required early replacement. Importantly, no serious complications occurred—there were no cases of vascular compromise, ulcers related to the cast or the brace, nor any infections or bleeding after tenotomy. All reported complications resolved with simple local care and minor treatment adjustments, such as temporary suspension of casting.

In order to ensure consistency in follow-up and outcome evaluation, only patients who had completed at least 12 months of follow-up were included in the final analysis. This led to the inclusion of 72 patients. The remaining 19 were excluded for specific reasons: ten were still undergoing treatment at the time of data collection, six were lost to follow-up, and three had incomplete medical records. To address potential concerns about selection bias, we compared the baseline characteristics (age at treatment initiation, sex, and laterality) of included and excluded patients. No significant differences were observed between the groups.

In the final sample of 72 patients, the mean follow-up period was 54.15 months, ranging from 12 to 127 months. Treatment was initiated during the first month of life in 46 of these children. Nineteen began treatment between the first and twelfth month, while the remaining seven started after their first birthday. During the initial treatment phase, patients were followed weekly, and later monitored monthly and quarterly depending on their clinical stage. During follow-up, relapse of the deformity was observed in 16 patients, corresponding to 22.2% of the final cohort. Interestingly, relapse was more frequent among those who had started treatment earlier: 11 of the 46 children treated before one month of age experienced a relapse, compared to four among those treated between one and twelve months, and only one among those treated after one year of age.

All relapses were managed successfully. In nine patients, relapse was corrected through a new cycle of casting alone. Five required a Hoke tenotomy combined with plantar fasciotomy, and one underwent tibialis anterior tendon transfer in addition to plantar fasciotomy, according to international scientific literature [6,7,8]. Details of the patients who relapsed—including the age at relapse, type of deformity, laterality, treatment, and final functional outcome—are summarized in

Table 1. Details of relapses.

Patient Nº	Congenital Clubfoot Laterality	Age of Relapse	Side of Relapse	Type of Relapse	Relapse Treatment	Treatment Results
1	Right	7.5 years	Right	Forefoot adducted	Plasters	Excellent
2	Bilateral	6.8 years	Left	Equinism + forefoot adducted	Hokes tenotomy + plantar fasciotomy	Excellent
3	Bilateral	6.8 years	Left	Forefoot adducted	Plasters	Excellent
4	Left	8.7 years	Left	Equinism + forefoot adducted	Hokes tenotomy + plantar fasciotomy	Excellent
5	Bilateral	7.9 years	Left	Equinism + forefoot adducted	Hokes tenotomy + plantar fasciotomy	Good
6	Bilateral	4.4 years	Bilateral	Equinism + forefoot adducted	TATT	Excellent
7	Right	3.1 years	Right	Forefoot adducted	Plasters	Excellent
8	Bilateral	5.5 years	Bilateral	Forefoot addicted	Plasters	Good
9	Left	4.1 years	Left	Equinism + forefoot adducted	Hokes tenotomy + plantar fasciotomy	Excellent
10	Left	5.9 years	Left	Equinism + forefoot adducted	Plasters	Excellent
11	Bilateral	1.4 years	Left	Forefoot adducted + varus	Hokes tenotomy + plantar fasciotomy	Poor
12	Right	2.5 years	Right	Forefoot adducted	Plasters	Fair
13	Bilateral	1.8 years	Bilateral	Equinism + forefoot adducted	Percoutaneous Tenotomy	Good
14	Bilateral	1.7 years	Right	Forefoot adducted	Plasters	Fair
15	Bilateral	1.1 years	Bilateral	Forefoot adducted	Plasters	Fair
16	Bilateral	2.4 years	Right	Varus	Plasters	Excellent

.

Overall, the final outcomes were excellent or good in most patients. Specifically, 56 patients (77.8%) achieved an excellent Ponseti functional score, 10 (13.9%) had good results, five (6.9%) had fair results, and only one child (1.4%) had a poor outcome. As part of the functional follow-up, we also assessed age at onset of independent walking. Thirteen children began walking between 12 and 14 months of age, nine between 16 and 18 months, and two after 18 months. Three children had not yet reached an age or developmental stage appropriate for walking at the time of evaluation.

We looked for statistical correlations between the start date of treatment and the occurrence or otherwise of relapses by dividing patients into three groups based on the age when they had started treatment: group A: before 1 month; group B: between 1 month and 1 year; and group C: after 1 year of age. The statistical correlation was not significant between the two variables (p = 0.06) (Figure 4). Therefore, it does not appear that the start of treatment in the analyzed time frame impacts the occurrence of relapses.

In our analysis. we explored the relationship between the initial severity of the deformity and the number of plaster casts required to achieve correction. Specifically. we compared the Pirani scores of 48 clubfeet with the number of casts applied for each case. The analysis revealed a moderate statistical correlation (p = 0.42) between the two variables. as illustrated in Figure 5. The average Pirani score was 5.06. reflecting a generally moderate to high severity of deformity at presentation. while the average number of casts was 9.51.

Finally. we evaluated whether the correct use of the brace can prevent relapses. It is well established in the literature that the occurrence of post-tenotomy relapses and their number. severity. and date are correlated to a lack of use or incorrect and inconsistent use of the Denis Browne brace (Figure 6).

Regarding physical activity. a small number of children were engaged in regular sports: two played football. two swam. one practiced volleyball. and another practiced judo. The majority of the remaining children did not participate in organized sports. a decision attributed to personal or family preference rather than physical limitations.

4. Discussion

Among the available therapeutic approaches for congenital clubfoot. the Ponseti method is currently the preferred strategy in our clinical practice. Carrero et al. conducted a systematic review confirming the Ponseti method as the gold standard due to its favorable safety profile and consistent efficacy. Over the past years. it has become widely adopted as a conservative management option for clubfoot globally. with reported success rates typically nearing 90%. Although recurrences can occur. they tend to be less frequent than with more invasive surgical interventions [9].

Both the Kite and Ponseti techniques have demonstrated satisfactory clinical outcomes; however. the Ponseti method is generally associated with superior correction. Specifically. it often requires fewer cast changes. results in shorter treatment durations. and achieves improved ankle dorsiflexion. In addition. residual deformities and recurrence appear slightly less common in comparison to the Kite method [9,10,11,12].

In a comparative analysis. Gintautenie et al. evaluated the Ponseti method against early tibialis anterior tendon transfer. While the latter approach reduced the required duration of orthotic use. a mild reduction in dorsiflexion strength was observed. Given the comparable clinical outcomes. the authors concluded that conservative treatment with the Ponseti method remains a valid and reliable option [13]. Similarly. Zwick et al. compared Ponseti casting with surgical correction and found that the non-surgical approach yielded better functional outcomes. such as pain-free. plantigrade feet. greater parental satisfaction. and enhanced mobility [14].

The Ponseti method is particularly valued for preserving joint mobility after correction. Nonetheless. its effectiveness can be influenced by several patient-specific factors. including the age at treatment initiation. sex. early diagnosis. presence of comorbid deformities. and the number of casts required. Sanghvi et al. recommend starting the technique in the first 15 days of life [11]. This means that clubfoot should be treated as soon as possible so that good results are easier to obtain [15].

According to other authors. however. the age at which treatment begins makes no significant difference. and clubfoot can be corrected even later. A retrospective study examined children with CAVE treated at University Malaya Medical Center from 2013 to 2017. A total of 54 children (35 males and 19 females) were divided into two cohorts: group 1 received treatment before the age of 1 month. and group 2 received treatment after 1 month. All affected feet (100%) achieved complete correction. one foot in group 1 had a relapse. and three feet in group 2 had a relapse. but the difference was not statistically significant. All relapsed feet were successfully treated with the repeated Ponseti method [16].

Bilateral deformity does not appear to be a parameter that worsens functional outcomes after treatment. Sapienza et al. showed that patients with bilateral CTEV treated with tenotomy achieve static and dynamic values comparable to healthy controls. Tenotomy promotes mid-term dynamic development similar to that in the healthy population and results in better postural outcomes than non-surgical cases. Additionally. bilateral patients outperform unilateral cases in dynamic values [17].

Another aspect that we focused on is whether higher Pirani scores corresponded to a greater number of casts. The literature shows that at least six casts are needed on average. but this depends on the severity of the foot deformity. In the study by Agarwal et al. with 297 children (442 feet). the average initial Pirani score was 4.8. and the number of corrective casts was 7 per child (ranging from 2 to 18). Their regression analysis showed that both the Pirani score and age had a positive correlation with the number of casts. although it was weak (r² = 0.05–0.20). Compared to age. the correlation of the initial Pirani score with the number of casts was 10 times stronger. which suggests a probable correlation between them [18].

Pavone et al. demonstrated that there was no significant correlation between the number of casts (mean number of casts: 7.1 ± 1.8) and the months required to reach the independent gait stage [19].

In our analysis. we explored the relationship between the initial severity of the deformity and the number of plaster casts required to achieve correction.

These findings suggest a probable association between more severe deformities—indicated by higher Pirani scores—and the need for a greater number of casts to achieve correction. However. the correlation was only moderate. indicating that other factors. such as tissue stiffness. patient age at treatment initiation. or brace compliance. may also play a role in determining the number of casting sessions required.

It should be noted that the number of casts is represented in the graph as average values. which explains the appearance of decimal values on the X-axis. despite the fact that the actual number of casts applied was always an integer. Additionally. all Pirani scores remained within the standard range of 0 to 6; the graph’s Y-axis extends slightly beyond 6 due to automatic scaling by the plotting software. not due to actual scores exceeding this threshold.

The brace protocol involves full-time application (24 h a day) for at least 3 to 4 months. followed by application during rest and at night for the following 2 to 5 years (from 2 to 4 h in the middle of the day and for 12 h at night for a total of 14 to 16 h a day). up to 3 or 4 years of age.

These relapses were all due to noncompliance with the Denis Browne splint and infrequent use of the splint due to a lack of education and the socioeconomic status of the parents of the children with clubfoot [17,20,21].

In the present study. which was performed about 10 years later. we examined whether there was a statistical correlation between the duration of Denis Browne brace use and the risk of relapse. To explore this. we categorized the 72 patients into four groups: those who did not use the brace at all (n = 16). those who used it for less than one year (n = 19). for one to four years (n = 21). and for more than four years (n = 16). Relapses were more frequent among patients with poor adherence to the bracing protocol: six cases were observed in the group with no brace use. eight in the group that used the brace for less than one year. while only one relapse was reported in each of the two groups with longer durations of brace use.

Although the statistical correlation between shorter brace use and relapse was not significant (p = 0.47). the trend observed is consistent with findings reported in the literature. which emphasize the role of sustained brace use in maintaining mid-term correction and reducing relapse risk.

Data collected through retrospective questionnaires further revealed that non-compliance with the bracing regimen was often associated with lower socioeconomic status and insufficient parental supervision in applying the prescribed treatment. These findings suggest that social and educational factors may have played a significant role in influencing treatment adherence and. ultimately. clinical outcomes. However. it is important to acknowledge that the lack of a control group. the retrospective design of the questionnaire. and the potential for recall bias limit the strength of these conclusions. These aspects have been considered and are discussed as limitations of the study.

5. Limitations of the Study

This study has several limitations that should be acknowledged.

First. although data collection was comprehensive. it relied in part on retrospective data extracted from medical records and parental recall through telephone interviews and online questionnaires. This introduces a potential recall bias and incomplete data capture. particularly for variables such as brace adherence. relapse timing. and patient satisfaction.

Second. while the study initially followed a prospective approach in clinical monitoring. the data analysis was retrospective. which may affect the consistency and accuracy of recorded information. Furthermore. the classification of the study as “cross-sectional” in earlier versions was misleading; the current revised design more accurately reflects a retrospective observational cohort study.

Third. radiographic imaging was not used during follow-up assessments. Although clinical evaluation tools such as the Ponseti score provide valuable functional information. the absence of radiological data may limit the objectivity of deformity assessment. especially in cases with subtle structural changes.

Another limitation is that the Ponseti Functional Scoring System. while widely used and accepted in clinical settings. has not been formally validated in the specific population under study. This could limit the generalizability and comparability of the functional outcome measures to other demographic or geographic groups.

Finally. the study was conducted at a single center. which may reduce the external validity of the findings. Multicenter studies with larger. more diverse populations and longer follow-up periods would be beneficial to confirm and expand upon these results.

6. Conclusions

Children treated with the Ponseti method achieved feet that appear anatomically normal and function comparably to those of healthy individuals. enabling them to engage in sports and recreational activities without significant limitations later in life. These findings reinforce the clinical value of the Ponseti method as a first-line. conservative approach for managing idiopathic clubfoot. However. the success of this method depends heavily on strict adherence to the bracing protocol and mid-term follow-up. especially in the first three years after correction. when the risk of relapse is highest. This highlights the importance of structured rehabilitation programs and sustained clinical supervision well into adolescence. Future research should focus on multicenter studies and. where feasible. randomized controlled trials to further validate these findings and improve the generalizability of results beyond single-center experiences. Such studies are needed to better define best practices for relapse prevention. optimize follow-up protocols. and address socioeconomic barriers that may affect treatment adherence.