Congenital talipes equinovarus (CTEV), also known as clubfoot, is one of the most common complex congenital musculoskeletal deformities, with a global prevalence of approximately 1–2 cases per 1,000 live births (1, 2). The deformity comprises four main components: midfoot cavus, forefoot adduction, hindfoot varus, and ankle equinus (1, 3). Before widespread adoption of the Ponseti method, extensive posteromedial or circumferential soft-tissue release was commonly used for resistant deformity (2, 6). Long-term retrospective studies subsequently showed that extensive surgical releases could be associated with arthrofibrosis, chronic pain, muscle wasting, and early degenerative changes, sometimes requiring complex revision procedures later in life (2, 3, 19).

Management changed substantially after the Ponseti method was developed and widely adopted (1, 6, 7). The method uses the biological plasticity of infant connective tissue and consists of serial gentle manipulation followed by toe-to-groin plaster casting to correct cavus, forefoot adduction, and hindfoot varus around the talar head (1, 3, 19). When residual equinus persists, percutaneous Achilles tenotomy is performed to obtain adequate ankle dorsiflexion (1, 6, 17). After correction, a foot abduction orthosis is worn for approximately 23 hours per day during the first 3 months and subsequently during sleep and naps until 4–5 years of age (8, 9, 21).

Initial non-operative correction is achieved in approximately 90%–98% of patients, but recurrence remains an important clinical problem (3, 6, 9). Reported relapse rates vary widely, from approximately 10% to more than 40%, depending on the cohort and duration of follow-up (9, 10, 20). Atypical or complex morphology, older age at initiation of casting, and greater baseline deformity severity have been associated with recurrence (4, 5, 15, 18).

However, success during the maintenance phase also depends on caregiver commitment and adherence to prolonged brace use outside the clinical setting (8, 11, 12). Recent studies have focused on family-level and socioeconomic barriers to brace adherence, including limited health literacy, financial burden, distance from specialized centers, caregiver anxiety, infant distress, and difficulties with brace application (11, 13, 14, 21). The Pirani and Dimeglio classifications are validated clinical tools for quantifying baseline deformity severity (4, 5); however, they do not capture caregiver burden or other factors that may influence orthosis adherence.

Few prospective studies have evaluated anatomical severity together with multidimensional parent-reported socioeconomic and behavioral factors within a single prognostic framework. Characterizing both baseline clinical severity and family-level factors may help identify patients at increased risk during the maintenance phase.

This prospective cohort study assessed clinical and parent-reported predictors of treatment outcomes following Ponseti treatment for idiopathic clubfoot. We evaluated primary correction, baseline deformity severity, brace adherence, recurrence, and 24-month functional outcomes.

Study Design and Setting

A prospective cohort study was conducted in the pediatric orthopedic surgery department of a tertiary university hospital from January 2021 to December 2024.

The study protocol was approved by the Institutional Ethics Committee and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from parents or legal guardians before enrollment.

Patient Cohort and Eligibility Criteria

Infants presenting with untreated idiopathic clubfoot before 6 months of age were assessed for eligibility. The inclusion criteria were:

• Definite clinical diagnosis of unilateral or bilateral idiopathic congenital talipes equinovarus.
• First presentation at age ≤ 6 months.
• No previous surgical release or formal serial corrective casting/manipulation, other than routine gentle passive manipulation.
• Commitment by the primary caregiver(s) to attend scheduled clinical follow-up and survey assessments for up to 24 months after correction.

Exclusion criteria were:

• Non-idiopathic clubfoot, including syndromic, neurogenic, or teratologic clubfoot (e.g., associated with arthrogryposis, myelomeningocele, or chromosomal abnormalities).
• Previous surgical treatment for clubfoot.
• Missing baseline clinical data or loss to follow-up before 12 months.

Standardized Ponseti Treatment Protocol

Fellowship-trained pediatric orthopedic surgeons implemented standardized Ponseti principles in all patients (1, 6, 15). Serial manipulation was performed weekly, followed by application of toe-to-groin plaster casts. The first ray was elevated to correct cavus and align the forefoot with the hindfoot (1, 3). The forefoot was then abducted in supination around the lateral aspect of the talar head to correct forefoot adduction and heel varus (1, 6).

At each visit before cast reapplication, deformity severity was recorded using the 6-point Pirani score (hindfoot score 0–3; midfoot score 0–3) (4) and the 20-point Dimeglio score (Grade I: 0–5; Grade II: 6–10; Grade III: 11–15; Grade IV: 16–20) (5). When forefoot abduction was approximately 60° but ankle dorsiflexion remained < 15°, percutaneous Achilles tenotomy was performed in the outpatient minor procedure room under local infiltration anesthesia (1, 6, 17). The final cast maintained approximately 60°–70° of external rotation and 15°–20° of dorsiflexion for 3 weeks (1, 3).

After removal of the post-tenotomy cast, infants were placed in a standard foot abduction orthosis (Steenbeek or Denis Browne bar with straight-last shoes), set at approximately 60° of external rotation for the affected foot and 40° for the unaffected foot, with the bar adjusted to shoulder width (8, 9). Caregivers received standardized counseling on the wear protocol: 23 hours per day during the first 3 months, followed by 12–14 hours per day during sleep and naps until 4 years of age (8, 12).

Caregiver Survey and Adherence Monitoring

At baseline and at the 3-, 6-, 12-, and 24-month maintenance follow-up visits, caregivers completed a structured 14-item questionnaire.

The baseline survey recorded household income, maternal education (years), distance from home to the treatment center (km), and caregiver health literacy regarding the duration and requirements of clubfoot treatment, rated on a 5-point Likert scale.

Follow-up and Adherence Log: Caregivers recorded daily hours of orthosis use. Non-compliance was defined a priori as < 10 hours of orthosis use per day for more than 2 consecutive weeks. Adherence was reviewed during scheduled clinic visits and follow-up telephone calls at 8, 12, and 21 weeks. Caregivers also reported skin breakdown, blistering, difficulties with brace application, and emotional distress.

Functional and patient-centered outcomes at 24 months after correction were assessed using the Clubfoot Disease-Specific Index (CDSI) parent questionnaire (16), which yields a score from 0 to 100 reflecting disease-specific functional and patient-reported outcomes.

Clinical Outcome Definitions

Initial Correction: A post-casting Pirani score ≤ 0.5, a plantigrade foot with passive dorsiflexion ≥ 15°, and full correction of hindfoot varus and forefoot adduction.

Recurrence/Relapse: Re-emergence of one or more components of the primary deformity during the 24-month follow-up period, including passive dorsiflexion < 0°, persistent hindfoot varus, or dynamic forefoot supination during gait, requiring repeat casting, repeat tenotomy, and/or operative tendon transfer (9, 10, 20).

Statistical Analysis

Baseline and clinical variables are presented as mean ± standard deviation (SD) or median with interquartile range (IQR), as appropriate. Categorical variables are presented as frequencies and percentages. Student's t-test or the Mann–Whitney U test was used for continuous variables, and the chi-square test or Fisher's exact test was used for categorical variables, as appropriate.

Potential clinical, structural, and parent-reported risk factors for recurrence were screened using univariate logistic regression. Variables with p < 0.10 in univariate analysis were entered into a multivariable logistic regression model using backward stepwise elimination. Adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were reported. A two-tailed p value < 0.05 was considered statistically significant. Analyses were performed using SPSS version 26.0 (IBM Corp., Armonk, NY, USA).

Demographic and Clinical Cohort Profile

A consecutive series of 155 infants was screened during the enrollment period. Thirteen infants were excluded according to the prespecified eligibility and follow-up criteria, leaving a final cohort of 142 infants with 208 affected feet; 66 infants had bilateral involvement and 76 had unilateral involvement.

The mean age at first cast application was 21.4 ± 14.8 days. Males comprised 68.3% (n = 97) of the cohort. Of the 208 affected feet, 16 (7.7%) were Dimeglio Grade I (mild), 62 (29.8%) Grade II (moderate), 98 (47.1%) Grade III (severe), and 32 (15.4%) Grade IV (very severe). The mean baseline Pirani score across treated feet was 4.82 ± 0.91.

To place our findings in context, the outcomes of the present institutional cohort are compared with representative published multicenter studies, meta-analyses, and international series in Table 1.

Table 1 summarizes representative published data alongside the present prospective hospital cohort.

Table 1: Benchmark Clinical Outcomes Across Published Ponseti Cohorts and Institutional Data

Primary Casting and Tenotomy Outcomes

Primary anatomical correction without open surgical release was achieved in 134 of 142 infants (94.4%). Eight infants (5.6%) had severe structural resistance and/or atypical or complex deformity that could not be fully corrected by casting and required limited posterior soft-tissue release.

Among successfully corrected feet, the mean number of casts was 5.7 ± 1.6 (range, 3–11). Percutaneous Achilles tenotomy was performed in 180 of 208 feet (86.5%). Feet with Dimeglio Grade I–II deformity required fewer casts (4.6 ± 1.1) than Grade IV feet (7.2 ± 1.8; p < 0.001). Age at presentation showed a weak positive correlation with the number of casts required (r = 0.22, p = 0.008).

Maintenance Phase and Relapse Profile

During the 24-month follow-up period, 26 of 142 patients (18.3%) developed clinical recurrence. The mean interval between removal of the post-tenotomy cast and first documented recurrence was 11.4 ± 4.2 months.

Management of the 26 recurrent cases was as follows:

Eighteen patients were successfully treated with repeat manipulation and serial casting (mean, 3.2 casts) followed by re-bracing. Five patients required repeat percutaneous Achilles tenotomy followed by continued bracing. Three patientsdeveloped dynamic forefoot supination during gait and underwent tibialis anterior tendon transfer to the lateral cuneiform at a mean age of 26 months. When stratified by brace adherence, recurrence occurred in 8.5% (9/106) of compliant families and 47.2% (17/36) of non-compliant families (p < 0.001).

Table 2 presents the distribution of baseline clinical, anatomical, and family-level variables between patients who maintained complete correction and those who relapsed.

Table 2: Comparison of Baseline Clinical and Caregiver Variables by Recurrence Status

Caregiver Survey and Adherence Analysis

The 14-item caregiver survey identified practical and psychological barriers encountered during maintenance bracing. Table 3 summarizes responses according to brace-adherence status.

Table 3: Caregiver Survey Responses and Association with Brace Adherence (n = 142)

Infant crying during brace application and concerns about skin erythema were prominent contributors to caregiver distress. Poor adherence was significantly associated with skin irritation during the first 6 weeks: 44.4% of non-compliant caregivers reported redness or blistering compared with 13.2% of compliant caregivers (p < 0.001). Qualitative comments indicated that heel blistering often led to temporary discontinuation of bracing, which could progress to prolonged non-use.

Multivariable Logistic Regression

Variables associated with recurrence in univariate analyses were evaluated in multivariable logistic regression to identify independent predictors of relapse (Table 4).

Table 4: Univariate and Multivariable Logistic Regression Models for Clubfoot Recurrence

Orthosis non-compliance was the strongest independent predictor of recurrence (aOR = 7.42; 95% CI: 3.12–17.65; p < 0.001). Baseline Dimeglio Grade IV severity was also independently associated with recurrence (aOR = 2.84; 95% CI: 1.18–6.85; p = 0.020). Travel distance > 50 km was an additional independent predictor (aOR = 2.31; 95% CI: 1.05–5.09; p = 0.038), highlighting the potential importance of geographic barriers to regular follow-up and timely intervention.

Fnctional Outcomes at 24 Monthsu

CDSI scores at 24 months were significantly higher among patients from compliant families (87.4 ± 9.8) than among those from non-compliant families (71.3 ± 14.2; p < 0.001). Reported satisfaction with cosmetic appearance, joint flexibility, and shoe fitting was also higher in the compliant group (92.5%) than in the recurrence group (58.3%).

This prospective cohort study demonstrates a high initial correction rate with the Ponseti method while also showing that mid-term maintenance outcomes are influenced by baseline deformity severity and adherence to orthotic treatment. The strongest independent predictor of recurrence was brace non-compliance (aOR = 7.42). Baseline Dimeglio Grade IV severity was associated with nearly threefold higher odds of recurrence (aOR = 2.84), while travel distance > 50 km was also independently associated with relapse (aOR = 2.31).

The primary correction rate of 94.4% and tenotomy rate of 86.5% are comparable with published international cohorts (Table 1). Large studies and meta-analyses have reported primary correction rates of approximately 94%–98%, with tenotomy rates generally ranging from 80% to 92% (3, 6, 9, 17). Likewise, the 24-month recurrence rate of 18.3% in our cohort falls within the range reported in other prospective and retrospective series (9, 10, 13, 20).

Baseline severity scores have long been used to anticipate casting requirements and the need for tenotomy (4, 5, 18). In our cohort, Dimeglio Grade IV feet required significantly more casts (mean, 7.2) than less severe feet, consistent with greater soft-tissue rigidity and resistance to correction (1, 15).

Baseline Pirani scores were significantly associated with recurrence in univariate analysis, but only Dimeglio Grade IV remained significant in the multivariable model. This difference may reflect the Dimeglio system's greater emphasis on rigidity across multiple planes of deformity (5, 9, 20).

The caregiver survey also helped identify behavioral and socioeconomic factors associated with brace non-compliance. Consistent with previous reports by Sangiorgio et al. (12), Banskota et al. (11), and Hu et al. (21), adherence was lower when caregivers encountered mechanical-fit problems, including skin erythema, heel sores, and difficulty maintaining heel position in the brace. More than 44% of non-compliant caregivers reported skin irritation during the first 6 weeks. Temporary brace removal to allow irritated skin to heal may make subsequent reapplication more difficult and can contribute to prolonged non-use and recurrence (8, 12).

Travel distance > 50 km was an independent predictor of recurrence in the multivariable model. In low- and middle-income settings, missed clinic appointments have been associated with long travel times and transportation costs (13, 14). Reduced access to follow-up may delay recognition of early loss of dorsiflexion or brace-fitting problems, allowing recurrent deformity to progress before intervention (8, 13, 20).

Parent-reported CDSI scores at 24 months further demonstrated the functional impact associated with adherence and recurrence. Functional scores were significantly higher among compliant patients (87.4 vs. 71.3), and recurrent deformity was associated with greater caregiver concern regarding shoe fit, gait, and the need for further intervention.

Clinical Implications

Based on these findings, there are some practical priorities for clubfoot care pathways:

1. Risk-Stratified Surveillance: Children with Dimeglio Grade IV deformity may benefit from closer follow-up during the maintenance phase because of their increased risk of recurrence.
2. Proactive Brace Onboarding: The first 2–6 weeks of brace use represent an important period for identifying practical difficulties. A brace-check appointment 10–14 days after fitting may help identify areas of friction, correct strap placement, and address caregiver concerns before adherence is interrupted.
3. Accessible Follow-up: For families living more than 50 km from the treatment center, decentralized or remote support, including photo-based telehealth check-ins and collaboration with local community health workers, may reduce travel-related barriers to timely follow-up.

Limitations

This study has several limitations. First, the data were obtained from a single tertiary academic medical center and may therefore overrepresent more complex referrals and local socioeconomic patterns. Second, caregiver-reported brace wear is susceptible to recall and social-desirability bias; objective sensors embedded in the brace or bar could provide more accurate adherence data (12, 21). Third, 24 months is sufficient to assess early and mid-term recurrence, but longer follow-up is required to evaluate late relapse and long-term outcomes.

Successful outcomes following Ponseti treatment depend on both the severity of clubfoot at presentation and sustained adherence to bracing. Baseline Dimeglio Grade IV deformity was an independent risk factor for recurrence, while orthosis non-compliance was the strongest predictor of mid-term relapse. Early identification of family-level barriers, structured brace education, prompt skin-care and fit support, and accessible follow-up may improve maintenance-phase outcomes.

1. Ponseti IV. Congenital clubfoot: fundamentals of treatment. Oxford: Oxford University Press; 1996.
2. Dobbs MB, Nunley R, Schoenecker PL. Long-term follow-up of patients with clubfeet treated with extensive soft-tissue release. J Bone Joint Surg Am. 2006;88(5):986–996.
3. Radler C. The Ponseti method for the treatment of congenital clubfoot: review of the current literature and treatment recommendations. Int Orthop. 2013;37(9):1747–1753.
4. Pirani S, Hodges D, Sekeramayi F. A reliable and valid method of assessing the amount of deformity in the congenital clubfoot foot. J Bone Joint Surg Br. 2008;90(Suppl II):218.
5. Diméglio A, Bensahel H, Souchet P, Mazeau P, Bonnet F. Classification of clubfoot. J Pediatr Orthop B. 1995;4(2):129–136.
6. Morcuende JA, Dolan LA, Dietz FR, Ponseti IV. Radical reduction in the rate of extensive surgery for idiopathic clubfoot using the Ponseti method. Pediatrics. 2004;113(2):376–380.
7. Shabtai L, Specht SC, Herzenberg JE. Worldwide spread of the Ponseti method for clubfoot. World J Orthop. 2014;5(5):585–590.
8. Zionts LE, Dietz FR. Bracing following correction of idiopathic clubfoot using the Ponseti method. J Am Acad Orthop Surg. 2010;18(8):486–493.
9. Zhao D, Shen X, Fang Y, Zhao L. Risk factors for recurrence of idiopathic clubfoot treated by the Ponseti method: a systematic review and meta-analysis. J Orthop Surg Res. 2022;17(1):472.
10. Cosma D, Vasilescu D. Relapse in idiopathic clubfoot after Ponseti treatment: a long-term follow-up. Int Orthop. 2015;39(12):2447–2452.
11. Banskota B, Banskota AK, Regmi R, Rajbhandary T, Shrestha OP, Spiegel DA. The activation of caregivers in Ponseti clubfoot treatment: evaluating parent-reported outcome measures and brace compliance. J Pediatr Orthop. 2021;41(4):e356–e363.
12. Sangiorgio SN, Ebramzadeh E, Morgan RD, Zionts LE. Factors associated with brace compliance in children with clubfoot. J Pediatr Orthop. 2016;36(5):522–527.
13. Smythe T, Kuper H, Macleod D, Foster A, Lavy C. Social and clinical determinants of clubfoot treatment adherence in low- and middle-income settings: a prospective cohort. BMJ Open. 2020;10(11):e039516.
14. Ganesan B, Luximon A, Al-Jumaily A, Balasankar SK. Ponseti method in the management of clubfoot under resource-constrained conditions: parental challenges and clinical outcomes. Front Public Health. 2019;7:261.
15. Dietz FR. Treatment of normal and atypical clubfoot: the Ponseti method. Foot Ankle Clin. 2020;25(2):227–241.
16. Roye BD, Vitale MG, Gelijns AC, Roye DP. Patient-based outcomes after clubfoot treatment: the Clubfoot Disease-Specific Index. J Pediatr Orthop. 2001;21(1):42–49.
17. Gray K, Pacey V, Gibbons P, Little D, Frost C. Interventions for congenital talipes equinovarus (clubfoot). Cochrane Database Syst Rev. 2014;(8):CD008602.
18. Goldstein RY, Seehausen DA, Chu A, D'Addesi LL, Scher DM. Predicting the need for surgical intervention in pediatric clubfoot. J Pediatr Orthop. 2015;35(4):395–402.
19. Nogueira MP, Fox M, Miller NH, Morcuende JA. The Ponseti method for congenital clubfoot: history, principles, and long-term results. J Foot Ankle Surg. 2019;25(3):143–151.
20. Bozkurt C, Sarıkaya B, Sipahioğlu S, Cetinus E. Factors affecting recurrence after Ponseti method in patients with idiopathic clubfoot. J Orthop Surg (Hong Kong). 2021;29(1):2309499021998006.
21. Hu W, Ke M, Rong X, et al. Evaluation of compliance with brace protocol in idiopathic clubfoot: parent factors and objective monitoring. Orthop Surg. 2022;14(6):1120–1128.
22. Haft CA, Walker CG, Crawford HA. Early results of the Ponseti method for the treatment of clubfoot: the Auckland experience. J Pediatr Orthop. 2007;27(5):522–528.