Comparison of Radiological Outcome of Conventional vs Accelerated Ponseti Casting Technique for Treatment of Club Foot

Comparison of Radiological Outcome of Conventional vs Accelerated Ponseti Casting Technique for Treatment of Club Foot: Randomized Controlled Trial

Club foot (congenital talipes equinovarus) is a common birth deformity affecting 1-2 per 1,000 live births, with even higher rates in low-income countries. The standard treatment is the Ponseti method using weekly serial casts, but weekly visits for several weeks can be challenging for families in hot climates or with limited resources. This randomized controlled trial compares the standard once-weekly Ponseti casting with an accelerated twice-weekly casting technique. The primary outcome is radiological correction measured by the lateral talocalcaneal angle (target ≥35°) on standardized foot X-rays taken six weeks after brace fitting. Secondary outcomes include the talocalcaneal index (>40) and the tibio-calcaneal (dorsiflexion) angle (60-90°). Babies under six months of age with idiopathic club foot will be randomly assigned to either the standard or accelerated casting group. All other aspects of the Ponseti method (manipulation, number of casts, tenotomy when needed, final cast for three weeks, and foot abduction orthosis) remain identical. Adverse events such as skin problems, swelling, or cast complications will be recorded. The study aims to determine whether accelerated casting achieves better radiographic correction without increasing risks.

Study Overview

• Status: Recruiting
• Conditions: Club Foot
• Intervention / Treatment: Procedure: Ponseti Casting; Procedure: Accelerated Ponseti Casting

Detailed Description

This open-label randomized controlled trial will be conducted at the dedicated Ponseti clinic, Department of Orthopedic and Trauma, Khyber Teaching Hospital, Peshawar, Pakistan, over six months. A total of 158 club feet (105 infants) with idiopathic club foot aged <6 months will be enrolled using non-probability consecutive sampling. After informed consent and baseline X-ray, participants are randomly allocated (sealed envelope, odd/even numbers from OpenEpi) to either standard once-weekly casting (every Monday) or accelerated twice-weekly casting (Monday and Friday). All other Ponseti protocol elements (manipulation, number of casts, tendo Achillis tenotomy when indicated, final cast for 3 weeks, and foot abduction orthosis) are identical. The primary outcome is lateral talocalcaneal angle (mean of dorsiflexion and plantar flexion views) ≥35° on standardized X-ray six weeks after bracing. Secondary outcomes are talocalcaneal index >40 and tibio-calcaneal angle 60-90°. Adverse events (skin sores, swelling, cast issues) are recorded. Allocation concealment is blinded to investigator and parents; the outcome assessor (pediatric orthopaedic fellow) is blinded to group assignment. Data will be analyzed using SPSS v20 (intention-to-treat, independent t-test or Mann-Whitney U, adjusted odds ratios, p<0.05 significant). Ethical approval will be obtained from Khyber Medical College, KMU, and ASRB. Treatment is free, but no financial compensation is provided.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sikandar Hayat, MBBS, FCPS (Orthopedic Surgery; Phone Number: 03329474849; Email: drsikandar68@gmail.com
• Study Contact Backup: Name: Dr Khalid Rehman, MBBS; Phone Number: +92 333 9432032; Email: drkhalidrehman@kmu.edu.pk

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25000
      • Recruiting
      • Khyber Teaching Hospital
      • Contact: Dr Sikandar Hayat, MBBS; Phone Number: 92 332 9474849; Email: drsikandar68@gmail.com
      • Contact: Dr Khalid Rehman, MBBS; Phone Number: Ali Naqvi +92 333 9432032; Email: drkhalidrehman@kmu.edu.pk
      • Principal Investigator: Dr Syed Muhammad Shabbir Ali Naqvi, PhD*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-Both gender with idiopathic club foot with age less than 6 months

Exclusion Criteria:

• Syndromic club foot (e.g., associated with arthrogryposis, myelomeningocele, or other genetic syndromes)
• Previous treatment for club foot (either serial casting or surgical intervention)
• Any other significant congenital anomaly or medical condition that, in the opinion of the investigator, would interfere with treatment or follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Ponseti Casting (Once Weekly); Participants in this arm receive standard Ponseti serial casting once per week (every Monday) until clubfoot correction is achieved. Each casting session includes manipulation followed by application of a plaster cast. Typically 5 to 6 casts are required. When indicated, a tendo Achillis tenotomy is performed under local anesthesia in the clinic, followed by a final cast worn for three weeks. After cast removal, a foot abduction orthosis (Miracle Feet brace) is applied and worn full-time for three months, then nights only until five years of age. Radiological outcome is assessed six weeks after brace fitting.	Procedure: Ponseti Casting; Participants receive serial manipulation and plaster cast application according to the standard Ponseti technique to correct clubfoot deformity (cavus, adduction, varus, and equinus). A long-leg plaster cast is applied after each manipulation session. Casts are changed either once weekly (every Monday) for the standard group or twice weekly (Monday and Friday) for the accelerated group. Typically 5 to 6 casts are required over the treatment course. When all deformities except equinus are corrected, a percutaneous tendo Achillis tenotomy is performed under local anesthesia in the clinic, followed by a final cast worn continuously for three weeks. After final cast removal, a foot abduction orthosis (Miracle Feet brace) is applied and worn full-time for the first three months, then nights only until the child reaches five years of age. Radiological outcome is assessed six weeks after brace fitting.; Other Names: Serial casting, Ponseti method, Ponseti technique
Active Comparator: Accelerated Ponseti Casting (Twice Weekly); Participants in this arm receive accelerated Ponseti serial casting twice per week (every Monday and Friday) until clubfoot correction is achieved. All other elements are identical to the standard arm: manipulation technique, number of casts (typically 5-6), tendo Achillis tenotomy under local anesthesia when indicated, a final cast for three weeks, followed by the same foot abduction orthosis (Miracle Feet brace) with identical wearing schedule. Radiological outcome is assessed six weeks after brace fitting. The only difference from the standard arm is the frequency of cast changes.	Procedure: Accelerated Ponseti Casting; erial manipulation and long-leg plaster cast applied twice every week (every Monday and Friday) until clubfoot correction is achieved. Typically 5-6 casts are applied over 2.5-3 weeks. This is the only difference compared to the standard arm. Tenotomy is performed under local anesthesia in the clinic when residual equinus remains after serial casting. A tenotomy knife is used to transect the Achilles tendon percutaneously, followed by a final cast for 3 weeks. This procedure is identical in both study arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lateral Talocalcaneal Angle (TCA-Lat)	The lateral talocalcaneal angle measured on standardized lateral foot X-ray. The angle is calculated as the mean of measurements taken in both dorsiflexion and plantar flexion views. A value of 35 degrees or above indicates successful correction of hindfoot varus. The measurement will be performed by a pediatric orthopaedic fellow blinded to treatment group assignment.	6 weeks after application of foot abduction orthosis (i.e., approximately 6 weeks following final cast removal and tenotomy healing)

Collaborators and Investigators

• Sponsor: Khyber Medical University Peshawar
• Collaborators: Khyber Teaching Hospital
• Investigators: Principal Investigator: Sikandar Hayat, MBBS, FCPS (Orthopedic Surgery, Khyber Medical University Peshawar; Principal Investigator: Dr Khalid Rehman, MBBS, Institute of Public Health & Social Science, Khyber Medical University Peshawar

Publications and helpful links

General Publications

• Cady R, Hennessey TA, Schwend RM. Diagnosis and Treatment of Idiopathic Congenital Clubfoot. Pediatrics. 2022 Feb 1;149(2):e2021055555. doi: 10.1542/peds.2021-055555.
• Bridgens J, Kiely N. Current management of clubfoot (congenital talipes equinovarus). BMJ. 2010 Feb 2;340:c355. doi: 10.1136/bmj.c355. No abstract available.
• Ponseti IV, Smoley EN. The classic: congenital club foot: the results of treatment. 1963. Clin Orthop Relat Res. 2009 May;467(5):1133-45. doi: 10.1007/s11999-009-0720-2. Epub 2009 Feb 14.
• Zimmerman CC, Nemeth BA, Noonan KJ, Vanderbilt TP, Winston MJ, O'Halloran CP, Sund SA, Hetzel SJ, Halanski MA. Reliability of radiographic measures in infants with clubfoot treated with the Ponseti method. J Child Orthop. 2015 Apr;9(2):99-104. doi: 10.1007/s11832-015-0647-y. Epub 2015 Mar 17.
• Shaheen S, Jaiballa H, Pirani S. Interobserver reliability in Pirani clubfoot severity scoring between a paediatric orthopaedic surgeon and a physiotherapy assistant. J Pediatr Orthop B. 2012 Jul;21(4):366-8. doi: 10.1097/BPB.0b013e3283514183.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 25, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Club Foot; Ponseti Casting Technique; Congenital talipes equinovarus
• Additional Relevant MeSH Terms: Talipes; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Clubfoot
• Other Study ID Numbers: KMU/DIR/CTU/2026/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the primary publication (including de-identified radiological measurements, Pirani scores, adverse event data, and baseline demographics) will be shared upon reasonable request for the purpose of meta-analysis or independent verification. No identifiable information (names, contact details, photographs) will be shared.
• IPD Sharing Time Frame: Data will become available 6 months after publication of the primary results and will remain available for 3 years thereafter.
• IPD Sharing Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal and sign a data access agreement. Requests should be directed to the principal investigator (Dr Sikandar Hayat).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No