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

StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07554092
Lead Sponsor Khyber Medical University Peshawar
Collaborators: Khyber Teaching Hospital
Conditions
(from sponsor)
Club Foot
Related terms Clubfoot
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov