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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 5 months
Healthy Volunteers: f
View:

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

Locations
Other Locations
Pakistan
Khyber Teaching Hospital
RECRUITING
Peshawar
Contact Information
Primary
Sikandar Hayat, MBBS, FCPS (Orthopedic Surgery
drsikandar68@gmail.com
03329474849
Backup
Dr Khalid Rehman, MBBS
drkhalidrehman@kmu.edu.pk
+92 333 9432032
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2026-11-25
Participants
Target number of participants: 144
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Khyber Teaching Hospital
Leads: Khyber Medical University Peshawar

This content was sourced from clinicaltrials.gov