Comparing standard once-weekly versus accelerated twice-weekly Ponseti casting for club foot
Comparison of Radiological Outcome of Conventional vs Accelerated Ponseti Casting Technique for Treatment of Club Foot: Randomized Controlled Trial
This test will see if doing Ponseti casts twice a week instead of once helps correct club foot in babies younger than six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 1 Day to 5 Months |
| Sex | All |
| Sponsor | Khyber Medical University Peshawar Academic / other |
| Locations | 1 site (Peshawar, KPK) |
| Trial ID | NCT07554092 on ClinicalTrials.gov |
What this trial studies
This randomized open-label trial at Khyber Teaching Hospital will assign infants under six months with idiopathic club foot to either standard once-weekly Ponseti casting or an accelerated twice-weekly schedule. All other components of the Ponseti method (manipulation, tenotomy when needed, final cast, and foot abduction orthosis) are identical between groups. The primary outcome is radiological correction measured by the lateral talocalcaneal angle ≥35° on standardized X-rays six weeks after brace fitting, with secondary radiographic indices and adverse events recorded. An outcome assessor is blinded to allocation and analysis will use intention-to-treat methods.
Who should consider this trial
Good fit: Babies younger than six months with untreated idiopathic club foot who can attend scheduled clinic visits are ideal candidates.
Not a fit: Infants with syndromic or previously treated club foot, other major congenital anomalies, or those unable to complete follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the accelerated schedule could shorten treatment time and reduce the burden of clinic visits while achieving equivalent correction.
How similar studies have performed: Other randomized and observational reports of accelerated Ponseti casting have shown similar short-term radiologic and clinical outcomes to standard weekly casting, though long-term recurrence data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Peshawar, KPK
- Khyber Teaching Hospital — Peshawar, Kpk, Pakistan (Recruiting)
Study contacts
- Principal investigator: Sikandar Hayat, MBBS, FCPS (Orthopedic Surgery — Khyber Medical University Peshawar
- Study coordinator: Sikandar Hayat, MBBS, FCPS (Orthopedic Surgery
- Email: drsikandar68@gmail.com
- Phone: 03329474849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.