An interventional study of Ponseti Casting and Accelerated Ponseti Casting in Club Foot, sponsored by Khyber Medical University Peshawar. Recruiting at 1 site in Pakistan. Open to participants aged 1 Day to 5 Months. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Khyber Medical University Peshawar · Not applicable, Interventional, and Treatment
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.
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.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
This study's planned enrollment of 144 is above the median of 38 across 40 interventional studies indexed under Clubfoot.
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-Both gender with idiopathic club foot with age less than 6 months
Exclusion Criteria:
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 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
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.
Also known as: Serial casting, Ponseti method, Ponseti technique
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.
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.
Time frame: 6 weeks after application of foot abduction orthosis (i.e., approximately 6 weeks following final cast removal and tenotomy healing)
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will become available 6 months after publication of the primary results and will remain available for 3 years thereafter.
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).
Started Feb 2026 (actual). Primary completion is estimated for Oct 2026, 8 months after the start.
Of 20 interventional studies with no phase under Clubfoot, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's planned 8 months is below that.
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Khyber Medical University Peshawar