Club Foot
Conditions
Keywords
Club Foot, Ponseti Casting Technique, Randomized controlled trial, Congenital talipes equinovarus
Brief 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.
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.
Interventions
PROCEDUREPonseti 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.
PROCEDUREAccelerated 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.
Sponsors
Khyber Medical University Peshawar
Khyber Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The principal investigator does not perform casting, and the pediatric orthopaedic fellow who measures the radiological outcomes is blinded to treatment group assignment; however, patients, parents, and the personnel applying casts cannot be blinded because of the visibly different casting frequencies (once versus twice per week).
Intervention model description
This study uses a parallel assignment model comparing two groups: standard once-weekly Ponseti casting versus accelerated twice-weekly Ponseti casting.
Eligibility
Sex/Gender
ALL
Age
1 Days to 5 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lateral Talocalcaneal Angle (TCA-Lat) | 6 weeks after application of foot abduction orthosis (i.e., approximately 6 weeks following final cast removal and tenotomy healing) | 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. |
Countries
Pakistan
Contacts
CONTACTSikandar Hayat, MBBS, FCPS (Orthopedic Surgery
CONTACTDr Khalid Rehman, MBBS
PRINCIPAL_INVESTIGATORSikandar Hayat, MBBS, FCPS (Orthopedic Surgery
Khyber Medical University Peshawar
PRINCIPAL_INVESTIGATORDr Khalid Rehman, MBBS
Institute of Public Health & Social Science, Khyber Medical University Peshawar
Outcome results
None listed