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

NCT07554092 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

  • Club Foot

Interventions

PROCEDURE

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.

PROCEDURE

Accelerated 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 & Collaborators

  • Khyber Teaching Hospital

    collaborator OTHER
  • Khyber Medical University Peshawar

    lead OTHER

Principal Investigators

  • Sikandar Hayat, MBBS, FCPS (Orthopedic Surgery · Khyber Medical University Peshawar

  • Dr Khalid Rehman, MBBS · Institute of Public Health & Social Science, Khyber Medical University Peshawar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
5 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-10-30
Completion
2026-11-25

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07554092 on ClinicalTrials.gov