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

NCT07554092 | Recruiting DMC

• 1 other identifier: KMU/DIR/CTU/2026/001
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Club Foot

Keywords

Club Foot; Ponseti Casting Technique; Randomized controlled trial; Congenital talipes equinovarus

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks after application of foot abduction orthosis (i.e., approximately 6 weeks following final cast removal and tenotomy healing)

Study Arms (2)

Standard Ponseti Casting (Once Weekly)

EXPERIMENTAL

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

Accelerated Ponseti Casting (Twice Weekly)

ACTIVE COMPARATOR

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

Interventions

Ponseti Casting PROCEDURE

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

Standard Ponseti Casting (Once Weekly)

Accelerated Ponseti Casting PROCEDURE

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.

Accelerated Ponseti Casting (Twice Weekly)

Eligibility Criteria

• Age: 1 Day - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead
• Khyber Teaching Hospital: collaborator

Study Sites (1)

Khyber Teaching Hospital

Peshawar, KPK, 25000, Pakistan

RECRUITING

Related Publications (5)

• Cady R, Hennessey TA, Schwend RM. Diagnosis and Treatment of Idiopathic Congenital Clubfoot. Pediatrics. 2022 Feb 1;149(2):e2021055555. doi: 10.1542/peds.2021-055555.

  PMID: 35104362 BACKGROUND

• Bridgens J, Kiely N. Current management of clubfoot (congenital talipes equinovarus). BMJ. 2010 Feb 2;340:c355. doi: 10.1136/bmj.c355. No abstract available.

  PMID: 20124368 BACKGROUND

• Ponseti IV, Smoley EN. The classic: congenital club foot: the results of treatment. 1963. Clin Orthop Relat Res. 2009 May;467(5):1133-45. doi: 10.1007/s11999-009-0720-2. Epub 2009 Feb 14.

  PMID: 19219519 BACKGROUND

• Zimmerman CC, Nemeth BA, Noonan KJ, Vanderbilt TP, Winston MJ, O'Halloran CP, Sund SA, Hetzel SJ, Halanski MA. Reliability of radiographic measures in infants with clubfoot treated with the Ponseti method. J Child Orthop. 2015 Apr;9(2):99-104. doi: 10.1007/s11832-015-0647-y. Epub 2015 Mar 17.

  PMID: 25777178 BACKGROUND

• Shaheen S, Jaiballa H, Pirani S. Interobserver reliability in Pirani clubfoot severity scoring between a paediatric orthopaedic surgeon and a physiotherapy assistant. J Pediatr Orthop B. 2012 Jul;21(4):366-8. doi: 10.1097/BPB.0b013e3283514183.

  PMID: 22343939 BACKGROUND

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sikandar Hayat, MBBS, FCPS (Orthopedic Surgery

  Khyber Medical University Peshawar

  PRINCIPAL INVESTIGATOR

• Dr Khalid Rehman, MBBS

  Institute of Public Health & Social Science, Khyber Medical University Peshawar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sikandar Hayat, MBBS, FCPS (Orthopedic Surgery

CONTACT

03329474849; drsikandar68@gmail.com

Dr Khalid Rehman, MBBS

CONTACT

+92 333 9432032; drkhalidrehman@kmu.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a parallel assignment model comparing two groups: standard once-weekly Ponseti casting versus accelerated twice-weekly Ponseti casting.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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).

Locations

PA (1)