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

Official title

Comparison of Radiological Outcome of Conventional vs Accelerated Ponseti Casting Technique for Treatment of Club Foot: Randomized Controlled Trial

Overview

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

• 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 correct
• 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

Primary outcome measures

• Lateral Talocalcaneal Angle (TCA-Lat) [Time frame: 6 weeks after application of foot abduction orthosis (i.e., approximately 6 weeks following final cast removal and tenotomy healing)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Khyber Teaching Hospital — Peshawar

Publications

• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07554092 · KMU/DIR/CTU/2026/001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗