Complications Arising From the Use of Foot Abduction Orthosis (FAO) in Ponseti-Treated Clubfoot Patients.

BACKGROUND

Although the Ponseti method is a gold-standard, noninvasive treatment for clubfoot, the bracing phase is often associated with complications, such as skin reddening, pressure sores, callus, pain, etc, leading to noncompliance and risk of recurrence. Despite its clinical relevance, very few studies have incidentally reported these. This study aims to assess the prevalence, progression, and resolution of brace-related complications to optimize brace design, improve compliance, and reduce recurrence rates.

METHODS

This prospective study was conducted at the MiracleFeet-supported Clubfoot Clinic in Khyber Teaching Hospital, Pakistan. Ninety-one clubfoot patients under age 2 years with postcasting Pirani score "0" were enrolled through convenience sampling. Complications were recorded at 24 hours, day 7, day 14, and day 30 using a standardized, pilot-tested questionnaire. Brace ease-of-use was assessed using an adapted USAID MiracleFeet tool. Descriptive statistics were applied using SPSS v29.

RESULTS

Among the recorded complications, skin reddening (75.8%) and pain (88%) were the most common complications at 24 hours, followed by blisters/sores (42.9%) and distal tibial swelling (26.4%). Both sores and swelling were notably consistent till day 7, affecting 41.8% and 25.3% of the patients, respectively. While most complications declined significantly by day 30, muscle atrophy and weakness peaked at 32% on day 14 and persisted in 24.2% of patients. Callus formation was also reported in 10% of patients. Sweating-related discomfort and abduction bar breakage (9 cases) appeared as late issues. Parental feedback showed generally favorable brace usability, with heel placement being most difficult. Most complications declined over time, although several persisted or appeared later, such as muscle atrophy and swelling; however, brace compliance was high regardless. No relapse occurred during the 6-month study period.

CONCLUSIONS

Given the lack of focused research, these findings underscore the need for improved brace design, more personalized follow-ups, and effective caregiver guidance. In low-resource settings, these will improve treatment protocols and help prevent disease recurrence.

LEVEL OF EVIDENCE: Level IV-Prospective case series on early brace-related complications in Ponseti-treated clubfoot patients.