Design and evaluation of a unilateral brace for preventing clubfoot relapse: A prospective study
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Introduction The Ponseti technique is highly effective for correcting congenital clubfoot; however, recurrence must be prevented using orthoses. The double abduction brace (D- A) is recommended by Ponseti and is widely used. However, more user-friendly orthoses have been developed because treatment abandonment with the traditional orthosis is frequent. We report the results obtained using a newly designed unilateral orthosis. Methods A unilateral orthosis (UNIC-Brace) was developed and tested in a prospective non-randomized study conducted between 2017 and 2020. The Pirani score was used to monitor the progression of the deformity during plaster correction. The D-A brace (Denis Browne model) served as the control group. The primary outcomes were recurrence rate, treatment adherence, and caregiver satisfaction. Results The study included 58 patients (87 feet) in the test group and 51 patients (75 feet) in the control group, with a minimum follow-up period of 3 years. No significant differences in epidemiological data or follow-up duration were observed between the two groups. The failure feet rates in D-A brace and UNIC-Brace groups were 41.3% and 17.2%, respectively ( p < .001). Non-adherence patients to treatment were 23.5% in the D-A brace and 13.8% in the UNIC-Brace group ( p < .001). Overall, 13.7% of families were not satisfied with the D-A orthosis, whereas 5.2% were not satisfied with the UNIC- Brace ( p < .001). Conclusions The UNIC-Brace yielded better outcomes than the traditional orthosis at a minimum follow-up period of 3 years.
Authors: Fabricio Y Zapparoli, José B Volpon
Institution: Universidade de São Paulo
Language: English
Topic: Foot and Ankle Surgery
Subfield: Orthopedics and Sports Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,100
OpenAlex ID: W4407151868