Design and evaluation of a unilateral brace for preventing clubfoot relapse: A prospective study.

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.