Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot

Clubfoot Clinical Trial

Official title: Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot in Newborns and Infants

Status Completed

Clinical Trial Summary

Congenital idiopathic clubfoot (CC) is the fifth most common congenital malformation in children. The Ponseti method is an effective protocol for treatment of congenital idiopathic clubfoot. Plaster is essential for the Ponseti treatment. This paper describes a new brace that can be used for the treatment of clubfoot in newborns and infants instead of plaster.

Clinical Trial Description

Methods In the orthopedic department of our hospital, 38 infants and newborns, (57 feet) ,all the patients were under the age of 3 months with congenital clubfoot underwent polyaxial braces between Jan, 2011 to Oct ,2013. Polyaxial brace was used for the deformity correction. Then, during the following 1-3 years, the Dennis braces were used during the night in case of recurrence. Prospective follow-up for a mean duration of 25 months (range, 15-36months) was carried out. The efficacy of the treatment was assessed by Pirani's scoring system before and after treatment. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity

• NCT number: NCT02815306
• Study type: Interventional
• Source: Children's Hospital of Chongqing Medical University
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Completion date: October 2013