NCT02815306

Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Children's Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 1 Day – 3 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Clubfoot

Interventions

Type	Name	Description
DEVICE	Polyaxial brace	The Polyaxial brace were made by a technician trained by the China National Disabled Persons Federation. For all patients, gypsum models were prepared first, and then braces were fabricated according to the models. The detailed technique was fully in accordance with the Ponseti method.

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2016-06-28
• Last updated: 2016-06-28