Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot

Chongqing Medical University

Status: Completed

Conditions: Clubfoot

Treatments: Device: Polyaxial brace

Study type: Interventional

Funder types: Other

Identifiers

NCT02815306

Guoxin CFB-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 1 day to 3 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

0-6 months infants parents would like to cooperate with the doctors.

Exclusion criteria

over 6 months.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

88 participants in 1 patient group

Brace goup

Experimental group

Description:

The infants who were brace group treated by braces which were designed and made by us.

Treatment:

Device: Polyaxial brace