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Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot

Not Applicable
Completed
Conditions
Clubfoot
Interventions
Device: Polyaxial brace
Registration Number
NCT02815306
Lead Sponsor
Children's Hospital of Chongqing Medical University
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
88
Inclusion Criteria

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

Exclusion Criteria

over 6 months.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Brace goupPolyaxial braceThe infants who were brace group treated by braces which were designed and made by us.
Primary Outcome Measures
NameTimeMethod
hindfoot1 month

severity of the posterior crease, emptiness of the heel and rigidity of the equinus

midfoot1 month

curvature of the lateral border of the foot, severity of the medial crease and position of the lateral part of the head of the talus

Secondary Outcome Measures
NameTimeMethod
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