Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot

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.

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Key information

Conditions

Clubfoot Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

1 day–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

over 6 months.

Treatment and study plan

Polyaxial brace

Device

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.

Primary outcomes

hindfoot

Time frame: 1 month

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

Time frame: 1 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jun 28, 2016
Registry last updated: Jun 28, 2016

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed