Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02815306

Enrollment

Registered

2016-06-28

Start date

2011-03-31

Completion date

2013-10-31

Last updated

2016-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clubfoot

Keywords

Congenital idiopathic clubfoot, Pirani score, infant, polyaxial brace

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.

Interventions

DEVICEPolyaxial 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 3 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

over 6 months.

Design outcomes

Primary

Measure	Time frame	Description
hindfoot	1 month	severity of the posterior crease, emptiness of the heel and rigidity of the equinus
midfoot	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026