Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot

Clubfoot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815306
• Other study ID #: Guoxin CFB-2016
• Status: Completed
• Phase: N/A
• First received: March 24, 2016
• Last updated: June 23, 2016
• Start date: March 2011
• Est. completion date: October 2013

Study information

• Verified date: June 2016
• Source: Children's Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Chongqing City
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

over 6 months.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Chongqing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hindfoot	severity of the posterior crease, emptiness of the heel and rigidity of the equinus	1 month	Yes
Primary	midfoot	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	1 month	Yes