Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot

• Sponsor: Children's Hospital of Chongqing Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02815306
• Collaborator: (none)
• Enrollment: 88
• Arm: 1
• Duration (Months): 31

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clubfoot	Device: Polyaxial brace	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot in Newborns and Infants
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brace goup The infants who were brace group treated by braces which were designed and made by us.	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.

Outcome Measures

Primary Outcome Measures

1. hindfoot [1 month]

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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 3 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

over 6 months.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Children's Hospital of Chongqing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guoxin Nan, Chief of the orthopeadic deapartment, Children's Hospital of Chongqing Medical University
• ClinicalTrials.gov Identifier: NCT02815306
• Other Study ID Numbers: Guoxin CFB-2016
• First Posted: Jun 28, 2016
• Last Update Posted: Jun 28, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Guoxin Nan, Chief of the orthopeadic deapartment, Children's Hospital of Chongqing Medical University: Congenital idiopathic clubfoot; Pirani score; infant; polyaxial brace
• Additional relevant MeSH terms: Clubfoot; Talipes; Equinus Deformity; Foot Deformities

Study Results

No Results Posted as of Jun 28, 2016