Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot
Primary Purpose
Clubfoot
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Polyaxial brace
Sponsored by
About this trial
This is an interventional treatment trial for Clubfoot focused on measuring Congenital idiopathic clubfoot, Pirani score, infant, polyaxial brace
Eligibility Criteria
Inclusion Criteria:
0-6 months infants parents would like to cooperate with the doctors.
Exclusion Criteria:
over 6 months.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brace goup
Arm Description
The infants who were brace group treated by braces which were designed and made by us.
Outcomes
Primary Outcome Measures
hindfoot
severity of the posterior crease, emptiness of the heel and rigidity of the equinus
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02815306
First Posted
March 24, 2016
Last Updated
June 23, 2016
Sponsor
Children's Hospital of Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02815306
Brief Title
Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot
Official Title
Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot in Newborns and Infants
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Chongqing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clubfoot
Keywords
Congenital idiopathic clubfoot, Pirani score, infant, polyaxial brace
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brace goup
Arm Type
Experimental
Arm Description
The infants who were brace group treated by braces which were designed and made by us.
Intervention Type
Device
Intervention Name(s)
Polyaxial brace
Intervention Description
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 Outcome Measure Information:
Title
hindfoot
Description
severity of the posterior crease, emptiness of the heel and rigidity of the equinus
Time Frame
1 month
Title
midfoot
Description
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
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
0-6 months infants parents would like to cooperate with the doctors.
Exclusion Criteria:
over 6 months.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot
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