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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
Children's Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clubfoot focused on measuring Congenital idiopathic clubfoot, Pirani score, infant, polyaxial brace

Eligibility Criteria

1 Day - 3 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 24, 2016
    Last Updated
    June 23, 2016
    Sponsor
    Children's Hospital of Chongqing Medical University
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    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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