NCT02815306

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

2.6 years

First QC Date

March 24, 2016

Last Update Submit

June 23, 2016

Conditions

Clubfoot

Keywords

Congenital idiopathic clubfootPirani scoreinfantpolyaxial brace

Outcome Measures

Primary Outcomes (2)

  • hindfoot

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

    1 month

  • 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

Study Arms (1)

Brace goup

EXPERIMENTAL

The infants who were brace group treated by braces which were designed and made by us.

Device: Polyaxial brace

Interventions

Polyaxial braceDEVICE

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.

Brace goup

Eligibility Criteria

Age1 Day - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • months infants parents would like to cooperate with the doctors.

You may not qualify if:

  • over 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the orthopeadic deapartment

Study Record Dates

First Submitted

March 24, 2016

First Posted

June 28, 2016

Study Start

March 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

June 28, 2016

Record last verified: 2016-06