Development of Child With Equinus Deformity Idiopathic

Equinus Deformity Clinical Trial

— DENEBO1  

Official title:

Development of Child With Equinus Deformity Idiopathic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382028
• Other study ID #: 35RC16_3061-DENEBO1
• Secondary ID: 2016-A01975-46
• Status: Completed
• Phase: N/A
• First received: November 16, 2017
• Last updated: December 18, 2017
• Start date: June 1, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: November 2017
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Identification and characterization of the link between psychomotor development and the appearance of associated signs in children with "Equinus Deformity " considered isolated at birth.

Description:

The main objective of this study is to define the frequency of developmental abnormalities in children with "Equinus Deformity Idiopathic" compared to the general population

The secondary objective is to identify the prenatal and / or neonatal characteristics that could be predictive of the occurrence of developmental abnormalities in

Prenatal and postnatal follow-up data are derived from the child's medical file. To complete these data and after inclusion, parents of children carrying "Equinus Deformity Idiopathic" will be sent a questionnaire that assesses overall psychomotor development and lists the medical events since the birth of their child (scoliosis, epilepsy ...).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

Inclusion Criteria:

• Children born between January 2002 and August 2015

• Prenatal or postnatal diagnosis of idiopathic or syndromic Equinus Deformity

• Followed by the pediatric orthopedic service of Rennes University Hospital

• Parent having received the information on the protocol and having not expressed their opposition.

Exclusion Criteria:

• Parents opposing the study

Related Conditions & MeSH terms

• Clubfoot
• Congenital Abnormalities
• Equinus Deformity

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of developmental abnormalities (with the exception of Equinus Deformity) in children with Equinus Deformity idiopathic compared to the general population.		through study completion an average of 1 year