NCT03382028

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
Last Updated

December 22, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

November 16, 2017

Last Update Submit

December 18, 2017

Conditions

Equinus Deformity

Keywords

developmental abnormalitiespsychomotor development

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age2 Years - 15 Years
Sexall(Gender-based eligibility)
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with Equinus Deformity

You may qualify if:

  • 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.

You may not qualify if:

  • Parents opposing the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

MeSH Terms

Conditions

Equinus Deformity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Laurent Pasquier

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2017

First Posted

December 22, 2017

Study Start

June 1, 2017

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

December 22, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)