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Research for Genetic Factors Involved in Congenital Dislocation of Hip: Genome-wide Association Study in Grand West France (GENETHIP)

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ClinicalTrials.gov Identifier: NCT02900482
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

The main objective is to identify the genes involved in congenital dislocation of the hip.

The secondary objectives are to measure the association between mechanical risk factors and congenital dislocation of hip and study the interactions between these factors and genetic factors.


Condition or disease Intervention/treatment
Congenital Hip Dislocation Other: Sampling saliva

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Research for Genetic Factors Involved in Congenital Dislocation of Hip: Genome-wide Association Study in Grand West France
Study Start Date : November 23, 2012
Estimated Primary Completion Date : May 23, 2019
Estimated Study Completion Date : May 23, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
case group
Patients with a history of congenital hip dislocation
Other: Sampling saliva
control group
Patients with no history of congenital hip dislocation
Other: Sampling saliva
parents of case group
Parents of patients with a history of congenital hip dislocation
Other: Sampling saliva



Primary Outcome Measures :
  1. Research for one or several genes involved in the congenital dislocation of hip by comparing the DNA from blood or saliva of patients and controls. [ Time Frame: inclusion ]
    The primary endpoint of the study is to sequence exome of patients affected by congenital dislocation of hip and of controls to identify one or several genes involved in the congenital dislocation of hip and compare the distribution of variants identified by exome sequencing between patients and controls.



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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Case group
Criteria

Inclusion Criteria:

  • Old patient at least of 3 weeks and under age 16 presenting a congenital pathology of hip defined by the following consensual criteria:

    1. Ultrasound criteria: osseous Cover of the femoral head 50 % or Bottom cotyloïdien = 6 mm or Type III and IV of the classification of Graf
    2. Radiographic criteria: acetabular angle = 30 ° or Absence of projection of the femoral pit in the infero-internal quadrant of the construction of Ombredanne or acetabular angle upper of more than 5 ° with regard to the healthy side (so reached unilateral)
  • Patient presenting family history of congenital hip dislocation
  • Patient of Caucasian origin
  • Signature of the consent

Exclusion Criteria:

  • Patient presenting anomalies of the collagen and/or the elastic tissue ( imperfect osteogenesis, syndromes of Ehlers-Danlos, Larsen and Marfan)
  • Patient presenting karyotype abnormalities
  • Refusal to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900482


Contacts
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Contact: Bertrand FENOLL, Professor bertrand.fenoll@chu-brest.fr

Locations
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France
Bertrand Fenoll Recruiting
Brest, France, 29200
Sponsors and Collaborators
University Hospital, Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02900482     History of Changes
Other Study ID Numbers: RB 11.042 GENETHIP
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Joint Dislocations
Hip Dislocation
Hip Dislocation, Congenital
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities