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

NCT02900482 | Completed DMC

• 1 other identifier: RB 11.042 GENETHIP
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Hip Dislocation

Outcome Measures

Primary Outcomes (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.

  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.

  inclusion

Study Arms (3)

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

Interventions

Sampling saliva OTHER

case group; control group; parents of case group

Eligibility Criteria

• Age: 3 Weeks - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Case group

You may qualify if:

• Old patient at least of 3 weeks and under age 16 presenting a congenital pathology of hip defined by the following consensual criteria:
• Ultrasound criteria: osseous Cover of the femoral head 50 % or Bottom cotyloïdien = 6 mm or Type III and IV of the classification of Graf
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Bertrand Fenoll

Brest, 29200, France

Location

MeSH Terms

Conditions

Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 14, 2016
• Study Start: November 23, 2012
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)