Developmental Dysplasia of the HipNCT04563819
Genetic Mechanisms and Additional Risk Factors Underlying Hip Dysplasia
An observational study of Developmental Dysplasia of the Hip, run by Helse-Bergen HF.
Trial summary
Hip Dysplasia, or Developmental dysplasia of the hip (DDH) is a congenital disorder of the hip joint characterized by a shallow, or dysplastic hip socket, with potential risks of developing progressive joint dislocation, early osteoarthritis from young adulthood and serious functional disability. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- Genom-wide association study (GWAS) and biological pathway analyses
- How many people
- 1,779 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Clinical and radiological assessments of 2380 18/19-year-olds (60.5% females) drawn from the Bergen Birth Hip Cohort Study (ClinicalTrials.gov ID: NCT01818934) were carried out at Haukeland University Hospital during 2007-2009. Genetic samples are available on 1779 of these participants, all of whom have been assessed radiologically and clinically at 18/19 years.
Who may be able to join
- Clinical and radiological follow up of Hip Cohort Study members born during 1989 (n=4004, response rate 52%) and those revealing sonographically immature or dysplastic hips in the newborn period during 1988 and 1990 (n= 480, response rate 67.7%) was performed during 2007- 2009, thereby enabling characterisation of DDH in 2406 subjects. Of these, 2380 had satisfying hip radiographs and clinical data.
- In 1779 of these, salivary samples were collected with consent.
Who cannot join
- No salivary sample available.
About this study
Official title: Genetic Mechanisms and Additional Risk Factors Underlying Hip Dysplasia. The Bergen Birth Hip Cohort and Bergen Hip Screening Databank.
Hip Dysplasia, or Developmental dysplasia of the hip (DDH) is a congenital disorder of the hip joint characterized by a shallow, or dysplastic hip socket, with potential risks of developing progressive joint dislocation, early osteoarthritis from young adulthood and serious functional disability. The Hip Cohort Study is the first longitudinal, population-based hip "phenobank" which includes standardized ultrasound examinations of the newborn hip, radiographs at skeletal maturity (around 19 years), as well as clinical data and DNA samples from the participants. The combination of genetic analyses with the rich radiological and clinical data collected at different life stages during the first two decades of life will enable identification of biological pathways (advanced genetic analyses) that are significantly associated with different radiological indices of hip dysplasia. This will allow for early, targeted treatment of the DDH disease and thus reduce the risk of later osteoarthritis.
Read the detailed description
Study population and DNA samples Clinical and radiological follow up of Hip Cohort Study members born during 1989 (n=4004, response rate 52%) and those revealing sonographically immature or dysplastic hips in the newborn period during 1988 and 1990 (n= 480, response rate 67.7%) was performed during 2007- 2009, thereby enabling characterisation of DDH in 2406 subjects. In 1779 of these, salivary samples were collected with consent, and DNA was extracted and stored in Professor Bill Ollier's laboratory at the University of Manchester.
The initial Hip Cohort Study is well described in ClinicalTrials.gov ID: NCT01818934.
Genome-wide genotyping, SNP and CNV association analyses:
DNA samples will be sent to the Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Norway, for the genome-wide SNP (single nucleotide polymorphism) genotyping. For this study, we will use the latest version of Illumina Core Exome array, covering known genes, selected exones and promoter regions, as well as a backbone of common genetic variation allowing for imputation of genotypes that will widen the genomic content we will examine. Thus, this array will provide sufficient coverage of the genome for biological pathway analyses. Initial quality control will be performed in Illumina's Genome Studio Software. Subsequent quality control will be performed as described in the paper by Anderson et al in order to avoid common confounding factors such as batch effect (Lam et al 2020, Anderson et al 2010). Coverage of the genome-wide variation will be further improved by imputation of non-genotyped SNPs using directly genotyped SNPs and linkage disequilibrium information from the Haplotype Reference Consortium. Imputation will be performed using Impute2 software, according to recommended guidelines (Howie et al, 2011). In addition to the pathway analysis, an overall association analysis will be performed to uncover SNPs associated with DDH. For these analyses, standard quality control and statistical methods will be used (Purcell et al, 2007). Copy number variations (CNVs) will be determined using PennCNV (Wang, Li, Hadley et al, 2007) and their association with hip dysplasia indices will be examined using regression analyses. Given our current sample size, we have about 50% power to detect a variant in this sample (frequency of 20% of hip dysplasia, and a similar allele frequency and OR of the top candidate in GDF5). However, using multiple phenotypes and genetic analyses, we will be able to explore the genetics of hip dysplasia and hip shape in a unique way.
Biological Pathway Analyses: The use of conventional genome-wide association methods does not fully explore the potentially complicated relationships between genetic variants, or between the proteins resulting from the genetic variants. Pathway- and network-based analysis methods have been developed to help address this problem ((e.g. Wang, Li, Bucan et al 2007; Torkamani et al 2008; Baranzini et al 2009; Eleftherohorinou et al 2009; Perry et al 2009; Peng et al 2010). These methods typically combine evidence of multiple genes/SNPs within a particular biological pathway, in order to establish if a pathway may be implicated in the development of a phenotype. Permutation methods are often employed to assess the significance in these analyses. This type of analysis may also help to interpret the biological meaning of association signals. This approach will allow the exploration of the relative contributions of different biological mechanisms possibly underlying DDH, using genetic information to group genes into putative pathways and relate them to different anatomical and clinical features of DDH. For the current study, biological pathways will be obtained from established databases, such as the Gene Ontology and Reactome databases, and other public resources (Ashburner et al, 2000; Croft et al, 2014). Pathways will be analysed in MAGMA, using the genome-wide SNP and/or CNV information to identify underlying biological pathways for an individual radiological index (de Leeuw et al, 2015). Distinctive biological mechanisms related to radiological indices may be identified through pathway analyses. To date, most predictors of severe DDH outcome have been based on clinical and x-ray findings, and on evaluation of the patient's functional impairment. We will, using multivariable prognostic models, construct a more focused, multivariate model for the prediction of improvement, based not only on traditional clinical and radiological risk factors but also on novel genetic information and imaging biomarkers.
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- Genom-wide association study (GWAS) and biological pathway analyses
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genom-wide association study (GWAS) and biological pathway analysesGenetic
| Study group | Role | What they receive |
|---|---|---|
| Newborns with DDH | Newborns (born 1988-90) with sonographic hip dysplasia (DDH) Receives: Genetic: Genom-wide association study (GWAS) and biological pathway analyses | |
| Newborns without DDH | Newborns (born 1988-90) without sonographic hip dysplasia (DDH) Receives: Genetic: Genom-wide association study (GWAS) and biological pathway analyses | |
| Hip dysplasia at skeletal maturity | Subjects that show signs of acetabular dysplasia at skeletal maturity (age 17-19 years), in 2007-09, when hip radiographs and salivary samples were collected. Receives: Genetic: Genom-wide association study (GWAS) and biological pathway analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic factors underlying DDH
identify the biological pathways underlying the different radiological features of DDH.
Measured: Analyses performed within 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study startMar 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,779 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse-Bergen HF
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway, Helse Forde
- Responsible party
- Principal investigator, Lene Bjerke Laborie, Helse-Bergen HF
- Investigators
- Karen Rosendahl, MD PhD, Principal investigator, University Hospital of North Norway, The Arctic University of Northern Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563819
- Sponsor's protocol ID
- REK 24714
- Other IDs
- REK 20594
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Genetic material not allowed to share to others than our collaborators
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Mechanisms and Additional Risk Factors Underlying Hip Dysplasia. The Bergen Birth Hip Cohort and Bergen Hip Screening Databank.
- ClinicalTrials.gov ID
- NCT04563819
- Acronym / sponsor ID
- REK 24714
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,779 participants (actual)
- Lead sponsor
- Helse-Bergen HFUniversity, hospital or other
- Collaborators
- University Hospital of North Norway, Helse Forde
- Study start
- Mar 2007 (actual)
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hip Dysplasia, or Developmental dysplasia of the hip (DDH) is a congenital disorder of the hip joint characterized by a shallow, or dysplastic hip socket, with potential risks of developing progressive joint dislocation, early osteoarthritis from young adulthood and serious functional disability. The Hip Cohort Study is the first longitudinal, population-based hip "phenobank" which includes standardized ultrasound examinations of the newborn hip, radiographs at skeletal maturity (around 19 years), as well as clinical data and DNA samples from the participants. The combination of genetic analyses with the rich radiological and clinical data collected at different life stages during the first two decades of life will enable identification of biological pathways (advanced genetic analyses) that are significantly associated with different radiological indices of hip dysplasia. This will allow for early, targeted treatment of the DDH disease and thus reduce the risk of later osteoarthritis.
Detailed description
Study population and DNA samples Clinical and radiological follow up of Hip Cohort Study members born during 1989 (n=4004, response rate 52%) and those revealing sonographically immature or dysplastic hips in the newborn period during 1988 and 1990 (n= 480, response rate 67.7%) was performed during 2007- 2009, thereby enabling characterisation of DDH in 2406 subjects. In 1779 of these, salivary samples were collected with consent, and DNA was extracted and stored in Professor Bill Ollier's laboratory at the University of Manchester.
The initial Hip Cohort Study is well described in ClinicalTrials.gov ID: NCT01818934.
Genome-wide genotyping, SNP and CNV association analyses:
DNA samples will be sent to the Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Norway, for the genome-wide SNP (single nucleotide polymorphism) genotyping. For this study, we will use the latest version of Illumina Core Exome array, covering known genes, selected exones and promoter regions, as well as a backbone of common genetic variation allowing for imputation of genotypes that will widen the genomic content we will examine. Thus, this array will provide sufficient coverage of the genome for biological pathway analyses. Initial quality control will be performed in Illumina's Genome Studio Software. Subsequent quality control will be performed as described in the paper by Anderson et al in order to avoid common confounding factors such as batch effect (Lam et al 2020, Anderson et al 2010). Coverage of the genome-wide variation will be further improved by imputation of non-genotyped SNPs using directly genotyped SNPs and linkage disequilibrium information from the Haplotype Reference Consortium. Imputation will be performed using Impute2 software, according to recommended guidelines (Howie et al, 2011). In addition to the pathway analysis, an overall association analysis will be performed to uncover SNPs associated with DDH. For these analyses, standard quality control and statistical methods will be used (Purcell et al, 2007). Copy number variations (CNVs) will be determined using PennCNV (Wang, Li, Hadley et al, 2007) and their association with hip dysplasia indices will be examined using regression analyses. Given our current sample size, we have about 50% power to detect a variant in this sample (frequency of 20% of hip dysplasia, and a similar allele frequency and OR of the top candidate in GDF5). However, using multiple phenotypes and genetic analyses, we will be able to explore the genetics of hip dysplasia and hip shape in a unique way.
Biological Pathway Analyses: The use of conventional genome-wide association methods does not fully explore the potentially complicated relationships between genetic variants, or between the proteins resulting from the genetic variants. Pathway- and network-based analysis methods have been developed to help address this problem ((e.g. Wang, Li, Bucan et al 2007; Torkamani et al 2008; Baranzini et al 2009; Eleftherohorinou et al 2009; Perry et al 2009; Peng et al 2010). These methods typically combine evidence of multiple genes/SNPs within a particular biological pathway, in order to establish if a pathway may be implicated in the development of a phenotype. Permutation methods are often employed to assess the significance in these analyses. This type of analysis may also help to interpret the biological meaning of association signals. This approach will allow the exploration of the relative contributions of different biological mechanisms possibly underlying DDH, using genetic information to group genes into putative pathways and relate them to different anatomical and clinical features of DDH. For the current study, biological pathways will be obtained from established databases, such as the Gene Ontology and Reactome databases, and other public resources (Ashburner et al, 2000; Croft et al, 2014). Pathways will be analysed in MAGMA, using the genome-wide SNP and/or CNV information to identify underlying biological pathways for an individual radiological index (de Leeuw et al, 2015). Distinctive biological mechanisms related to radiological indices may be identified through pathway analyses. To date, most predictors of severe DDH outcome have been based on clinical and x-ray findings, and on evaluation of the patient's functional impairment. We will, using multivariable prognostic models, construct a more focused, multivariate model for the prediction of improvement, based not only on traditional clinical and radiological risk factors but also on novel genetic information and imaging biomarkers.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Newborns with DDH | – | Genetic: Genom-wide association study (GWAS) and biological pathway analysesNewborns (born 1988-90) with sonographic hip dysplasia (DDH) |
| Newborns without DDH | – | Genetic: Genom-wide association study (GWAS) and biological pathway analysesNewborns (born 1988-90) without sonographic hip dysplasia (DDH) |
| Hip dysplasia at skeletal maturity | – | Genetic: Genom-wide association study (GWAS) and biological pathway analysesSubjects that show signs of acetabular dysplasia at skeletal maturity (age 17-19 years), in 2007-09, when hip radiographs and salivary samples were collected. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical and radiological assessments of 2380 18/19-year-olds (60.5% females) drawn from the Bergen Birth Hip Cohort Study (ClinicalTrials.gov ID: NCT01818934) were carried out at Haukeland University Hospital during 2007-2009. Genetic samples are available on 1779 of these participants, all of whom have been assessed radiologically and clinically at 18/19 years.
Key inclusion criteria (2 listed)
- Clinical and radiological follow up of Hip Cohort Study members born during 1989 (n=4004, response rate 52%) and those revealing sonographically immature or dysplastic hips in the newborn period during 1988 and 1990 (n= 480, response rate 67.7%) was performed during 2007- 2009, thereby enabling characterisation of DDH in 2406 subjects. Of these, 2380 had satisfying hip radiographs and clinical data.
- In 1779 of these, salivary samples were collected with consent.
Key exclusion criteria (1 listed)
- No salivary sample available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genom-wide association study (GWAS) and biological pathway analyses | Genetic | Hip dysplasia at skeletal maturity, Newborns with DDH, Newborns without DDH |
Primary outcome
Genetic factors underlying DDH
Time frame: Analyses performed within 2024
identify the biological pathways underlying the different radiological features of DDH.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Individual participant dataSharing planned: No. Genetic material not allowed to share to others than our collaborators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Rosendahl, MD PhD principal investigator
University Hospital of North Norway, The Arctic University of Northern Norway
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Dysplasia of the Hip, run by Helse-Bergen HF.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic factors underlying DDH (time frame: Analyses performed within 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.