Developmental Dysplasia of the HipNCT01866527
Selective Ultrasound Screening for DDH 1991-2006
An observational study of Developmental Dysplasia of the Hip, run by University of Bergen at 1 site in Norway.
Trial summary
Early treatment is considered essential for developmental dysplasia of the hip (DDH), but the choice of screening strategy is debated. The investigators evaluated the effect of a selective ultrasound (US) screening programme. All infants born in a defined region during 1991-2006 with increased risk of DDH, i.e. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Developmental Dysplasia of the Hip
- How many people
- 81,564 participants
- Where
- 1 siteNorway
- Study dates
- Jan 1991to Aug 2012
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All infants born at the maternity unit at Haukeland University Hospital from January 1991 through December 2006 were included. The hospital provides the only delivery unit for the city and suburbs of Bergen and a large rural area within the Hordaland County. It serves a population of approximately 400 000 inhabitants, predominantly ethnic Norwegians. The annual birth rates varied from 4723 to 6010. Minimum observation time was 5,5 years.
Who may be able to join
- born at Haukeland University hospital January 1991-December 2006
Who cannot join
- Children with DDH due to neuromuscular syndromes were excluded.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Paediatric section, Radiology department, Haukeland University hospital, Bergen, Norway
Bergen, 5021
About this study
Official title: Selective Ultrasound Screening for Developmental Hip Dysplasia: Effect on Management and Late Detected Cases. A Prospective Survey During 1991-2006.
Early treatment is considered essential for developmental dysplasia of the hip (DDH), but the choice of screening strategy is debated. The investigators evaluated the effect of a selective ultrasound (US) screening programme.
All infants born in a defined region during 1991-2006 with increased risk of DDH, i.e. clinical hip instability, breech presentation, congenital foot deformities or a family history of DDH, were subjected to US screening at age one to three days. Severe sonographic dysplasia and/or dislocatable/dislocated hips were treated with abduction splints. Mild dysplasia and/or pathological instability, i.e. not dislocatable/dislocated hips were followed clinically and sonographically until spontaneous resolution, or until treatment became necessary. The minimum observation period was 5,5 years.
Read the detailed description
Of 81564 newborns, 11539 (14,1%) were identified as at risk, of which 11190 (58% girls) were included for further analyses. Of the 81564 infants, 2433 (3•0%) received early treatment; 1882 (2,3%) from birth and 551 (0,7%) after six weeks or more of clinical and sonographic surveillance. Another 2700 (3,3%) normalised spontaneously after watchful waiting from birth. Twenty-six infants (0,32 per 1000, 92% girls, two from the risk group) presented with late subluxated/dislocated hips (after one month of age). Another 126 (1,5 per 1000, 83% girls, one from the risk group) were treated after isolated late residual dysplasia. Thirty-one children (0,38 per 1000) had surgical treatment before age five years. Avascular necrosis was diagnosed in seven of all children treated (0.27%), four after early and three after late treatment.
Interpretation The first 16 years of a standardised selective US screening programme for DDH resulted in acceptable rates of early treatment and US follow-ups, and low rates of late subluxated/dislocated hips compared to similar studies.
- Conditions
- Developmental Dysplasia of the Hip
- Keywords
- Developmental dysplasia of the hip,, DDH,, avascular necrosis,, late detected cases
- Medical subject headings
- Developmental Dysplasia of the Hip, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| all newborns born 1991-2006 | all newborns born 1991-2006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
late dislocated or subluxated hips
late detected after 1 month of life, requiring treatment
Measured: first 5 years of life
Secondary outcomes (4)
Number of participants who receive ultrasound follow-up for 6 weeks or more
Number of participants who receive ultrasound follow-up (i.e sonographic surveillance) for 6 weeks or more
Measured: first months of life
early treatment
abduction treatment for DDH
Measured: first months of life
first surgical treatment
the need for a first surgical treatment the first 5 years of life (closed and open reductions, osteotomies)
Measured: first five years of life
avascular necrosis of femoral head
avascular necrosis of femoral head as complication to treatment
Measured: first five years of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJan 1991
- Primary completionAug 2012
- Study completionAug 2012
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81,564 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Vest
- Responsible party
- Principal investigator, Lene Bjerke Laborie, University of Bergen
- Investigators
- Karen Rosendahl, PhD, Study director, Paediatric Section, Department of Radiology, Haukeland University hospital, Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866527
- Sponsor's protocol ID
- 003.07
- Status last verified
- May 2013
- First submitted
- 23 May 2013
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Ultrasound Screening for Developmental Hip Dysplasia: Effect on Management and Late Detected Cases. A Prospective Survey During 1991-2006.
- ClinicalTrials.gov ID
- NCT01866527
- Acronym / sponsor ID
- 003.07
- Conditions
- Developmental Dysplasia of the Hip
- Keywords
- Developmental dysplasia of the hip,, DDH,, avascular necrosis,, late detected cases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81,564 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Helse Vest
- Study start
- Jan 1991
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 31 May 2013 (estimated)
- 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.
Early treatment is considered essential for developmental dysplasia of the hip (DDH), but the choice of screening strategy is debated. The investigators evaluated the effect of a selective ultrasound (US) screening programme.
All infants born in a defined region during 1991-2006 with increased risk of DDH, i.e. clinical hip instability, breech presentation, congenital foot deformities or a family history of DDH, were subjected to US screening at age one to three days. Severe sonographic dysplasia and/or dislocatable/dislocated hips were treated with abduction splints. Mild dysplasia and/or pathological instability, i.e. not dislocatable/dislocated hips were followed clinically and sonographically until spontaneous resolution, or until treatment became necessary. The minimum observation period was 5,5 years.
Detailed description
Of 81564 newborns, 11539 (14,1%) were identified as at risk, of which 11190 (58% girls) were included for further analyses. Of the 81564 infants, 2433 (3•0%) received early treatment; 1882 (2,3%) from birth and 551 (0,7%) after six weeks or more of clinical and sonographic surveillance. Another 2700 (3,3%) normalised spontaneously after watchful waiting from birth. Twenty-six infants (0,32 per 1000, 92% girls, two from the risk group) presented with late subluxated/dislocated hips (after one month of age). Another 126 (1,5 per 1000, 83% girls, one from the risk group) were treated after isolated late residual dysplasia. Thirty-one children (0,38 per 1000) had surgical treatment before age five years. Avascular necrosis was diagnosed in seven of all children treated (0.27%), four after early and three after late treatment.
Interpretation The first 16 years of a standardised selective US screening programme for DDH resulted in acceptable rates of early treatment and US follow-ups, and low rates of late subluxated/dislocated hips compared to similar studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all newborns born 1991-2006 | – | –all newborns born 1991-2006 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All infants born at the maternity unit at Haukeland University Hospital from January 1991 through December 2006 were included. The hospital provides the only delivery unit for the city and suburbs of Bergen and a large rural area within the Hordaland County. It serves a population of approximately 400 000 inhabitants, predominantly ethnic Norwegians. The annual birth rates varied from 4723 to 6010. Minimum observation time was 5,5 years.
Key inclusion criteria (1 listed)
- born at Haukeland University hospital January 1991-December 2006
Key exclusion criteria (1 listed)
- Children with DDH due to neuromuscular syndromes were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
late dislocated or subluxated hips
Time frame: first 5 years of life
late detected after 1 month of life, requiring treatment
4 secondary outcomes
Number of participants who receive ultrasound follow-up for 6 weeks or more
Time frame: first months of life
early treatment
Time frame: first months of life
first surgical treatment
Time frame: first five years of life
avascular necrosis of femoral head
Time frame: first five years of life
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 31 May 2013.
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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, PhD study director
Paediatric Section, Department of Radiology, Haukeland University hospital, Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Dysplasia of the Hip, run by University of Bergen at 1 site in Norway.
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 1 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 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
late dislocated or subluxated hips (time frame: first 5 years of life). 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 31 May 2013.