Developmental Dysplasia of the Hip (DDH)NCT01053299
Universal Ultrasound-screening for Developmental Dysplasia of the Hip in Newborn
A study testing open, prospective cohort-study in people with Developmental Dysplasia of the Hip (DDH), run by Vestre VikenHF Kongsberg Sykehus at 1 site in Norway.
Trial summary
All newborn from the period 12.1988 to 31.12.2006 During the two last decades, hip ultrasound has gained acceptance as an accurate screening test for developmental dysplasia of the hip (DDH) and for monitoring the development and treatment of the condition. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dysplasia of the Hip (DDH)
- What is being tested?
- open, prospective cohort-study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,200 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2010to Dec 2011
- Phase
- Interventional
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All newborns form the period 1.21998-31.12.2006
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Universal Ultrasound-screening for Developmental Dysplasia of the Hip. 5-12 Years Followup of 4 200 Newborns
All newborn from the period 12.1988 to 31.12.2006 During the two last decades, hip ultrasound has gained acceptance as an accurate screening test for developmental dysplasia of the hip (DDH) and for monitoring the development and treatment of the condition. Debate continues over whether DDH that is detected by ultrasonography is necessarily clinically relevant. The diagnostic accuracy of ultrasound imaging for DDH in the screening population has not been investigated adequately. Studies that investigate the natural course of the disorder, the optimal treatment for DDH, and the best strategy for ultrasound screening are needed. Ultrasound screening at birth for DDH in all newborn infants is standard practice in some European countries but not in the United Kingdom, the United States, or Scandinavia. Evidence is insufficient to support or reject general ultrasound screening of newborns for DDH. (N.F.Woolacott etc 2006, systematic review BMJ) At Vestre Viken HF, Kongsberg, Norway, the investigators implemented universal ultrasound screening in 1998. We will present the long term outcome, including radiographs of the hips after 5-12 years.
Read the detailed description
All the newborn from the period 1.2.1988 to 31.12.2006 will be called for to take an AP X-ray of the pelvis for assessment of their hips. The data compares to the primary ultrasound-recordings taken newborn.
Radiographs of the pelvis: The x-ray examinations will be performed using low-dose technique. Scrotal lead shield will be used in boys, and the girls will be examined during a menstrual period to exclude pregnancy. The examination will include an erect AP view (feet pointing forward, neutral ab-adduction position of the hips) using a film/focus distance of 1.2 m and centred at 2cm proximal to the pubic bone. To standardise the projection, a rotation index between 0.7 and 1.8 (49;50) will be required. Repeat images will be avoided. A tubing containing a contrast medium will be placed in the x-ray field to give the true horizontal level for measurements of leg length discrepancy. The assessment of the images will be done by a specialist in pediatric radiology in another hospital, and blinded for the primary ultrasound-results. In cases of pathology, the patient will be scheduled for an urgent appointment with a paediatric orthopaedic surgeon.
Image analysis: the following measurements will be performed using a validated digitising program (Pedersen et al, J Pediatric Orthopedic 2004):
- Markers for DDH: CE (centre-edge) angle of Wiberg, Refined CE angle (Ogata) Sharp's angle ADR (the acetabular depth ratio, Murray) FHEI (femoral head extrusion index, Heyman and Herndon) The shape of the lateral acetabulum (subjective assessment)
- Markers for previous avascular necrosis (AVN)
AP:
Femoral head shape (classified as spherical, mildly flattened or flattened). Caput - trochanter height Projected CCD angle Length and width of the femoral neck (Shape of the physis) Leg length (Trendelenburg) In addition Body Mass Index (BMI) for itch child will be calculated.
- Conditions
- Developmental Dysplasia of the Hip (DDH)
- Being tested
- open, prospective cohort-study
- Keywords
- Developmental dysplasia of the hip (DDH), newborn, universal screening, Universal ultrasound-screening for DDH in newborns, The accuracy of ultrasound-recording of the hip in newborns
- 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.
open, prospective cohort-studyOther
Specific measurements from the X-ray to assess the hip status 5-12 years from the born.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Active comparator | Every child, without exception, born in the peroid 1.2.1998 - 31.12.2006, still alive, will be called for to take a Xray of their hips aimed at comparing the ultrasound-values taken newborn. Receives: Other: open, prospective cohort-study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific measurements of the hip out of an AP Xray of pelvis to assess the diagnostic accuracy of ultrasound imaging for DDH in newborns.
Measured: 1.5 - 2 years
Secondary outcomes (1)
Assess the outcome of those treated for DDH from birth based on the primary ultrasound-imaging.
Measured: 1,5.2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
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 Hip (DDH)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre VikenHF Kongsberg Sykehus
- Sponsor type
- University, hospital or other
- Investigators
- Erlend Skraastad, MD, Study director, Vestre Viken HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053299
- Sponsor's protocol ID
- VestreVikenKS 21517
- Status last verified
- Jan 2010
- First submitted
- 20 Jan 2010
- Last updated
- 28 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Ultrasound-screening for Developmental Dysplasia of the Hip. 5-12 Years Followup of 4 200 Newborns
- ClinicalTrials.gov ID
- NCT01053299
- Acronym / sponsor ID
- VestreVikenKS 21517
- Conditions
- Developmental Dysplasia of the Hip (DDH)
- Keywords
- Developmental dysplasia of the hip (DDH), newborn, universal screening, Universal ultrasound-screening for DDH in newborns, The accuracy of ultrasound-recording of the hip in newborns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,200 participants (estimated)
- Lead sponsor
- Vestre VikenHF Kongsberg SykehusUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 21 Jan 2010 (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.
All newborn from the period 12.1988 to 31.12.2006 During the two last decades, hip ultrasound has gained acceptance as an accurate screening test for developmental dysplasia of the hip (DDH) and for monitoring the development and treatment of the condition. Debate continues over whether DDH that is detected by ultrasonography is necessarily clinically relevant. The diagnostic accuracy of ultrasound imaging for DDH in the screening population has not been investigated adequately. Studies that investigate the natural course of the disorder, the optimal treatment for DDH, and the best strategy for ultrasound screening are needed. Ultrasound screening at birth for DDH in all newborn infants is standard practice in some European countries but not in the United Kingdom, the United States, or Scandinavia. Evidence is insufficient to support or reject general ultrasound screening of newborns for DDH. (N.F.Woolacott etc 2006, systematic review BMJ) At Vestre Viken HF, Kongsberg, Norway, the investigators implemented universal ultrasound screening in 1998. We will present the long term outcome, including radiographs of the hips after 5-12 years.
Detailed description
All the newborn from the period 1.2.1988 to 31.12.2006 will be called for to take an AP X-ray of the pelvis for assessment of their hips. The data compares to the primary ultrasound-recordings taken newborn.
Radiographs of the pelvis: The x-ray examinations will be performed using low-dose technique. Scrotal lead shield will be used in boys, and the girls will be examined during a menstrual period to exclude pregnancy. The examination will include an erect AP view (feet pointing forward, neutral ab-adduction position of the hips) using a film/focus distance of 1.2 m and centred at 2cm proximal to the pubic bone. To standardise the projection, a rotation index between 0.7 and 1.8 (49;50) will be required. Repeat images will be avoided. A tubing containing a contrast medium will be placed in the x-ray field to give the true horizontal level for measurements of leg length discrepancy. The assessment of the images will be done by a specialist in pediatric radiology in another hospital, and blinded for the primary ultrasound-results. In cases of pathology, the patient will be scheduled for an urgent appointment with a paediatric orthopaedic surgeon.
Image analysis: the following measurements will be performed using a validated digitising program (Pedersen et al, J Pediatric Orthopedic 2004):
- Markers for DDH: CE (centre-edge) angle of Wiberg, Refined CE angle (Ogata) Sharp's angle ADR (the acetabular depth ratio, Murray) FHEI (femoral head extrusion index, Heyman and Herndon) The shape of the lateral acetabulum (subjective assessment)
- Markers for previous avascular necrosis (AVN)
AP:
Femoral head shape (classified as spherical, mildly flattened or flattened). Caput - trochanter height Projected CCD angle Length and width of the femoral neck (Shape of the physis) Leg length (Trendelenburg) In addition Body Mass Index (BMI) for itch child will be calculated.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | Active comparator | Other: open, prospective cohort-studyEvery child, without exception, born in the peroid 1.2.1998 - 31.12.2006, still alive, will be called for to take a Xray of their hips aimed at comparing the ultrasound-values taken newborn. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All newborns form the period 1.21998-31.12.2006
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| open, prospective cohort-studySpecific measurements from the X-ray to assess the hip status 5-12 years from the born. | Other | No treatment |
Primary outcome
Specific measurements of the hip out of an AP Xray of pelvis to assess the diagnostic accuracy of ultrasound imaging for DDH in newborns.
Time frame: 1.5 - 2 years
1 secondary outcome
Assess the outcome of those treated for DDH from birth based on the primary ultrasound-imaging.
Time frame: 1,5.2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2010.
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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.
Erlend Skraastad, MD study director
Vestre Viken HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open, prospective cohort-study in people with Developmental Dysplasia of the Hip (DDH), run by Vestre VikenHF Kongsberg Sykehus 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 0 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: status not confirmed, as of the sponsor's last update on 28 Jan 2010. 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?
Results are not available in the source record.
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?
Specific measurements of the hip out of an AP Xray of pelvis to assess the diagnostic accuracy of ultrasound imaging for DDH in newborns. (time frame: 1.5 - 2 years). 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 28 Jan 2010.