Universal Ultrasound-screening for Developmental Dysplasia of the Hip in Newborn
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|ClinicalTrials.gov Identifier: NCT01053299|
Recruitment Status : Unknown
Verified January 2010 by Vestre VikenHF Kongsberg Sykehus.
Recruitment status was: Enrolling by invitation
First Posted : January 21, 2010
Last Update Posted : January 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Developmental Dysplasia of the Hip (DDH)||Other: open, prospective cohort-study||Not Applicable|
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)
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Universal Ultrasound-screening for Developmental Dysplasia of the Hip. 5-12 Years Followup of 4 200 Newborns|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
Active Comparator: No treatment
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.
Other: open, prospective cohort-study
Specific measurements from the X-ray to assess the hip status 5-12 years from the born.
- 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 ]
- Assess the outcome of those treated for DDH from birth based on the primary ultrasound-imaging. [ Time Frame: 1,5.2 years ]
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): NCT01053299
|VestreViken HF Kongsberg|
|Kongsberg, Buskerud, Norway, 3600|
|Study Director:||Erlend Skraastad, MD||Vestre Viken HF|