COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Universal Ultrasound-screening for Developmental Dysplasia of the Hip in Newborn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Vestre VikenHF Kongsberg Sykehus

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Developmental Dysplasia of the Hip (DDH) Other: open, prospective cohort-study Not Applicable

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):

  1. 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)

  2. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4200 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound X-Rays

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Assess the outcome of those treated for DDH from birth based on the primary ultrasound-imaging. [ Time Frame: 1,5.2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All newborns form the period 1.21998-31.12.2006

Information from the National Library of Medicine

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 identifier (NCT number): NCT01053299

Layout table for location information
VestreViken HF Kongsberg
Kongsberg, Buskerud, Norway, 3600
Sponsors and Collaborators
Vestre VikenHF Kongsberg Sykehus
Layout table for investigator information
Study Director: Erlend Skraastad, MD Vestre Viken HF
Layout table for additonal information
Responsible Party: Hans Christian Blom and Guro Elbert (researchcooridinator), VestreVikenHF Kongsberg hospital Identifier: NCT01053299    
Other Study ID Numbers: VestreVikenKS 21517
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2010
Keywords provided by Vestre VikenHF Kongsberg Sykehus:
Developmental dysplasia of the hip (DDH)
universal screening
Universal ultrasound-screening for DDH in newborns
The accuracy of ultrasound-recording of the hip in newborns
Additional relevant MeSH terms:
Layout table for MeSH terms
Hip Dislocation, Congenital
Pathologic Processes
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities