Trial record 1 of 38 for:    "Developmental dysplasia of hip"
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Universal Ultrasound-screening for Developmental Dysplasia of the Hip in Newborn

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Vestre VikenHF Kongsberg Sykehus
ClinicalTrials.gov Identifier:
NCT01053299
First received: January 20, 2010
Last updated: January 27, 2010
Last verified: January 2010
  Purpose

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 Intervention
Developmental Dysplasia of the Hip (DDH)
Other: open, prospective cohort-study

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Vestre VikenHF Kongsberg Sykehus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the outcome of those treated for DDH from birth based on the primary ultrasound-imaging. [ Time Frame: 1,5.2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 4200
Study Start Date: March 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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)

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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All newborns form the period 1.21998-31.12.2006
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053299

Locations
Norway
VestreViken HF Kongsberg
Kongsberg, Buskerud, Norway, 3600
Sponsors and Collaborators
Vestre VikenHF Kongsberg Sykehus
Investigators
Study Director: Erlend Skraastad, MD Vestre Viken HF
  More Information

No publications provided

Responsible Party: Hans Christian Blom and Guro Elbert (researchcooridinator), VestreVikenHF Kongsberg hospital
ClinicalTrials.gov Identifier: NCT01053299     History of Changes
Other Study ID Numbers: VestreVikenKS 21517
Study First Received: January 20, 2010
Last Updated: January 27, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Vestre VikenHF Kongsberg Sykehus:
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

Additional relevant MeSH terms:
Hip Dislocation, Congenital
Joint Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 28, 2014