Universal Ultrasound-screening for Developmental Dysplasia of the Hip in Newborn
Primary Purpose
Developmental Dysplasia of the Hip (DDH)
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
open, prospective cohort-study
Sponsored by
About this trial
This is an interventional basic science trial for Developmental Dysplasia of the Hip (DDH) focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- All newborns form the period 1.21998-31.12.2006
Sites / Locations
- VestreViken HF Kongsberg
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
No treatment
Arm Description
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.
Outcomes
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.
Secondary Outcome Measures
Assess the outcome of those treated for DDH from birth based on the primary ultrasound-imaging.
Full Information
NCT ID
NCT01053299
First Posted
January 20, 2010
Last Updated
January 27, 2010
Sponsor
Vestre VikenHF Kongsberg Sykehus
1. Study Identification
Unique Protocol Identification Number
NCT01053299
Brief Title
Universal Ultrasound-screening for Developmental Dysplasia of the Hip in Newborn
Official Title
Universal Ultrasound-screening for Developmental Dysplasia of the Hip. 5-12 Years Followup of 4 200 Newborns
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Vestre VikenHF Kongsberg Sykehus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
4200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
open, prospective cohort-study
Intervention Description
Specific measurements from the X-ray to assess the hip status 5-12 years from the born.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Assess the outcome of those treated for DDH from birth based on the primary ultrasound-imaging.
Time Frame
1,5.2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All newborns form the period 1.21998-31.12.2006
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erlend Skraastad, MD
Organizational Affiliation
Vestre Viken HF
Official's Role
Study Director
Facility Information:
Facility Name
VestreViken HF Kongsberg
City
Kongsberg
State/Province
Buskerud
ZIP/Postal Code
3600
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Universal Ultrasound-screening for Developmental Dysplasia of the Hip in Newborn
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