Ultrasound Screening for Developmental Dysplasia of the Hip in Newborns
Primary Purpose
Hip Dysplasia
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
hip ultrasound
Sponsored by
About this trial
This is an interventional screening trial for Hip Dysplasia focused on measuring hip dysplasia, screening
Eligibility Criteria
Inclusion Criteria:
- all babies born at our institution during 1/1988-06/1990
Exclusion Criteria:
- low birthweight <1500 grams, severe malformations, death within first month
Sites / Locations
- Haukeland University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
expert clinical exam only
selective hip ultrasound screening
universal hip ultrasound screening
Arm Description
all babies assigned to this group had expert clinical examination only, no hip ultrasound
all children classified at increased risk, based on clinical findings and/or risk factors (breech presentation, family history, foot deformity)received a hip ultrasound at birth, in addition to expert clinical screening
All newborns assigned to this arm received hip ultrasound at birth in addition to expert clinical examination
Outcomes
Primary Outcome Measures
prevalence of DDH detected after newborn period
prevalence of late cases of DDH, detected after newborn period (after first month of age, including in childhood as assessed in original RCT during 1988-90, with a minimum follow-up time of 27 months, and also at skeletal maturity, as assessed in follow-up study during 2007-09.
Secondary Outcome Measures
treatment rate
abduction treatment and/or surgery during infancy, later childhood and skeletal maturity
Full Information
NCT ID
NCT01818934
First Posted
March 21, 2013
Last Updated
March 21, 2013
Sponsor
University of Bergen
Collaborators
Institute of Child Health
1. Study Identification
Unique Protocol Identification Number
NCT01818934
Brief Title
Ultrasound Screening for Developmental Dysplasia of the Hip in Newborns
Official Title
Ultrasound Screening for Developmental Dysplasia of the Hip in the Neonate: The Effect on Treatment Rate and Prevalence of Late Cases
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 1988 (undefined)
Primary Completion Date
June 1990 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
Institute of Child Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the randomized controlled trial was to determine whether the addition of a general or of a selective ultrasound screening program resulted in more appropriate criteria for treatment and a reduced prevalence of late DDH compared with clinical examination alone.
Detailed Description
This is a retrospective registration of a RCT carried out in 1988-90, with a IRB approved follow-up at skeletal maturity carried out in 2007-09. Both the RCT and the follow-up study were carried out in the same institution, by the same PI (Prof. Karen Rosendahl) and her co-workers.
Detailed information is published in the following paper:
Rosendahl K, Markestad T, Lie RT. Ultrasound screening for developmental dysplasia of the hip in the neonate: the effect on treatment rate and prevalence of late cases. Pediatrics 1994;94:47-52.
A sample of the initial RCT was invited for a maturity review/follow-up at skeletal maturity.
The follow-up at skeletal maturity is called:
Radiological indices of hip dysplasia and osteoarthritis at skeletal maturity in the Bergen Birth Cohort. Associations with neonatal hip dysplasia, childhood growth and genetic predisposition
and is included in the approval by the Regional Ethical Committee for Medical and Health Research (No 3.2006.144). All participants of the follow-up study gave written informed consent according to the 1964 Declaration of Helsinki.
The follow-up had the following main aims:
1) estimate the prevalence of radiologically defined hip dysplasia, femoroacetabular impingement and osteoarthritis assessed at skeletal maturity 2)report the frequency of 4 longitudinal dysplasia phenotypes based on sonographic assessments in the newborn and radiological assessments at skeletal maturity 3)investigate associations of dysplasia as defined in 1 and 2 above in univariate and multivariate models with clinically assessed hip joint mobility/joint hypermobility, weight, height and body mass index (BMI) at age 18/19 years, prepubertal weight, height and BMI trajectories using data from child health records, first degree family history of hip dysplasia with or without hip arthroplasty, perinatal factors, measures of OA including minimum joint space, acetabular depth ratio and reported hip pain 5) establish a genetic resource by obtaining and archiving salivary DNA samples.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Dysplasia
Keywords
hip dysplasia, screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11925 (Actual)
8. Arms, Groups, and Interventions
Arm Title
expert clinical exam only
Arm Type
Active Comparator
Arm Description
all babies assigned to this group had expert clinical examination only, no hip ultrasound
Arm Title
selective hip ultrasound screening
Arm Type
Active Comparator
Arm Description
all children classified at increased risk, based on clinical findings and/or risk factors (breech presentation, family history, foot deformity)received a hip ultrasound at birth, in addition to expert clinical screening
Arm Title
universal hip ultrasound screening
Arm Type
Active Comparator
Arm Description
All newborns assigned to this arm received hip ultrasound at birth in addition to expert clinical examination
Intervention Type
Procedure
Intervention Name(s)
hip ultrasound
Intervention Description
Standardized single-examiner Hip ultrasound was offered to all babies in the universal group, babies at increased risk in the selective group, and to no babies in the clinical exam only group
Primary Outcome Measure Information:
Title
prevalence of DDH detected after newborn period
Description
prevalence of late cases of DDH, detected after newborn period (after first month of age, including in childhood as assessed in original RCT during 1988-90, with a minimum follow-up time of 27 months, and also at skeletal maturity, as assessed in follow-up study during 2007-09.
Time Frame
20 years
Secondary Outcome Measure Information:
Title
treatment rate
Description
abduction treatment and/or surgery during infancy, later childhood and skeletal maturity
Time Frame
20 years
Other Pre-specified Outcome Measures:
Title
avascular necrosis of femoral head (AVN)
Description
avascular necrosis of femoral head (AVN) as a complication to treatment
Time Frame
20 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all babies born at our institution during 1/1988-06/1990
Exclusion Criteria:
low birthweight <1500 grams, severe malformations, death within first month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Rosendahl, Prof
Organizational Affiliation
Pediatric section, Department of Radiology, Haukeland University hospital, University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
8008537
Citation
Rosendahl K, Markestad T, Lie RT. Ultrasound screening for developmental dysplasia of the hip in the neonate: the effect on treatment rate and prevalence of late cases. Pediatrics. 1994 Jul;94(1):47-52.
Results Reference
result
PubMed Identifier
23354528
Citation
Laborie LB, Engesaeter IO, Lehmann TG, Sera F, Dezateux C, Engesaeter LB, Rosendahl K. Radiographic measurements of hip dysplasia at skeletal maturity--new reference intervals based on 2,038 19-year-old Norwegians. Skeletal Radiol. 2013 Jul;42(7):925-35. doi: 10.1007/s00256-013-1574-y. Epub 2013 Jan 27.
Results Reference
result
PubMed Identifier
21613440
Citation
Laborie LB, Lehmann TG, Engesaeter IO, Eastwood DM, Engesaeter LB, Rosendahl K. Prevalence of radiographic findings thought to be associated with femoroacetabular impingement in a population-based cohort of 2081 healthy young adults. Radiology. 2011 Aug;260(2):494-502. doi: 10.1148/radiol.11102354. Epub 2011 May 25.
Results Reference
result
PubMed Identifier
23412733
Citation
Laborie LB, Lehmann TG, Engesaeter IO, Engesaeter LB, Rosendahl K. Is a positive femoroacetabular impingement test a common finding in healthy young adults? Clin Orthop Relat Res. 2013 Jul;471(7):2267-77. doi: 10.1007/s11999-013-2850-9. Epub 2013 Feb 15.
Results Reference
result
PubMed Identifier
21946945
Citation
Engesaeter IO, Laborie LB, Lehmann TG, Sera F, Fevang J, Pedersen D, Morcuende J, Lie SA, Engesaeter LB, Rosendahl K. Radiological findings for hip dysplasia at skeletal maturity. Validation of digital and manual measurement techniques. Skeletal Radiol. 2012 Jul;41(7):775-85. doi: 10.1007/s00256-011-1283-3. Epub 2011 Sep 25.
Results Reference
result
PubMed Identifier
23365042
Citation
Engesaeter IO, Laborie LB, Lehmann TG, Fevang JM, Lie SA, Engesaeter LB, Rosendahl K. Prevalence of radiographic findings associated with hip dysplasia in a population-based cohort of 2081 19-year-old Norwegians. Bone Joint J. 2013 Feb;95-B(2):279-85. doi: 10.1302/0301-620X.95B2.30744.
Results Reference
result
PubMed Identifier
23958776
Citation
Laborie LB, Engesaeter IO, Lehmann TG, Eastwood DM, Engesaeter LB, Rosendahl K. Screening strategies for hip dysplasia: long-term outcome of a randomized controlled trial. Pediatrics. 2013 Sep;132(3):492-501. doi: 10.1542/peds.2013-0911. Epub 2013 Aug 19.
Results Reference
derived
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Ultrasound Screening for Developmental Dysplasia of the Hip in Newborns
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