Clinical trial NCT01818934: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hip Dysplasia
Keywords: hip dysplasia
screening
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Institute of Child Health
First posted: 2013-03-27
Enrollment: 11925
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: prevalence of DDH detected after newborn period
timeFrame: 20 years
Secondary outcomes:
measure: treatment rate
timeFrame: 20 years
Other outcomes:
measure: avascular necrosis of femoral head (AVN)
timeFrame: 20 years
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Pediatric section, Department of Radiology, Haukeland University hospital, University of Bergen
name: Karen Rosendahl, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.