Ultrasound Screening for Developmental Dysplasia of the Hip in Newborns

Sponsor

University of Bergen (Other)

Overall Status

Completed

CT.gov ID

NCT01818934

Collaborator

Institute of Child Health (Other)

11,925

Enrollment

Location

Arms

254

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Dysplasia	Procedure: hip ultrasound	N/A

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:

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

11925 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Ultrasound Screening for Developmental Dysplasia of the Hip in the Neonate: The Effect on Treatment Rate and Prevalence of Late Cases

Study Start Date :

Jan 1, 1988

Actual Primary Completion Date :

Jun 1, 1990

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: expert clinical exam only all babies assigned to this group had expert clinical examination only, no hip ultrasound	Procedure: hip ultrasound 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
Active Comparator: selective hip ultrasound screening 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	Procedure: hip ultrasound 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
Active Comparator: universal hip ultrasound screening All newborns assigned to this arm received hip ultrasound at birth in addition to expert clinical examination	Procedure: hip ultrasound 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

Arm

Intervention/Treatment

Active Comparator: expert clinical exam only

all babies assigned to this group had expert clinical examination only, no hip ultrasound

Procedure: hip ultrasound

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

Active Comparator: selective hip ultrasound screening

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

Procedure: hip ultrasound

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

Active Comparator: universal hip ultrasound screening

All newborns assigned to this arm received hip ultrasound at birth in addition to expert clinical examination

Procedure: hip ultrasound

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

Outcome Measures

Primary Outcome Measures

prevalence of DDH detected after newborn period [20 years]
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 [20 years]
abduction treatment and/or surgery during infancy, later childhood and skeletal maturity

Other Outcome Measures

avascular necrosis of femoral head (AVN) [20 years]
avascular necrosis of femoral head (AVN) as a complication to treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haukeland University Hospital	Bergen		Norway	5021

Sponsors and Collaborators

University of Bergen
Institute of Child Health

Investigators

Principal Investigator: Karen Rosendahl, Prof, Pediatric section, Department of Radiology, Haukeland University hospital, University of Bergen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lene Bjerke Laborie, MD, Phd, University of Bergen

ClinicalTrials.gov Identifier:

NCT01818934

Other Study ID Numbers:

3.2006.144

First Posted:

Mar 27, 2013

Last Update Posted:

Mar 27, 2013

Last Verified:

Mar 1, 2013

Keywords provided by Lene Bjerke Laborie, MD, Phd, University of Bergen

hip dysplasia

screening

Additional relevant MeSH terms:

Hip Dislocation

Developmental Dysplasia of the Hip

Hip Dislocation, Congenital

Hyperplasia

Study Results

No Results Posted as of Mar 27, 2013