Ultrasound Screening for Developmental Dysplasia of the Hip in Newborns

March 21, 2013 updated by: Lene Bjerke Laborie, University of Bergen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11925

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of DDH detected after newborn period
Time Frame: 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.
20 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment rate
Time Frame: 20 years
abduction treatment and/or surgery during infancy, later childhood and skeletal maturity
20 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
avascular necrosis of femoral head (AVN)
Time Frame: 20 years
avascular necrosis of femoral head (AVN) as a complication to treatment
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Institute of Child Health

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1988

Primary Completion (ACTUAL)

June 1, 1990

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (ESTIMATE)

March 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 27, 2013

Last Update Submitted That Met QC Criteria

March 21, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3.2006.144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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