Completed

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

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What is being tested

hip ultrasound

+ hip ultrasound

+ hip ultrasound

Procedure
Who is being recruted

Joint Dislocations+3

+ Joint Diseases

+ Musculoskeletal Diseases

Until 20 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Screening Study

Interventional
Study Start: January 1988
See protocol details

Summary

Principal SponsorUniversity of Bergen
Last updated: March 27, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1988

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Bergen
Last updated: March 27, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

11925 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip InjuriesHip Dislocation

Criteria

1 inclusion criteria required to participate
all babies born at our institution during 1/1988-06/1990

1 exclusion criteria prevent from participating
low birthweight < 1500 grams, severe malformations, death within first month

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Active Comparator
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

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Haukeland University Hospital

Bergen, NorwayOpen Haukeland University Hospital in Google Maps
CompletedOne Study Center