Ultrasound Screening for Developmental Dysplasia of the Hip in Newborns

University of Bergen

Status: Completed

Conditions: Hip Dysplasia

Treatments: Procedure: hip ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT01818934

3.2006.144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11,925 patients

Sex: All

Ages: Under 20 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11,925 participants in 3 patient groups

expert clinical exam only

Active Comparator group

Description:

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

Treatment:

Procedure: hip ultrasound

selective hip ultrasound screening

Active Comparator group

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

Treatment:

Procedure: hip ultrasound

universal hip ultrasound screening

Active Comparator group

Description:

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

Treatment:

Procedure: hip ultrasound