Ultrasound Screening for Developmental Dysplasia of the Hip in the Neonate: The Effect on Treatment Rate and Prevalence of Late Cases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Bergen
- Enrollment
- 11,925
- Locations
- 1
- Primary Endpoint
- prevalence of DDH detected after newborn period
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- — to 20 Years (Child, Adult)
- Sex
- 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
Arms & Interventions
expert clinical exam only
all babies assigned to this group had expert clinical examination only, no hip ultrasound
Intervention: hip ultrasound (Procedure)
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
Intervention: hip ultrasound (Procedure)
universal hip ultrasound screening
All newborns assigned to this arm received hip ultrasound at birth in addition to expert clinical examination
Intervention: hip ultrasound (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- treatment rate(20 years)
Investigators
Lene Bjerke Laborie
MD, Phd
University of Bergen