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Selective Ultrasound Screening for DDH 1991-2006

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01866527
First Posted: May 31, 2013
Last Update Posted: May 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Helse Vest
Information provided by (Responsible Party):
Lene Bjerke Laborie, University of Bergen
  Purpose

Early treatment is considered essential for developmental dysplasia of the hip (DDH), but the choice of screening strategy is debated. The investigators evaluated the effect of a selective ultrasound (US) screening programme.

All infants born in a defined region during 1991-2006 with increased risk of DDH, i.e. clinical hip instability, breech presentation, congenital foot deformities or a family history of DDH, were subjected to US screening at age one to three days. Severe sonographic dysplasia and/or dislocatable/dislocated hips were treated with abduction splints. Mild dysplasia and/or pathological instability, i.e. not dislocatable/dislocated hips were followed clinically and sonographically until spontaneous resolution, or until treatment became necessary. The minimum observation period was 5,5 years.


Condition
Developmental Dysplasia of the Hip

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Selective Ultrasound Screening for Developmental Hip Dysplasia: Effect on Management and Late Detected Cases. A Prospective Survey During 1991-2006.

Resource links provided by NLM:


Further study details as provided by Lene Bjerke Laborie, University of Bergen:

Primary Outcome Measures:
  • late dislocated or subluxated hips [ Time Frame: first 5 years of life ]
    late detected after 1 month of life, requiring treatment


Secondary Outcome Measures:
  • Number of participants who receive ultrasound follow-up for 6 weeks or more [ Time Frame: first months of life ]
    Number of participants who receive ultrasound follow-up (i.e sonographic surveillance) for 6 weeks or more

  • early treatment [ Time Frame: first months of life ]
    abduction treatment for DDH

  • first surgical treatment [ Time Frame: first five years of life ]
    the need for a first surgical treatment the first 5 years of life (closed and open reductions, osteotomies)

  • avascular necrosis of femoral head [ Time Frame: first five years of life ]
    avascular necrosis of femoral head as complication to treatment


Enrollment: 81564
Study Start Date: January 1991
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
all newborns born 1991-2006
all newborns born 1991-2006

Detailed Description:

Of 81564 newborns, 11539 (14,1%) were identified as at risk, of which 11190 (58% girls) were included for further analyses. Of the 81564 infants, 2433 (3•0%) received early treatment; 1882 (2,3%) from birth and 551 (0,7%) after six weeks or more of clinical and sonographic surveillance. Another 2700 (3,3%) normalised spontaneously after watchful waiting from birth. Twenty-six infants (0,32 per 1000, 92% girls, two from the risk group) presented with late subluxated/dislocated hips (after one month of age). Another 126 (1,5 per 1000, 83% girls, one from the risk group) were treated after isolated late residual dysplasia. Thirty-one children (0,38 per 1000) had surgical treatment before age five years. Avascular necrosis was diagnosed in seven of all children treated (0.27%), four after early and three after late treatment.

Interpretation The first 16 years of a standardised selective US screening programme for DDH resulted in acceptable rates of early treatment and US follow-ups, and low rates of late subluxated/dislocated hips compared to similar studies.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

All infants born at the maternity unit at Haukeland University Hospital from January 1991 through December 2006 were included. The hospital provides the only delivery unit for the city and suburbs of Bergen and a large rural area within the Hordaland County. It serves a population of approximately 400 000 inhabitants, predominantly ethnic Norwegians. The annual birth rates varied from 4723 to 6010.

Minimum observation time was 5,5 years.

Criteria

Inclusion Criteria:

  • born at Haukeland University hospital January 1991-December 2006

Exclusion Criteria:

  • Children with DDH due to neuromuscular syndromes were excluded.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866527


Locations
Norway
Paediatric section, Radiology department, Haukeland University hospital, Bergen, Norway
Bergen, Norway, 5021
Sponsors and Collaborators
University of Bergen
Helse Vest
Investigators
Study Director: Karen Rosendahl, PhD Paediatric Section, Department of Radiology, Haukeland University hospital, Bergen
  More Information

Responsible Party: Lene Bjerke Laborie, MD, University of Bergen
ClinicalTrials.gov Identifier: NCT01866527     History of Changes
Other Study ID Numbers: 003.07
First Submitted: May 23, 2013
First Posted: May 31, 2013
Last Update Posted: May 31, 2013
Last Verified: May 2013

Keywords provided by Lene Bjerke Laborie, University of Bergen:
Developmental dysplasia of the hip,
DDH,
avascular necrosis,
late detected cases

Additional relevant MeSH terms:
Hip Dislocation, Congenital
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities