Selective Ultrasound Screening for DDH 1991-2006

This study has been completed.
Sponsor:
Collaborator:
Helse Vest
Information provided by (Responsible Party):
Lene Bjerke Laborie, University of Bergen
ClinicalTrials.gov Identifier:
NCT01866527
First received: May 23, 2013
Last updated: May 28, 2013
Last verified: May 2013
  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.

Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • late dislocated or subluxated hips [ Time Frame: first 5 years of life ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    abduction treatment for DDH

  • first surgical treatment [ Time Frame: first five years of life ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Lene Bjerke Laborie, MD, University of Bergen
ClinicalTrials.gov Identifier: NCT01866527     History of Changes
Other Study ID Numbers: 003.07
Study First Received: May 23, 2013
Last Updated: May 28, 2013
Health Authority: Norway: Norwegian Institute of Public Health

Keywords provided by 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

ClinicalTrials.gov processed this record on August 01, 2014