Selective Ultrasound Screening for DDH 1991-2006

Sponsor
University of Bergen (Other)
Overall Status
Completed
CT.gov ID
NCT01866527
Collaborator
Helse Vest (Other)
81,564
1
259
314.9

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    81564 participants
    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.
    Study Start Date :
    Jan 1, 1991
    Actual Primary Completion Date :
    Aug 1, 2012
    Actual Study Completion Date :
    Aug 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    all newborns born 1991-2006

    all newborns born 1991-2006

    Outcome Measures

    Primary Outcome Measures

    1. late dislocated or subluxated hips [first 5 years of life]

      late detected after 1 month of life, requiring treatment

    Secondary Outcome Measures

    1. Number of participants who receive ultrasound follow-up for 6 weeks or more [first months of life]

      Number of participants who receive ultrasound follow-up (i.e sonographic surveillance) for 6 weeks or more

    2. early treatment [first months of life]

      abduction treatment for DDH

    3. first surgical treatment [first five years of life]

      the need for a first surgical treatment the first 5 years of life (closed and open reductions, osteotomies)

    4. avascular necrosis of femoral head [first five years of life]

      avascular necrosis of femoral head as complication to treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lene Bjerke Laborie, MD, University of Bergen
    ClinicalTrials.gov Identifier:
    NCT01866527
    Other Study ID Numbers:
    • 003.07
    First Posted:
    May 31, 2013
    Last Update Posted:
    May 31, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by Lene Bjerke Laborie, MD, University of Bergen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 31, 2013