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Completed

NCT Number: NCT01866527

Selective Ultrasound Screening for DDH 1991-2006

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.

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Key information

Conditions

Developmental Dysplasia of the Hip Bone Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hip Dislocation Joint Diseases Joint Dislocations Musculoskeletal Abnormalities Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Paediatric section, Radiology department, Haukeland University hospital, Bergen, Norway

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • born at Haukeland University hospital January 1991-December 2006

Exclusion criteria

  • Children with DDH due to neuromuscular syndromes were excluded.

Treatment and study plan

Primary outcomes

  1. late dislocated or subluxated hips

    Time frame: first 5 years of life

    late detected after 1 month of life, requiring treatment

Secondary outcomes

  1. 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

  2. early treatment

    Time frame: first months of life

    abduction treatment for DDH

  3. 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)

  4. avascular necrosis of femoral head

    Time frame: first five years of life

    avascular necrosis of femoral head as complication to treatment

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Helse Vest

Registry information

Official study title

Selective Ultrasound Screening for Developmental Hip Dysplasia: Effect on Management and Late Detected Cases. A Prospective Survey During 1991-2006.

Important dates

Study start
1991
Primary completion
2012
Study completion
2012
First posted
May 31, 2013
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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