Selective Ultrasound Screening for DDH 1991-2006

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81564 participants

Study Classification

OBSERVATIONAL

Study Start Date

1991-01-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Developmental Dysplasia of the Hip

Keywords

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Developmental dysplasia of the hip, DDH, avascular necrosis, late detected cases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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all newborns born 1991-2006

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* born at Haukeland University hospital January 1991-December 2006

Exclusion Criteria

* Children with DDH due to neuromuscular syndromes were excluded.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Lene Bjerke Laborie

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Rosendahl, PhD

Role: STUDY_DIRECTOR

Paediatric Section, Department of Radiology, Haukeland University hospital, Bergen

Locations

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

Bergen, , Norway

Site Status

Countries

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Norway

Other Identifiers

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003.07

Identifier Type: -

Identifier Source: org_study_id