Trials / Completed
CompletedNCT01866527
Selective Ultrasound Screening for DDH 1991-2006
Selective Ultrasound Screening for Developmental Hip Dysplasia: Effect on Management and Late Detected Cases. A Prospective Survey During 1991-2006.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 81,564 (actual)
- Sponsor
- University of Bergen · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
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.
Conditions
Timeline
- Start date
- 1991-01-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
- First posted
- 2013-05-31
- Last updated
- 2013-05-31
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT01866527. Inclusion in this directory is not an endorsement.