Selective Ultrasound Screening for DDH 1991-2006
|ClinicalTrials.gov Identifier: NCT01866527|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : May 31, 2013
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|
|Developmental Dysplasia of the Hip|
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 Type :||Observational|
|Actual Enrollment :||81564 participants|
|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 :||January 1991|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
all newborns born 1991-2006
all newborns born 1991-2006
- late dislocated or subluxated hips [ Time Frame: first 5 years of life ]late detected after 1 month of life, requiring treatment
- 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
- early treatment [ Time Frame: first months of life ]abduction treatment for DDH
- 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)
- avascular necrosis of femoral head [ Time Frame: first five years of life ]avascular necrosis of femoral head as complication to treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866527
|Paediatric section, Radiology department, Haukeland University hospital, Bergen, Norway|
|Bergen, Norway, 5021|
|Study Director:||Karen Rosendahl, PhD||Paediatric Section, Department of Radiology, Haukeland University hospital, Bergen|