Selective Ultrasound Screening for DDH 1991-2006

Completed

• Conditions: Developmental Dysplasia of the Hip

• Registration Number: NCT01866527
• Lead Sponsor: University of Bergen

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.

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 Timeline

• Study Start: 1991-01
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-05
• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2013-05-28
• Last Update Submitted: 2013-05-28
• Study First Posted: 2013-05-31
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81564

Inclusion Criteria

• born at Haukeland University hospital January 1991-December 2006

Exclusion Criteria

• Children with DDH due to neuromuscular syndromes were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
late dislocated or subluxated hips	first 5 years of life	late detected after 1 month of life, requiring treatment

Secondary Outcome Measures

Name	Time	Method
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
early treatment	first months of life	abduction treatment for DDH
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)
avascular necrosis of femoral head	first five years of life	avascular necrosis of femoral head as complication to treatment

Trial Locations

Locations (1)

Paediatric section, Radiology department, Haukeland University hospital, Bergen, Norway; 🇳🇴 Bergen, Norway