Selective Ultrasound Screening for DDH 1991-2006

Developmental Dysplasia of the Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866527
• Other study ID #: 003.07
• Status: Completed
• Phase: N/A
• First received: May 23, 2013
• Last updated: May 28, 2013
• Start date: January 1991
• Est. completion date: August 2012

Study information

• Verified date: May 2013
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Institute of Public Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81564
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• born at Haukeland University hospital January 1991-December 2006

Exclusion Criteria:

• Children with DDH due to neuromuscular syndromes were excluded.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Dislocation, Congenital

Locations

Country	Name	City	State
Norway	Paediatric section, Radiology department, Haukeland University hospital, Bergen, Norway	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Helse Vest

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late dislocated or subluxated hips	late detected after 1 month of life, requiring treatment	first 5 years of life	No
Secondary	Number of participants who receive ultrasound follow-up for 6 weeks or more	Number of participants who receive ultrasound follow-up (i.e sonographic surveillance) for 6 weeks or more	first months of life	No
Secondary	early treatment	abduction treatment for DDH	first months of life	No
Secondary	first surgical treatment	the need for a first surgical treatment the first 5 years of life (closed and open reductions, osteotomies)	first five years of life	No
Secondary	avascular necrosis of femoral head	avascular necrosis of femoral head as complication to treatment	first five years of life	No