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.

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.

Study Overview

• Status: Completed
• Conditions: Developmental Dysplasia of the Hip

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 Type: Observational
• Enrollment (Actual): 81564

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Paediatric section, Radiology department, Haukeland University hospital, Bergen, Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All infants born at the maternity unit at Haukeland University Hospital from January 1991 through December 2006 were included. The hospital provides the only delivery unit for the city and suburbs of Bergen and a large rural area within the Hordaland County. It serves a population of approximately 400 000 inhabitants, predominantly ethnic Norwegians. The annual birth rates varied from 4723 to 6010.

Minimum observation time was 5,5 years.

Description

Inclusion Criteria:

• born at Haukeland University hospital January 1991-December 2006

Exclusion Criteria:

• Children with DDH due to neuromuscular syndromes were excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
all newborns born 1991-2006

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late dislocated or subluxated hips	late detected after 1 month of life, requiring treatment	first 5 years of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
early treatment	abduction treatment for DDH	first months of life
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
avascular necrosis of femoral head	avascular necrosis of femoral head as complication to treatment	first five years of life

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: Helse Vest
• Investigators: Study Director: Karen Rosendahl, PhD, Paediatric Section, Department of Radiology, Haukeland University hospital, Bergen

Study record dates

Study Major Dates

• Study Start: January 1, 1991
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: May 23, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Estimate): May 31, 2013
• Last Update Submitted That Met QC Criteria: May 28, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Developmental dysplasia of the hip,; DDH,; avascular necrosis,; late detected cases
• Additional Relevant MeSH Terms: Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Joint Dislocations; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: 003.07