Selective Ultrasound Screening for DDH 1991-2006

NCT01866527 | Completed DMC

• 1 other identifier: 003.07
• Study Type: observational
• Target: 81,564
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Dysplasia of the Hip

Keywords

Developmental dysplasia of the hip,; DDH,; avascular necrosis,; late detected cases

Outcome Measures

Primary Outcomes (1)

• late dislocated or subluxated hips

  late detected after 1 month of life, requiring treatment

  first 5 years of life

Secondary Outcomes (4)

• Number of participants who receive ultrasound follow-up for 6 weeks or more

  first months of life

• early treatment

  first months of life

• first surgical treatment

  first five years of life

• avascular necrosis of femoral head

  first five years of life

Study Arms (1)

all newborns born 1991-2006

all newborns born 1991-2006

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• born at Haukeland University hospital January 1991-December 2006

You may not qualify if:

• Children with DDH due to neuromuscular syndromes were excluded.

Sponsors & Collaborators

• University of Bergen: lead
• Helse Vest: collaborator

Study Sites (1)

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

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Developmental Dysplasia of the Hip; Osteonecrosis

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Rosendahl, PhD

  Paediatric Section, Department of Radiology, Haukeland University hospital, Bergen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 31, 2013
• Study Start: January 1, 1991
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 31, 2013

Record last verified: 2013-05

Locations

NO (1)