Universal Ultrasound-screening for Developmental Dysplasia of the Hip in Newborn

NCT01053299 | Unknown DMC

• 1 other identifier: VestreVikenKS 21517
• Study Type: interventional
• Target: 4,200
• Locations: 1 country
• Sites: 1

Brief Summary

All newborn from the period 12.1988 to 31.12.2006 During the two last decades, hip ultrasound has gained acceptance as an accurate screening test for developmental dysplasia of the hip (DDH) and for monitoring the development and treatment of the condition. Debate continues over whether DDH that is detected by ultrasonography is necessarily clinically relevant. The diagnostic accuracy of ultrasound imaging for DDH in the screening population has not been investigated adequately. Studies that investigate the natural course of the disorder, the optimal treatment for DDH, and the best strategy for ultrasound screening are needed. Ultrasound screening at birth for DDH in all newborn infants is standard practice in some European countries but not in the United Kingdom, the United States, or Scandinavia. Evidence is insufficient to support or reject general ultrasound screening of newborns for DDH. (N.F.Woolacott etc 2006, systematic review BMJ) At Vestre Viken HF, Kongsberg, Norway, the investigators implemented universal ultrasound screening in 1998. We will present the long term outcome, including radiographs of the hips after 5-12 years.

Conditions

Developmental Dysplasia of the Hip (DDH)

Keywords

Developmental dysplasia of the hip (DDH); newborn; universal screening; Universal ultrasound-screening for DDH in newborns; The accuracy of ultrasound-recording of the hip in newborns

Outcome Measures

Primary Outcomes (1)

• Specific measurements of the hip out of an AP Xray of pelvis to assess the diagnostic accuracy of ultrasound imaging for DDH in newborns.

  1.5 - 2 years

Secondary Outcomes (1)

• Assess the outcome of those treated for DDH from birth based on the primary ultrasound-imaging.

  1,5.2 years

Study Arms (1)

No treatment

ACTIVE COMPARATOR

Every child, without exception, born in the peroid 1.2.1998 - 31.12.2006, still alive, will be called for to take a Xray of their hips aimed at comparing the ultrasound-values taken newborn.

Other: open, prospective cohort-study

Interventions

open, prospective cohort-study OTHER

Specific measurements from the X-ray to assess the hip status 5-12 years from the born.

No treatment

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All newborns form the period 1.21998-31.12.2006

Sponsors & Collaborators

• Vestre VikenHF Kongsberg Sykehus: lead

Study Sites (1)

VestreViken HF Kongsberg

Kongsberg, Buskerud, 3600, Norway

Location

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Interventions

Prospective Studies

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Erlend Skraastad, MD

  Vestre Viken HF

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 21, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 28, 2010

Record last verified: 2010-01

Locations

NO (1)