Recruiting

Observational Study

Sponsor:

British Columbia Children's Hospital

Code:

NCT02796768

Conditions

Developmental Dysplasia of the Hip

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

3D US Scanning

2D US Scanning

Study Details

Brief summary:

Ultrasound imaging (US), a radiation-free imaging modality, is currently used in diagnosis of developmental dysplasia of the hip (DDH) in infants. The current protocol involves manually identifying specific measures that are prone to error, and may give rise to false positives. We aim to use 2-dimensional (2D) and 3-dimensional (3D) ultrasound imaging to create an automatic measurement procedure that we hope will reduce the errors in measurement and increase reliability.

Conditions

Developmental Dysplasia of the Hip

Study ID

NCT02796768

Start date

Dec, 2014

Status verified date

Jun, 2016

Completion date

Jun, 2017

Anticipated

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children with suspected DDH at our institution
  • Ages 0 to 4 months of age

Exclusion Criteria:

  • US not performed at our institution
  • No diagnosis of DDH or not suspected of having DDH
  • Other congenital hip abnormalities or genetic syndromes
  • Patient/family does not live in the Lower Mainland

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants

Study participants will be 0 to 4 months of age and undergoing DDH screening. They will have the following scans:

BASELINE - 1 3D US scanning session of right and left hip by Specialist 1, 1 3D US scanning session of right and left hip by Specialist 2, 1 2D US scanning session of right and left hip by Specialist 1, 1 2D US scanning session of right and left hip by Specialist 2.

FOLLOW-UP (OPTIONAL) - 1 3D US scanning session of right and left hip by Specialist 1, 1 3D US scanning session of right and left hip by Specialist 2,

1 2D US scanning session of right and left hip by Specialist 1,

1 2D US scanning session of right and left hip by Specialist 2.

Interventions

3D US Scanning

3D ultrasound will be used by both clinicians to scan both the right and left hips of the infant.

2D US Scanning

2D ultrasound will be used by both clinicians to scan both the right and left hips of the infant.

Primary outcome measure

  • Alpha angles automatically extracted from 3D US images as a measure of dysplasia of the infant hip [ Time Frame: Baseline ]
  • Alpha angles automatically extracted/measured from 2D US images as a measure of dysplasia of the infant hip [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Kishore Mulpuri, MBBS, MS(Ortho), MHSc

6048752054kmulpuri@cw.bc.ca

Emily Schaeffer, PhD

6048752359emily.schaeffer@cw.bc.ca

Locations

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Contacts

Kishore Mulpuri, MBBS, MS(Ortho), MHSc

6048752054kmulpuri@cw.bc.ca

More Information

Sponsor

British Columbia Children's Hospital

Last update posted

Jun 13, 2016

Last verified

Jun, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Children's Hospital on 2016-06-13.