Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Automatic Characterization of the Neonatal Hip Using Ultrasound Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02796768
Recruitment Status : Unknown
Verified June 2016 by Kishore Mulpuri, British Columbia Children's Hospital.
Recruitment status was:  Recruiting
First Posted : June 13, 2016
Last Update Posted : June 13, 2016
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Kishore Mulpuri, British Columbia Children's Hospital

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.

Condition or disease Intervention/treatment
Developmental Dysplasia of the Hip Other: 3D US Scanning Other: 2D US Scanning

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Automatic Characterization of the Neonatal Hip Using Ultrasound Imaging
Study Start Date : December 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
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.

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

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




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

Secondary Outcome Measures :
  1. Beta angles automatically extracted from 3D US images as a measure of dysplasia of the infant hip [ Time Frame: Baseline ]
  2. Beta angles automatically extracted/measured from 2D US images as a measure of dysplasia of the infant hip [ Time Frame: Baseline ]
  3. Femoral head coverage automatically extracted from 3D US images as a measure of dysplasia of the infant hip [ Time Frame: Baseline ]
  4. Femoral head coverage automatically extracted/measured from 2D US images as a measure of dysplasia of the infant hip [ Time Frame: Baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants that have been referred to the Orthopaedic Clinic at our institution for suspected or diagnosed Developmental Dysplasia of the Hip (DDH).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796768


Contacts
Layout table for location contacts
Contact: Kishore Mulpuri, MBBS, MS(Ortho), MHSc 6048752054 kmulpuri@cw.bc.ca
Contact: Emily Schaeffer, PhD 6048752359 emily.schaeffer@cw.bc.ca

Locations
Layout table for location information
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Kishore Mulpuri, MBBS, MS(Ortho), MHSc    6048752054    kmulpuri@cw.bc.ca   
Sponsors and Collaborators
British Columbia Children's Hospital
University of British Columbia
Investigators
Layout table for investigator information
Principal Investigator: Kishore Mulpuri, MBBS, MS(Ortho), MHSc Provincial Health Services Authority
Principal Investigator: Antony Hodgson, BASc, MASc, PhD University of British Columbia
Principal Investigator: Anthony Cooper, BSc, MBChB, FRCS Provincial Health Services Authority
Principal Investigator: Rafeef Abugharbieh, BSc, MSc, PhD University of British Columbia

Layout table for additonal information
Responsible Party: Kishore Mulpuri, Pediatric Orthopaedic Surgeon, British Columbia Children's Hospital
ClinicalTrials.gov Identifier: NCT02796768     History of Changes
Other Study ID Numbers: H14-01448
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Hip Dislocation, Congenital
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities