Clinical Trial: Automatic Characterization of the Neonatal Hip Using Ultrasound Imaging

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Automatic Characterization of the Neonatal Hip Using Ultrasound Imaging

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.

Detailed Summary:

STUDY OBJECTIVES To investigate the use of a novel approach for accurate and automatic extraction of bone, cartilage and muscle surfaces from 3D US images, and to automatically characterize the infant DDH hip. To evaluate the performance of the 3D US-based approach, we will be comparing the results with regular 2D US images of the same patients from the radiology archives at our institution.

HYPOTHESIS We hypothesize that automatically extracted bone/cartilage boundaries can provide useful information about DDH, enable more reliable and reproducible diagnoses, and reduce false diagnostic positives and negatives of DDH. Using 3D US may reveal clinically significant disease or dysplasia metrics that have the potential to change diagnostic procedures.

AIMS:

  1. To determine if automatically extracted 3D bone/cartilage surfaces provide useful information (i.e., disease or dysplasia metrics) during the assessment of DDH and provide better visualization of the infant hip anatomy in comparison to regular 2D US-based DDH assessment.
  2. To determine if diagnosing DDH using the 3D US images reduces the operator dependent false positive and false negative rates.
  3. To determine if 3D US-based dysplasia metrics are as valuable in tracking disease progression as 2D US-based dysplasia metrics.

RESEARCH METHOD Parents and their infants that have been referred to the Orthopaedic Clinic at our institution for suspected or diagnosed DDH will be approached by the Orthopaedic Department's research staff to participate in the study. We are hoping to reach an n=75 as we expect 33% will be lost to follow up. Once eligible infants have been identified
Sponsor: British Columbia Children's Hospital

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: British Columbia Children's Hospital

Dates:
Date Received: May 26, 2016
Date Started: December 2014
Date Completion: June 2017
Last Updated: June 7, 2016
Last Verified: June 2016