Automatic Characterization of the Neonatal Hip Using Ultrasound Imaging

NCT02796768 | Unknown

• 1 other identifier: H14-01448
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Alpha angles automatically extracted from 3D US images as a measure of dysplasia of the infant hip

  Baseline

• Alpha angles automatically extracted/measured from 2D US images as a measure of dysplasia of the infant hip

  Baseline

Secondary Outcomes (4)

• Beta angles automatically extracted from 3D US images as a measure of dysplasia of the infant hip

  Baseline

• Beta angles automatically extracted/measured from 2D US images as a measure of dysplasia of the infant hip

  Baseline

• Femoral head coverage automatically extracted from 3D US images as a measure of dysplasia of the infant hip

  Baseline

• Femoral head coverage automatically extracted/measured from 2D US images as a measure of dysplasia of the infant hip

  Baseline

Study Arms (1)

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; Other: 2D US Scanning

Interventions

3D US Scanning OTHER

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

Participants

2D US Scanning OTHER

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

Participants

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Children's Hospital: lead
• University of British Columbia: collaborator

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

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

Study Officials

• Kishore Mulpuri, MBBS, MS(Ortho), MHSc

  Provincial Health Services Authority British Columbia

  PRINCIPAL INVESTIGATOR

• Antony Hodgson, BASc, MASc, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Anthony Cooper, BSc, MBChB, FRCS

  Provincial Health Services Authority British Columbia

  PRINCIPAL INVESTIGATOR

• Rafeef Abugharbieh, BSc, MSc, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kishore Mulpuri, MBBS, MS(Ortho), MHSc

CONTACT

6048752054; kmulpuri@cw.bc.ca

Emily Schaeffer, PhD

CONTACT

6048752359; emily.schaeffer@cw.bc.ca

Study Design

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

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 13, 2016
• Study Start: December 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 13, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)