Clinical Trial: Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: External Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles. MRI Correlation.

Brief Summary: The purpose of this study is to test the external validity of the systemic ultrasound protocol for data acquisition and interpretation, in order to diagnose soft tissue and osteochondral abnormalities in hemophilic children.

Detailed Summary: Ultrasound has advantages over MRI as it is less expensive, does not require sedation and is more readily available in centres around the world. Given these characteristics of ultrasound it is an ideal imaging tool for early assessment of hemophilic joints in countries whose access to MRI is limited. Early evaluation of soft tissue changes in young hemophilic patients may lead to earlier interventions and better mid-term and long-term clinical outcomes. By this way the joint function of hemophilic patients can be preserved, saving their joints from severe arthropathy and offering them the possibility of a normal professional life in the society.
Sponsor: The Hospital for Sick Children

Current Primary Outcome: Ultrasound findings according to the International Prophylaxis Study Group (IPSG) scale [ Time Frame: Day 1 ]

The readers will mark all the positive findings on a standardized spreadsheet and providing a final score for each component of the scale. Color Doppler findings will be rated as normal (grade 0), mild/moderate (grade 1) or severe (grade 2) synovial hyperemia according to an atlas that shows the intensity of hyperemia, which has been prepared by our group.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • MRI findings according to the International Prophylaxis Study Group (IPSG) scale [ Time Frame: Day 1 ]
    The readers will interpret the MRI findings in an additive way, i.e., marking all positive findings on a standardized spreadsheet and providing a final score for the soft tissue and osteochondral components of the MRI scale.
  • X-ray findings according to the Pettersson radiographic system [ Time Frame: Day 1 ]
    Each joint will be rated on a 13-point score after the Pettersson system.
  • Physical Assessment according to the HJHS and FISH scores [ Time Frame: Day 1 ]
    Each knee, elbow and ankle joint receives a numeric score, which can be compared to itself over time to determine whether it is showing degeneration due to bleeding. FISH score is a seven item measure of disability used to evaluate change in functional independence over time.


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: October 29, 2010
Date Started: September 2010
Date Completion:
Last Updated: November 8, 2016
Last Verified: November 2016