Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||External Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles. MRI Correlation.|
- Ultrasound findings according to the International Prophylaxis Study Group (IPSG) scale [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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.
- MRI findings according to the International Prophylaxis Study Group (IPSG) scale [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232634
|Contact: Andrea Doria, MDfirstname.lastname@example.org|
|Universidade de Sao Paulo||Not yet recruiting|
|Sao Paulo, Brazil|
|Contact: , MD|
|Principal Investigator: Jorge David Aivazoglou Carneiro, MD|
|Sub-Investigator: Paula Ribeiro Villaca, MD|
|Sub-Investigator: Marcelo Bordalo Rodrigues, MD|
|Sub-Investigator: Elbio Damico, MD|
|Universidade Estaduale de Campinas||Not yet recruiting|
|Sao Paulo, Brazil|
|Principal Investigator: Margareth Castro Ozelo, MD|
|Sub-Investigator: Erich Vinicius de Paula, MD|
|Universidade Federal de Sao Paulo||Not yet recruiting|
|Sao Paulo, Brazil|
|Principal Investigator: Sandra Vallin Antunes, MD|
|Principal Investigator: Artur Fernandes, MD|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Carina Man 416 813 7654 ext 2482 email@example.com|
|Principal Investigator: Andrea Doria, MD|
|Sub-Investigator: Victor Blanchette, MD|
|Sub-Investigator: Pam Hilliard|
|Sub-Investigator: Rahim Moineddin|
|Principal Investigator:||Andrea Doria, MD||The Hospital for Sick Children, Toronto Canada|