Status:
COMPLETED
Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
University of Sao Paulo
Federal University of São Paulo
Conditions:
Hemophilia
Hemophilic Arthropathy
Eligibility:
MALE
7-18 years
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...
Detailed Description
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 idea...
Eligibility Criteria
Inclusion
- Diagnosis of hemophilia A (factor VIII deficiency ≤1%) or B (factor IX deficiency ≤1.0%)
- Cooperative patients (age of 7 to 18 years old)
- Patients under 7 years old who have clinical evidence of arthropathy and imaging studies are required for clinical reasons. In these cases, the procedures may be done under sedation.
- Male sex (higher prevalence in males)
- History of previous ankle or knee bleed
Exclusion
- Co-morbid illness such as juvenile idiopathic arthritis, muscular dystrophy, neuropathic arthropathy that cause osteoarticular findings that may obscure or confound the hemophilia-based joint findings
- Non-cooperative patients
- Active bleed (defined as evidence of a recent bleed with one week of the proposing imaging studies and/or musculoskeletal changes on physical examination suggestive of a bleed within one week of the proposed imaging studies).
- Prior synovectomy
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01232634
Start Date
September 1 2010
End Date
March 1 2014
Last Update
November 9 2016
Active Locations (4)
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1
Universidade de Sao Paulo
São Paulo, Brazil
2
Universidade Estaduale de Campinas
São Paulo, Brazil
3
Universidade Federal de Sao Paulo
São Paulo, Brazil
4
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8