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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Sao Paulo
Federal University of São Paulo
University of Campinas, Brazil
Baxter Healthcare Corporation
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01232634
First received: October 29, 2010
Last updated: November 1, 2010
Last verified: October 2010

October 29, 2010
November 1, 2010
September 2010
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01232634 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles
External Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles. MRI Correlation.

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Children attending the Hemophilia clinics at the participating institutions (Universidade de São Paulo, Universidade Federal de São Paulo and Universidade Estadual de Campinas), who have a history of ankle or knee bleed(s), will be recruited to take part in this study.

  • Hemophilia
  • Hemophilic Arthropathy
Not Provided
All Subjects
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
December 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Male
7 Years to 18 Years
No
Contact: Andrea Doria, MD 416-813-6079 andrea.doria@sickkids.ca
Brazil,   Canada
 
NCT01232634
1000010841
No
Dr. Andrea Doria / The Hospital for Sick Children, The Hospital for Sick Children
The Hospital for Sick Children
  • University of Sao Paulo
  • Federal University of São Paulo
  • University of Campinas, Brazil
  • Baxter Healthcare Corporation
Principal Investigator: Andrea Doria, MD The Hospital for Sick Children, Toronto Canada
The Hospital for Sick Children
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP