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
  Purpose

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.


Condition Phase
Hemophilia
Hemophilic Arthropathy
Phase 2

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 72
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)
Groups/Cohorts
All Subjects

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 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.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232634

Contacts
Contact: Andrea Doria, MD 416-813-6079 andrea.doria@sickkids.ca

Locations
Brazil
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         
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Carina Man    416 813 7654 ext 2482    carin.ma@sickkids.ca   
Principal Investigator: Andrea Doria, MD         
Sub-Investigator: Victor Blanchette, MD         
Sub-Investigator: Pam Hilliard         
Sub-Investigator: Rahim Moineddin         
Sponsors and Collaborators
The Hospital for Sick Children
University of Sao Paulo
Federal University of São Paulo
University of Campinas, Brazil
Baxter Healthcare Corporation
Investigators
Principal Investigator: Andrea Doria, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Dr. Andrea Doria / The Hospital for Sick Children, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01232634     History of Changes
Other Study ID Numbers: 1000010841
Study First Received: October 29, 2010
Last Updated: November 1, 2010
Health Authority: Canada: Ethics Review Committee
Brazil: Ethics Committee

Keywords provided by The Hospital for Sick Children:
pediatrics
haemophilia
ultrasound
MRI
arthropathy

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 16, 2014