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

NCT ID: NCT01232634

Last Updated: 2016-11-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-03-31

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 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.

Conditions

Hemophilia; Hemophilic Arthropathy

Keywords

pediatrics; haemophilia; ultrasound; MRI; arthropathy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

All Subjects

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: collaborator

University of Campinas, Brazil

OTHER

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Andrea Doria

Clinician Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Doria, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

Universidade de Sao Paulo

São Paulo, , Brazil

Universidade Estaduale de Campinas

São Paulo, , Brazil

Universidade Federal de Sao Paulo

São Paulo, , Brazil

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Brazil; Canada

Other Identifiers

1000010841

Identifier Type: -

Identifier Source: org_study_id