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

The Hospital for Sick Children

Status: Completed

Conditions: Hemophilic Arthropathy; Hemophilia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01232634

1000010841

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: Male

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

57 participants in 1 patient group

All Subjects