Clinical trial NCT01232634: Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles
Official title: External Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles. MRI Correlation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia
Hemophilic Arthropathy
Keywords: pediatrics
haemophilia
ultrasound
MRI
arthropathy
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: Federal University of São Paulo
name: University of Campinas, Brazil
name: Baxter Healthcare Corporation
First posted: 2010-11-02
Enrollment: 57
Sex: MALE
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Ultrasound findings according to the International Prophylaxis Study Group (IPSG) scale
timeFrame: Day 1
Secondary outcomes:
measure: MRI findings according to the International Prophylaxis Study Group (IPSG) scale
timeFrame: Day 1
measure: X-ray findings according to the Pettersson radiographic system
timeFrame: Day 1
measure: Physical Assessment according to the HJHS and FISH scores
timeFrame: Day 1
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Universidade Estaduale de Campinas
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Andrea Doria, MD
role: PRINCIPAL_INVESTIGATOR
References: