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RECRUITINGINTERVENTIONAL

Embolization in Hereditary Coagulopathies

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a longitudinal, prospective study, which will include 30 subjects with hereditary coagulopathies, with arthropathy, chronic synovitis resulting from hemarthrosis of the elbows, knees and/or ankles followed up at the Centro de Hemofilia HCFMUSP, after approval by the ethics and research committee. They will undergo imaging tests (X-rays and Magnetic Resonance of knee, elbow, or ankle), physical, pain, quality of life and functional assessments (Hemophilia Joint Health Score, Functional Independence Score in Hemophilia, Perimeter, Test Timed up and Go, 30 second sit and stand test, Haemophilia - Adult - Quality of Life questionnaire (HAEM-A-QoL), Knee Injury and Osteoarthritis Outcome Score, EQ-5D, numerical rating scale for pain and embolization procedure (superselective embolization of target arteries with spherical microparticles Embosphere 100-300 micrometers (Biosphere Medical, Roissy, France), until partial vascular stasis and decharacterization of pathological synovial enhancement. These evaluations will be performed at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months after the procedure.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients with hereditary coagulopathies with arthropathy (i.e., chronic synovitis due to hemarthrosis), with X-ray and MRI (documenting synovitis) followed up at the Hemophilia Center HC-FMUSP. Who Should NOT Join This Trial: - Patients who do not complete the planned assessments - Patients who do not accept to continue with the study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patients with hereditary coagulopathies with arthropathy (i.e., chronic synovitis due to hemarthrosis), with X-ray and MRI (documenting synovitis) followed up at the Hemophilia Center HC-FMUSP. Exclusion Criteria: * Patients who do not complete the planned assessments * Patients who do not accept to continue with the study.

Treatments Being Tested

DEVICE

embolization with spherical microparticles embosphere

embolization of affected joints with spherical microparticles embosphere

Locations (1)

Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil