Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-01-16
2029-12-31
Brief Summary
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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.
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Detailed Description
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Patients will be evaluated by imaging (X-rays and Magnetic Resonance of the affected joint, i.e., knee, elbow, and/or ankle); physical and functional assessments (Hemophilia Joint Health Score, Functional Independence Score in Hemophilia, Perimeter of the affected joint(s), Test Timed up and Go, 30 second sit and stand test, Knee Injury and Osteoarthritis Outcome Score (KOOS); quality of life (Haemophilia - adult - quality of life questionnaires (HAEM-A-QoL), Knee Injury and Osteoarthritis Outcome Score (KOOS), EQ-5D; pain measured by numerical rating scale.
Volunteers will be submitted to embolization procedure (superselective embolization of target arteries with spherical microparticles embosphere 100-300 micrometers (Biosphere Medical, Roissy, France) of the affected joint(s), 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Embolization
embolization procedure (superselective embolization of target arteries with spherical microparticles Embosphere 100-300 micrometers (Biosphere Medical, Roissy, France) of the affected joint, until partial vascular stasis and decharacterization of pathological synovial enhancement.
embolization with spherical microparticles embosphere
embolization of affected joints with spherical microparticles embosphere
Interventions
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embolization with spherical microparticles embosphere
embolization of affected joints with spherical microparticles embosphere
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who do not accept to continue with the study.
ALL
No
Sponsors
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Merit Medical Systems, Inc.
INDUSTRY
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Fabiane E FArias, PT
Role: PRINCIPAL_INVESTIGATOR
IOT-HC-FMUSP (Orthopedics Institute - General Hospital- School of Medicine - University of Sao Paulo
Andre M Assis, MD, PhD
Role: STUDY_DIRECTOR
Radiology Insititute, General Hospital, School Medicine, University of São Paulo
Paula Villaça, MD, PhD
Role: STUDY_DIRECTOR
Hematology department, General Hospital, School of Medicine, University of Sâo Paulo
Locations
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Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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63452822.1.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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