Arthropathy, Clotting Factor Deficiency, Embolization, Hemarthrosis, Hemophilia, Synovitis
Conditions
Brief summary
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.
Detailed description
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 Hemophilia do Hospital das Clinicas, Faculdade de Medicina da Universidade de São Paulo, i.e. HC-FMUSP), after approval by the ethics and research committee and registry at the clinical trials. 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.
Interventions
DEVICEembolization with spherical microparticles embosphere
embolization of affected joints with spherical microparticles embosphere
Sponsors
Merit Medical Systems, Inc.
University of Sao Paulo General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
no masking - all treatement
Intervention model description
longitudinal, prospective study.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of synovium thickness by embolization | 6 months | Measure (in milimeters) changes of synovial thickness in patients with hereditary coagulopathies with arthropathy due to hemarthrosis with MRI (measure synovium thickness) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inferior limb strength | 1, 3, 6, 12, 24, 36, 48, 60 months | Measure changes in muscle strength by timed up and go (by time of performance, in seconds). |
| Balance and fall risk | 1, 3, 6, 12, 24, 36, 48, 60 months | Measure (in seconds, period of time to perform the test) changes in balance and risk of falls by Timed up and go test. |
| Quality of life of the patient | 1, 3, 6, 12, 24, 36, 48, 60 months | Measure, according to the scale of the questionnaire, changes in quality of life with Haemophilia - Adult - Quality of life Questionnaires (HAEM-A-QoL, 10 dimensions, 0 to 100, being 0 the best health related quality of life) |
| Reduction of synovitis by embolization | 1, 3 12, 24, 36, 48 and 60 months | Measure (in milimeters) changes on synovial thickness in patients with hereditary coagulopathies with arthropathy due to hemarthrosis with MRI |
| Physical capacity | 1, 3, 6, 12, 24, 36, 48, 60 months | Measure changes in physical capacity by Hemophilia Joint Health Score (HJHS), 0 to 124, 0 being the best result. |
| Pain of the affected joint | 1, 3, 6, 12, 24, 36, 48, 60 months | Measure changes in pain by Hemophilia Joint Health Score (HJHS, 0-12, 0 being the best result) |
| Stifness | 1, 3, 6, 12, 24, 36, 48, 60 months | Measure (0 to 100, 100 being the best result) changes in knee stiffness by Knee Injury and Osteoarthritis Outcome Score (KOOS) |
| Functional capacity | 1, 3, 6, 12, 24, 36, 48, 60 months | Measure (according to the scale of the questionnaire) changes in functional capacity with Functional Independence Score in Hemophilia (FISH score, 0 to 32, 32 being the best result) |
Countries
Brazil
Contacts
Primary Contactmarcia u rezende, MD PhD
Backup ContactFabiane E Farias, PT
Outcome results
None listed