Embolization in Hereditary Coagulopathies
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction of synovium thickness by embolization
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking - all treatement
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who do not complete the planned assessments
- •Patients who do not accept to continue with the study.
结局指标
主要结局
Reduction of synovium thickness by embolization
时间窗: 6 months
Measure (in milimeters) changes of synovial thickness in patients with hereditary coagulopathies with arthropathy due to hemarthrosis with MRI (measure synovium thickness)
次要结局
- Reduction of synovitis by embolization(1, 3 12, 24, 36, 48 and 60 months)
- Balance and fall risk(1, 3, 6, 12, 24, 36, 48, 60 months)
- Pain of the affected joint(1, 3, 6, 12, 24, 36, 48, 60 months)
- Inferior limb strength(1, 3, 6, 12, 24, 36, 48, 60 months)
- Quality of life of the patient(1, 3, 6, 12, 24, 36, 48, 60 months)
- Functional capacity(1, 3, 6, 12, 24, 36, 48, 60 months)
- Physical capacity(1, 3, 6, 12, 24, 36, 48, 60 months)
- Stifness(1, 3, 6, 12, 24, 36, 48, 60 months)