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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05629130
Other study ID # 63452822.1.0000.0068
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 16, 2023
Est. completion date December 31, 2029

Study information

Verified date September 2022
Source University of Sao Paulo General Hospital
Contact marcia u rezende, MD PhD
Phone +5511 981226282
Email marcia.uchoa@hc.fm.usp.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2029
Est. primary completion date December 31, 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
embolization with spherical microparticles embosphere
embolization of affected joints with spherical microparticles embosphere

Locations

Country Name City State
Brazil Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo São Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital Merit Medical Systems, Inc.

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of synovium thickness by embolization Measure (in milimeters) changes of synovial thickness in patients with hereditary coagulopathies with arthropathy due to hemarthrosis with MRI (measure synovium thickness) 6 months
Secondary Reduction of synovitis by embolization Measure (in milimeters) changes on synovial thickness in patients with hereditary coagulopathies with arthropathy due to hemarthrosis with MRI 1, 3 12, 24, 36, 48 and 60 months
Secondary Inferior limb strength Measure changes in muscle strength by timed up and go (by time of performance, in seconds). 1, 3, 6, 12, 24, 36, 48, 60 months
Secondary Inferior limb strength Measure changes in muscle strength of lower limbs by 30 seconds sit to stand test (by number of repetitions) 1, 3, 6, 12, 24, 36, 48, 60 months
Secondary Balance and fall risk Measure (in seconds, period of time to perform the test) changes in balance and risk of falls by Timed up and go test. 1, 3, 6, 12, 24, 36, 48, 60 months
Secondary Quality of life of the patient 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) 1, 3, 6, 12, 24, 36, 48, 60 months
Secondary Quality of life of the patient Measure, according to the scale of the questionnaire, changes in quality of life with Knee Injury and Osteoarthritis Outcome Score (KOOS, 0-100, 100 being the best quality of life). 1, 3, 6, 12, 24, 36, 48, 60 months
Secondary Quality of life of the patient Measure, according to the scale of the questionnaire, changes in quality of life with by EQ-5D, up to 1, being 1 the best quality of life). Please note: "Since 2009, EQ-5D has been available in three versions: the three-level EQ-5D-3L; the five-level EQ-5D-5L; and a 'youth' adaptation, EQ-5D-Y. Although the EQ is in recognition of the EuroQol group name, the D refers to dimensions, the L signifies level, and the Y stands for youth, the name of the instrument should not be spelled out in this manner as this is inaccurate. Therefore, EQ-5D is not an abbreviation and is the correct term to use when referring to the instrument in general." Brooks R, Boye KS, Slaap B. EQ-5D: a plea for accurate nomenclature. J Patient Rep Outcomes. 2020 Jul 3;4(1):52. doi: 10.1186/s41687-020-00222-9. PMID: 32620995; PMCID: PMC7334333. 1, 3, 6, 12, 24, 36, 48, 60 months
Secondary Functional capacity 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) 1, 3, 6, 12, 24, 36, 48, 60 months
Secondary Functional capacity Measure (according to the scale of the questionnaire) changes in functional capacity with Functional Independence Score by Knee Injury and Osteoarthritis Outcome Score (KOOS, 0-100, 100 being the best result) 1, 3, 6, 12, 24, 36, 48, 60 months
Secondary Physical capacity Measure changes in physical capacity by Hemophilia Joint Health Score (HJHS), 0 to 124, 0 being the best result. 1, 3, 6, 12, 24, 36, 48, 60 months
Secondary Pain of the affected joint Measure changes in pain by Hemophilia Joint Health Score (HJHS, 0-12, 0 being the best result) 1, 3, 6, 12, 24, 36, 48, 60 months
Secondary Pain of the affected joint Measure changes in pain by numerical rating scale (NRS, 0-10, 0 being no pain and 10 being the worst pain possible) 1, 3, 6, 12, 24, 36, 48, 60 months
Secondary Pain of the affected joint Measure changes in pain by Knee Injury and Osteoarthritis Outcome Score (KOOS, 0 to 100, 100 being the best result) 1, 3, 6, 12, 24, 36, 48, 60 months
Secondary Stifness Measure (0 to 100, 100 being the best result) changes in knee stiffness by Knee Injury and Osteoarthritis Outcome Score (KOOS) 1, 3, 6, 12, 24, 36, 48, 60 months
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