Study of the Laboratory-based Evaluation of the Degrees of Activity of Osteoarthritis

NCT ID: NCT03164070

Last Updated: 2019-01-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2018-12-29

Brief Summary

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This study evaluates laboratory-based method to estimate the degrees of activity of medium and large joint osteoarthritis.

Detailed Description

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Osteoarthritis (OA) is a chronic progressive disease, characterized by degradation of joint cartilage, synovial inflammation and joint dysfunction. This study evaluates laboratory-based method to estimate the degrees of activity of medium and large joint OA. Samples of synovial fluid (SF) from the patients with the OA (ICD-10 codes: M15, M16 and M17) will be assessed for T-cell subsets, msast cells, fibroblast-like synoviocytes (FLS) and macrophage-like synoviocytes (MLS) by flow cytometry. Subpopulations of blood T-cells involved in the inflammation will also be assayed. Standard clinical investigation will be performed and the results will be used to estimate the laboratory criteria or degrees of activity of medium and large joint OA.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with osteoarthritis

Patients with medium and large joint osteoarthritis

No interventions assigned to this group

Control group

Control group of healthy persons

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* medium and large joint active osteoarthritis

Exclusion Criteria

* refuse of patient to participate in the trial;
* acute infectious diseases;
* pregnancy/lactation;
* intercurrent severe chronic diseases;
* HIV, Hepatites B/C;
* active tuberculosis;
* alcohol use disorder/drug addiction;
* malignant neoplasms/leukemia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian Medical Academy of Post-Graduate Education

OTHER

Sponsor Role collaborator

The Republican Research and Practical Center for Epidemiology and Microbiology

OTHER

Sponsor Role lead

Responsible Party

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Andrei Y. Hancharou

Head of the Laboratory for Immunology and Cellular Biotechnology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrei Y Hancharou, Dr

Role: STUDY_DIRECTOR

Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

Locations

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Andrei Hancharou

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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RRPCEM_OA

Identifier Type: -

Identifier Source: org_study_id

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