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

Study of the Laboratory-based Evaluation of the Degrees of Activity of Medium and Large Joint Osteoarthritis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03164070

Enrollment

121

Registered

2017-05-23

Start date

2016-07-01

Completion date

2018-12-29

Last updated

2019-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Osteoarthritis, Flow cytometry, Synovial fluid

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The sensitivity of the proposed laboratory-based method in the diagnostics of the activity of osteoarthritis	2 month	The sensitivity of the proposed laboratory-based method in the diagnostics of the activity of medium and large joint osteoarthritis

Countries

Belarus

Outcome results