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NCT Number: NCT03164070

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

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Andrei Hancharou

Minsk, 220114, Belarus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The sensitivity of the proposed laboratory-based method in the diagnostics of the activity of osteoarthritis

    Time frame: 2 month

    The sensitivity of the proposed laboratory-based method in the diagnostics of the activity of medium and large joint osteoarthritis

Sponsors and collaborators

Lead sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology

Other

Collaborators

  • Belarusian Medical Academy of Post-Graduate Education

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 23, 2017
Registry last updated
Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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