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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164070
• Other study ID #: RRPCEM_OA
• Status: Completed
• Start date: July 1, 2016
• Est. completion date: December 29, 2018

Study information

• Verified date: January 2019
• Source: The Republican Research and Practical Center for Epidemiology and Microbiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 29, 2018
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
Belarus	Andrei Hancharou	Minsk

Sponsors (2)

Lead Sponsor	Collaborator
The Republican Research and Practical Center for Epidemiology and Microbiology	Belarusian Medical Academy of Post-Graduate Education

Country where clinical trial is conducted

Belarus, 

Outcome

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