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

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

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• Belarus
  • Minsk, Belarus, 220114
    • Andrei Hancharou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with medium and large joint osteoarthritis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control group; Control group of healthy persons
Patients with osteoarthritis; Patients with medium and large joint osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology
• Collaborators: Belarusian Medical Academy of Post-Graduate Education
• Investigators: Study Director: Andrei Y Hancharou, Dr, Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 10, 2018
• Study Completion (Actual): December 29, 2018

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Osteoarthritis; Flow cytometry; Synovial fluid
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: RRPCEM_OA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No