Investigating the Impact of Ex Vivo Ozone Injection on Synovial Fluids in Patients Diagnosed With Knee Osteoarthritis

The objective of this study is to examine the effect of varying ozone doses on the levels of pro-inflammatory cytokines in synovial fluid collected from individuals with knee osteoarthritis.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Ozone injection

Detailed Description

In this study, synovial fluid samples will be collected from patients diagnosed with knee osteoarthritis for in vitro studies. The synovial fluid will be collected under sterile conditions by a joint puncture, and ultrasonography will be performed before sample collection. The synovial fluid samples will then be transferred to sterile urine culture tubes, with one containing only synovial fluid and the others containing synovial fluid and ozone gas. Afterward, the synovial fluid samples will be centrifuged, and the upper portion will be stored at -80°C for biochemical analyses. The total protein content will be measured using a commercial kit based on the Bradford method, and the total antioxidant level and Total oxidant levels will be measured using commercially purchased kits according to the manufacturer's instructions. The oxidative stress index will be calculated using the formula (TOS/TAS) and will be normalized to the total protein content measured in the synovial fluid.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kadıköy
    • Istanbul, Kadıköy, Turkey
      • Sağlık Bilimleri Üniversitesi Sultan Abdülhamid Han Eğitim ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being diagnosed with knee osteoarthritis.
• Giving consent to participate in the study.

Exclusion Criteria:

- Not giving consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group 1; The synovial fluid taken from the patients and not treated in any way.
Active Comparator: Group 2; The synovial fluid taken from the patients and injected 10 gamma ozone.	Other: Ozone injection; Ozone injection is a process where ozone gas is injected into a substance or system for various purposes. Ozone gas (O3) is a highly reactive form of oxygen that can be generated through the use of specialized ozone generators. Ozone injection can be used in a variety of applications, including water treatment, air purification, and medical therapy.
Active Comparator: Group 3; The synovial fluid taken from the patients and injected 30 gamma ozone.	Other: Ozone injection; Ozone injection is a process where ozone gas is injected into a substance or system for various purposes. Ozone gas (O3) is a highly reactive form of oxygen that can be generated through the use of specialized ozone generators. Ozone injection can be used in a variety of applications, including water treatment, air purification, and medical therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein Determination	The the total protein content in synovial fluid samples will be determined using a commercial kit based on the Bradford method (Coomassie Plus, Protein Assay, Thermofisher Scientific, Massachusetts, USA) and will be measured at 595 nm. A rapid and sensitive method will be used for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding. The Bradford protein test will be based on the principle that when protein molecules bind to Coomassie dye under acidic conditions, the color will change from brown to blue.	1 day
Measurement of Total Antioxidant Level (TAL)	TAL refers to the measurement of the total antioxidant capacity of a substance. This capacity measures a substance's ability to prevent harm from free radicals and reactive oxygen species. Measuring the total antioxidant capacity can be done using different laboratory assays and can be affected by various factors, such as diet, lifestyle, and environment.TAL levels of the samples will be measured using commercially purchased kits according to the manufacturer's instructions (Rel Assay Diagnostics, Mega Tıp, Gaziantep, Turkey).	1 day
Measurement of Total Oxidant Level (TOL)	TOL refers to the total amount of oxidizing agents, such as ROS, in a substance or biological sample. Oxidative stress is caused by an imbalance between ROS production and antioxidant defense mechanisms, leading to cellular damage. Various lab assays, detecting biomarkers like MDA or protein carbonyls, can measure TOL, which can help diagnose and monitor diseases associated with oxidative stress, like cardiovascular disease and cancer. TOL levels of the samples will be measured using commercially purchased kits according to the manufacturer's instructions (Rel Assay Diagnostics, Mega Tıp, Gaziantep, Turkey).	1 day
Oxidative Stress Index (OSI)	OSI is a calculated value that assesses the balance between oxidative stress and antioxidant defense mechanisms in the body by dividing TOS by TAS. A higher OSI value indicates higher oxidative stress and lower antioxidant defense mechanisms. OSI measurement is helpful for diagnosing and monitoring diseases associated with oxidative stress like cardiovascular disease, diabetes, and cancer.	1 day

Collaborators and Investigators

• Sponsor: Uskudar State Hospital
• Collaborators: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Investigators: Principal Investigator: Emre Ata, M.D., Sultan Abdulhamid Han Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2023
• Primary Completion (Actual): May 20, 2023
• Study Completion (Actual): May 24, 2023

Study Registration Dates

• First Submitted: April 8, 2023
• First Submitted That Met QC Criteria: April 9, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: knee osteoarthritis; synovial fluid; ozone therapy; pro-inflammatory cytokines; Dose-dependent effect
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Ozone1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) will be shared upon reasonable request by the principal investigator.
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: Individual participant data (IPD) will be shared upon reasonable request by the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No