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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05824052
• Other study ID #: Ozone1
• Status: Completed
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: May 24, 2023

Study information

• Verified date: May 2023
• Source: Uskudar State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 24, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Being diagnosed with knee osteoarthritis.

• Giving consent to participate in the study.

Exclusion Criteria:

• Not giving consent.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Üniversitesi Sultan Abdülhamid Han Egitim ve Arastirma Hastanesi	Istanbul	Kadiköy

Sponsors (2)

Lead Sponsor	Collaborator
Uskudar State Hospital	Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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 Tip, Gaziantep, Turkey).	1 day
Primary	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 Tip, Gaziantep, Turkey).	1 day
Primary	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