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Completed

NCT Number: NCT05824052

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sağlık Bilimleri Üniversitesi Sultan Abdülhamid Han Eğitim ve Araştırma Hastanesi

Istanbul, Kadıköy, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Not giving consent.

Treatment and study plan

ozone injection

Other

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.

Primary outcomes

  1. Protein Determination

    Time frame: 1 day

    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.

  2. Measurement of Total Antioxidant Level (TAL)

    Time frame: 1 day

    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).

  3. Measurement of Total Oxidant Level (TOL)

    Time frame: 1 day

    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).

  4. Oxidative Stress Index (OSI)

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Uskudar State Hospital

Other Gov

Collaborators

  • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2023
Registry last updated
May 25, 2023

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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