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

NCT05824052 | Completed

• 1 other identifier: Ozone1
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Dose-dependent effect; knee osteoarthritis; ozone therapy; pro-inflammatory cytokines; synovial fluid

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Group 1

NO INTERVENTION

The synovial fluid taken from the patients and not treated in any way.

Group 2

ACTIVE COMPARATOR

The synovial fluid taken from the patients and injected 10 gamma ozone.

Other: Ozone injection

Group 3

ACTIVE COMPARATOR

The synovial fluid taken from the patients and injected 30 gamma ozone.

Other: Ozone injection

Interventions

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.

Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Not giving consent.

Sponsors & Collaborators

• Uskudar State Hospital: lead
• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: collaborator

Study Sites (1)

Sağlık Bilimleri Üniversitesi Sultan Abdülhamid Han Eğitim ve Araştırma Hastanesi

Istanbul, Kadıköy, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ozone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Study Officials

• Emre Ata, M.D.

  Sultan Abdulhamid Han Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Synovial fluid samples taken from patients will be prepared to form 3 separate groups, one fluid will not be treated, one will be injected with 10 gamma and the other with 30 gamma ozone.

Study Record Dates

• First Submitted: April 8, 2023
• First Posted: April 21, 2023
• Study Start: April 21, 2023
• Primary Completion: May 20, 2023
• Study Completion: May 24, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1 year
• Access Criteria: Individual participant data (IPD) will be shared upon reasonable request by the principal investigator.

Locations

TU (1)