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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-21

Study Completion Date

2023-05-24

Brief Summary

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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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Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

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

Group Type ACTIVE_COMPARATOR

Ozone injection

Intervention Type 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 3

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

Group Type ACTIVE_COMPARATOR

Ozone injection

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER