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

Uskudar State Hospital

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Other: Ozone injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05824052

Ozone1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Not giving consent.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 3 patient groups

Group 1

No Intervention group

Description:

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

Group 2

Active Comparator group

Description:

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

Treatment:

Other: Ozone injection

Group 3

Active Comparator group

Description:

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

Treatment:

Other: Ozone injection