Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis

Clalit Health Services

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis Knee

Treatments: Device: Ozone gas; Drug: Steroid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02833545

751-15-RMC

Details and patient eligibility

About

Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single Center.

Enrollment: 50 patients

Sex: All

Ages: 55 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 55 to 79 years of age
• Symptomatic Knee osteoarthritis
• VAS pain intensity is at least 40 mm on a 100 mm scale
• Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits.

Exclusion criteria

• Any known tumor of the ipsilateral knee.
• Any known infection of the treated knee.
• Osteoarthritis of the operated knee Kelgren Lawrence < grade 2.
• Chemotherapy treatment in the past 12 months.
• Patients who are sensitive to ozone.
• Pregnant women, or breastfeeding women.
• Evidence of any significant systemic disease (such as but not limited to HIV infection, hepatitis infection or HTLV infection), known coagulopathies, that might compromise the Subject's welfare.
• Substance abuse or alcohol abuse.
• Participation in other clinical trials in parallel to this study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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50 participants in 2 patient groups

OZONE

Experimental group

Description:

injection of ozone gas

Treatment:

Device: Ozone gas

control

Active Comparator group

Description:

injeciton of steroids intra articularly

Treatment:

Drug: Steroid injection