Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis
Phase 4
Completed
- Conditions
- Osteoarthritis Knee
- Interventions
- Device: Ozone gasDrug: Steroid injection
- Registration Number
- NCT02833545
- Lead Sponsor
- Rabin Medical Center
- Brief Summary
Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single Center.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description OZONE Ozone gas injection of ozone gas control Steroid injection injeciton of steroids intra articularly
- Primary Outcome Measures
Name Time Method Improvement in VAS Pain intensity 6 months The outcome measure will be measured according to patient response to the question: during the last week what was your average pain intensity. The response will be measured in millimeters as marked on a 10 cm long line. No pain equals 0 mm and maximal possible pain equals 100mm
- Secondary Outcome Measures
Name Time Method