Osteoarthritis Knee
Conditions
Brief summary
Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single Center.
Interventions
DEVICEOzone gas
Injection of ozone gas intra articularly
Injection of steroids (diprospan) intra articularly
Sponsors
Rabin Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
the outcome assessor was not aware of the therapy administered
Intervention model description
A sequential series of patients receiving steroid injections was compared to a sequential series of patients receiving ozone injections
Eligibility
Sex/Gender
ALL
Age
55 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed