Clinical trial: Intra-articular Oxygen-ozone Therapy for the Treatment of Knee Osteoarthritis Compared With Hyaluronic Acid (NCT04426721)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female at least 18 years of age at time of screening.

          2. Ability to comply with study procedures and visit schedules and able to follow oral
             and written instructions.

          3. Patients with symptomatic OA in one knee from 3 months

          4. A standing knee radiograph showing a K-L grade of 2 to 3 and an absence of severe
             osteoarthritis (defined as advanced stage osteoarthritis, including large osteophytes,
             chronic fractures or bone remodeling, severe deformity or bone attrition, and/or
             bone-on-bone contact indicative of severe osteoarthritis/full thickness cartilage
             loss).

          5. Body mass index ≤ 40 kg/m2.

          6. A WOMAC LK 3.1 pain subscale total score ≥ 9 and ≤ 19.

          7. Has undergone at least one prior conservative OA treatment (e.g. physical therapy,
             simple analgesics).

          8. Signed an ethics committee-reviewed an approved informed consent form.

        Exclusion Criteria:

          1. Presence of clinically observed active infection or severe inflammation in the index
             knee joint or skin disease/breakdown or infection in the area of the planned injection
             site of the index knee.

          2. Presence of symptomatic OA in the non-study knee at screening; if unclear then the
             WOMAC LK 3.1 pain subscale for the non-index knee must be ≤ 5.0.

          3. Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout,
             ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; Human
             Immunodeficiency Virus (HIV), viral hepatitis; chondrocalcinosis, Paget's disease, or
             villonodular synovitis.

          4. Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or
             planned chemotherapeutic treatment.

          5. Disease of spine, hip or other lower extremity joints judged by the investigator to be
             contributing to the pain in the index knee (e.g. sciatica, nerve pain, hip OA). Note:
             Patients with contralateral knee replacement, or hip replacement in either hip, may be
             enrolled provided there is sufficient pain relief after knee replacement or hip
             replacement that analgesics are not required.

          6. Untreated symptomatic injury of the index knee (e.g., acute traumatic injury, anterior
             cruciate ligament injury, clinically symptomatic meniscus injury characterized by
             mechanical issue such as locking or catching).

          7. Presence of surgical hardware or other foreign body intended to treat arthritis or
             cartilage-related pathology in the index knee. Note: this does not include small
             hardware (e.g. screws).

          8. Presence of venous or lymphatic stasis in the index leg.

          9. Orally administered systemic steroid use within 2 weeks prior to screening

         10. Planned/anticipated surgery of the index knee during the study period.

         11. Major surgery of the index knee within 12 months prior to screening.

         12. Minor surgery (e.g. arthroscopy) of the index knee within 6 months prior to screening.

         13. Any documented clinically significant degree of cognitive impairment or other
             condition, finding, or psychiatric illness at screening, which, in the opinion of the
             investigator, could compromise patient safety or interfere with the assessment of the
             safety and treatment effects of the study injection.

         14. Pregnant or nursing mothers or women planning to become pregnant during the time they
             will be participating in the study.

         15. Know hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations.

         16. Previously documented failed treatment with OOT or Sinovial

         17. Known drug or alcohol dependence currently or within the last year.

         18. Use of any investigational drug or device within 30 days prior to screening.

         19. Use of any investigational biologics within 60 days prior to screening.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment