Intra-articular Oxygen-ozone Therapy for the Treatment of Knee Osteoarthritis Compared With Hyaluronic Acid

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Knee osteoarthritis is a very common pathology, characterized by pain, stiffness and functional deficit. The various therapeutic options used include anti-inflammatory drug treatment, physiokinesitherapy, minimally invasive procedures and, finally, in non-responsive cases, surgical treatment. To date, several studies have been conducted on the intra-articular use of oxygen-ozone in knee osteoarthritis and its potential therapeutic benefits. However, the methodological quality of the RCTs available in the literature is not satisfactory, so it is necessary to define a standardized protocol for therapy and procedures. The aim of this study will be to develop a rigorous protocol to evaluate the effectiveness of intra-articular oxygen-ozone therapy (OOT) in knee osteoarthritis and compare it with injection therapy with hyaluronic acid (HA), currently widely used in the treatment of knee osteoarthritis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Humanitas Clinical and Research Center
• Treatments: Hyaluronic Acid

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.