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

NCT04426721 | Unknown Phase 3

• 1 other identifier: OZKOA1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Oxygene-Ozone; Ozone; Hyaluronic acid; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index using the Likert scale, Version 3.1, Pain subscale (WOMAC LK 3.1)

  Assessment of pain. Score range 0-20. Higher scores indicate worse pain.

  3 months

Secondary Outcomes (3)

• The Western Ontario and McMaster Universities Osteoarthritis Index using the Likert scale, Version 3.1(WOMAC LK 3.1)

  1,3,6,12 months

• Numeric Rating Scale (NRS)

  1,3,6,12 months

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  1,3,6,12 months

Study Arms (2)

Ozone

EXPERIMENTAL

Participant will receive an intraarticular injection of oxygen-ozone, once a week for three weeks. During procedure a clear ultrasound image is to be taken to document needle placement in the synovial space. The injector may choose the position of the knee (e.g., extended or bent) and the approach for the injection (e.g., medial or lateral).

Drug: Ozone

Hyaluronic acid

ACTIVE COMPARATOR

Participant will receive an intraarticular injection of hyaluronic acid, once a week for three weeks. During procedure a clear ultrasound image is to be taken to document needle placement in the synovial space. The injector may choose the position of the knee (e.g., extended or bent) and the approach for the injection (e.g., medial or lateral).

Drug: Hyaluronic Acid

Interventions

Ozone DRUG

10 cc of oxygen-ozone

Also known as: Oxygene-Ozone therapy; O2-O3

Ozone

Hyaluronic Acid DRUG

Sinovial forte 32 mg\\2ml

Also known as: Sinovial forte

Hyaluronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at least 18 years of age at time of screening.
• Ability to comply with study procedures and visit schedules and able to follow oral and written instructions.
• Patients with symptomatic OA in one knee from 3 months
• 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).
• Body mass index ≤ 40 kg/m2.
• A WOMAC LK 3.1 pain subscale total score ≥ 9 and ≤ 19.
• Has undergone at least one prior conservative OA treatment (e.g. physical therapy, simple analgesics).
• Signed an ethics committee-reviewed an approved informed consent form.

You may not qualify if:

• 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.
• 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.
• 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.
• Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment.
• 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.
• 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).
• 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).
• Presence of venous or lymphatic stasis in the index leg.
• Orally administered systemic steroid use within 2 weeks prior to screening
• Planned/anticipated surgery of the index knee during the study period.
• Major surgery of the index knee within 12 months prior to screening.
• Minor surgery (e.g. arthroscopy) of the index knee within 6 months prior to screening.
• 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.
• Pregnant or nursing mothers or women planning to become pregnant during the time they will be participating in the study.
• Know hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations.

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Study Sites (1)

Humanitas Clinical and Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Ozone; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Cristiano Sconza, MD

  Humanitas Clinical and Research Hospital

  PRINCIPAL INVESTIGATOR

• Berardo Di Matteo, MD, PhD

  Humanitas Clinical and Research Hospital

  STUDY CHAIR

Central Study Contacts

Cristiano Sconza, MD

CONTACT

3332781989; cristiano.sconza@humanitas.it

Roberta Amenta, MD

CONTACT

3286935530; roberta8928@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: June 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

IT (1)