drugset / Trial / NCT04426721

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

NCT04426721

Phase 3 Unknown 120 enrolled Humanitas Clinical and Research Center
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2020-06
Primary completion
2021-12
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hyaluronic Acid Other / unclassified 2 ml Other
Comparator Hyaluronic Acid Other / unclassified 32 mg Other
Subject Ozone Other / unclassified 10 ml Other

Indications