NCT04426721

Intra-articular Oxygen-ozone Therapy for the Treatment of Knee Osteoarthritis: a Randomized, Double-blind, Clinical Trial Compared With Hyaluronic Acid

Status unknown Phase 3 Last updated 13 June 2020

What this trial tests

Phase 3 trial testing Ozone in Knee Osteoarthritis in 120 participants. Status unknown.

Timeline

1 June 2020

Primary endpoint
1 December 2021

1 December 2022

Quick facts

Lead sponsor	Humanitas Clinical and Research Center
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	120
Start date	1 June 2020
Primary completion	1 December 2021
Estimated completion	1 December 2022
Sites	1 location across Italy

Drugs / interventions tested

• Ozone (OZONE) — full drug profile →
• Hyaluronic Acid (HYALURONIC ACID) — full drug profile →

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

Humanitas Clinical and Research Center

Who can join

18 and older, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Western Ontario and McMaster Universities Osteoarthritis Index using the Likert scale, Version 3.1, Pain subscale (WOMAC LK 3.1)
  Time frame: 3 months
  Assessment of pain. Score range 0-20. Higher scores indicate worse pain.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Molecular Classification of Knee Osteoarthritis.
   Lv Z, Yang YX, Li J, Fei Y, et al · · 2021 · cited 69× · PMID 34513847 · DOI 10.3389/fcell.2021.725568
2. Ozone Therapy versus Hyaluronic Acid Injections for Pain Relief in Patients with Knee Osteoarthritis: Preliminary Findings on Molecular and Clinical Outcomes from a Randomized Controlled Trial.
   Sconza C, Di Matteo B, Queirazza P, Dina A, et al · · 2023 · cited 30× · PMID 37240135 · DOI 10.3390/ijms24108788
3. Challenges and opportunities of pharmacological interventions for osteoarthritis: A review of current clinical trials and developments.
   Vrouwe JPM, Burggraaf J, Kloppenburg M, Stuurman FE. · · 2021 · cited 16× · PMID 36474768 · DOI 10.1016/j.ocarto.2021.100212
4. Ozone therapy for knee osteoarthritis: a literature visualization analysis of research hotspots and prospects.
   Liu Q, Liu J, Cao G, Liu Y, et al · · 2025 · cited 5× · PMID 39648327 · DOI 10.4103/mgr.medgasres-d-24-00099