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

NCT04426721 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-06-16

No results posted yet for this study

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

Interventions

DRUG

Ozone

10 cc of oxygen-ozone

DRUG

Hyaluronic Acid

Sinovial forte 32 mg\\2ml

Sponsors & Collaborators

  • Humanitas Clinical and Research Center

    lead OTHER

Principal Investigators

  • Cristiano Sconza, MD · Humanitas Clinical and Research Hospital

  • Berardo Di Matteo, MD, PhD · Humanitas Clinical and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04426721 on ClinicalTrials.gov