Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis

NCT02833545 | Completed Phase 4

• 1 other identifier: 751-15-RMC
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single Center.

Conditions

Osteoarthritis Knee

Outcome Measures

Primary Outcomes (1)

• Improvement in VAS Pain intensity

  The outcome measure will be measured according to patient response to the question: during the last week what was your average pain intensity. The response will be measured in millimeters as marked on a 10 cm long line. No pain equals 0 mm and maximal possible pain equals 100mm

  6 months

Study Arms (2)

OZONE

EXPERIMENTAL

injection of ozone gas

Device: Ozone gas

control

ACTIVE COMPARATOR

injeciton of steroids intra articularly

Drug: Steroid injection

Interventions

Ozone gas DEVICE

Injection of ozone gas intra articularly

OZONE

Steroid injection DRUG

Injection of steroids (diprospan) intra articularly

control

Eligibility Criteria

• Age: 55 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 79 years of age
• Symptomatic Knee osteoarthritis
• VAS pain intensity is at least 40 mm on a 100 mm scale
• Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits.

You may not qualify if:

• Any known tumor of the ipsilateral knee.
• Any known infection of the treated knee.
• Osteoarthritis of the operated knee Kelgren Lawrence \< grade 2.
• Chemotherapy treatment in the past 12 months.
• Patients who are sensitive to ozone.
• Pregnant women, or breastfeeding women.
• Evidence of any significant systemic disease (such as but not limited to HIV infection, hepatitis infection or HTLV infection), known coagulopathies, that might compromise the Subject's welfare.
• Substance abuse or alcohol abuse.
• Participation in other clinical trials in parallel to this study.

Sponsors & Collaborators

• Rabin Medical Center: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Steroids

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the outcome assessor was not aware of the therapy administered
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Orthopedic Research Unit

Model Details: A sequential series of patients receiving steroid injections was compared to a sequential series of patients receiving ozone injections

Study Record Dates

• First Submitted: June 19, 2016
• First Posted: July 14, 2016
• Study Start: September 1, 2016
• Primary Completion: May 31, 2018
• Study Completion: August 1, 2018
• Last Updated: September 4, 2018

Record last verified: 2018-08