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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis Knee
• Intervention / Treatment: Device: Ozone gas; Drug: Steroid injection

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 55 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OZONE; injection of ozone gas	Device: Ozone gas; Injection of ozone gas intra articularly
Active Comparator: control; injeciton of steroids intra articularly	Drug: Steroid injection; Injection of steroids (diprospan) intra articularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: June 19, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 751-15-RMC