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

Osteoarthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02833545
• Other study ID #: 751-15-RMC
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2016
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 1, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Knee
• Osteoarthritis, Knee

Intervention

Device:
• Ozone gas
Injection of ozone gas intra articularly

Drug:
• Steroid injection
Injection of steroids (diprospan) intra articularly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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