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

This study is not yet open for participant recruitment.
Verified July 2016 by DROR ROBINSON, Rabin Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02833545
First Posted: July 14, 2016
Last Update Posted: July 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
DROR ROBINSON, Rabin Medical Center
  Purpose
Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single Center.

Condition Intervention Phase
Osteoarthritis Knee Device: Ozone gas Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by DROR ROBINSON, Rabin Medical Center:

Primary Outcome Measures:
  • Improvement in VAS Pain intensity [ Time Frame: 6 months ]
    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


Estimated Enrollment: 20
Study Start Date: September 2016
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OZONE
injection of ozone gas
Device: Ozone gas
Injection of ozone gas intra articularly

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: DROR ROBINSON, Head Orthopedic Research Unit, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02833545     History of Changes
Other Study ID Numbers: 751-15-RMC
First Submitted: June 19, 2016
First Posted: July 14, 2016
Last Update Posted: July 14, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases