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

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ClinicalTrials.gov Identifier: NCT02833545
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
DROR ROBINSON, Rabin Medical Center

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Knee Device: Ozone gas Drug: Steroid injection Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: A sequential series of patients receiving steroid injections was compared to a sequential series of patients receiving ozone injections
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: the outcome assessor was not aware of the therapy administered
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis Ozone

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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   55 Years to 79 Years   (Adult, Older Adult)
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.

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 Posted: July 14, 2016    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018

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