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

Primary Purpose

Osteoarthritis Knee

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ozone gas
Steroid injection
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Knee

Eligibility Criteria

55 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    OZONE

    control

    Arm Description

    injection of ozone gas

    injeciton of steroids intra articularly

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 19, 2016
    Last Updated
    August 30, 2018
    Sponsor
    Rabin Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02833545
    Brief Title
    Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis
    Official Title
    Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    May 31, 2018 (Actual)
    Study Completion Date
    August 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rabin Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Sequential Assignment
    Model Description
    A sequential series of patients receiving steroid injections was compared to a sequential series of patients receiving ozone injections
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    the outcome assessor was not aware of the therapy administered
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    OZONE
    Arm Type
    Experimental
    Arm Description
    injection of ozone gas
    Arm Title
    control
    Arm Type
    Active Comparator
    Arm Description
    injeciton of steroids intra articularly
    Intervention Type
    Device
    Intervention Name(s)
    Ozone gas
    Intervention Description
    Injection of ozone gas intra articularly
    Intervention Type
    Drug
    Intervention Name(s)
    Steroid injection
    Intervention Description
    Injection of steroids (diprospan) intra articularly
    Primary Outcome Measure Information:
    Title
    Improvement in VAS Pain intensity
    Description
    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
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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