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OpenTrials
Completed

NCT Number: NCT02833545

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

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

Completed

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Key information

Conditions

Osteoarthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

55 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ozone gas

Device

Injection of ozone gas intra articularly

Steroid Injection

Drug

Injection of steroids (diprospan) intra articularly

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2016
Registry last updated
Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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