Osteoarthritis KneePhase 4NCT02833545
Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis
A Phase 4 study testing Ozone gas and Steroid injection in people with Osteoarthritis Knee, run by Rabin Medical Center.
Trial summary
Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single Center. Read more about this study
- Who is it for?
- Ages 55 to 79 years
- Conditions the study is for
- Osteoarthritis Knee
- What is being tested?
- Ozone gas and Steroid injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
About this study
Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single Center.
- Conditions
- Osteoarthritis Knee
- Being tested
- Ozone gas, Steroid injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone gasDevice
Injection of ozone gas intra articularly
Steroid injectionDrug
Injection of steroids (diprospan) intra articularly
| Study group | Role | What they receive |
|---|---|---|
| OZONE | Experimental | injection of ozone gas Receives: Device: Ozone gas |
| control | Active comparator | injeciton of steroids intra articularly Receives: Drug: Steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start1 Sep 2016
- Primary completion31 May 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A sequential series of patients receiving steroid injections was compared to a sequential series of patients receiving ozone injections
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DROR ROBINSON, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833545
- Sponsor's protocol ID
- 751-15-RMC
- Status last verified
- Aug 2018
- First submitted
- 19 Jun 2016
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02833545
- Acronym / sponsor ID
- 751-15-RMC
- Conditions
- Osteoarthritis Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A sequential series of patients receiving steroid injections was compared to a sequential series of patients receiving ozone injections
| Arm | Type | Receives |
|---|---|---|
| OZONE | Experimental | Device: Ozone gasinjection of ozone gas |
| control | Active comparator | Drug: Steroid injectioninjeciton of steroids intra articularly |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozone gasInjection of ozone gas intra articularly | Device | OZONE |
| Steroid injectionInjection of steroids (diprospan) intra articularly | Drug | control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
Related trials for Osteoarthritis Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ozone gas and Steroid injection in people with Osteoarthritis Knee, run by Rabin Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in VAS Pain intensity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.