Osteoarthritis of the KneePhase 2NCT00832312
Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
A Phase 2 study testing ozone-oxygen mixture in people with Osteoarthritis of the Knee, run by Ben-Gurion University of the Negev at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether an intraarticular injection of Ozone into the knee joint is an effective therapy for pain control in patients with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- ozone-oxygen mixture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Aug 2016
- Phase
- Phase 2
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of knee
Who cannot join
- Positive rheumatologic serologic tests
- Cognitive impairment
- Adjacent osteomyelitis
- Bacteremia
- Hemarthrosis
- Impending (scheduled within days) joint replacement surgery
Show all 12Show fewer
- Infectious arthritis
- Joint prosthesis
- Osteochondral fracture
- Periarticular cellulitis
- Poorly controlled diabetes mellitus
- Uncontrolled bleeding disorder or coagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether an intraarticular injection of Ozone into the knee joint is an effective therapy for pain control in patients with osteoarthritis of the knee.
Read the detailed description
Ozone, as a gas made of three atoms of oxygen with a cyclic structure, has been used as a medical therapy from the mid ninetieth century. Today, this therapy is a recognized modality in many European and Latin American nations for orthopedic problems, infections, ischemic diseases, and skin problems. However, despite of this wide use internationally, there is minimal mention of this treatment modality in the Anglo-American literature.
The present is the first of a series of studies planned to scientifically test the effectiveness of ozone as a main-stream therapy, introducing it to the Anglo-American literature. In this first study we will check whether intraarticular injections of Ozone into the knee joint are effective as a therapy for pain control in patients with osteoarthritis of the knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- ozone-oxygen mixture, placebo (saline)
- Keywords
- Osteoarthritis, Knee, Pain management, Ozone therapy, Intraarticular injection
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozone-oxygen mixtureOther
10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml)
placebo (saline)Other
Injection of 1cc of saline into the knee joint
| Study group | Role | What they receive |
|---|---|---|
| ozone-oxygen mixture | Experimental | 10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml) injected into the knee joint Receives: Other: ozone-oxygen mixture |
| Saline | Placebo comparator | Injection of 1cc of saline into the knee joint Receives: Other: placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control
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 posted30 Jan 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2016
- Study completionAug 2016 (estimated)
Why it stopped: Because of technical problems (researcher moved to different city).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ben-Gurion University of the Negev
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard Tandeter, Ben-Gurion University of the Negev
- Investigators
- Howard B Tandeter, MD, Principal investigator, Ben GurionUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832312
- Sponsor's protocol ID
- 20080780
- Status last verified
- Jul 2016
- First submitted
- 29 Jan 2009
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00832312
- Acronym / sponsor ID
- 20080780
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, Knee, Pain management, Ozone therapy, Intraarticular injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of technical problems (researcher moved to different city).
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ben-Gurion University of the NegevUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 30 Jan 2009 (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.
The purpose of this study is to determine whether an intraarticular injection of Ozone into the knee joint is an effective therapy for pain control in patients with osteoarthritis of the knee.
Detailed description
Ozone, as a gas made of three atoms of oxygen with a cyclic structure, has been used as a medical therapy from the mid ninetieth century. Today, this therapy is a recognized modality in many European and Latin American nations for orthopedic problems, infections, ischemic diseases, and skin problems. However, despite of this wide use internationally, there is minimal mention of this treatment modality in the Anglo-American literature.
The present is the first of a series of studies planned to scientifically test the effectiveness of ozone as a main-stream therapy, introducing it to the Anglo-American literature. In this first study we will check whether intraarticular injections of Ozone into the knee joint are effective as a therapy for pain control in patients with osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ozone-oxygen mixture | Experimental | Other: ozone-oxygen mixture10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml) injected into the knee joint |
| Saline | Placebo comparator | Other: placebo (saline)Injection of 1cc of saline into the knee joint |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis of knee
Key exclusion criteria (12 listed)
- Positive rheumatologic serologic tests
- Cognitive impairment
- Adjacent osteomyelitis
- Bacteremia
- Hemarthrosis
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-oxygen mixture10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml) | Other | ozone-oxygen mixture |
| placebo (saline)Injection of 1cc of saline into the knee joint | Other | Saline |
Primary outcome
Pain control
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Because of technical problems (researcher moved to different city).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
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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.
Howard B Tandeter, MD principal investigator
Ben GurionUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ozone-oxygen mixture in people with Osteoarthritis of the Knee, run by Ben-Gurion University of the Negev at 1 site in Israel.
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 1 inclusion and 12 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: stopped early, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Because of technical problems (researcher moved to different city).). Results are not available in the source record.
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?
Pain control (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 28 Jul 2016.