Spontaneous Osteonecrosis of the KneePhase 1NCT01950858
Hyper Baric Oxygen Therapy (HBOT) for Spontaneous Osteonecrosis of the Knee
A Phase 1 study testing Weight reduction in people with Spontaneous Osteonecrosis of the Knee, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous osteonecrosis of the knee Read more about this study
- Who is it for?
- Ages 40 months to 85 years
- Conditions the study is for
- Spontaneous Osteonecrosis of the Knee
- What is being tested?
- Weight reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- May 2012to Aug 2015
- Phase
- Phase 1
- 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 40 months to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age40-85 years
- Diagnosis of Spontaneous osteonecrosis of the knee (SONK)in last month, Stage 1 or 2 by MRI.
Who cannot join
- Hyperbaric treatment (HBOT) in the last 2 years.
- Any contraindication for HBOT
- Pregnancy.
- Inability to sign inform consent
- Any contraindication for MRI
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf-Harofeh Medical Center
Tsrifin, 70300
Yiftah Beer, MD, 972-8-9779432, yiftah.beer@gmail.com
About this study
Official title: Safety and Efficacy of Hyper Baric Oxygen Therapy (HBOT) in Patients Presenting With Spontaneous Osteonecrosis of the Knee
safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous osteonecrosis of the knee
- Conditions
- Spontaneous Osteonecrosis of the Knee
- Being tested
- Weight reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight reductionBiological
| Study group | Role | What they receive |
|---|---|---|
| Biological | Experimental | 6 weeks of HBO treatment as well as non weight bearing Receives: Biological: Weight reduction |
| Control | Active comparator | non weight bearing Receives: Biological: Weight reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Pain Reduction
Measured: 6 weeks
Safety
Number of Participants with Adverse Events during HBOT
Measured: end of HBOT
Secondary outcomes (1)
Reduction In AVN size by MRI
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startMay 2012
- Primary completionMay 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Osteonecrosis 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
- Investigators
- Shai Efrati, MD, Study chair, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950858
- Sponsor's protocol ID
- 91/12*1
- Status last verified
- Sep 2013
- First submitted
- 28 Aug 2013
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Hyper Baric Oxygen Therapy (HBOT) in Patients Presenting With Spontaneous Osteonecrosis of the Knee
- ClinicalTrials.gov ID
- NCT01950858
- Acronym / sponsor ID
- 91/12*1
- Conditions
- Spontaneous Osteonecrosis of the Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- May 2012
- Primary completion
- May 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 26 Sep 2013 (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.
safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous osteonecrosis of the knee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological | Experimental | Biological: Weight reduction6 weeks of HBO treatment as well as non weight bearing |
| Control | Active comparator | Biological: Weight reductionnon weight bearing |
Who may qualify
- Ages
- 40 months to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age40-85 years
- Diagnosis of Spontaneous osteonecrosis of the knee (SONK)in last month, Stage 1 or 2 by MRI.
Key exclusion criteria (5 listed)
- Hyperbaric treatment (HBOT) in the last 2 years.
- Any contraindication for HBOT
- Pregnancy.
- Inability to sign inform consent
- Any contraindication for MRI
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 |
|---|---|---|
| Weight reduction | Biological | Biological, Control |
Primary outcome
Efficacy
Time frame: 6 weeks
Pain Reduction
Safety
Time frame: end of HBOT
Number of Participants with Adverse Events during HBOT
1 secondary outcome
Reduction In AVN size by MRI
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
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.
Shai Efrati, MD study chair
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Weight reduction in people with Spontaneous Osteonecrosis of the Knee, run by Assaf-Harofeh Medical Center 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Sep 2013. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yiftah Beer, MD (972-8-9779432, yiftah.beer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 26 Sep 2013.