Necrosis, Avascular, of BoneNCT01979666
Nitrate Patch Use as Treatment of Knee AVN
A study testing nitrate patch and MRI scan in people with Necrosis, Avascular, of Bone, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The pathogenesis of AVN includes a defective blood supply to the knee joint. Local nitrates induce peripheral vasodilation and may improve blood supply to the affected tissue. This study aims to test whether the use of a nicotine patch may accelerate the healing process from AVN of the knee. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Necrosis, Avascular, of Bone
- What is being tested?
- nitrate patch and MRI scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Jan 2019
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (18-80 y.o)
- diagnosis of AVN according to MRI
Who cannot join
- Terminal illness
- Cognitive impairment / any condition disturbing informed concent.
- Nitrate intolerance
- Patients using Cyclic GMP inhibitiors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of a Nitrate Patch on the Healing Process of AVN of the Knee
The pathogenesis of AVN includes a defective blood supply to the knee joint. Local nitrates induce peripheral vasodilation and may improve blood supply to the affected tissue.
This study aims to test whether the use of a nicotine patch may accelerate the healing process from AVN of the knee.
Read the detailed description
The main purpose of this study is to examine whether treatment with a local nitrate patch will improve MRI findings and clinical outcomes in patients with AVN of the knee.
This is a double-blind prospective study that will include 50 adult volunteers, randomly assigned to a "nitrate" group that will be given a nitrate patch, and a "placebo" group that will be given a placebo patch.
The following outcomes will be measured:
- MRI findings before and after the patch treatment
- Use of analgesics
- Subjective pain relief.
- Conditions
- Necrosis, Avascular, of Bone
- Being tested
- nitrate patch, placebo patch, MRI scan
- Keywords
- Knee AVN, Nitrates
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitrate patchDrug
patients in the study group will get a nitrate patch
placebo patchDrug
Also called placebo
control group patients will get a placebo patch
MRI scanDevice
Also called MRI
MRI scan after 6 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | the patients that will get a nitrate patch Receives: Drug: nitrate patch; Device: MRI scan |
| control group | Placebo comparator | the patients that will get the placebo patch Receives: Drug: placebo patch; Device: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in bone substrate edema
the area and percent of the knee which the edema involves
Measured: 6 weeks
Secondary outcomes (3)
other MRI changes
reduction of subchondral fracture resolution of accompanied findings presence of femoral head or condyle flattening
Measured: 6 weeks
analgesics use
according to the patient's self report
Measured: 6 weeks
pain severity
according to a visual analouge scale
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 posted8 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2019
- Study completionJan 2019
Why it stopped: Failure to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrosis, Avascular, of BoneStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof.Avi Livneh, Sheba Medical Center
- Investigators
- avi livneh, Principal investigator, Sheba Medical Centerarik asman, MD, Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979666
- Sponsor's protocol ID
- SHEBA-12-9707-AL-CTIL
- Status last verified
- Mar 2024
- First submitted
- 3 Nov 2013
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of a Nitrate Patch on the Healing Process of AVN of the Knee
- ClinicalTrials.gov ID
- NCT01979666
- Acronym / sponsor ID
- SHEBA-12-9707-AL-CTIL
- Conditions
- Necrosis, Avascular, of Bone
- Keywords
- Knee AVN, Nitrates
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to recruit patients
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2014
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 8 Nov 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.
The pathogenesis of AVN includes a defective blood supply to the knee joint. Local nitrates induce peripheral vasodilation and may improve blood supply to the affected tissue.
This study aims to test whether the use of a nicotine patch may accelerate the healing process from AVN of the knee.
Detailed description
The main purpose of this study is to examine whether treatment with a local nitrate patch will improve MRI findings and clinical outcomes in patients with AVN of the knee.
This is a double-blind prospective study that will include 50 adult volunteers, randomly assigned to a "nitrate" group that will be given a nitrate patch, and a "placebo" group that will be given a placebo patch.
The following outcomes will be measured:
- MRI findings before and after the patch treatment
- Use of analgesics
- Subjective pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: nitrate patch, Device: MRI scanthe patients that will get a nitrate patch |
| control group | Placebo comparator | Drug: placebo patch, Device: MRI scanthe patients that will get the placebo patch |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients (18-80 y.o)
- diagnosis of AVN according to MRI
Key exclusion criteria (4 listed)
- Terminal illness
- Cognitive impairment / any condition disturbing informed concent.
- Nitrate intolerance
- Patients using Cyclic GMP inhibitiors
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 |
|---|---|---|
| nitrate patchpatients in the study group will get a nitrate patch | Drug | study group |
| placebo patchAlso: placebocontrol group patients will get a placebo patch | Drug | control group |
| MRI scanAlso: MRIMRI scan after 6 weeks of treatment | Device | control group, study group |
Primary outcome
Reduction in bone substrate edema
Time frame: 6 weeks
the area and percent of the knee which the edema involves
3 secondary outcomes
other MRI changes
Time frame: 6 weeks
analgesics use
Time frame: 6 weeks
pain severity
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Failure to recruit patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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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.
avi livneh principal investigator
Sheba Medical Center
arik asman, MD study director
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nitrate patch and MRI scan in people with Necrosis, Avascular, of Bone, run by Sheba 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 4 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 2 Apr 2024. 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.
Are results available for this study?
The study was stopped early (reason given: Failure to recruit patients). 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?
Reduction in bone substrate edema (time frame: 6 weeks). 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 2 Apr 2024.